Loteprednol Etabonate

Class: Corticosteroids
VA Class: OP300
Chemical Name: 17-(ethyl carbonate) chloromethyl 11β,17-dihydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate
Molecular Formula: C₂₄H₃₁ClO₇
CAS Number: 82034-46-6
Brands: Alrex, Lotemax, Zylet

Introduction

Synthetic nonfluorinated corticosteroid.^{1 2 3 4 5 6 7 8 9 10 11 16 17}

Uses for Loteprednol Etabonate

Allergic Conjunctivitis

Symptomatic relief of seasonal allergic (hay fever, pollinosis) conjunctivitis.^{1 2 10 12 17 19}

Inflammatory Ocular Disorders

Symptomatic relief of corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (i.e., allergic conjunctivitis, acne rosacea keratitis, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis.^{1 8 9 10 11 17} Use in conjunction with appropriate anti-infective therapy in some cases of conjunctival infection, when the benefits of reducing edema and inflammation outweigh the risks associated with use of topical corticosteroids.¹

Loteprednol etabonate 0.5% less effective than prednisolone acetate 1% in the management of anterior uveitis.^{1 29}

Postoperative Ocular Inflammation

Treatment of postoperative ocular inflammation following ocular surgery.^{1 27 28}

Bacterial Ophthalmic Infections

Used in fixed combination with tobramycin in certain bacterial ocular infections.³¹

Loteprednol Etabonate Dosage and Administration

General

• 
  

  For seasonal allergic rhinitis, do not use for >2 weeks.²⁶

  
  


• 
  

  For inflammatory ocular disorders, do not discontinue therapy prematurely.¹

  
  


• 
  

  When used in fixed combination with tobramycin, do not discontinue prematurely.³¹

  
  


• 
  

  Reevaluate patient if ocular signs and symptoms fail to improve after 2 days of therapy.^{1 2 26 31}

  
  


• 
  

  Monitor intraocular pressure (IOP) in patients receiving therapy for ≥10 days.^{1 2 31}

  
  

Administration

Ophthalmic Administration

Apply topically to the eyes as an ophthalmic suspension.^{1 2 8 9 10 11 12}

In fixed combination with tobramycin, apply topically to the eyes as an ophthalmic suspension.³¹

Shake suspension vigorously prior to use.^{1 2 30 31}

Avoid contamination of the dropper tip.^{1 2}

Dosage

Available as loteprednol etabonate; dosage expressed in terms of the salt.^{1 2}

Adults

Seasonal Allergic Conjunctivitis

Ophthalmic

1 drop of a 0.2% suspension in the affected eye(s) 4 times daily.²

Inflammatory Ocular Disorders

Ophthalmic

1 or 2 drops of a 0.5% suspension in the affected eye(s) 4 times daily.^{1 8 9 10 11} During initial treatment (within the first week), may increase dosage up to 1 drop every hour.¹ When improvement occurs, decrease frequency of application.^{1 26 30}

Postoperative Ocular Inflammation

Ophthalmic

1 or 2 drops of a 0.5% suspension to the eye(s) undergoing surgery 4 times daily beginning 24 hours after surgery and continuing for 2 weeks after surgery.^{1 27 28}

Bacterial Ophthalmic Infections

Ophthalmic

Loteprednol etabonate and tobramycin ophthalmic suspension: 1 or 2 drops in the affected eye(s) every 4–6 hours.³¹ During the initial 24–48 hours, dosing may be increased to every 1–2 hours.³¹ When improvement occurs, decrease frequency of application.³¹

Cautions for Loteprednol Etabonate

Contraindications

• 
  

  Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella), mycobacterial infection of the eye, and fungal diseases of ocular structures.^{1 2 31}

  
  


• 
  

  Known hypersensitivity to loteprednol, other corticosteroids, or any ingredient in the formulations.^{1 2 31}

  
  

Warnings/Precautions

Warnings

Ocular Effects

Risk of glaucoma (with damage to optic nerve), defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.^{1 2 31} Use with caution in the presence of glaucoma.^{1 2 31} Marked elevation in IOP (≥10 mm Hg) reported with loteprednol use; incidence lower than that reported with prednisolone acetate.^{1 2 31}

In conditions causing thinning of the cornea or sclera, perforations reported with use of topical corticosteroids.^{1 2 31}

Corticosteroid use after cataract surgery may delay healing and increase incidence of bleb formation.^{1 2 31}

Immunosuppressive Effects

Risk of secondary ocular infection with prolonged use of corticosteroids.^{1 2 31}

In acute purulent ocular conditions, corticosteroids may mask infection or exacerbate existing infection.^{1 2 31}

Risk of prolongation or exacerbation of ocular viral infections (e.g., herpes simplex) with ophthalmic corticosteroids.^{1 2 31} Use with extreme caution in patients with history of herpes simplex.^{1 2 31}

General Precautions

Use of Fixed Combination

Observe the usual precautions associated with tobramycin therapy when loteprednol is used in fixed combination with tobramycin.³¹

Evaluation of Ocular Condition

Initial prescription or renewal of medication order beyond 14 days should be provided only after examination of the patient with the aid of magnification (e.g., slit lamp biomicroscopy, fluorescein staining where appropriate).^{1 2 31}

Fungal Infections

Long-term local corticosteroid application associated with development of fungal infections of the cornea.^{1 2 31} Consider fungus invasion in patients with persistent corneal ulceration who have or are receiving corticosteroid therapy; obtain fungal cultures when appropriate.^{1 2 31}

Specific Populations

Pregnancy

Category C.^{1 2 31}

Lactation

Not known whether distributed into human milk following topical application to the eye.^{1 2 31} Systemic corticosteroids distributed into human milk and may suppress growth, interfere with endogenous corticosteroid production, and cause other adverse effects.^{1 2 31} Use with caution.^{1 2 31}

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 2 26 31}

Common Adverse Effects

Abnormal/blurred vision, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, photophobia.^{1 2}

Adverse systemic events include headache, rhinitis, and pharyngitis.^{1 2}

Loteprednol Etabonate Pharmacokinetics

Absorption

Bioavailability

Limited systemic exposure following topical application to the eye; plasma concentrations usually are undetectable.¹

Onset

In clinical studies in patients with seasonal allergic conjunctivitis, improvement in ocular itching and bulbar conjunctival injection occurred within 2 hours following initiation of therapy.^{2 12 17 19}

In clinical studies in patients with contact lens-associated giant papillary conjunctivitis, improvement in papillae, conjunctival injection and itching, and lens intolerance was evident within 1 week of therapy.^{1 8 9 11 17}

Duration

In patients with seasonal allergic conjunctivitis, improvement in ocular itching and bulbar conjunctival injection persisted through day 14 of therapy.²

In patients with contact lens-associated giant papillary conjunctivitis, improvement in papillae, conjunctival injection and itching, and lens intolerance persisted for up to 6 weeks while therapy was continued.^{1 8 9 11 17}

Elimination

Metabolism

Undergoes extensive metabolism to inactive carboxylic acid metabolites.^{1 2}

Stability

Storage

Ophthalmic

Suspension

Upright at 15–25°C.^{1 2 31} Do not freeze.^{1 2 31}

ActionsActions

• 
  

  Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.^{1 2 31}

  
  


• 
  

  Corticosteroids may induce phospholipase A2 inhibitory proteins; these proteins may inhibit release of arachidonic acid and, thus, control biosynthesis of potent mediators of inflammation (e.g., prostaglandins, leukotrienes).^{1 2 31}

  
  

Advice to Patients

• 
  

  Importance of learning and adhering to proper administration techniques to avoid contamination of the tip of the suspension container.^{1 2 31}

  
  


• 
  

  Consult a clinician if pain, redness, itching, or inflammation worsens.^{1 2 31}

  
  


• 
  

  Importance of not wearing soft contact lenses during treatment with Lotemax or Zylet (benzalkonium chloride preservative may be absorbed by the lenses).^{1 31}

  
  


• 
  

  Importance of removing soft contact lenses prior to administration of each dose of Alrex.² Delay reinsertion for 10 minutes after administration if eyes are not red; do not wear contact lenses if eye(s) are red.² Not indicated for contact lens-related irritation.²

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{1 2 31}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{1 2 31} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Loteprednol Etabonate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Suspension	0.2%	Alrex (with benzalkonium chloride and povidone)	Bausch & Lomb
		0.5%	Lotemax (with benzalkonium chloride and povidone)	Bausch & Lomb

Loteprednol Etabonate Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Suspension	0.5% with Tobramycin 0.3%	Zylet (with benzalkonium chloride and povidone)	Bausch & Lomb

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Bausch & Lomb Pharmaceuticals, Inc. Lotemax (loteprednol etabonate) ophthalmic suspension 0.5% prescribing information. Tampa, FL; 2005 May.

2. Bausch & Lomb Pharmaceuticals, Inc. Alrex (loteprednol etabonate) ophthalmic suspension 0.2% prescribing information. Tampa, FL; 1998 Mar.

3. Hochhaus G, Chen LS, Ratka A et al. Pharmacokinetic characterization and tissue distribution of the new glucocorticoid soft drug loteprednol etabonate in rats and dogs. J Pharm Sci. 1992; 81:1210-15. [PubMed 1491342]

4. Loftsson T, Bodor N. The pharmacokinetics and transdermal delivery of loteprednol etabonate and related soft steroids. Adv Drug Delivery Rev. 1994; 14:293-9.

5. Bodor N, Wu WM, Murakami T et al. Soft drugs 19. Pharmacokinetics, metabolism and excretion of a novel soft corticosteroid, loteprednol etabonate, in rats. Pharm Res. 1995; 12:875-9. [PubMed 7667193]

6. Druzgala P, Wu WM, Bodor N. Ocular absorption and distribution of loteprednol etabonate, a soft steroid, in rabbit eyes. Curr Eye Res. 1991; 10:933-7. [PubMed 1959381]

7. Anon. Corticosteroids. In: Zimmerman TJ, Kooner KS, Sharir M et al, eds. Textbook of ocular pharmacology. Philadelphia: Lippincott-Raven; 1997:620-6.

8. Asbell P, Howes J. A double-masked, placebo-controlled evaluation of the efficacy and safety of loteprednol etabonate in the treatment of giant papillary conjunctivitis. CLAO J. 1997; 23:31-6. [PubMed 9001768]

9. Friedlaender MH, Howes J for the Loteprednol etabonate Giant Papillary Conjunctivitis Study Group I. A double-masked, placebo-controlled evaluation of the efficacy and safety of loteprednol etabonate in the treatment of giant papillary conjunctivitis. Am J Ophthalmol. 1997; 123:455-64. [IDIS 383467] [PubMed 9124242]

10. Dell SJ, Shulman DG, Lowry GM et al, for the Loteprednol Allergic Conjunctivitis Study Group. Am J Ophthalmol. 1997; 123:791-7. (IDIS 387183)

11. Bartlett JD, Howes JF, Ghormley NR et al. Safety and efficacy of loteprednol etabonate for treatment of papillae in contact lens-associated giant papillary conjunctivitis. Curr Eye Res. 1993; 12:313-21. [PubMed 8319490]

12. Dell SJ, Lowry GM, Northcutt JA et al. A randomized, double-masked, placebo-controlled parallel study of a 0.2% loteprednol etabonate in patients with seasonal allergic conjunctivitis. J Allergy Clin Immunol. 1998; 102: 251-5. [IDIS 412946] [PubMed 9723669]

13. Novack GD, Howes J, Crockett RS et al. Changes in intraocular pressure during long-term use of loteprednol etabonate. J Glaucoma. 1998; 7: 266-9. [PubMed 9713785]

14. Bodor N, Bodor N, Wu WM. A comparison of intraocular pressure elevating activity of loteprednol etabonate and dexamethasone in rabbits. Curr Eye Res. 1992; 11:525-30. [PubMed 1505197]

15. Bartlett JD, Horwitz B, Laibovitz R et al. Intraocular pressure response to loteprednol etabonate in known steroid responders. J Ocul Pharmacol. 1993; 9:157-65. [PubMed 8345288]

16. Bodor N. Design of novel soft corticosteroids. Curr Probl Dermatol. 1993; 21:11-9. [PubMed 8299363]

17. Anon. Loteprednol etabonate. Drugs Future. 1997; 22:1086-90.

18. Howes JF, Baru H, Vered M et al. Loteprednol etabonate: comparison with other steroids in two models of intraocular inflammation. J Ocul Pharmacol. 1994; 10:289-93. [PubMed 8207332]

19. Schulman DG, Lothringer LL, Rubin JM et al. A randomized, double-masked, placebo controlled , parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis. Ophthalmology. 1999; 106:362-9. [IDIS 422861] [PubMed 9951491]

20. Ciprandi G, Buscaglia S, Cerqueti PM et al. Drug treatment of allergic conjunctivitis: a review of the evidence. Drugs. 1992; 43:154-76. [IDIS 360840] [PubMed 1372215]

21. Friedlaender MH. Current concepts in ocular allergy. Ann Allergy. 1991; 67:5-10,13. [IDIS 312766] [PubMed 1859041]

22. Trocme SD. Medical therapy for ocular allergy. Mayo Clin Proc. 1992; 67:557-65. [IDIS 296611] [PubMed 1359206]

23. 137. Reviewers’ comments (personal observation) Reviewers’ comments (personal observation) ketorolac tromethamine ophthalmic solution.

24. Tinkelman DG, Rupp G, Kaufman H et al. Double-masked, paired-comparison clinical study of ketorolac tromethamine 0.5% ophthalmic solution compared with placebo eyedrops in the treatment of seasonal allergic conjunctivitis. Surv Ophthalmol. 1993; 38(Suppl): 133-140. [PubMed 8236004]

25. Ballas Z, Blumenthal M, Tinkeman DG et al. Clinical evaluation of ketorolac tromethamine 0.5% ophthalmic solution for the treatment of seasonal allergic conjunctivitis. Surv Ophthalmol. 1993; 38(Suppl): 141-8.

26. Reviewers’ comments (personal observations).

27. The Loteprednol Etabonate Postoperative Inflammation Study Group 2. A double-masked, placebo-controlled evaluation of 0.5% loteprednol etabonate in the treatment of postoperative inflammation. Ophthalmology. 1998; 105:1780-6. [IDIS 413091] [PubMed 9754192]

28. Stewart R, Horwitz B, Howes J et al. Double-masked, placebo-controlled evaluation of loteprednol etabonate 0.5% for postoperative inflammation. Loteprednol Etabonate Post-operative Inflammation Study Group 1. J Cataract Refract Surg. 1998; 24:1480-9. [PubMed 9818338]

29. Loteprednol Etabonate US Uveitis Study Group. Controlled evaluation of loteprednol etabonate and prednisolone acetate in the treatment of acute anterior uveitis. Am J Ophthalmol. 1999; 127:537-44. [IDIS 428957] [PubMed 10334346]

30. Bausch & Lomb, Tampa, FL: Personal communication.

31. Bausch & Lomb Pharmaceuticals, Inc. Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%) ophthalmic suspension prescribing information. Tampa, FL; 2004 Dec.

More Loteprednol Etabonate resources

• Loteprednol Etabonate Side Effects (in more detail)
• Loteprednol Etabonate Dosage
• Loteprednol Etabonate Use in Pregnancy & Breastfeeding
• Loteprednol Etabonate Drug Interactions
• Loteprednol Etabonate Support Group
• 0 Reviews for Loteprednol Etabonate - Add your own review/rating

Compare Loteprednol Etabonate with other medications

• Conjunctivitis
• Cyclitis
• Iritis
• Keratitis
• Postoperative Ocular Inflammation
• Rosacea
• Seasonal Allergic Conjunctivitis

Effico Tonic

EFFICO TONIC ORAL SOLUTION

Read all of this label carefully because it because it contains important information for you.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do no improve.

If you notice any side effects please tell your doctor or pharmacist.

In this label:

1. What is Effico Tonic and what is it used for?

2. Before you take Effico Tonic

3. How to take Effico Tonic

4. Possible Side Effects

5. How to Store Effico Tonic

6. Further Information

What Is Effico Tonic And What Is It Used For?

Effico Tonic is a vitamin tonic and appetite promoter which helps to combat the tiredness and listlessness that can follow a weakening illness or hospitalisation, thus aiding recovery.

Effico Tonic contains two ‘B’ vitamins; Thiamine (B1) and Nicotinamide.

Deficiency of these vitamins can cause fatigue, lethargy and loss of appetite.

Effico Tonic also contains caffeine, which acts as a gentle stimulant to combat tiredness.

Before You Take Effico Tonic

Do not take Effico Tonic if:

You are allergic (hypersensitive) to any of the ingredients (see section 6).

You are pregnant or breast-feeding.

Talk to your doctor or pharmacist before taking Effico Tonic if:

You have been told by your doctor that you have an intolerance to some sugars. Effico Tonic contains 2g sucrose (sugar) per 5ml dose.

You have been told by your doctor that you should avoid alcohol. Effico Tonic contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.

Using other medicines

You can take Effico Tonic whilst taking other medicines.

How To Take Effico Tonic

Adults and the Elderly:

10ml (two 5ml spoonfuls)

immediately before meals, three times a day.

Children (over 6 years):

2.5 to 5ml (half to one 5ml spoonful) taken as for adults.

May be diluted with water if desired.

If you take more Effico Tonic than you should

An overdose is unlikely to do any harm but speak to your doctor or pharmacist if you take too much.

If you miss a dose of Effico Tonic

Do not worry if you miss a dose of Effico Tonic. Just take your next dose at the usual time.

Effico Tonic Side Effects

Normally there are no side effects associated with the use of Effico Tonic.

However, if you think that Effico Tonic is causing you any problems, please contact your doctor or pharmacist.

How To Store Effico Tonic

Keep out of the reach and sight of children.

Do not use Effico Tonic after the expiry date on the front label. The expiry date refers to the last day of that month.

Do not store above 25°C. Protect from sunlight.

Further Information

Effico tonic is available in 300ml and 500ml in plastic and glass bottles. Not all packaging types are marketed.

Ingredients

Active ingredients in 5ml:

Vitamin B₁ (Thiamine Hydrochloride), Nicotinamide, Caffeine.

Other ingredients:
ethanol 96%,sodium benzoate (E211), citric acid (E330), concentrated hydrochloric acid (E507), sucrose, compound gentian infusion, H&R summer fruit flavour 288234, purified water.

Marketing Authorisation Holder

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent

DA2 6SL

Manufacturer and site of batch release

William Ransom & Son plc

Witham

Essex

CM8 3AG

UK

PL0108/5013R

This leaflet was last approved:

March 2009

Other formats:

To listen to or to request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product Name Effico Tonic

Reference Number 0108/5013R

This is a service provided by the Royal National Institute for Blind People.

Avail

Pronunciation: VYE-ta-mins/KAL-see-um
Generic Name: Multiple Vitamins with Calcium
Brand Name: Examples include Avail and One-A-Day Within

Avail is used for:

Supplementing the diet with vitamins, minerals, and calcium.

Avail is a multivitamin and mineral combination. It increases the amount of calcium and vitamins in the body.

Do NOT use Avail if:

• you are allergic to any ingredient in Avail


• you have high levels of calcium in the blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Avail:

Some medical conditions may interact with Avail. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are dehydrated, have kidney stones, kidney problems, have unusual growths or tumors, or have excess calcium in your urine

Some MEDICINES MAY INTERACT with Avail. However, no specific interactions with Avail are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Avail may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Avail:

Use Avail as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Avail may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Avail, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Avail.

Important safety information:

• Avail contains iron. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. In case of accidental overdose, call a doctor or poison control center immediately.


• Do not take large doses of vitamins (megadoses or megavitamin therapy) unless directed to by your doctor.


• Avail may cause false test results with kits used to check for blood in the stool. Check with your doctor if you are taking Avail when using the test kit.


• Diabetes patients - Avail may cause incorrect test results with some urine glucose tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.


• Use Avail with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Avail, discuss with your doctor the benefits and risks of using Avail during pregnancy. If you are or will be breast-feeding while you are using Avail, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Avail:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the proper use of Avail. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Avail:

Store Avail at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Avail out of the reach of children and away from pets.

General information:

• If you have any questions about Avail, please talk with your doctor, pharmacist, or other health care provider.


• Avail is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Avail. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Avail resources

• Avail Use in Pregnancy & Breastfeeding
• Avail Drug Interactions
• Avail Support Group
• 4 Reviews for Avail - Add your own review/rating

Compare Avail with other medications

• Vitamin/Mineral Supplementation and Deficiency

Isodermal

Isodermal may be available in the countries listed below.

Ingredient matches for Isodermal

Isotretinoin

Isotretinoin is reported as an ingredient of Isodermal in the following countries:

• Greece

International Drug Name Search

Mixtard 30 InnoLet 100 IU / ml suspension for injection in a pre-filled pen

Mixtard 30 InnoLet

100 IU/ml suspension for injection in a pre-filled pen

Insulin human (rDNA)

Read all of this leaflet carefully before you start using your insulin.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor, diabetes nurse or your pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.

This side of the leaflet:

• 
  1. What Mixtard is and what it is used for
  


• 
  2. Before you use Mixtard
  


• 
  3. How to use Mixtard
  


• 
  4. What to do in an emergency
  


• 
  5. Possible side effects
  


• 
  6. How to store Mixtard
  


• 
  7. Further information
  

Overleaf: How to use your InnoLet

What Mixtard

is and what it is used for

Mixtard is human insulin to treat diabetes. Mixtard is a mixture of fast-acting insulin and long-acting insulin. This means that it will start to lower your blood sugar about half an hour after you take it, and the effect will last for approximately 24 hours.

Before you use Mixtard

Do not use Mixtard

• 
  If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information). Look out for the signs of allergy in 5 Possible side effects


• 
  If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar). See 4 What to do in an emergency for more about hypos.

Take special care with Mixtard

• 
  If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands


• 
  If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach


• 
  If you are exercising more than usual or if you want to change your usual diet


• 
  If you are ill: carry on taking your insulin


• 
  If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.

Using other medicines

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.

Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide or lanreotide.

Pregnancy and breastfeeding

If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.

Driving and using machines

If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

How to use Mixtard

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advice carefully. This leaflet is a general guide.

If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Eat a meal or snack containing carbohydrates within 30 minutes of the injection.

It is recommended that you measure your blood glucose regularly.

Injecting insulin

See overleaf for detailed instructions.

Before using Mixtard

• 
  Check the label to make sure it is the right type of insulin


• 
  Always use a new needle for each injection to prevent contamination.

Do not use Mixtard

• 
  In insulin infusion pumps
  


• 
  If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin


• 
  If it hasn’t been stored correctly or been frozen (see 6 How to store Mixtard)


• 
  If it’s not uniformly white and cloudy when it’s resuspended.

Mixtard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. Your insulin will work more quickly if you inject it around the waist.

What to do in an emergency

If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away. They must not give you any food or drink as it could choke you.

• 
  If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death


• 
  If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

• If you take too much insulin


• If you eat too little or miss a meal


• If you exercise more than usual.

If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.

If you get any of these signs, test your blood sugar level and test your urine for ketones if you can. Then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of hyperglycaemia

• Having forgotten to take your insulin


• Repeatedly taking less insulin than you need


• An infection or a fever


• Eating more than usual


• Less exercise than usual.

Possible side effects

Like all medicines, Mixtard can cause side effects, although not everybody gets them. Mixtard may cause hypoglycaemia (low blood sugar). See the advice in 4 What to do in an emergency.

Side effects reported uncommonly

(in less than 1 patient in 100)

Changes at the injection site (Lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.

Seek medical advice immediately:

• if signs of allergy spread to other parts of the body, or


• if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting.

You may have a very rare serious allergic reaction to Mixtard or one of its ingredients (called a systemic allergic reaction). See also warning in 2 Before you use Mixtard.

Diabetic retinopathy (eye background changes). If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon disappears.

Painful neuropathy (nerve related pain). If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.

Side effects reported very rarely

(in less than 1 patient in 10,000)

Vision problems. When you first start your treatment, it may disturb your vision, but the reaction usually disappears.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.

How to store Mixtard

Keep out of the reach and sight of children.

Do not use Mixtard after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

The InnoLet
that is not being used is to be stored in a refrigerator (2°C - 8°C).

Do not store them in or too near the freezer section or cooling element.

Do not freeze.

The InnoLet that is being used, about to be used or carried as a spare is not to be kept in a refrigerator. After removing the InnoLet from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use. See 3 How to use Mixtard. You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks. Always keep the pen cap on your InnoLet when you’re not using it in order to protect it from light. Mixtard must be protected from
excessive heat and sunlight.

Mixtard should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Mixtard 30 contains

• 
  The active substance is insulin human made by recombinant biotechnology (30% as soluble insulin and 70% as isophane insulin). 1 ml contains 100 IU of insulin human. 1 pre-filled pen contains 3 ml equivalent to 300 IU


• 
  The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.

What Mixtard looks like and contents of the pack

The suspension for injection comes as a cloudy, white, aqueous suspension.

It is supplied in packs of 1, 5 or 10 pre-filled pens of 3 ml. Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

Now turn over for information on how to use your InnoLet.

This leaflet was last approved in 09/2007

Mixtard
, InnoLet
and NovoFine
S
are trademarks owned by Novo Nordisk A/S, Denmark

© 2000/2007

Novo Nordisk A/S

Information on how to use Mixtard

30 InnoLet

Please read the following instructions carefully before using your Mixtard
30 InnoLet
.

Introduction

Mixtard 30 InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit. Mixtard 30 InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length. Look for an S on the needle box. The S stands for short cap.

As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.

Preparing for injection

Check the label to make sure that your Mixtard 30 InnoLet contains the correct type of insulin. Take off the pen cap (as shown by the arrow).

Resuspending is easier when the insulin has reached room temperature.

Suspending the insulin

Before every injection:

• 
  Check there are at least 12 units of insulin left in the cartridge to allow even resuspending. If there are less than 12 units left, use a new Mixtard 30 InnoLet


• 
  Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times. Repeat this movement at least 10 times before each injection. The movement must always be repeated until the liquid appears uniformly white and cloudy


• 
  After resuspending, complete all of the following stages of injection without delay.
  

Attaching the needle

• 
  Disinfect the rubber membrane with a medicinal swab


• 
  Always use a new needle for each injection to prevent contamination


• 
  Remove the protective tab from a NovoFine S needle


• 
  Screw the needle straight and tightly onto Mixtard 30 InnoLet (picture 1B)


• 
  Pull off the big outer needle cap and the inner needle cap. You may want to store the big outer needle cap in the compartment.

Priming to expel air

Small amounts of air may collect in the needle and cartridge during normal use.

To avoid injection of air and ensure proper dosing:

• 
  Dial 2 units by turning the dose selector clockwise


• 
  Hold Mixtard 30 InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (picture 1C).


• 
  Keeping the needle upwards, press the push-button and the dose selector returns to zero


• 
  A drop of insulin must appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

If a drop of insulin still does not appear, the device is defective and must not be used.

Setting the dose

• 
  Always check that the push-button is fully depressed and the dose selector is set at zero
  


• 
  Dial the number of units required by turning the dose selector clockwise (picture 2). Do not use the residual scale to measure your dose of insulin


• 
  You will hear a click for every single unit dialled. The dose can be corrected by turning the dial either way.

You cannot set a dose larger than the number of units left in the cartridge.

Injecting the insulin

• 
  Insert the needle into your skin. Use the injection technique advised by your doctor


• 
  Deliver the dose by pressing the push-button fully down (picture 3). You will hear clicks as the dose selector returns to zero


• 
  After the injection, the needle must remain under the skin for at least 6 seconds to ensure that the full dose has been delivered


• 
  Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to zero when you press the push-button


• 
  Remove the needle after each injection.
  

Removing the needle

• 
  Replace the big outer needle cap and unscrew the needle (picture 4). Dispose of it carefully.

Use a new needle for each injection.

Remove the needle after each injection and store InnoLet without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate
dosing.

Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.

Dispose of your used Mixtard 30 InnoLet carefully without the needle attached.

Maintenance

Your Mixtard 30 InnoLet is designed to work accurately and safely. It must be handled with care.

Do not refill Mixtard 30 InnoLet.

You can clean your Mixtard 30 InnoLet by wiping it with a medicinal swab. Do not soak it, wash or lubricate it. This may damage the mechanism.

8-9603-01-002-3

Inexium EuropharmaDK

Inexium EuropharmaDK may be available in the countries listed below.

Ingredient matches for Inexium EuropharmaDK

Esomeprazole

Esomeprazole magnesium, trihydrate (a derivative of Esomeprazole) is reported as an ingredient of Inexium EuropharmaDK in the following countries:

• Denmark

International Drug Name Search

Guna-Ischial

Dosage Form: injection, solution
GUNA®-ISCHIAL (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Sciatica pain

1.2.    Lumbar-sciatic pain (use with GUNA®-LUMBAR)

1.3.    Nerve pain in the lower lumbar spine

1.4.    Leg nerve pain due to post-surgery treatment of disc herniation L4-L5, L5-S1

1.5.    Mortons neuroma. The simultaneous administration of GUNA®- NEURAL gives wider therapeutic coverage

2. DOSAGE AND ADMINISTRATION

2.1.    Standard protocol for IM administration: 1 vial 1-3 times a week according to severity and clinical response.

2.2.    Standard protocol according to mesotherapy technique: 1 vial per treatment: 2 treatments for the first 2 weeks, 1 treatment a week till pain relief (average 8-10 sessions). For chronic pathologies: continue 1 treatment a week for 1 month till pain relief, then 1 treatment a month.

Select application site according to trigger points, tender points, referred pain zones, acupuncture points, key nerve points or “local pain points”. Using a 13 mm, 30G or a 4 mm, 27G needle, make the classic intradermal injection according to mesotherapyic technique.

Discard unused solution.

2.3.    Opening of Vials: Use sterile needles and sterile syringe. Do not reuse. Do not use if foreign particles are present. Draw 1 cc of air into syringe, insert needle into vial inject air and withdraw the solution.

3. DOSAGE FORMS AND STRENGTHS

3.1.    2 ml glass vials

Each ingredient is attenuated according to the procedures stated in the Homeopathic Pharmacopeia of the United States.

Active ingredients: Aconitum napellus 8X, Anti interleukin 1 alpha 4C, Anti interleukin 1 beta 4C, Arsenicum album 6X, Beta-Endorphin 4C, Cimicifuga racemosa 4X, Gnaphalium  polycephalum 4X, Lachesis mutus 8X, Rhododendron chrysanthum 6X, Rhus toxicodendron 4X.

Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to GUNA®-ISCHIAL. However patients with a known hypersensitivity to any ingredient should be tested before  use. Make a spot injection (0.1ml) into the forearm and observe for any reactions for 1 hour.

5. WARNINGS AND PRECAUTIONS

5.1.    Sciatic pain requires differential diagnosis for disc injuries, herniated disk, primary or secondary cancer pain; classification according to simple spinal pain, projected and referred pain from internal organs.

5.2.    Skin cleansing/disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation.

6. ADVERSE REACTIONS

6.1.    The most common mild adverse reaction is slight reddening at the injection site due to the mechanical effect of the needle or a superficial skin reaction of mild erythema.

7. DRUG INTERACTIONS

7.1.    None Known.

8. USE IN SPECIFIC POPULATIONS

8.1    Pregnancy:  Pregnancy  category  C.  Animal  reproduction  studies  have  not  been conducted  with  GUNA®-ISCHIAL.  GUNA®- ISCHIAL should  not  be  given  to  a pregnant woman. 

8.2    Nursing mothers:    It is not known whether any of the ingredients in GUNA®- ISCHIAL  are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when GUNA®- ISCHIAL is administered to a nursing woman.

8.3    Pediatric use: No restrictions.

8.4    Geriatric use: No restrictions

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known.

10. OVERDOSAGE

10.1.    No Known.

11. DESCRIPTION

11.1.    GUNA®-ISCHIAL is a sterile solution made with isotonic sodium chloride solution.

It is a homeopathic complex medicine, whose active ingredients have been selected in order to promote 2 main activities:

•    Detoxification of the connective tissue matrix

•    Pain modulation through stimulation of the physiological mechanism of pain control.

Attenuation of the biological substrates acts to target the area of activity of the product

12. CLINICAL PHARMACOLOGY

12.1.    Mechanism of Action

Due to the homeopathic nature of the active ingredients, receptors may be activated by feedback regulation. Beta-endorphins at the 4C dose activate the membrane receptors for endogenous endorphins that play a key role in pain relief. Anti IL-1 induces a download regulation of IL-1 inflammatory activity.

12.2.    Pharmacodynamics

The physiological effects of GUNA®-ISCHIAL are due to the action of the ingredients, as described in the Homeopathic Materia Medica.

In Homeopathy there is no direct relationship between dose and effect, but rather there is a relationship between attenuation and balancing effect on biochemical pathways.

In GUNA®-ISCHIAL the attenuation of each ingredient has been selected according to the Arndt-Schulz Principle (inverted effect law). Attenuation of the physiological ingredients promotes membrane receptor feedback in order to normalize altered biological pathways. In Addition the attenuation technique activates the low dilutions and stabilizes clinical activity of the compound.

12.3.    Pharmacokinetics

Homeopathic attenuation provides complete bioavailability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

13.1.    GUNA®-ISCHIAL has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1.    GUNA®-ISCHIAL formulation is based on classical Homeopathy and each ingredient has been selected according to its description in the Homeopathic Materia Medica. The product is intended for application to target points such as acupuncture points, Weihe points, and key neurological points.

  Clinical indications of the key ingredients:

Anti interleukin 1 alpha 4C / Anti interleukin 1 beta 4C:

•    Biological classification: Interleukin 1 receptor antagonist (IL-1ra) belongs to the IL-1 family. Endogenous IL-1ra is produced in human autoimmune and chronic inflammatory diseases.

•    Etiopathogenesis: It binds to IL-1 receptors in competition with IL-1, but does not elicit intracellular response from this binding. Its key role  is counteracting the proinflammatory effects of IL-1.

•    Space-time localization: next to Arnica.  Reference group: Arnica-Mercurius.

•    Clinical: Immunological based diseases, autoimmune and chronic inflammatory diseases, acute and chronic pain, osteoarthritis, chronic arthritis, inflammatory psoriasis, wet eczema, localized inflammatory swelling.  Appropriate for local application.

•    Modalities: Worsens with cold and   movement. Improves with rest and warmth.

•    Association with other cell mediators: TNF 15C / IL8 4C /

NT4 4C / GCSF 4C.

 Beta-Endorphin 4C:

•    Biological classification: Neuropeptide  and neurotransmitter. It is produced by the  anterior lobe of the hypophysis  and by the hypothalamus.

•    Etiopathogenesis: It acts on the mechanism that enhances pain. It suppresses the memory of painful events and negative experiences.

•    Space-time localization: next to Arnica.

 Reference group: Mercurius.

•    Clinical: Pain management by enhancing the immune response. It acts on modulating pain, cardiac, gastric and vascular function as well as panic syndrome and satiation. Organic and functional pain. Remedy for somatization disorders. It enhances acupuncture sessions. Antidepressive activity. It may improve individual positive attitudes.

14.2.    Modalities: It worsens with fatigue and intensive exercise.

•    Association with other cell mediators: Sepia / Arnica / Aconitum / Bromum / Aurum / Iodium / IL-6 4C / Melatonin 15C, 30C, 12LM, 18LM, 30LM / NT4 4C / BDNF 4C.

15. REFERENCES

15.1.    I. Bianchi: Citochine e Interferoni. Farmacologia e Clinica. Nuova IPSA Editore.

15.2.    L. Milani: Weihe e altri Punti tra Agopuntura e Omeopatia. Guna Editore.

15.3.    J. Malzac: Materia Medica Immunologia. IPSA Editore.

15.4.    H.H.Reckeweg: Homeopathic Materia Medica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC  17089-277-31  10 glass vials packed in carton box

16.2.    NDC  17089-277-32   50 glass vials packed in carton box

16.3.    Store at room temperature, 20-25°C (68-77° F). Avoid  freezing  and  excessive  heat.

17. PATIENT COUNSELING INFORMATION

17.1.    Patients should be informed about Homeopathy and Acupuncture and the main differences with conventional clinical approaches.

PACKAGE LABEL

Guna-Ischial  aconitum napellus - arsenic trioxide - black cohosh - canakinumab - lachesis muta venom - metenkefalin - pseudognaphalium obtusifolium - rhododendron aureum leaf - toxicodendron pubescens leaf - anti-interleukin-1.alpha. immunoglobulin g rabbit -   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17089-277 Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 8 [hp_X]  in 2 mL ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT) ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT 4 [hp_C]  in 2 mL CANAKINUMAB (CANAKINUMAB) CANAKINUMAB 4 [hp_C]  in 2 mL ARSENIC TRIOXIDE (ARSENIC TRIOXIDE) ARSENIC TRIOXIDE 6 [hp_X]  in 2 mL METENKEFALIN (METENKEFALIN) METENKEFALIN 4 [hp_C]  in 2 mL BLACK COHOSH (BLACK COHOSH) BLACK COHOSH 4 [hp_X]  in 2 mL PSEUDOGNAPHALIUM OBTUSIFOLIUM (PSEUDOGNAPHALIUM OBTUSIFOLIUM) PSEUDOGNAPHALIUM OBTUSIFOLIUM 4 [hp_X]  in 2 mL LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 8 [hp_X]  in 2 mL RHODODENDRON AUREUM LEAF (RHODODENDRON AUREUM LEAF) RHODODENDRON AUREUM LEAF 6 [hp_X]  in 2 mL TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 4 [hp_X]  in 2 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.018 mL  in 2 mL WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17089-277-31 10 VIAL In 1 BOX contains a VIAL, GLASS 1 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-277-31) 2 17089-277-32 50 VIAL In 1 BOX contains a VIAL, GLASS 2 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-277-32)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/29/2006

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Operations
Guna spa		430538264	manufacture

Revised: 06/2010Guna spa