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1. Name Of The Medicinal Product

Erbitux 5 mg/ml solution for infusion

2. Qualitative And Quantitative Composition

Each ml of solution for infusion contains 5 mg cetuximab.

Each vial of 10 ml contains 50 mg cetuximab.

Each vial of 20 ml contains 100 mg cetuximab.

Each vial of 50 ml contains 250 mg cetuximab.

Each vial of 100 ml contains 500 mg cetuximab.

Cetuximab is a chimeric monoclonal IgG1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology.

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for infusion.

Colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer

in combination with irinotecan-based chemotherapy,

in first-line in combination with FOLFOX,

as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

For details, see section 5.1.

Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck

in combination with radiation therapy for locally advanced disease,

in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

4.2 Posology And Method Of Administration

Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Close monitoring i

1. Name Of The Medicinal Product

Edrophonium Injection BP 10mg/1ml.

2. Qualitative And Quantitative Composition

Each ampoule contains 10mg Edrophonium Chloride BP in 1ml of solution.

3. Pharmaceutical Form

Ampoules

4. Clinical Particulars

4.1 Therapeutic Indications

Myasthenia gravis, as a diagnostic test; to distinguish between overdosage and underdosage of cholinergic drugs in myasthenic patients; diagnosis of suspected 'dual block'; antagonist to non-depolarising neuromuscular blockade.

4.2 Posology And Method Of Administration

Edrophonium Injection BP is for intramuscular or intravenous injection. In view of the possibility of provoking a cholinergic crisis it is recommended that facilities for resuscitation should be available whenever Edrophonium Injection BP is administered.

Adults - Test for myasthenia gravis:

A syringe is filled with the contents of 1 ampoule (10mg) and 2mg is given intravenously, the needle and syringe being left in situ. If no response occurs within 30 seconds, the remaining 8mg is injected. In adults with unsuitable veins, 10mg is given by intramuscular injection.

To differentiate between 'myasthenic' and 'cholinergic' crises:

In a myasthenic patient who is suffering from marked muscle weakness, in spite of taking large doses of Mestinon or Prostigmin, a test dose of 2mg Edrophonium Injection BP is given intravenously one hour after the last dose of the cholinergic compound. If therapy has been inadequate, there is a rapid, transient increase in muscle strength; if the patient has been overtreated, Edrophonium Injection BP causes a transient increase of muscle weakness.

Diagnosis of suspected 'dual block':

Edrophonium

1. Name Of The Medicinal Product

Elocon Cream

2. Qualitative And Quantitative Composition

Mometasone Furoate 0.1% w/w

Propylene glycol stearate 8.0% w/w

Stearyl alcohol 68.5-74.5 %w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

Elocon Cream is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.

4.2 Posology And Method Of Administration

Adults, including elderly patients and Children : A thin film of Elocon Cream should be applied to the affected areas of skin once daily.

Use of topical corticosteroids in children or on the face should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days.

4.3 Contraindications

Elocon is contraindicated in facial rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo), viral (e.g. herpes simplex, herpes zoster and chickenpox) and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions. Elocon should not be used in patients who are sensitive to mometasone furoate or to other corticosteroids.

4.4 Special Warnings And Precautions For Use

If irritation or sensitisation develop with the use of Elocon, treatment should be withdrawn and appropriate therapy instituted.

Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be

1. Name Of The Medicinal Product

Epaxal suspension for injection in a prefilled syringe

Hepatitis A vaccine (inactivated, virosome).

2. Qualitative And Quantitative Composition

1 vaccine dose (0.5 ml) contains at least 24 IU of inactivated hepatitis A virus (strain RG-SB), propagated in human diploid (MRC-5) cells.

The virus particles are adsorbed on virosomes as the adjuvant system, composed of highly purified influenza virus surface antigens (10 micrograms haemagglutinin) of the A/Singapore/6/86 (H1N1) strain and the phospholipids lecithin (80 micrograms) and cephalin (20 micrograms).

For more information on the adjuvant, see section 5.1.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Suspension for injection in a prefilled syringe. Clear, colourless liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

Active immunisation against hepatitis A of children from 1 year of age and adults.

4.2 Posology And Method Of Administration

One dose of 0.5 ml is injected intramuscularly. To ensure optimal immune response, the vaccine should be injected into the deltoid muscle. In patients with coagulation disorders, the vaccine may be administered subcutaneously in the upper arm.

In order to provide long-term protection, a second (booster) dose of 0.5 ml should be administered. This is preferably given between 6-12 months after the first dose but may be given up to 10 years later based on limited experience in healthy adult travellers (see section 5.1).

Epaxal can be used interchangeably with other inactivated hepatitis A vaccines for the first and second (booster) dose.

Simultaneous active and passive i

1. Name Of The Medicinal Product

Erdotin

2. Qualitative And Quantitative Composition

Each capsule contains 300 mg of erdosteine

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsules, hard. The product appears as a capsule with a green cap and a yellow body

4. Clinical Particulars

4.1 Therapeutic Indications

As an expectorant. For the symptomatic treatment of acute exacerbations of chronic bronchitis in adults.

4.2 Posology And Method Of Administration

Elderly and adults above 18 years:

300 mg twice daily for maximum 10 days.

The capsules must be swallowed whole with a glass of water.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the other excipients.

Since there are no data in patients with creatinine clearance <25ml/min, or with severe liver failure, the use of erdosteine is not recommended in these patients.

Patients with active peptic ulcer.

4.4 Special Warnings And Precautions For Use

No increase in adverse events has been observed with erdosteine in patients with mild liver failure; however these patients should not exceed a dose of 300 mg per day.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No adverse interactions have been reported.

4.6 Pregnancy And Lactation

Pregnancy:

There is no experience for the use of erdosteine in pregnant women.

Lactation:

Experience is missing.

Therefore, the use of er

ELLIMANS UNIVERSAL MUSCLE RUB Lotion

(turpentine oil, glacial acetic acid)

Important Information about Ellimans

  • This medicine relieves symptoms of various rheumatic and muscular pains when applied to the skin.
  • It can be used on adults, the elderly and children over 12 years.

Do not use

  • On broken or inflamed skin.
  • On children under 12 years.

Now read the rest of the leaflet before you use this medicine. It includes other information which might be especially important for you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need any more information or advice.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What the medicine is for

Ellimans is a skin lotion which has warming and soothing properties. It is used to relieve the symptoms of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain. It can also be used by athletes to massage the arm or leg muscles.

Before you use this medicine

Do not use the medicine if you have

  • An allergy to any of the ingredients listed in section 6.
  • Broken or inflamed skin.
  • Or on a child under 12 years old.

1. Name Of The Medicinal Product

EXTEROL 5% w/w EAR DROPS, SOLUTION

2. Qualitative And Quantitative Composition

Urea Hydrogen Peroxide 5.0% w/w.

3. Pharmaceutical Form

Ear drops, solution.

Clear, straw-coloured, viscous ear drops.

4. Clinical Particulars

4.1 Therapeutic Indications

As an aid in the removal of hardened ear wax.

4.2 Posology And Method Of Administration

For adults, children and the elderly: Instil up to 5 drops into the ear. Retain drops in ear for several minutes by keeping the head tilted and then wipe away any surplus. Repeat once or twice daily for at least 3 to 4 days, or as required.

4.3 Contraindications

Do not use if the eardrum is known or suspected to be damaged, in cases of dizziness, or if there is any other ear disorder (such as pain, discharge, inflammation, infection or tinnitus). Do not use after ill-advised attempts to dislodge wax using fingernails, cotton buds or similar implements, as such mechanical efforts can cause the ear's delicate inner lining to become damaged, inflamed or infected, whereupon the use of ear drops can be painful. For similar reasons, it is inadvisable to use Exterol within 2 to 3 days of syringing. Do not use where there is a history of ear problems, unless under close medical supervision. Do not use if sensitive to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep Exterol away from the eyes. For external use only. Replace cap after use, and return bottle to carton.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Exterol should not be used at the same time as anything else in the ear.

4.6 Pregnanc

1. Name Of The Medicinal Product

Enbrel 25 mg/ml powder and solvent for solution for injection for paediatric use.

2. Qualitative And Quantitative Composition

Each vial contains 25 mg of etanercept. When reconstituted, the solution contains 25 mg/ml of etanercept.

Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1. Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. The specific activity of etanercept is 1.7 x 106 units/mg.

The solution contains benzyl alcohol 9 mg/ml as a preservative (see section 4.4). For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder and solvent for solution for injection (powder for injection).

The powder is white. The solvent is a clear, colourless liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

Polyarticular juvenile idiopathic arthritis

Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Enbrel has not been studied in children aged less than 2 years.

Paediatric plaque psoriasis

Tre

1. Name Of The Medicinal Product

Eporatio 3,000 IU/0.5 ml solution for injection in pre

2. Qualitative And Quantitative Composition

One pre-filled syringe contains 3,000 international units (IU) (25 g) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 g) epoetin theta per ml.

Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection (injection) in pre

The solution is clear and colourless.

4. Clinical Particulars

4.1 Therapeutic Indications

- Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.

- Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

4.2 Posology And Method Of Administration

Special requirements

Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications.

Routes of administration

The solution can be administered subcutaneously (SC) or intravenously (IV). Subcutaneous use is preferable in patients who are not undergoing haemodialysis, in order to avoid puncturing peripheral veins. If epoetin theta is substituted for another epoetin, the same route of administration should be used. Epoetin theta should be administered by the subcutaneous route to cancer patients with non

Posology

Symptomatic anaemia associated with chronic renal

1. Name Of The Medicinal Product

Eumocream 25% w/w

2. Qualitative And Quantitative Composition

Glycerol 25% w/w

For excipients, see 6.1

3. Pharmaceutical Form

Cream

Smooth, white cream

4. Clinical Particulars

4.1 Therapeutic Indications

This product is indicated for the management of dry or flaky skin conditions which may also be pruritic such as eczema or dermatitis.

4.2 Posology And Method Of Administration

For topical application to the skin.

Adults, the elderly, infants, babies and children:

The cream should be applied to the affected areas as often as required.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes, as the product may cause irritation to the epithelial cells of the cornea.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated

4.6 Pregnancy And Lactation

Animal studies are insufficient with respect to effects on pregnancy, foetal development, parturition or postnatal developments. The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

4.7 Effects On Ability To Drive And Use Machines

None stated

4.8 Undesirable Effects

Hypersensitivity reactions have been rarely reported; they usually consist of localised skin reactions.

4.9 Overdose

Eumocream is of low toxicity. If accidental ingestion occurs, conservative treatment only is requi

1. Name Of The Medicinal Product

E-Z-HD 98 % w/w powder for oral suspension

2. Qualitative And Quantitative Composition

Active Constituent:

Barium sulfate 98.45 % w/w

Excipients include:

Sorbitol (E420), 2 g per 340 g dose.

Approximately 310 mg sodium per 340 g dose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for oral suspension.

White powder.

4. Clinical Particulars

4.1 Therapeutic Indications

This medicinal product is for diagnostic use only.

E-Z-HD is a high density suspension for use as a radiopaque agent during X-ray visualisation of the upper gastro-intestinal tract (oesophagus, stomach and duodenum). It is designed for optimal use in double contrast X-ray examinations.

4.2 Posology And Method Of Administration

E-Z-HD must be administered orally. The powder must be reconstituted prior to administration (see section 6.6).

The administered dose of E-Z-HD will depend on the patient in question and the section of the gastrointestinal tract to be viewed.

Adults: The contents of one prefilled bottle (340 g) are dispersed in 65 mL of water to produce a 250 % w/v suspension which is swallowed by the patient after a suitable gas producing agent has been administered.

Children: The dosage will be dependent on the size, age, health state and anatomical region to be imaged of the child. Individual requirements should be determined, from experience, by the radiologist.

Elderly: There are no special dosage recommendations. The dosage should be determined, from exp

Elleste Duet 1mg and 2mg

(estradiol and norethisterone acetate)

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, please ask your doctor or 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 or pharmacist.

In this leaflet:

  • 1. What Elleste Duet is and what it is used for
  • 2. Before you take Elleste Duet
  • 3. How to take Elleste Duet
  • 4. Possible side effects
  • 5. How to store Elleste Duet
  • 6. Further information

What Elleste Duet Is And What It Is Used For

Elleste Duet is a form of hormone replacement therapy (HRT).

It contains two hormones, estradiol hemihydrate and norethisterone acetate. Elleste Duet is one of a group of medicines called combined estrogen-progestogen preparations. It is not an oral contraceptive.

Why has your doctor given you Elleste Duet?

Elleste Duet treats the symptoms of the menopause (change of life).

As you approach the menopause, your ovaries gradually produce fewer hormones. This may cause unpleasant symptoms such as hot flushes and swea

1. Name Of The Medicinal Product

Etrivex500 micrograms/g shampoo

2. Qualitative And Quantitative Composition

One gram of shampoo contains 500 micrograms of clobetasol propionate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Shampoo.

Viscous, translucent, colourless to pale yellow liquid shampoo with alcoholic odour.

4. Clinical Particulars

4.1 Therapeutic Indications

Topical treatment of moderate scalp psoriasis in adults.

4.2 Posology And Method Of Administration

For cutaneous use on the scalp only.

Etrivex 500 micrograms/g shampoo should be applied directly on dry scalp once daily taking care to well cover and massage the lesions. An amount equivalent to around a half tablespoon (around 7.5 ml) per application is sufficient to cover all the scalp. Etrivex 500 micrograms/g shampoo should be then kept in place without covering for 15 minutes before rinsing. Hands should be washed carefully after application. After 15 minutes, the product must be rinsed with water and / or hair can be washed by using an additional amount of regular shampoo if needed to facilitate washing. Then, hair can be dried as usual.

The treatment duration should be limited to a maximum of 4 weeks. As soon as clinical results are observed, applications should be spaced out or replaced, if needed, by an alternative treatment. If no improvement is seen within four weeks, reassessment of the diagnosis may be necessary.

Repeated courses of Etrivex 500 micrograms/g shampoo may be used to control exacerbations provided the patient is under regular medical supervision.

Paediatric population

The experience in

1. Name Of The Medicinal Product

ESTRADIOL IMPLANT 25mg

2. Qualitative And Quantitative Composition

Each implant contains 25mg estradiol.

3. Pharmaceutical Form

Implant

4. Clinical Particulars

4.1 Therapeutic Indications

Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women.

Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

4.2 Posology And Method Of Administration

Dosage and Administration

Dose

Adults: 25 - 100 mg

Estradiol implants are available in strengths of 25, 50 and 100mg. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used. In most patients, implantation of a 25mg dose provides relief of symptoms and prevents osteoporosis. Some patients may require 50 mg or even higher doses initially.

If possible, subsequent doses should be reduced stepwise (for example, 100mg to 50mg to 25mg), eventually using 25mg as a maintenance dose. Frequency of replacement depends on the duration of activity of the implants administered and the severity of the symptoms. Patients require a further implant when symptoms return, usually every 4 to 8 months.

Use of a progestagen

Women with an intact uterus:

Because of the sustained absorption of estradiol, the endometrium of post-menopausal or ovariectomised women is liable to progressive hypertrophy. Therefor

1. Name Of The Medicinal Product

Exorex Lotion 5% v/w Cutaneous Emulsion

2. Qualitative And Quantitative Composition

The active ingredient is coal tar solution 5% v/w.

Excipients:

Methyl hydroxybenzoate (E218)

0.10% w/w

Propyl hydroxybenzoate (E216)

0.05% w/w

Hydrogenated polyoxyl castor oil

0.45% w/w

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Cutaneous emulsion

A smooth mustard coloured emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

Exorex is for the treatment of psoriasis of the skin and scalp.

4.2 Posology And Method Of Administration

Adults and children over 12 years of age:

Ensure that the lesions are clean. Apply a thin layer of Exorex two or three times per day to the affected areas. Massage gently and leave to dry.

For young children under 12 years of age and the elderly:

1. Name Of The Medicinal Product

Equasym XL 10 mg modified-release capsules, hard

Equasym XL 20 mg modified-release capsules, hard

Equasym XL 30 mg modified-release capsules, hard

2. Qualitative And Quantitative Composition

Each capsule contains 10 mg methylphenidate hydrochloride corresponding to 8.65 mg methylphenidate.

Excipient: 45 mg sucrose/capsule for Equasym XL 10 mg

Each capsule contains 20 mg methylphenidate hydrochloride corresponding to 17.30 mg methylphenidate.

Excipient: 90 mg sucrose/capsule for Equasym XL 20 mg

Each capsule contains 30 mg methylphenidate hydrochloride corresponding to 25.94 mg methylphenidate.

Excipient: 135 mg sucrose/capsule for Equasym XL 30 mg

For a full list excipients, see Section 6.1

3. Pharmaceutical Form

Modified release capsule, hard.

Equasym XL 10 mg capsule: The capsule has a dark green opaque cap imprinted with S544 in white and a white opaque body imprinted with 10 mg in black.

Equasym XL 20 mg capsule: The capsule has a blue opaque cap imprinted with S544 in white and a white opaque body imprinted with 20 mg in black.

Equasym XL 30 mg capsule: The capsule has a reddish-brown opaque cap imprinted with S544 in white and a white opaque body imprinted with 30 mg in black.

4. Clinical Particulars

4.1 Therapeutic Indications

Methylphenidate is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should

1. Name Of The Medicinal Product

Equasym 5 mg tablets

Equasym 10 mg tablets

Equasym 20 mg tablets

2. Qualitative And Quantitative Composition

One tablet contains 5 mg, 10 mg or 20 mg of methylphenidate hydrochloride.

For excipients, see section 6.1

3. Pharmaceutical Form

Tablet

Tablet with breakline, 'Medeva' and strength embossed on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Methylphenidate is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history or evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptom.

The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources.

A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired.

Methylphenidate treatment is not indicated in all children with this syndrome and the decision to use the drug m

Epaxal

Hepatitis A Vaccine

inactivated, virosome

Read all of this leaflet carefully before this vaccine is given.

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, please ask your doctor or your pharmacist.

In this leaflet:

  • 1. What Epaxal is and what it is used for
  • 2. Before having Epaxal
  • 3. How Epaxal is given
  • 4. Possible side effects
  • 5. Storing Epaxal
  • 6. Further information

The full name of the vaccine is Epaxal, emulsion for injection in pre-filled syringe, Hepatitis A vaccine (inactivated, virosome)

  • The active substance in Epaxal is 24 international units of inactivated (killed) hepatitis A virus (strain RG-SB) that has been grown in human diploid cells. The viruses have been adsorbed on to particles called virosomes that are made from parts of the outer coat of a type of influenza virus and phospholipids called lecithin and cephalin.
  • The other ingredients are sodium chloride and water for injections.

The Product License Holder is

Berna Biotech Italia S.r.l.
Via Zambeletti 25
20021 Baranzate (MI)
Italy

Epaxal is manufactured by

Berna Biotech Ltd
Rehhagstrasse 79
3018 Berne
Switzerland

1. Name Of The Medicinal Product

Elantan 20

2. Qualitative And Quantitative Composition

Isosorbide-5-mononitrate-lactose trituration 90%, 22.20 mg equivalent to Isosorbide-5-mononitrate, 20.00 mg.

(The lactose complies with Ph.Eur.).

For excipients see 6.1.

3. Pharmaceutical Form

Tablets

White tablets with breakscore and marked 'E20'.

4. Clinical Particulars

4.1 Therapeutic Indications

For the prophylaxis of angina pectoris

As adjunctive therapy in congestive heart failure not responding to cardiac glycosides or diuretics.

4.2 Posology And Method Of Administration

For oral administration

Adults

One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. For patients not already receiving prophylactic nitrate therapy it is recommended that the initial dose be one tablet of Elantan 20 twice a day.

The dosage may be increased up to 120 mg per day.

The lowest effective dose should be used.

Elderly

There is no evidence to suggest that an adjustment of the dosage is necessary.

Children

The safety and efficacy of Elantan 20 has yet to be established in children.

Treatment with Elantan, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.4)

4.3 Contraindications

Elantan 20 should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure (sh

1. Name Of The Medicinal Product

Eldepryl 10 mg Tablets

2. Qualitative And Quantitative Composition

Selegiline hydrochloride 10 mg

Full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablets for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Selegiline is indicated for the treatment of Parkinson's disease, or symptomatic parkinsonism. It may be used alone in early Parkinson's disease for symptomatic relief to delay the need for levodopa (with or without decarboxylase inhibitor) or as an adjunct to levodopa (with or without decarboxylase inhibitor). Selegiline in combination with maximal levodopa therapy is indicated particularly in patients who experience fluctuations in their condition such as 'end-dose' type fluctuations, 'on-off' symptoms or other dyskinesias.

4.2 Posology And Method Of Administration

10 mg daily either alone or as an adjunct to levodopa or levodopa/peripheral decarboxylase inhibitor. Selegiline may be administered either as a single dose in the morning or in two divided doses of 5 mg, taken at breakfast and lunch. When selegiline is added to a levodopa regimen it is possible to reduce the levodopa dosage by an average of 10 -30%. Reduction of the levodopa dose should be gradual in steps of 10% every 3 to 4 days.

No dosage adjustment is required for patients with renal or hepatic impairment.

4.3 Contraindications

Eldepryl is contra-indicated in patients with known hypersensitivity (including severe dizziness or hypotension) to selegiline or any of the excipients used in this product.

Eldepryl is contra-indicated in patients receiving treatment with serotonin-agonists (e.g. sumatriptan, naratriptan, zolmi