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Viramune 200 mg tablets

nevirapine

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

  • Keep this leaflet. You may need to read it again.
  • If you have 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 VIRAMUNE is and what it is used for
  • 2. Before you take VIRAMUNE
  • 3. How to take VIRAMUNE
  • 4. Possible side effects
  • 5. How to store VIRAMUNE
  • 6. Further information

What Viramune Is And What It Is Used For

VIRAMUNE belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection.

The active ingredient of your medicine is called nevirapine. The active ingredient is the substance in this medicine that reduces the amount of viruses in the blood thus improving your medical condition.

Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs in order to multiply. Nevirapine stops reverse transcriptase from working. By stopping reverse transcriptase from working, VIRAMUNE helps control HIV-1 infection.

You must take VIRAMUNE togeth

1. Name Of The Medicinal Product

Valcyte 450 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each tablet contains 496.3 mg of valganciclovir hydrochloride equivalent to 450 mg of valganciclovir (as free base).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablets

Pink, convex oval film-coated tablets, with “VGC” embossed on one side and “450” on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Valcyte is indicated for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

Valcyte is indicated for the prevention of CMV disease in CMV-negative patients who have received a solid organ transplant from a CMV-positive donor.

4.2 Posology And Method Of Administration

Caution – Strict adherence to dosage recommendations is essential to avoid overdose; see sections 4.4 and 4.9.

Valganciclovir is rapidly and extensively metabolised to ganciclovir after oral dosing. Oral valganciclovir 900 mg b.i.d. is therapeutically equivalent to intravenous ganciclovir 5 mg/kg b.i.d.

Standard dosage in adults

Induction treatment of CMV retinitis:

For patients with active CMV retinitis, the recommended dose is 900 mg valganciclovir (two Valcyte 450 mg tablets) twice a day for 21 days and, whenever possible, taken with food. Prolonged induction treatment may increase the risk of bone marrow toxicity (see section 4.4).

Maintenance treatment of CMV retinitis:

1. Name Of The Medicinal Product

Value Health Cold Relief Powders Lemon

2. Qualitative And Quantitative Composition

Active ingredient

mg/sachet

Paracetamol fine cryst EP

650

Ascorbic Acid fine PDR EP

50

3. Pharmaceutical Form

Powder for oral solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of colds and influenza.

4.2 Posology And Method Of Administration

Adults and children over 12 years: The contents of the sachet dissolved in hot water to be taken at bedtime and repeated every four hours during the day if necessary up to a maximum of 4 doses in 24 hours.

Children under 12 years: Not to be given without medical advice.

There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Severe liver disease or kidney damage.

4.4 Special Warnings And Precautions For Use

Caution in patients with impaired liver or kidney function.

The hazards of overdose are greater in those with non-cirrhotic alcoho

1. Name Of The Medicinal Product

Voltarol® Ophtha

2. Qualitative And Quantitative Composition

Eye drop solution containing 0.1% (w/v) diclofenac sodium in a preservative-free formulation.

3. Pharmaceutical Form

Eye drop solution presented in single dose units for administration by instillation in the conjunctival sac.

4. Clinical Particulars

4.1 Therapeutic Indications

i. Inhibition of peroperative miosis during cataract surgery (Voltarol Ophtha has no intrinsic mydriatic properties and does not replace standard mydriatic agents).

ii. Treatment of post-operative inflammation in cataract surgery.

iii. Control of ocular pain and discomfort associated with corneal epithelial defects after excimer PRK surgery or accidental non- penetrating trauma.

iv. Control of inflammation after Argon Laser Trabeculoplasty (ALT).

v. The relief of the ocular signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).

vi. Treatment of inflammation and discomfort after strabismus surgery

vii. Treatment of ocular pain and discomfort after radial keratotomy

4.2 Posology And Method Of Administration

Voltarol Ophtha eye drop solution is for instillation into the conjunctival sac only. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

Adults:

Prophylaxis of preoperative miosis

Apply 1 drop four times during the 2 hours before surgery.

1. Name Of The Medicinal Product

Venlafaxine 75mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains venlafaxine hydrochloride equivalent to 75mg of venlafaxine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Peach coloured, round tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Major depressive disorder

Treatment of major depressive episodes

For prevention of recurrence of major depressive episodes

4.2 Posology And Method Of Administration

Major depressive episodes

The recommended starting dose of immediate-release venlafaxine is 75mg/day in two or three divided doses taken with food. Patients not responding to the initial 75mg/day dose may benefit from dose increases up to a maximum dose of 375mg/day. Dosage increases can be made at intervals of 2 weeks or more. If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days.

Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4). The lowest effective dose should be maintained.

Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly on a case-by-case basis. Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the current episode.

Antidepressive medicinal products should cont

1. Name Of The Medicinal Product

Vicks Cough Syrup for Chesty Coughs

2. Qualitative And Quantitative Composition

ACTIVE INGREDIENTS

  %w/v Specification
Guaifenesin 1.333 Ph. Eur.

3. Pharmaceutical Form

Syrup for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

To relieve a cough, loosen mucus, soothe and coat the throat and make the cough more productive.

4.2 Posology And Method Of Administration

Adults and children 12 years and over: 3 x 5ml spoonfuls

Repeat every 4 hours as needed.

No more than 6 doses a day

4.3 Contraindications

Not to be used in children under the age of 6 years

Known hypersensitivity to guaifenesin.

4.4 Special Warnings And Precautions For Use

Do not exceed the stated dose.

Do not administer to children under 2 years except on medical advice.

If symptoms persist, consult your doctor.

Keep out of reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no literature evidence of hazard due to

VERTAB SR 240 Tablets

VERAPAMIL HYDROCHLORIDE

Please read this leaflet carefully before you start taking your tablets.

  • Keep this leaflet. You may need to read it again.
  • This leaflet provides some useful information for you about your medicine.
  • If you have any questions or are not sure about anything ask your doctor or pharmacist.

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

In this leaflet:

  • 1. What Vertab SR 240 Tablets are and what they are used for
  • 2. Before you take Vertab SR 240 Tablets
  • 3. How to take Vertab SR 240 Tablets
  • 4. Possible side effects
  • 5. How to store Vertab SR 240 Tablets
  • 6. Further information

What Vertab Sr 240 Tablets Are And What They Are Used For

The name of your medicine is: Vertab SR 240 Tablets

Vertab SR 240 Tablets belong to a group of medicines called calcium channel blockers. Calcium channel blockers change the amount of calcium getting into the muscle cell in your heart and blood vessels. This can change the strength and speed with which your heart beats. It also opens up the blood vessels so blood can be pumped around the body more easily. This helps more oxygen to get to your heart muscle and can lower your blood pressure.

Vertab SR 240 Tablets are indicated for the treatment of mild to moderate hypertension (high blood pressure) and the treatment and prevention of angina pec

1. Name Of The Medicinal Product

VIRACEPT 250 mg film-coated tablets.

2. Qualitative And Quantitative Composition

Each film-coated tablet contains nelfinavir mesilate corresponding to 250 mg of nelfinavir.

Excipients:

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Blue, oblong biconvex film-coated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

VIRACEPT is indicated in antiretroviral combination treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children of 3 years of age and older.

In protease inhibitor (PI) experienced patients the choice of nelfinavir should be based on individual viral resistance testing and treatment history.

See section 5.1.

4.2 Posology And Method Of Administration

Therapy with VIRACEPT should be initiated by a physician experienced in the management of HIV infection.

VIRACEPT is administered orally and should always be ingested with food (see section 5.2).

Patients older than 13 years: the recommended dose of VIRACEPT 250 mg film-coated tablets is 1250 mg (five tablets) twice a day (BID) or 750 mg (three tablets) three times a day (TID) by mouth.

The efficacy of the BID (twice daily) regimen has been evaluated versus the TID (three times daily) regimen primarily in patients na?ve to PIs (see section 5.1).

Patients aged 3 to 13 years: for children, the recommended starting dose is 50-55 mg/kg BID or, if using a TID regimen, 25 – 30

1. Name Of The Medicinal Product

Valsartan 160 mg film-coated tablets

2. Qualitative And Quantitative Composition

Valsartan 160 mg film-coated tablets: One film-coated tablet contains 160 mg of valsartan

Excipients:

Valsartan 160 mg film-coated tablets:

Each tablet contains

sorbitol.................... 18.5 mg

lactose...................... 2.16 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Valsartan 160 mg film-coated tablets: oblong, biconvex, coated, ochre tablets, scored on one side, 'snap-tab' tablets.. The tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension

Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 18 years of age.

Recent myocardial infarction

Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours- 10 days) myocardial infarction (see sections 4.4 and 5.1).

Heart failure

Treatment of symptomatic heart failure in adult patients when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).

4.2 Posology And Method Of Administration

Posology

Recent myocard

1. Name Of The Medicinal Product

Videx 25 mg chewable or dispersible tablet

2. Qualitative And Quantitative Composition

Each chewable or dispersible tablet contains 25 mg of didanosine.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Chewable or dispersible tablet

White tablet, imprinted with “25” on one side and “VIDEX” on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Videx is indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infected patients.

4.2 Posology And Method Of Administration

Oral use.

Because didanosine absorption is reduced in the presence of food, Videx should be administered at least 30 minutes before a meal (see section 5.2).

Posology

Different tablet strengths of Videx may be administered on a once-daily (QD) or a twice daily (BID) regimen (see section 5.1). To ensure that patients receive a sufficient amount of antacid, and to avoid degradation of didanosine at an acidic pH, each dose must be given minimally as 2 tablets.

Adults: The recommended daily dose is dependent on patient weight:

ADULT DOSING GUIDELINES

Patient Weight

BID(*)

(dose, mg)

QD(**)

(dose, mg)

1. Name Of The Medicinal Product

Valsartan/hydrochlorothiazide 80 mg/12.5 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide.

Excipient:

One tablet contains 16.27 mg lactose.

3. Pharmaceutical Form

Film-coated tablet.

The film-coated tablets are pink, oval, biconvex.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of essential hypertension in adults.

Valsartan/hydrochlorothiazide fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy.

4.2 Posology And Method Of Administration

Posology

The recommended dose of Valsartan/hydrochlorothiazide 80 mg/12.5 mg is one film coated tablet once daily. Dose titration with the individual components is recommended. In each case, up- titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events.

When clinically appropriate direct change from monotherapy to the fixed dose combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed.

The clinical response to Valsartan/hydrochlorothiazide should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of valsartan/hydrochlorothiazide 320 mg/25 m

1. Name Of The Medicinal Product

VEXOL 1% (10 mg/ml) eye drops, suspension

2. Qualitative And Quantitative Composition

Rimexolone 10 mg/ml.

For excipients, see section 6.1.

3. Pharmaceutical Form

Eye drops, suspension.

Vexol is a white to off-white suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

VEXOL is indicated for the treatment of postoperative inflammation following ocular surgery, for the treatment of anterior uveitis, and for the treatment of corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. The inflammation should be of a non-infectious nature. In more serious cases, and if the posterior part of the globe is affected, subconjunctival injection or systemic treatment is recommended (see section 4.4).

4.2 Posology And Method Of Administration

Postoperative Inflammation

Apply one drop of VEXOL into the conjunctival sac of the affected eye four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period. There are no clinical data on the use of VEXOL immediately after surgery.

Steroid Responsive Inflammation

Apply one drop of VEXOL into the conjunctival sac of the affected eye four times or more daily. The duration of treatment should be determined by the prescribing physician according to the severity of the disease, but should not exceed four weeks.

Uveitis

Apply one drop of VEXOL into the conjunctival sac of the affected eye every hour during the daytime for the first week, one

1. Name Of The Medicinal Product

Vividrin Nasal Spray

2. Qualitative And Quantitative Composition

Active

Sodium cromoglycate EP 2.00% w/v.

3. Pharmaceutical Form

Nasal spray.

4. Clinical Particulars

4.1 Therapeutic Indications

For the prevention and relief of seasonal and perennial allergic rhinitis.

4.2 Posology And Method Of Administration

Route of Administration

For intra-nasal use.

Adults, Children and the Elderly

One spray into each nostril four to six times daily.

Note: Due to the prophylactic nature of sodium cromoglycate the patient should be encouraged to continue use even when symptoms have ceased.

4.3 Contraindications

Known hypersensitivity to benzalkonium chloride, sodium cromoglycate or other constituents.

4.4 Special Warnings And Precautions For Use

Addition of Vividrin Nasal spray to existing sodium cromoglycate or steroid controlled asthma therapy may exaggerate the effects of that therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

It may be possible to reduce concomitant antihistamine therapy.

4.6 Pregnancy And Lactation

Use in Pregnancy: Vividrin Nasal Spray should be used cautiously during pregnancy and lactation. The widespread use of sodium cromoglycate has yet to reveal any adverse effects to mother or child during pregnancy.

Use in Lactation: It is not known whether sodium cromoglycat

1. Name Of The Medicinal Product

Vectavir Cold Sore Cream

2. Qualitative And Quantitative Composition

Each gram of the cream contains:

Active substance: 10 mg penciclovir

Excipients: cetostearyl alcohol, propylene glycol.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Cream

Smooth white cream of homogeneous appearance.

4. Clinical Particulars

4.1 Therapeutic Indications

Vectavir Cold Sore Cream is indicated for the treatment of cold sores (herpes labialis) .

4.2 Posology And Method Of Administration

Adults (including the elderly) and children over 12 years of age:

Vectavir Cold Sore Cream should be applied at approximately two hourly intervals during waking hours. Vectavir Cold Sore Cream may be applied with a clean finger or with a single-use applicator (for packages which contain applicators), in the amount required for the size of the affected area of skin. Treatment should be continued for 4 days.

Treatment should be started as early as possible after the first sign of an infection.

Children (under 12 years):

No work has been carried out in children below 12 years of age.

4.3 Contraindications

Known hypersensitivity to penciclovir, famciclovir or the other constituents of the formulation, eg. propylene glycol.

4.4 Special Warnings And Precautions For Use

The cream should only be used on cold sores on the lips and around the mouth. It is not recommended for application to mucous membranes. Particular care should be taken to avoid application in or

Vesicare 5 mg film-coated tablets

Vesicare 10 mg film-coated tablets

(solifenacin succinate)

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

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, 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 Vesicare is and what it is used for
  • 2. Before you take Vesicare
  • 3. How to take Vesicare
  • 4. Possible side effects
  • 5. How to store Vesicare
  • 6. Further information

What Vesicare Is And What It Is Used For

The active substance of Vesicare belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This enables you to wait longer before having to go to the bathroom and increases the amount of urine that can be held by your bladder.

Vesicare is used to treat the symptoms of a condition called overactive bladder. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting yourself because you could not get to the bathroom in time.

Before You Take Vesicare

1. Name Of The Medicinal Product

Volplex 4% w/v Solution for Infusion

2. Qualitative And Quantitative Composition

Succinylated gelatin (Modified Fluid Gelatin) 4% w/v in Water for Injections, also containing sodium chloride.

Electrolytes

Sodium ion (Na+) 154 mmol/litre

Chloride ion (Cl?) 125 mmol/litre

3. Pharmaceutical Form

Sterile non-pyrogenic solution for infusion.

A clear pale yellow or straw coloured solution contained within a flexible infusion bag.

Key Physico-chemical properties:

Weight average molecular weight (Mw) 30 000 Dalton
Number average molecular weight(Mn) 20 000 Dalton
pH 7.4 + 0.5
Osmolarity 284 mOsm/litre

4. Clinical Particulars

4.1 Therapeutic Indications

Volplex is a colloidal plasma substitute indicated for the initial management of hypovolaemic shock caused by, for example, haemorrhage, acute trauma or surgery, burns, sepsis, peritonitis, pancreatitis or crush injury.

Volplex may be used in the initial treatment of blood loss during pregnancy where plasma volume replac

1. Name Of The Medicinal Product

Vivaglobin®, 160mg/ml solution for injection (subcutaneous use)

2. Qualitative And Quantitative Composition

1ml contains:

Human normal immunoglobulin (subcutaneous) 160mg,

one vial contains:

480 mg/3 ml or 1600 mg/10 ml or 3200 mg/20 ml of human normal immunoglobulin,

one ampoule contains:

800 mg/5 ml of human normal immunoglobulin,

corresponding to the total protein content of which at least 95% is IgG.

Distribution of IgG subclasses:

IgG1

ca. 61 %

IgG2

ca. 28 %

IgG3

ca. 5 %

IgG4

ca. 6 %

   

IgA

max. 1.7 mg/ml

 

1. Name Of The Medicinal Product

Vermox 100 mg/5 ml oral suspension

2. Qualitative And Quantitative Composition

Each 5 ml of suspension contains 100 mg of mebendazole.

Excipients: Each 5 ml also contains 500 mg of sucrose, 9 mg of methyl parahydroxybenzoate (E218) and 1 mg of propyl parahydroxybenzoate (E216).

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Oral suspension.

White homogeneous oral suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Broad spectrum gastrointestinal anthelmintic indicated for the treatment of:

Enterobius vermicularis (threadworm/pinworm)

Oxyuris vermicularis

Trichuris trichuria (whipworm)

Ascaris lumbricoides (large roundworm)

Ancylostoma duodenale (common hookworm)

Necator americanus (American hookworm)

There is no evidence that Vermox is effective in the treatment of cysticercosis.

4.2 Posology And Method Of Administration

Method of administration.

Oral Use

Adults and children over 2 years:

Enterobiasis:

1 x 5 ml (1 dosing cup).

It is highly recommended that a second dose is taken after 2 weeks, if reinfection is suspected.

Ascariasis, trichuriasis, ancylostomiasis, necatoriasis and mixed infections:

1 x 5 ml (1 dosing cup) bd for three days.

4.3 Contraindications

Vermox is contraindicated in pregnancy and in patients who have shown hypersensitivity to t

VentolinNebules2.5 mg and 5 mg

salbutamol sulphate

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, ask your doctor, nurse 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

  • 1 What Ventolin Nebules are and what they are used for
  • 2 Before you use Ventolin Nebules
  • 3 How to use Ventolin Nebules
  • 4 Possible side effects
  • 5 How to store Ventolin Nebules
  • 6 Further information

What Ventolin Nebules are and what they are used for

Ventolin Nebules contain a medicine called salbutamol. This belongs to a group of medicines called bronchodilators.

  • Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and out.
  • They help to relieve chest tightness, wheezing and cough.

Ventolin Nebules are used to treat breathing problems in people with asthma and other chest illnesses. They are usually given to people who suffer quite badly from these conditions when other forms of treatment do not help enough. Ventolin Nebules are also given to treat severe attacks of asthma.

A Nebule is a small plastic container that contain

1. Name Of The Medicinal Product

Vivadex 0.5 mg hard capsules

Vivadex 1 mg hard capsules

Vivadex 5 mg hard capsules

2. Qualitative And Quantitative Composition

Each Vivadex 0.5 mg hard capsule contains 0.5 mg tacrolimus

Each Vivadex 1 mg hard capsule contains 1 mg tacrolimus

Each Vivadex 5 mg hard capsule contains 5 mg tacrolimus

Excipient(s):

Each Vivadex 0.5 mg hard capsule contains 109.1 mg lactose anhydrous

Each Vivadex 1 mg hard capsule contains 108.6 mg lactose anhydrous

Each Vivadex 5 mg hard capsule contains 104.6 mg lactose anhydrous

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsules, hard.

Vivadex 0.5 mg hard capsule: Ivory cap and ivory body hard shell capsules with white powder

Vivadex 1 mg hard capsule: White cap and white body hard shell capsules with white powder

Vivadex 5 mg hard capsule: Red cap and red body hard shell capsules with white powder

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients.

Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.

4.2 Posology And Method Of Administration

Vivadex therapy requires careful monitoring by adequately qualified and equipped personnel.

The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplanted patients.

Inadvertent, unintentional or unsupervised