VOLUTRIP Film-coated tablet (2018)

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Περιεχόμενα

1. Name of the medicinal product

VOLUTRIP (tablet).

2. Qualitative and quantitative composition

Each VOLUTRIP tablet contains dolutegravir sodium equivalent to 50 mg of dolutegravir, lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg which is equivalent to 245 mg of tenofovir disoproxil. ...

3. Pharmaceutical form

Pink coloured, oval, biconvex, film-coated tablet debossed with N33 on one side and plain on the other side.

4.1. Therapeutic indications

The VOLUTRIP is a triple combination therapy which is indicated for the treatment of human immunodeficiency virus (HIV) infection in adults aged 18 years and older.

4.2. Posology and method of administration

Therapy should be initiated by a medical practitioner experienced in the management of HIV infection. Adults The dose of VOLUTRIP is one tablet taken orally, once daily, without regard to food. Paediatrics ...

4.3. Contraindications

VOLUTRIP tablets are contra-indicated in patients with known hypersensitivity to lamivudine, tenofovir or dolutegravir or to any of the components of the tablets. Impairment of renal function. Pregnancy ...

4.4. Special warnings and precautions for use

LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE WARNINGS AND ...

4.5. Interaction with other medicinal products and other forms of interaction

The likelihood of interactions is low due to the limited metabolism as plasma protein binding and almost complete renal clearance. Zidovudine plasma levels are not significantly altered when coadministered ...

4.6. Pregnancy and lactation

Pregnancy VOLUTRIP is contraindicated in pregnancy and lactation. Neural tube defects have been noted in an observational study in humans, where DTG-bases regimens were used at the time of conception and ...

4.8. Undesirable effects

VOLUTRIP can have side effects. Lamivudine The following side effects have been reported during therapy for HIV disease with VOLUTRIP tablets alone and in combination with other antiretrovirals. Blood ...

4.9. Overdose

Tenofovir disoproxil fumarate If overdose occurs the patient must be monitored for evidence of toxicity and palliative supportive treatment be applied as necessary. Tenofovir can be removed by haemodialysis; ...

5.1. Pharmacodynamic properties

<b>Pharmacological classification:</b> A 20.2.8 Antiviral Medicines. Lamivudine Lamivudine, a nucleoside reverse transcriptase inhibitor (NRTI), is a selective inhibitor of HIV-1 and HIV-2 replication ...

5.2. Pharmacokinetic properties

Lamivudine <u>Pharmacokinetics in adults:</u> Lamivudine is well absorbed from the gastrointestinal tract and the bioavailability of oral lamivudine in adults is normally between 80% and 85%. The mean ...

6.1. List of excipients

The other ingredients of VOLUTRIP are colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, opadry II pink 85F94172, povidone, sodium ...

6.4. Special precautions for storage

Store at or below 30°C. Keep the desiccant sachet in the container. Do not remove the desiccant sachet. Keep the tablets in the original container. Keep HDPE containers tightly closed. KEEP OUT OF REACH ...

6.5. Nature and contents of container

Tablets are packed in white opaque round 100 mL HDPE container with 38 mm neck finish closed with white opaque polypropylene 38 mm 400 child resistant closure with wad having induction sealing liner. ...

6.6. Special precautions for disposal and other handling

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

7. Marketing authorization holder

Aurobindo Pharma (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa

8. Marketing authorization number(s)

52/20.2.8/0212.210

10. Date of revision of the text

31 August 2018

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