VOLUTRIP Film-coated tablet Ref.[50539] Active ingredients: Dolutegravir Lamivudine Tenofovir disoproxil

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

VOLUTRIP is not recommended for use in patients younger than 18 years of age.

Renal impairment

Significantly increased exposure occurred when tenofovir, as in VOLUTRIP, was administered to patients with moderate to severe renal impairment (see CONTRA-INDICATIONS). The pharmacokinetics of tenofovir, as in VOLUTRIP, have not been evaluated in non-haemodialysis patients with creatinine clearance ˂80 mL/min); therefore, no dosing recommendations is available for these patients.

For treatment-naïve and treatment experienced patients the recommended dose of VOLUTRIP is one tablet once daily.

VOLUTRIP is contraindicated in patients with moderate or severe hepatic impairment (see CONTRAINDICATIONS).

VOLUTRIP is contra-indicated in patients with renal impairment with creatinine clearance less than 80 mL/min.

Rifampicin decreases the blood levels of dolutegravir. A supplementary dose dolutegravir should be given in patients taking VOLUTRIP.

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; the median haemodialysis clearance of tenofovir is 134 mL/min. The elimination of tenofovir by peritoneal dialysis has not been studied.

Lamivudine

Limited data are available on the consequences of ingestion of acute overdose in humans. If overdosage occurs the patient should be monitored, and palliative supportive treatment applied are required.

Dolutegravir

Management should be as clinically indicated or as recommended by the national poisons centre, where available. There is no specific treatment for an overdose of VOLUTRIP. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. As VOLUTRIP is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

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 AND SIGHT OF CHILDREN.

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. The HDPE container also contains 3 g of silica gel sachet.

Each container contains 30 tablets.

Pack size: 30’s – One HDPE container contains 30 tablets.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).