TELADO Film-coated tablet Ref.[115303] Active ingredients: Dolutegravir Lamivudine Tenofovir disoproxil

Posology

Therapy should be initiated by a medical practitioner experienced in the management of HIV infection.

Adults

The dose of TELADO is one tablet taken orally, once daily, without regard to food.

Paediatrics

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

Dose adjustment for renal impairment

Significantly increased exposure occurred when tenofovir, as in TELADO, was administered to patients with moderate to severe renal impairment (see section 4.3). The pharmacokinetics of tenofovir, as in TELADO, have not been evaluated in non- haemodialysis patients with creatinine clearance <50 mL/min; therefore, no dosing recommendations are available for these patients.

TELADO is not suitable for use in patients with renal impairment with creatinine clearance less than 50 mL/min.

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

Method of administration

TELADO tablets are to be taken orally, once daily, without regard to food.

If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.

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 TELADO. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. As TELADO is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

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 as required.

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.

24 months.

Store at or below 30°C.

Keep the container tightly closed.

Keep in the original container until required for use.

Containers of 28’s: TELADO is packed in a 85 cc white HDPE bottle with 38 mm non-child resistant cap containing 28 tablets and two 2 g silica gel bags.

Containers of 30’s: TELADO is packed in a 85 cc white HDPE bottle with 38 mm non-child resistant cap containing 30 tablets and two 2 g silica gel bags.

Containers of 84’s: TELADO is packed in a 200 cc white HDPE bottle with 45 mm screw cap containing 84 tablets and five 2 g silica gel bags.

Containers of 90’s: TELADO is packed in a 200 cc white HDPE bottle with 45 mm screw cap containing 90 tablets and five 2 g silica gel bags.

Not all pack sizes may be marketed.