Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Viatris Healthcare (Pty) Ltd, 4 Brewery Street, Isando, Johannesburg, 1600, Gauteng, South Africa
EFRIN in combination with other antiretroviral medicines is indicated for the treatment of HIV-1 infected adults and children weighing greater or equal to 40 kg.
The therapy should be initiated by a medical practitioner experienced in the management of HIV infection.
The recommended dosage of EFRIN in combination with a protease inhibitor, and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally, once daily.
In order to improve the tolerability of nervous system side effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms (see section 4.8).
EFRIN must be given in combination with other antiretroviral medications (see section 4.5).
The recommended dosage of EFRIN in combination with a protease inhibitor, and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally, once daily.
EFRIN should only be administered to children who are able to reliably swallow tablets.
EFRIN should not be used in adults and children weighing less than 40 kg.
For oral use.
EFRIN may be taken with or without food, preferably at bedtime (see section 4.4).
In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).
Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms and involuntary muscle contractions.
Administration of activated charcoal may be used to aid removal of unabsorbed substance. There is no specific antidote for overdose with EFRIN. Since EFRIN is highly protein bound, dialysis is unlikely to significantly remove the medicine from blood.
Store at or below 30°C.
Store in the original container.
Do not remove from the carton until required for use.
Keep the bottle tightly closed.
EFRIN is packed in high density polypropylene (HDPE) bottle pack (marketable pack) comprising of wide mouth white HDPE bottle with a white opaque polypropylene (PP) closure with induction sealing in pack sizes of 30’s packed in a carton.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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