RETROVIR 300 Milligram Tablets
Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Ciri produk
(SPC)
11-06-2024
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Bahan aktif:
ZIDOVUDINE
Boleh didapati daripada:
ViiV Healthcare UK Ltd
INN (Nama Antarabangsa):
ZIDOVUDINE
Dos:
300 Milligram
Borang farmaseutikal:
Tablets
Jenis preskripsi:
Product subject to prescription which may not be renewed (A)
Status kebenaran:
Withdrawn
Tarikh kebenaran:
2014-03-01
Ciri produk
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Retrovir 300 mg film coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg zidovudine:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets
White, round, biconvex, film-coated tablets, with a white to beige core scored and branded “WELLCOME X4F”.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Retrovir oral formulations are indicated in anti-retroviral combination therapy for Human Immunodeficiency Virus
(HIV) infected adults and children.
Retrovir chemoprophylaxis is indicated for use in HIV-positive pregnant women (over 14 weeks of gestation) for
prevention of maternal-foetal HIV transmission and for primary prophylaxis of HIV infection in newborn infants.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Retrovir should be prescribed by physicians who are experienced in the treatment of HIV infection.
_Dosage in adults and adolecents weighing at least 30 kg: _The usual recommended dose of Retrovir in combination
with other anti-retroviral agents is 250 or 300 mg twice daily.
_Dosage in children:_Retrovir 100 mg capsules and Retrovir 100 mg/10 ml oral solution are available for use in children.
_Dosage in the prevention of maternal-foetal transmission: _Pregnant women (over 14 weeks of gestation) should be
given 500 mg/day orally (100 mg five times per day) until the beginning of labour. During labour and delivery
Retrovir should be administered intravenously at 2 mg/kg bodyweight given over one hour followed by a continuous
intravenous infusion at 1 mg/kg/h until the umbilical cord is clamped.
The newborn infants should be given
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