Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nevirapine
Wockhardt UK Ltd
J05AG01
Nevirapine
200mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030100; GTIN: 5012727908878
2024828 Pre Folding : 130 x 30 mm Spec: Printed on 40 GSM Bible paper, front & back side printing. Pharma Code : Front 620 Back 621 Đọc toàn bộ tài liệu
OBJECT 1 NEVIRAPINE 200MG TABLETS Summary of Product Characteristics Updated 19-Jun-2014 | Wockhardt UK Ltd 1. Name of the medicinal product Nevirapine 200 mg tablets 2. Qualitative and quantitative composition Each tablet contains 200 mg of anhydrous nevirapine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. Off-white to pale yellow coloured, capsule shaped, biconvex tablets, debossed with 'H' on one side and '7' on the other side with breakline on both sides. The tablets are approximately 14.7mm in length and 5.7mm in width. 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 Nevirapine is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.4.). Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing (see section 5.1). 4.2 Posology and method of administration Nevirapine should be administered by physicians who are experienced in the treatment of HIV infection. Posology _Patients 16 years and older_ The recommended dose of Nevirapine is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents. If a dose is recognized as missed within 8 hours of when it was due, the patient should take the missed dose as soon as possible. If a dose is missed and it is more than 8 hours later, the patient should only take the next dose at the usual time. _Dose management considerations_ Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not have their Nevirapine dose increased until the rash Đọc toàn bộ tài liệu