País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nevirapine
Milpharm Ltd
J05AG01
Nevirapine
200mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030100
Pharmacode position may change as per Supplier's m/c requirement &additional small pharma code may appear on the front / back panel Additional Information : TEAM LEADER Tarique INITIATOR Viswanath Nevirapine 200 mg PRODUCT NAME CUSTOMER / COUNTRY Milpharm_UK DIMENSIONS 240 x 540 mm PHARMACODE 8346 COMPONENT 01 Leaflet VERSION NO. REASON OF ISSUE Revision P1508346 ITEM CODE REVIEWED / APPROVED BY DATE & TIME 08.08.2014 &10:30 AM SIGN / DATE COLOURS : Artist: Supersede Code: P1507609 NO OF COLOURS : 01 Black Size: 240 x 540 mm BOOKLET SIZE: 60 X 35 MM NEVIRAPINE 200 MG TABLETS P1508346 NEVIRAPINE 200 MG TABLETS P1508346 NEVIRAPINE 200 MG TABLETS Nevirapine PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Nevirapine is and what it is used for 2. What you need to know before you take Nevirapine 3. How to take Nevirapine 4. Possible side effects 5. How to store Nevirapine 6. Contents of the pack and other information Nevirapine belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection. The active substance of your medicine is called nevirapine. Nevirapine reduces the amount of viruses in the blood thus improving your medical condition. Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs in order to multiply. Nevirapine stops reverse transcriptase from working Leer el documento completo
OBJECT 1 NEVIRAPINE 200MG TABLETS Summary of Product Characteristics Updated 02-Aug-2017 | Aurobindo Pharma - Milpharm Ltd. • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Nevirapine 200 mg tablets 2. Qualitative and quantitative composition Each tablet contains 200 mg of nevirapine (as anhydrous). Excipient with known effect: Each tablet contains 340 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. White to off-white, oval shaped, biconvex tablets, debossed with "J" and "80" on either side of break line on one side and with break line on the other side. The size is 19.2 mm X 9.3 mm. 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 Leer el documento completo