Lamivudine/Zidovudine Mylan 150mg/300mg Film-coated tablet

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

ZIDOVUDINE, LAMIVUDINE

Tersedia dari:

Mylan Pharmaceuticals Limited Damastown Industrial Park Mulhuddart Dublin15 Dublin, Ireland

Kode ATC:

J05AR01

INN (Nama Internasional):

ZIDOVUDINE 300 mg LAMIVUDINE 150 mg

Bentuk farmasi:

FILM-COATED TABLET

Komposisi:

ZIDOVUDINE 300 mg LAMIVUDINE 150 mg

Jenis Resep:

POM

Area terapi:

ANTIVIRALS FOR SYSTEMIC USE

Status otorisasi:

Authorised

Tanggal Otorisasi:

2013-01-18

Selebaran informasi

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMIVUDINE/ZIDOVUDINE MYLAN 150 MG/300 MG FILM-COATED TABLETS
(lamivudine/zidovudine)
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.
•
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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lamivudine/Zidovudine Mylan is and what it is used for
2.
What you need to know before you take Lamivudine/Zidovudine Mylan
3.
How to take Lamivudine/Zidovudine Mylan
4.
Possible side effects
5.
How to store Lamivudine/Zidovudine Mylan
6.
Contents of the pack and other information
1.
WHAT LAMIVUDINE/ZIDOVUDINE MYLAN IS AND WHAT IT IS USED FOR
Lamivudine/Zidovudine Mylan is used to treat HIV (human
immunodeficiency virus) infection in
adults and children.
Lamivudine/Zidovudine Mylan contains two active substances that are
used to treat HIV infection:
lamivudine and zidovudine. Both of these belong to a group of
anti-retroviral medicines called
nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Lamivudine/Zidovudine Mylan does not completely cure HIV infection; it
reduces the amount of
HIV virus in your body, and keeps it at a low level. It also increases
the CD4 cell count in your
blood. CD4 cells are a type of white blood cell that are important in
helping your body to fight
infection.
Not everyone responds to treatment with Lamivudine/Zidovudine Mylan in
the same way. Your
doctor will be monitoring the effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE/ZIDOVUDINE MYLAN
DO NOT TAKE LAMIVUDINE/ZIDOVUDINE MYLAN:
•
If you are a

Karakteristik produk

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Lamivudine/Zidovudine Mylan 150 mg/300 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg lamivudine and 300 mg
zidovudine
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, capsule shaped, biconvex film-coated tablets,
debossed with “M” on the left of the
scoreline and “103” on the right, on one side of the tablet, and
scored on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine/Zidovudine Mylan is indicated in antiretroviral combination
therapy for the treatment of
Human Immunodeficiency Virus (HIV) infection (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_ _
_Adults and adolescents weighing at least 30 kg_
The recommended dose of Lamivudine/Zidovudine Mylan is one tablet
twice daily.
_Children weighing between 21 kg and 30 kg_
The recommended oral dose of Lamivudine/Zidovudine Mylan is one-half
tablet taken in the morning
and one whole tablet taken in the evening.
_Children weighing from 14 kg to 21 kg_
The recommended oral dose of Lamivudine/Zidovudine Mylan is one-half
tablet taken twice daily.
The dosing regimen for paediatric patients weighing 14-30 kg is based
primarily on pharmacokinetic
modelling and supported by data from clinical studies using the
individual components lamivudine
and zidovudine. A pharmacokinetic overexposure of zidovudine can
occur, therefore close safety
monitoring is warranted in these patients. If gastrointestinal
intolerance occurs in patients weighing
21-30 kg, an alternative dosing schedule with one-half tablet taken
thrice daily can be applied in
attempt to improve tolerability.
Lamivudine/Zidovudine Mylan tablets should not be used for children
weighing less than 1