EPIVIR 300 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LAMIVUDINE

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

J05AF05

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

LAMIVUDINE 300 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND

المجال العلاجي:

LAMIVUDINE

الخصائص العلاجية:

Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children. 28/10/2018 בקשה לשינוי משטר מינון

تاريخ الترخيص:

2016-04-12

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician's prescription only
Epivir 150 mg
Film-coated tablets
Each tablet contains Lamivudine 150 mg
Epivir 300 mg
Film-coated tablets
Each tablet contains Lamivudine 300 mg
For the list of the inactive and allergenic ingredients in the
medicine, see section 2 –
“Important information about some of the ingredients in the
medicine” and section 6 –
“Additional information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Epivir is used to treat HIV infection (human immunodeficiency virus)
in adults and
children.
Therapeutic group: The active ingredient in Epivir is lamivudine.
Epivir is a type of
medicine known as an anti-retroviral. It belongs to a group of
medicines called
nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Epivir does not completely cure HIV infection; it reduces the amount
of 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 cells that are important in
helping your body to
fight infection.
Not everyone responds to treatment with Epivir in the same way. Your
physician will
monitor the effectiveness of your treatment.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• you are sensitive (allergic) to lamivudine or to any of the
additional ingredients
contained in this medicine (listed in section 6).
→ Tell your physician if you think any of these may apply to you.
Special warnings regarding use of the medicine
Some people taking Epivir or other combination treatments for HIV are
more at risk of
serious si

خصائص المنتج

Page 1 of 16
EPIVIR 150 MG
EPIVIR
300 MG
1.
NAME OF THE MEDICINAL PRODUCT
Epivir 150 mg
Epivir 300 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Epivir 150 mg
Each film-coated tablet contains 150 mg lamivudine.
Epivir 300 mg
Each film-coated tablet contains 300 mg lamivudine
Excipient(s) with known effect:
Each 150 mg tablet contains 0.378 mg sodium.
Each 300 mg tablet contains 0.756 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Epivir 150 mg
Film-coated tablet
White, diamond shaped scored tablets engraved with “GX CJ7” on
both faces.
Epivir 300 mg
Film-coated tablet
Grey, diamond shaped and engraved with “GX EJ7” on one face
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epivir is indicated as part of antiretroviral combination therapy for
the treatment of Human
Immunodeficiency Virus (HIV) infected adults and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The therapy should be initiated by a physician experienced in the
management of HIV
infection.
Epivir may be administered with or without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing.
_ _
Page 2 of 16
Epivir is also available as an oral solution for children over three
months of age and who
weigh less than 14 kg or for patients who are unable to swallow
tablets (see section 4.4).
Patients changing between lamivudine oral solution and lamivudine
tablets should follow the
dosing recommendations that are specific for the formulation (see
section 5.2)
Alternatively, for patients who are unable to swallow tablets, the
tablet(s) may be crushed and
added to a small amount of semi-solid food or liquid, all of which
should be consumed
immediately (see section 5.2).
_Adults, adolescents and children (weighing at least 25 kg): _
_ _
The recommended dose of Epivir is 300 mg daily. This may be
administered as either 150 mg
twice daily or 300 mg once daily (see section 4.4).
The 300 mg tablet is only suitable for the once a day regimen.
_Children (weighi