RETROVIR CAPSULES 250 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ZIDOVUDINE

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

J05AF01

الشكل الصيدلاني:

CAPSULES

تركيب:

ZIDOVUDINE 250 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

S.C. EUROPHARM S.A., ROMANIA

المجموعة العلاجية:

ZIDOVUDINE

المجال العلاجي:

ZIDOVUDINE

الخصائص العلاجية:

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.

تاريخ الترخيص:

2013-02-28

نشرة المعلومات

ץרמ
2019 :ןודנה ריבורטר תולוספק
250
ג"מ
CAPSULES 250 MG
RETROVIR
ה/דבכנ ה/אפור
,ה/דבכנ ת/חקור
( מ"עב לארשי ןיילקתימסוסקלג תרבח
GSK
ולעה ןוכדע לע עידוהל תשקבמ )
ן
לש אפורל
רישכתה
RETROVIR CAPSULES 250MG
.
.םינונימה ףיעסל עגונ ןוכדעה
ןונימה רטשמב יונישב רבודמ אל
מב שומיש לע שגדב קר הלא ,
לש תותנש( רתוי ןטק קרז
0.1
)ל"מ
.םידוליב
ולעב .אפורל ןולעב םייתוהמה םייונישה
םילולכ וז העדוהב
ן
.םיפסונ םייוניש םנשי
:םקזוחו םיליעפ םיביכרמ
Zidovudine – 250mg :לארשיב רישכתל המושרה היוותה
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.
ע
: אפורל ןולעב םיאבה םיפיעסב ושענ
םייתוהמ םינוכד
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.
WEIGHT
(KG)
IN THE MORNING
IN THE EVENING
DAILY
DOSE
(MG)
8-13
one 100 mg capsule
one 100 mg capsule
200
14-21
one 100 mg capsule
two 100 mg capsules
300
22-30
two 100 mg capsules
two 100 mg capsules
400
Alternatively children weighing at least 28 kg to 30 kg (included)
could take:
28-30
one 250 mg capsule
one 250 mg capsule
500
Oral solution is available for dosin

خصائص المنتج

Page
1
of
15
_ _
_The format of this leaflet was determined by the Ministry of Health
and its content _
_was checked and approved by the Ministry of Health in August 2017 and
updated _
_according to the guidelines of the Ministry of Health in February
2019_
_ _
_ _
RETROVIR CAPSULES 250 MG
1.
NAME OF THE MEDICINAL PRODUCT
Retrovir 250 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg zidovudine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard
Hard gelatin capsules with opaque blue cap and opaque white body coded
GSJV2.
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.
WEIGHT
(KG)
IN THE MORNING
IN THE EVENING
DAILY
DOSE
(MG)
8-13
one 100 mg capsule
one 100 mg capsule
200
Page
2
of
15
14-21
one 100 mg capsule
two 100 mg capsules
300
22-30
two 100 mg capsules
two 100 mg capsules
400
Alternatively children weighing at least 28 kg to 30 kg (included)
could take:
28-30
one 250 mg capsule
one 250 mg capsule
500
Oral solution is available for dosing children less than 8 kg and for
those children above 8 kg
unable to swallow capsules (see Oral Solution SPC).
_Dosage in the prevention of maternal-foetal transmission:_
Pregnant women (over 14 wee