DOVATO

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DOLUTEGRAVIR AS SODIUM; LAMIVUDINE

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

J05AR25

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

LAMIVUDINE 300 MG; DOLUTEGRAVIR AS SODIUM 50 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

VIIV HEALTHCARE UK LIMITED, UK

المجال العلاجي:

LAMIVUDINE AND DOLUTEGRAVIR

الخصائص العلاجية:

Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine and viral load ≤500,000 c/mL.

تاريخ الترخيص:

2020-08-26

نشرة المعلومات

نولوانتي نيذلا صاخشلأا ىدل عئاش ريغ
لعف در اذه ربتعي
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ريڤارچيتولود
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يف
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ةنوخس •
_)قاهرإ(_
ةيويح ةلق •
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_)ةيئاعو ةمذو(_
مفلا وأ هجولا يف
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انايحأ ،خافتنإ
•
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.لصافملا وأ تلاضعلا يف ملاآ
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ادج ةعئاش ةيبناج ضارعأ
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عادص •
لاهسإ
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ةعئاش ةيبناج ضارعأ
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•
:مدلا صوحف يف رهظت نأ اهنأش نم يتلا
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دبكلا باهتلإ
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ةصاخ( راحتنلإا ةلواحم
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)ةيسفنلا ةحصلا

خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
Dovato
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains dolutegravir sodium equivalent to 50
mg dolutegravir and 300 mg
lamivudine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet.
Oval, biconvex, white, film coated tablet, approximately 18.5 x 9.5
mm,
debossed with “SV 137” on one face
.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dovato is indicated for the treatment of Human Immunodeficiency Virus
type 1 (HIV-1) infection in adults
and adolescents above 12 years of age weighing at least 40 kg, with no
known or suspected resistance to the
integrase inhibitor class, or lamivudine and viral load
≤
500,000 c/mL (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dovato should be prescribed by physicians experienced in the
management of HIV infection.
_ _
Posology
_Adults and adolescents (above 12 years of age weighing at least 40_
_kg). _
_ _
The recommended dose of Dovato in adults and adolescents is one 50
mg/300 mg tablet once daily.
_Dose adjustments _
A separate preparation of dolutegravir is available where a dose
adjustment is indicated due to drug-drug
interactions (e.g. rifampicin, carbamazepine, o
xcarbazepine, phenytoin, phenobarbital, St. John’s wort,
etravirine (without boosted protease inhibitors), efavirenz,
nevirapine, or tipranavir/ritonavir, see sections 4.4
and 4.5). In these cases the physician should refer to the individual
product information for dolutegravir.
_Missed doses _
If the patient misses a dose of Dovato, the patient should take Dovato
as soon as possible, providing the next
dose is not due within 4 hours. If the next dose is due within 4
hours, the patient should not take the missed
dose and simply resume the usual dosing schedule.
_Elderly _
There are limited data available on the use of Dovato in patients aged
65 years and over. No dose adjustment
is necessary (see section 5.2).
_ _
_Renal impairment _
Page 2 of 26
Dovato is not recommended for use i