DOVATO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DOLUTEGRAVIR AS SODIUM; LAMIVUDINE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J05AR25

Pharmaceutical form:

FILM COATED TABLETS

Composition:

LAMIVUDINE 300 MG; DOLUTEGRAVIR AS SODIUM 50 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

VIIV HEALTHCARE UK LIMITED, UK

Therapeutic area:

LAMIVUDINE AND DOLUTEGRAVIR

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.

Authorization date:

2020-08-26

Patient Information leaflet

نولوانتي نيذلا صاخشلأا ىدل عئاش ريغ
لعف در اذه ربتعي
.)صخش 100 نيب نم 1 ىتح ىدل رهظي دق(
ريڤارچيتولود
:ةيلاتلا ضارعلأا نم دحاو كيدل روطت لاح
يف
يدلج حفط •
ةنوخس •
_)قاهرإ(_
ةيويح ةلق •
ببسي يذلا ،
_)ةيئاعو ةمذو(_
مفلا وأ هجولا يف
ً
انايحأ ،خافتنإ
•
سفنتلا يف ةبوعص
.لصافملا وأ تلاضعلا يف ملاآ
•
ءارجإ ىلع ررقي نأ كبيبط نأش نم .بيبطلا
ىلإ
ً
لااح هجوت
←
نأ هنأش نمو ،كيدل مدلا وأ ىلكلا ،دبكلا
رابتخلإ تاصوحف
.وتاڤود لوانت نع فقوتلاب كيصوي
ً
ادج ةعئاش ةيبناج ضارعأ
:صاخشأ 10 نيب نم 1 نم رثكأ ىدل رهظت دق هذه
عادص •
لاهسإ
•
.نايثغ •
ةعئاش ةيبناج ضارعأ
:صاخشأ 10 نيب نم 1 ىتح ىدل رهظت دق هذه
)تاذلا ريدقت مدعو قيمع نزحب روعشلا(
بائتكإ
•
حفط •
_)pruritus(_
ةكح •
ؤيقت •
نطبلا يف جاعزنإ وأ نطبلا يف ملأ
•
نزولا يف ةدايز •
_)ةخفن(_
تازاغ •
راود •
ساعن •
قرأ
•
ةذاش ملاحأ
•
_)قاهرإ(_
ةيويحلا ةلق •
رعشلا طقاست •
قلق •
لصافملا يف ملأ
•
.تلاضعلا يف ملأ
•
:مدلا صوحف يف رهظت نأ اهنأش نم يتلا
ةعئاش ةيبناج ضارعأ
_)aminotransferases(_
دبكلا تاميزنإ ةبسن عافترإ
•
تلاضعلا
يف
جتن
ُ
ت
يتلا
تاميزنلإا
ةبسن
عافترإ
•
_.)creatine phosphokinase(_
ةعئاش ريغ ةيبناج ضارعأ
:صخش 100 نيب نم 1 ىتح ىدل رهظت دق هذه
_)hepatitis(_
دبكلا باهتلإ
•
يف مهيدل ناك نيذلا نيجلاعتملا ىدل
ةصاخ( راحتنلإا ةلواحم
•
)ةيسفنلا ةحصلا

Summary of Product characteristics

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