Dolutegravir Film Coated Tablet 10

Land: Tanzania

Sprog: engelsk

Kilde: Tanzania Medicinces & Medical Devices Authority

Aktiv bestanddel:

Dolutegravir Sodium

Tilgængelig fra:

Macleods Pharmaceuticals Limited, INDIA

INN (International Name):

Dolutegravir Sodium

Dosering:

10

Lægemiddelform:

Film Coated Tablet

Fremstillet af:

Macleods Pharmaceuticals Limited, INDIA

Produkt oversigt:

Physical description: Pink colored, caplet shaped, film coated tablets, debossed “K” and “1” separated by breakline on one side and breakline on other side; Local technical representative: Barnabas Maganga Shija (3292)

Autorisation status:

Registered/Compliant

Autorisation dato:

2022-01-10

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
Dolutegravir Sodium Tablet for Oral Suspension (Dispersible Tablets)
10mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains:
Dolutegravir Sodium equivalent to Dolutegravir 10 mg
_For excipients see point 6.1 _
3.
PHARMACEUTICAL FORM
Film coated dispersible tablet
Pink colored, caplet shaped, film coated tablets, debossed “K” and
“1” separated by breakline
on one side and breakline on other side
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Dolutegravir Sodium Tablet for Oral Suspension (Dispersible Tablets)
10mgare indicated in
combination with other antiretroviral agents for the
treatment
of
human immunodeficiency
virus type 1 (HIV-1) infection in adults (treatment-naïve or -
experienced) and in paediatric
patients (treatment-naïve or experienced but integrase strand
transfer inhibitor [INSTI]-naïve)
aged at least 4 weeks and weighing at least 3 kg_. This product is
intended for use in children. _
_Nonetheless, safety information is provided with respect to adult
health issues, to allow full _
_access to all relevant information. _
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Recommended Dosage in Paediatric Patients Weighing 3 to 14 kg
The recommended weight-based dosage of Dolutegravir Sodium Tablet for
Oral Suspension
(Dispersible Tablets) 10mg in paediatric patients weighing 3 to 14 kg
(4 weeks and older,
treatment-naïve or treatment-experienced but naïve to INSTI
treatment) is described in below
Table 1. Do not use Dolutegravir tablets in patients weighing 3 to 14
kg.
Table
1:
Recommended
Dosage
of
Dolutegravir
Sodium
Tablet
for
Oral
Suspension
(Dispersible Tablets) 10mg in Paediatric Patients 4 Weeks and Older
Weighing 3 to 14 kg
BODY WEIGHT
DOLUTEGRAVIR
SODIUM TABLET
FOR
ORAL
SUSPENSION
(DISPERSIBLE TABLETS) 10 MG
DAILY DOSE
A
NUMBER OF 10 MG TABLETS
3 kg to less than 6 kg
5mg once daily
0.5
6 kg to less than 10 kg
15mg once daily
1.5
10 kg to less than 14 kg
20mg once daily
2
a
If certa