DOLUTEGRAVIR SODIUM TABLET FOR ORAL SUSPENSION Film Coated Tablet 10

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Dolutegravir Sodium

Available from:

Macleods Pharmaceuticals Limited, INDIA

ATC code:

DIRECT ACTING ANTIVIRALS

INN (International Name):

Dolutegravir Sodium

Dosage:

10

Pharmaceutical form:

Film Coated Tablet

Manufactured by:

Macleods Pharmaceuticals Limited, INDIA

Product summary:

Physical description: Pink colored, capsule shaped, film coated tablets, debossed “K” and “1” separated by breakline on one side and breakline on other side; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)

Authorization status:

Registered/Compliant

Authorization date:

2022-09-21

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Dolutegravir Sodium 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains 10 mg dolutegravir (as sodium).
_Excipients with known effect: _
Each dispersible tablet also contains 29 mg of mannitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersible tablets.
Pink-coloured, capsule-shaped, film-coated tablet debossed with
‘K’ and ‘1’ and separated by a
break-line on one side and another break-line on the other side.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Dolutegravir Sodium is indicated, in combination with other
antiretroviral medicines, for the
treatment of human immunodeficiency virus (HIV) infection in children
at least 4 weeks of age or
older and weighing at least 3 kg.
Consideration should be given to the most recent official treatment
guidelines for HIV-1 infection,
e.g. those issued by WHO.
For use of antiretroviral agents for post-exposure prophylaxis the
most recent official guidelines
(e.g. those issued by WHO) should be consulted.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Dolutegravir Sodium should be prescribed by a health care provider
experienced in the management
of HIV infection.
_POSOLOGY _
_Children weighing from 3 to 25 kg _
The dose of dolutegravir for children at least 4 weeks of age and
weighing from 3 to 25 kg is
based on the child’s weight as shown in the table below. In the
presence of integrase inhibitor
resistance, there are insufficient data to recommend a dose for
dolutegravir in children.
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DOSE RECOMMENDATIONS FOR CHILDREN WEIGHING FROM 3 TO 25 KG
*For patients weighing at least 20 kg, the film-coated tablets
containing 50 mg of dolutegravir are
preferred. However, patients weighing between 20 and 25 kg who are
unable to swallow tablets
can take 30 mg (3 tablets) of dolutegravir dispersible tablets
instead. The dolutegravir dispersible
tablets
and
dolutegravir
film-coated
tablets
are
not
bi