Dolutegravir Tablets 50mg Oral tablet

국가: 탄자니아

언어: 영어

출처: Tanzania Medicinces & Medical Devices Authority

유효 성분:

Dolutegravir Tablets 50mg

제공처:

Hetero Laboratories Limited, INDIA

INN (International Name):

Dolutegravir Tablets 50mg

복용량:

50

약제 형태:

Oral tablet

Manufactured by:

HETERO LABS LIMITED (UNIT V), INDIA

제품 요약:

Physical description: Pink, round, biconvex, film coated tablets debossed with 'H' on one side 'D13' on the other side; Local technical representative: KAS MEDICS LIMITED

승인 상태:

Registered/Compliant

승인 날짜:

2021-10-09

제품 특성 요약

PRESCRIBING INFORMATION (SUMMARY OF PRODUCTS CHARACTERISTICS)
1. NAME OF THE MEDICINAL PRODUCT
Dolutegravir Tablets 50 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains Dolutegravir Sodium equivalent to 50
mg of Dolutegravir
Excipients: Microcrystalline cellulose, USP/NF (Avicel PH 101)
#
, Mannitol, USP (Monnogem
Powder), Sodium Starch Glycolate, USP/NF (Primojel ), Povidone, USP
(Kollidon 30), Sodium
Stearyl fumarate, USP/NF, Opadry II Pink 85F540088,Purified water
IHS/USP/Ph.Eur.
3. PHARMACEUTICAL FORM DOSAGE FORM: TABLETS.
Description: Pink, round, biconvex, film coated tablets debossed with
‘H’ on one side and ‘D 13’
on the other side.
4. CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
Dolutegravir is indicated in combination with other anti-retroviral
medicinal products for the
treatment of Human Immunodeficiency Virus (HIV) infected adults and
adolescents above 12
years of age.
4.2.POSOLOGY AND METHOD OF ADMINISTRATION
Dolutegravir should be prescribed by physicians experienced in the
management of HIV
infection.
Posology
Pregnancy Testing before Initiation of Dolutegravir Tablets
Perform pregnancy testing before initiation of dolutegravir tablets in
adolescents and adults of
childbearing potential
Adults
Dolutegravir tablets may be taken with or without food.
Table 1. Dosing Recommendations for Dolutegravir Tablets in Adult
patients
Hetero Labs Limited
Page
of 143
17
a
Rilpivirine dose is 25 mg once daily for those switching to
dolutegravir plus rilpivirine.
b
Alternative combinations that do not include metabolic inducers should
be considered where
possible.
Pediatric Patients
Dolutegravir tablets may be taken with or without food.
Treatment-Naïve or Treatment-Experienced INSTI-Naïve
The recommended dose of dolutegravir tablets in pediatric patients
weighing at least 30 kg is
provided in Table 2.
Table 2. Dosing Recommendations for Dolutegravir Tablets in Pediatric
Patients Weighing at
Least 30 kg
a
If certain UGT1A or CYP3A inducers are coadministered, then incre