Instgra tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dolutegravir (dolutegravir sodium)

Available from:

Emcure Pharmaceuticals Ltd.

ATC code:

J05AJ03

INN (International Name):

dolutegravir (dolutegravir sodium)

Dosage:

50mg

Pharmaceutical form:

tablets film-coated

Units in package:

N30in plastic container, N90in plastic container, N180 in plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-04-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INSTGRA
50 mg film-coated tablets
_Dolutegravir (as sodium)_
This medicine is subject to additional monitoring. This will allow
quick identification of new safety information.
You can help by reporting any side effects you may get.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU (OR YOUR CHILD, IF THEY
ARE THE PATIENT) START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you (or your child, if they are
the patient) only. Do not pass it
on to others. It may harm them, even if their signs of illness are the
same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Instgra is and what it is used for
2.
What you need to know before you take Instgra
3.
How to take Instgra
4.
Possible side effects
5.
How to store Instgra
6.
Contents of the pack and other information
1.
WHAT INSTGRA IS AND WHAT IT IS USED FOR
Instgra contains the active ingredient dolutegravir. Dolutegravir
belongs to a group of anti-retroviral
medicines called
_integrase inhibitors (INIs)_
.
Instgra is used to treat
HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
in adults, adolescents and children
of at least 6 years of age or older, and who weigh at least 14 kg.
Instgra does not cure HIV infection; it reduces the amount of virus in
your body, and keeps it at a low level.
As a result of that, it also increases the CD4 cell count in your
blood. CD4 cells are a type of white blood
cells that are important in helping your body to fight infection.
Not everyone responds to treatment with Instgra in the same way. Your
doctor will monitor the effectiveness
of your treatment.
Instgra is always used in combination with other anti-retroviral
medicines (
_combination therapy_
).
To control your HIV infec

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Instgra
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Dolutegravir sodium equivalent to 50
mg dolutegravir.
Excipients with known effects: this product contains Mannitol.
Quantity of Mannitol present in per
tablet is 184.4 mg;
the amount of Sodium content in a tablet is 3.95 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets.
Blue, round shaped, film-coated tablets debossed with “HP” on one
side and “526” on another side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Instgra is indicated in combination with other anti-retroviral
medicinal products for the treatment of
Human Immunodeficiency Virus (HIV) infected adults, adolescents and
children of at least 6 years
of age or older and weighing at least 14 kg.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Instgra
should be prescribed by physicians experienced in the management of
HIV infection.
Posology
_Adults_
_Patients infected with HIV-1 without documented or clinically
suspected resistance to the integrase_
_ _
_class_
The recommended dose of dolutegravir is 50 mg (one tablet) orally once
daily.
Instgra should be administered twice daily in this population when
co-administered with some
medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or
rifampicin). Please refer to section 4.5.
_Patients infected with HIV-1 with resistance to the integrase class
(documented or clinically_
_ _
_suspected) _
The recommended dose of dolutegravir is 50 mg (one tablet) twice
daily.
In the presence of documented resistance that includes Q148 +
≥
2 secondary mutations from
G140A/C/S, E138A/K/T, L74I, modelling suggests that an increased dose
may be considered for
patients with limited treatment options (less than 2 active agents)
due to advanced multi class
resistance (see section 5.2).
The decision to use dolutegravir for such patients should be informed
by the integrase resistance
pattern (see section 5.1).
_Adolescents