MYLTEGA (Dolutegravir Film Coated Tablets 50mg)

Šalis: Malaizija

kalba: anglų

Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Veiklioji medžiaga:

Dolutegravir Sodium

Prieinama:

MYLAN HEALTHCARE SDN. BHD.

INN (Tarptautinis Pavadinimas):

Dolutegravir Sodium

Vienetai pakuotėje:

30 Tablets

Pagaminta:

Mylan Laboratories Limited

Pakuotės lapelis

MYLTEGA (DOLUTEGRAVIR FILM COATED
TABLETS 50MG)
Dolutegravir (50mg)
1
Consumer Medication Information Leaflet (RIMUP)
WHAT IS IN THIS LEAFLET
1.
What Myltega is used for
2.
How Myltega works
3.
Before you use Myltega
4.
How to use Myltega
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Myltega
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT MYLTEGA IS USED FOR
Myltega contains the active
ingredient dolutegravir 50 mg
(as 52.6 mg dolutegravir
sodium) which is an
antiretroviral medicine known
as an integrase inhibitor (which
inhibit the reproduction of
retroviruses such as HIV).
Myltega is used for the
treatment of human
immunodeficiency virus (HIV)
infection in combination with
other antiretroviral agents
(inhibit the reproduction of
retroviruses) in adults and
children over 12 years of age.
HOW MYLTEGA WORKS
Myltega 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 Myltega in the
same way. Your doctor will
monitor the effectiveness of
your treatment.
Myltega is always used in
combination with other anti-
retroviral medicines
(combination therapy). To
control your HIV infection, and
to stop your illness from
getting worse, you must keep
taking all your medicines,
unless your doctor tells you to
stop taking any.
BEFORE YOU USE MYLTEGA
_-When you must not use it _
Don’t use Myltega
• If you are allergic to
dolutegravir or any of the other
ingredients of this medicine.
• In combination with the
medicine dofetilide or
pilsicainide (to treat heart
conditions), or fampridine (also
known as dalfampridine; used
in multiple sclerosis).
If you think this applies to you,
don’t use Myltega until you
have checked with your doctor.
Myltega should not be used in
children

Prekės savybės

MYLTEGA
DOLUTEGRAVIR TABLETS
50MG
1. NAME OF THE MEDICINAL PRODUCT
MYLTEGA (Dolutegravir Tablets 50mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 52.6mg dolutegravir sodium equivalent
to 50mg dolutegravir.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
A pink, film-coated, round, biconvex, bevelled edge tablet debossed
with M on one side of the tablet and DT5
on the other side.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MYLTEGA 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
MYLTEGA 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.
MYLTEGA 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 aged 12 and above
In adolescents (12 to less than 18 years of age and weighing at least
40 kg) infected with HIV-1 without
resistance to the integrase class, the recommended dose of
dol