Isentress

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

Raltegravir potassium

Dostopno od:

Merck Sharp & Dohme Australia Pty Ltd

Razred:

Medicine Listed (Export Only)

Navodilo za uporabo

ISENTRESS™

_raltegravir_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ISENTRESS.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ISENTRESS
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST OR TREATMENTS
OFFICER AT YOUR LOCAL AIDS COUNCIL.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ISENTRESS IS
USED FOR
ISENTRESS is used in combination
with other anti-HIV medicines to
treat adults, adolescents and children
2 years of age and older who are
infected with HIV (Human
Immunodeficiency Virus). The
children and adolescents (2 - 18 years
of age) who participated in the
ISENTRESS studies had previously
taken HIV medicines.
ISENTRESS belongs to a group of
medicines called integrase inhibitors.
It works by blocking HIV integrase,
one of the enzymes that is needed
during the replication process for
HIV to make more virus. When
integrase is blocked by ISENTRESS,
the virus is not able to reproduce
normally. This helps reduce the
amount of virus in the blood.
When used with other anti- HIV
medicines, ISENTRESS helps reduce
the amount of HIV virus in your
blood (called "viral load") and
increase the number of CD4 (T)
cells.
ISENTRESS may not have these
effects in all patients.
ISENTRESS DOES NOT CURE HIV
INFECTION OR AIDS.
It is very important that you stay
under the care of your doctor during
treatment with ISENTRESS.
BEFORE YOU TAKE
ISENTRESS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ISENTRESS IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
raltegravir
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other pa

Lastnosti izdelka

RTG-T-052013  

- 1 - 

PRODUCT INFORMATION 

ISENTRESS
TM

(raltegravir) 

DESCRIPTION 

ISENTRESS
1
 (raltegravir) is an HIV integrase strand transfer inhibitor active against 
the Human Immunodeficiency Virus (HIV-1).  

The  chemical  name  for  raltegravir  potassium  is  _N_-[(4-Fluorophenyl)methyl]-1,6-
dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-
yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide
monopotassium salt. 

The  empirical  formula  is  C
20
H
20
FKN
6
O
5 
and  the  molecular  weight  is  482.51.  The 
structural formula is: 

N
N
H
N
O
H
N
O
O
H
3
C
CH
3
H
3
C
O
N
N
O
H
3
C
F
K

CAS Registry Number: 871038-72-1 

Raltegravir  potassium  is  a  white  to  off-white  powder.  It  is  soluble  in  water,  slightly 
soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in 
isopropanol. The pKa is 6.6 in
water.  The octanol/water partition at pH 7.4 is 2.80. 

ISENTRESS 400 mg Tablet 
Each  film-coated  tablet  of  ISENTRESS  contains  400  mg  of  raltegravir  (as 
potassium  salt  and  the  following  inactive  ingredients:  microcrystalline  cellulose, 
lactose  monohydrate,  calcium  phosphate  dibasic  anhydrous,  hypromellose 2208, 
poloxamer 407  (contains  0.01%  butylated  hydroxytoluene  as  antioxidant),  sodium 
stearyl  fumarate,  magnesium  stearate.  In  addition,  the  film  coating  contains  the 
following  inactive  ingredients:  polyvinyl  alcohol,  titanium  dioxide,  polyethylene 
glycol 3350, talc, red iron oxide and black iron oxide.  

1

TRADEMARK of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,  Whitehouse Station, N.J �