Norvir

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

Ritonavir

Disponibbli minn:

Abbvie Pty Ltd

Klassi:

Medicine Registered

Fuljett ta 'informazzjoni

NORVIR
®

_ritonavir (ri-TO-na-veer)_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Norvir.
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 or pharmacist
has weighed the risks of you taking
this medicine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NORVIR IS USED
FOR
Norvir is used to treat HIV (Human
Immunodeficiency Virus) infections.
This medicine belongs to a group of
medicines called protease inhibitors.
Norvir works by inhibiting or
interfering with the protease enzyme
that the HIV virus needs to infect
new cells. It may be given alone or
with certain other anti-HIV
medicines. Your doctor will
determine which medicines are best
for you.
Norvir has not been shown to
decrease the chance of transmitting
HIV to a sexual partner. You must
continue to use safe sexual practices
(e.g. condoms) while taking Norvir.
Ask your doctor or pharmacist if you
have any questions about why it has
been prescribed for you.
Your doctor may have prescribed it
for another purpose.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 12
years.
BEFORE YOU TAKE NORVIR
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NORVIR IF YOU HAVE AN
ALLERGY TO:
•
ANY MEDICINE CONTAINING
(RITONAVIR)
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
•
YOU ARE CURRENTLY TAKING ANY OF
THE MEDICATIONS LISTED UNDER THE
SECTION "TAKING OTHER
MEDICINES"
If Norvir is taken with other
antiretroviral medicines, it is
important that you also carefully read
the leaflets that are provided with
these medicines. There may be
additional information in those

Karatteristiċi tal-prodott

_Norvir PI  _
_Version 22  _
_2 October 2012 _
_Page 1 of 29  _

PRODUCT INFORMATION 
NORVIR

 TABLETS AND ORAL SOLUTION 

NAME OF THE MEDICINE 
Ritonavir 80 mg/mL oral solution 
Ritonavir 100mg film coated tablets 

CHEMICAL STRUCTURE 
Ritonavir is chemically designated as 10-Hydroxy-2-methyl-5-(1-methylethyl) -1-[2-(1-methylethyl)-
4-thiazolyl]-3,  6-dioxo-8,  11-bis  (phenylmethyl)-2,  4,  7,  12-  tetraazatridecan-13-oic  acid,  5-
thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)].  Ritonavir has the following
structural formula:  

CAS NUMBER 
155213-67-5 
MOLECULAR WEIGHT 
720.95 
MOLECULAR FORMULA 
C
37
H
48
N
6
O
5
S
2

DESCRIPTION 
Ritonavir is a white to light tan powder.  Ritonavir has a bitter metallic taste.  It is freely soluble in 
methanol and ethanol, soluble
in isopropanol and practically insoluble in water.  

Norvir oral solution is available for oral administration as 80 mg/mL of ritonavir in a peppermint and 
caramel  flavoured  vehicle.    Each  240  mL  bottle  contains  7.2  and  19.2  grams  of  ritonavir, 
respectively.  Norvir oral solution also contains ethanol (43.2% v/v), propylene glycol, water, PEG- 
35 castor oil, anhydrous citric acid to adjust pH, saccharin sodium, peppermint oil, creamy caramel 
flavouring and sunset yellow colour (E110).  

Norvir film coated tablets are available for oral administration in a strength of 100mg ritonavir with 
the following  inactive  ingredients:    copovidone,  calcium  hydrogen  phosphate  anhydrous,  sorbitan 
monolaurate,  silica  -  colloidal  anhydrous,  and  sodium  stearylfumarate.  The  following  are  the 
ingredients 
in 
the 
film 
coating: 
hypromellose, 
titanium 
dioxide, 
macrogol 
400, 
hydroxypropylcellulose,  talc  -  purified, macrogol 3350,