NORVIR Ritonavir 600mg/7.5mL oral liquid bottle

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

ritonavir

Prieinama:

Abbvie Pty Ltd

Autorizacija statusas:

Registered

Pakuotės lapelis

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 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.
It belongs to a group of medicines
called protease inhibitors.
Norvir works by interfering with the
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
Some of the symptoms of an allergic
reaction include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
hives, rash or itching of the skin.
DO NOT TAKE NORVIR IF YOU ARE
CURRENTLY TAKING ANY OF THE
FOLLOWING MEDICINES:
•
alfuzosin hydrochloride
(treatment of Benign Prostatic
Hyperpl

Prekės savybės

Norvir PI
Version 34
6 May 2019
Page 1 of 46
AUSTRALIAN PI – NORVIR
®
RITONAVIR TABLETS AND ORAL SOLUTION
1
NAME OF THE MEDICINE
Ritonavir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ORAL SOLUTION
Norvir oral solution is available for oral administration as 80 mg/mL
of ritonavir in a peppermint and
caramel flavoured vehicle. Each 90mL, 225 mL and 240 mL bottle
contains 7.2, 18.0 and 19.2 grams
of ritonavir, respectively. Norvir oral solution also contains ethanol
(43.2% v/v), propylene glycol,
water, PEG- 35 castor oil, citric acid to adjust pH, saccharin sodium,
peppermint oil, creamy caramel
flavouring and sunset yellow colour (E110).
TABLETS
Norvir film coated tablets are available for oral administration in a
strength of 100mg ritonavir with
the following inactive ingredients: copovidone, calcium hydrogen
phosphate, sorbitan monolaurate,
colloidal anhydrous silica, and sodium stearylfumarate. The following
are the ingredients in the film
coating:
hypromellose,
titanium
dioxide,
macrogol
400,
hydroxypropylcellulose,
purified
talc,
macrogol 3350, colloidal anhydrous silica, and polysorbate 80.
3
PHARMACEUTICAL FORM
Orange-coloured liquid containing 600 mg ritonavir per 7.5 mL marked
dosage cup (80 mg/mL).
Norvir tablets are white film-coated oval tablets debossed with the
corporate Abbott
logo and
the Abbott-Code “NK” providing 100 mg ritonavir.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Norvir is indicated for use in combination with appropriate
antiretroviral agents or as monotherapy
if combination therapy is inappropriate, for the treatment of HIV-1
infection in adults and children
aged 12 years and older.
For persons with advanced HIV disease, the indication for ritonavir is
based on the results for one
study that showed a reduction in both mortality and AIDS defining
clinical events for patients who
Norvir PI
Version 34
6 May 2019
Page 2 of 46
received ritonavir. Median duration of follow-up in this study was 6
months. The clinical benefit from
ritonavir for longer periods of treatment is unk