Norvir

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Ritonavir 100mg

Dostupné z:

AbbVie Limited

INN (Medzinárodný Name):

Ritonavir 100 mg

Dávkovanie:

100 mg

Forma lieku:

Film coated tablet

Zloženie:

Active: Ritonavir 100mg Excipient: Calcium hydrogen phosphate Colloidal silicon dioxide Copovidone Opadry white 16B18449 Sodium stearyl fumarate Sorbitan laurate

Počet v balení:

Bottle, plastic, HDPE 60 ml bottle, Polyethylene cap, 30 tablets

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

AbbVie S.r.l

Terapeutické indikácie:

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 received ritonavir. Median duration of follow-up in this study was 6 months. The clinical benefit from ritonavir for longer periods of treatment is unknown. For persons with less advanced disease, the indication is based on changes in surrogate markers in controlled trials of up to 16 weeks duration.

Prehľad produktov:

Package - Contents - Shelf Life: Bottle, plastic, HDPE 60 ml bottle, Polyethylene cap - 30 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE 60 ml bottle, PP cap - 30 tablets - 24 months from date of manufacture stored at or below 30°C

Dátum Autorizácia:

2008-12-15

Príbalový leták

Norvir® CMI - VERSION 26 - 7 DECEMBER 2023
1
NORVIR®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or
pharmacist.
1.
WHY AM I TAKING NORVIR?
Norvir contains the active ingredient ritonavir.
Norvir is used to treat HIV (Human Immunodeficiency Virus) infection.
For more information, see Section 1. Why am I taking Norvir? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE NORVIR?
Check the list of ingredients at the end of the CMI. Do not take
Norvir if you have ever had an allergic reaction to any of them.
TALK TO YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE IF HE/SHE IS NOT
AWARE THAT YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I take
Norvir? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Norvir and affect how it works,
while Norvir may interfere with other medicines and affect
how they work.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE NORVIR?

Take six tablets in the morning and six tablets in the evening every
day

The six tablets in each dose should be taken together. Do not break,
crush, or chew the tablets. Swallow them whole with a
full glass of water.

Take Norvir during a meal or immediately after a meal.
More instructions can be found in Section 4. How do I take Norvir? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING/USING [MEDICINE NAME]?
THINGS YOU
SHOULD DO

If you have diabetes, monitor your sugar levels regularly

Remind any doctor, dentist, or pharmacist you visit that you are
taking Norvir.
THINGS YOU
SHOULD NOT DO

Do not stop taking this medicine, or change the dose unless your
doctor tells you to.

Do not give this medicine to a child younger than 12 years of age.
DRIVING OR USING
MACHINES

Do not

Súhrn charakteristických

Norvir Data Sheet
Version 37
17 January 2024
Page 1 of 37
NEW ZEALAND DATA SHEET
1. NORVIR 100 MG TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg ritonavir. For the full list
of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White film-coated oval tablets debossed with “NK” on one side.
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
received ritonavir. Median duration of follow-up in this study was 6
months. The clinical benefit from
ritonavir for longer periods of treatment is unknown. For persons with
less advanced disease, the
indication is based on changes in surrogate markers in controlled
trials of up to 16 weeks duration
(see section 5.1 Pharmacodynamic properties).
4.2
Dose and method of administration
General Dosing Guidelines
Prescribers should consult the full product information and clinical
study information of protease
inhibitors if they are co-administered with a reduced dose of
ritonavir.
The recommended dose of Norvir is 600 mg (six tablets) twice daily by
mouth, and should be given
with food.
Norvir tablets should be swallowed whole and not chewed, broken or
crushed.
Paediatric population
Ritonavir has not been studied in patients below the age of 12 years;
hence the safety and efficacy
of ritonavir in children below the age of 12 have not been
established.
Norvir Data Sheet
Version 37
17 January 2024
Page 2 of 37
4.3
Contraindications
Norvir is contraindicated in patients with known hypersensitivity to
ritonavir or any of the excipients
listed in section 6.1.
When co-administering ritonavir with other protease inhibitors