Norvir
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
18-05-2018
Charakterystyka produktu
(SPC)
18-05-2018
Sprawozdanie z oceny publicznego
(PAR)
24-11-2015
Składnik aktywny:
ritonavir
Dostępny od:
AbbVie Deutschland GmbH Co. KG
Kod ATC:
J05AE03
INN (International Nazwa):
ritonavir
Grupa terapeutyczna:
Antivirals for systemic use,
Dziedzina terapeutyczna:
HIV Infections
Wskazania:
Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older).,
Podsumowanie produktu:
Revision: 61
Status autoryzacji:
Authorised
Data autoryzacji:
1996-08-25
Ulotka dla pacjenta
124
B. PACKAGE LEAFLET
125
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORVIR 80 MG/ML ORAL SOLUTION
ritonavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU OR YOUR CHILD.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Norvir is and what it is used for
2.
What you need to know before you or your child takes Norvir
3.
How to take Norvir
4.
Possible side effects
5.
How to store Norvir
6.
Contents of the pack and other information
1.
WHAT NORVIR IS AND WHAT IT IS USED FOR
Norvir contains the active substance ritonavir. Norvir is a protease
inhibitor used to control HIV
infection. Norvir is used in combination with other anti-HIV medicines
(antiretrovirals) to control
your HIV infection. Your doctor will discuss with you the best
combination of medicines for you.
Norvir is used by children 2 years of age or older, adolescents and
adults who are infected with HIV,
the virus which causes AIDS.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKES NORVIR
DO NOT TAKE NORVIR
−
if you are allergic to ritonavir or any of the other ingredients of
Norvir (see section 6).
−
if you have severe liver disease.
−
if you are currently taking any of the following medicines:
−
astemizole or terfenadine (commonly used to treat allergy symptoms –
these medicines
may be available without prescription);
−
amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone,
quinidine (used to
correct irregular heartbeats);
−
dihydroergotamine, ergotamine (used to treat migraine headache);
−
ergonovine, methylergonovine (used to stop exces
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Norvir 80 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 80 mg of ritonavir.
Excipients with known effect:
Alcohol (43.2 % v/v)
Propylene glycol (26.0% v/v)
Polyoxyl 35 Castor Oil
Sunset Yellow (E110)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
The solution is a practically clear, orange solution for oral
administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ritonavir is indicated in combination with other antiretroviral agents
for the treatment of HIV-1
infected patients (adults and children of 2 years of age and older).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ritonavir should be administered by physicians who are experienced in
the treatment of HIV
infection.
Norvir solution is administered orally and should preferably be
ingested with food.
Posology
_Ritonavir dosed as a pharmacokinetic enhancer _
When ritonavir is used as a pharmacokinetic enhancer with other
protease inhibitors the Summary of
Product Characteristics for the particular protease inhibitor must be
consulted.
The following HIV-1 protease inhibitors have been approved for use
with ritonavir as a
pharmacokinetic enhancer at the noted doses.
_Adults _
Amprenavir 600 mg twice daily with ritonavir 100 mg twice daily.
Atazanavir 300 mg once daily with ritonavir 100 mg once daily.
Fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily.
Lopinavir co-formulated with ritonavir (lopinavir/ritonavir) 400
mg/100 mg or 800 mg/200 mg.
Saquinavir 1000 mg twice daily with ritonavir 100 mg twice daily in
ART experienced patients.
Initiate treatment with saquinavir 500 mg twice daily with ritonavir
100 mg twice daily for the
3
first 7 days, then saquinavir 1000 mg twice daily with ritonavir 100
mg twice daily in ART-
naïve patients.
Tipranavir 500 mg twice daily with ritonavir 200 mg twice daily.
Tipranavir with ritonavir
should not be used in treatment-naïve pati
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