Ritonavir Mylan
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
10-01-2024
Fachinformation
(SPC)
10-01-2024
Öffentlichen Beurteilungsberichts
(PAR)
20-11-2017
Wirkstoff:
ritonavir
Verfügbar ab:
Mylan S.A.S
ATC-Code:
J05AE03
INN (Internationale Bezeichnung):
ritonavir
Therapiegruppe:
Antivirals for systemic use
Therapiebereich:
HIV Infections
Anwendungsgebiete:
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).
Produktbesonderheiten:
Revision: 14
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-11-09
Gebrauchsinformation
52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE USER
RITONAVIR MYLAN 100 MG FILM-COATED TABLETS
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. 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 Ritonavir Mylan is and what it is used for
2.
What you need to know before you or your child takes Ritonavir Mylan
3.
How to take Ritonavir Mylan
4.
Possible side effects
5.
How to store Ritonavir Mylan
6.
Contents of the pack and other information
1.
WHAT RITONAVIR MYLAN IS AND WHAT IT IS USED FOR
Ritonavir Mylan contains the active substance ritonavir. Ritonavir is
a protease inhibitor used to
control HIV infection. Ritonavir 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.
Ritonavir Mylan 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 RITONAVIR MYLAN
DO NOT TAKE RITONAVIR MYLAN
-
if you are allergic to ritonavir or any of the other ingredients of
this medicine (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
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ritonavir Mylan 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of ritonavir.
Excipient with known effect
Each film-coated tablet contains 87.75 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Yellow, capsule shaped, biconvex, beveled edge film-coated tablet,
approximately 19.1 mm x
10.2 mm, debossed with ‘M163’ on one side and blank on the other
side.
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 Mylan should be administered by physicians who are
experienced in the treatment of HIV
infection.
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 1,000 mg twice daily with ritonavir 100 mg twice daily in
antiretroviral treatment (ART)
experienced patients.
Initiate treatment with saquinavir 500 mg twice daily with ritonavir
100 mg twice daily for the first
7 days, then saquinavir 1,000 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 tr
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