Ritonavir Accord 100mg film-coated tablets

מדינה: מלטה

שפה: אנגלית

מקור: Malta Medicines Authority

מרכיב פעיל:

RITONAVIR

זמין מ:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

קוד ATC:

J05AE03

INN (שם בינלאומי):

RITONAVIR 100 mg

טופס פרצבטיות:

FILM-COATED TABLET

הרכב:

RITONAVIR 100 mg

סוג מרשם:

POM

איזור תרפויטי:

ANTIVIRALS FOR SYSTEMIC USE

מצב אישור:

Withdrawn

תאריך אישור:

2017-08-18

עלון מידע

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
RITONAVIR ACCORD 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 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 Ritonavir Accord is and what it is used for
2.
What you need to know before you or your child takes Ritonavir Accord
3.
How to take Ritonavir Accord
4.
Possible side effects
5.
How to store Ritonavir Accord
6.
Contents of the pack and other information
1.
WHAT RITONAVIR ACCORD IS AND WHAT IT IS USED FOR
Ritonavir Accord 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 Accord 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 ACCORD
DO NOT TAKE RITONAVIR ACCORD
-
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 (us

מאפייני מוצר

Page 1 of 35
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ritonavir Accord 100 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablets contains 100 mg of ritonavir.
For the Full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, capsule shaped, film-coated tablets, with a
dimension of approx. 17.1 mm
in length and 9.1 mm in width, debossed with 'H' on one side and 'R9'
on 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 should be administered by physicians who are experienced in
the treatment of
HIV infection.
Ritonavir Accord film-coated tablets are administered orally and
should be ingested with food
(see section 5.2).
Ritonavir Accord film-coated tablets should be swallowed whole and not
chewed, broken or
crushed.
Posology
_Ritonavir dosed as a pharmacokinetic enhancer_
When ritonavir is used as a pharmacokinetic enhancer with other
protease inhibitors (PI)
the Summary of Product Characteristics (SmPC) 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
Page 2 of 35
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 first
7 days, then saquinavir 1000 mg twice daily with ritonavir 100 mg
twice daily in ART-naïve
patien