Atazanavir Rowex 200 mg Capsules hard

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Atazanavir sulfate

Διαθέσιμο από:

Rowex Ltd

Φαρμακολογική κατηγορία (ATC):

J05AE08

INN (Διεθνής Όνομα):

Atazanavir sulfate

Δοσολογία:

200 milligram(s)

Φαρμακοτεχνική μορφή:

Capsule, hard

Θεραπευτική περιοχή:

atazanavir

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2019-03-22

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATAZANAVIR ROWEX 200 MG HARD CAPSULES
ATAZANAVIR ROWEX 300 MG HARD CAPSULES
atazanavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 Atazanavir Rowex is and what it is used for
2.
What you need to know before you take Atazanavir Rowex
3.
How to take Atazanavir Rowex
4.
Possible side effects
5
How to store Atazanavir Rowex
6.
Contents of the pack and other information
1.
WHAT ATAZANAVIR ROWEX IS AND WHAT IT IS USED FOR
ATAZANAVIR ROWEX IS AN ANTIVIRAL (OR ANTIRETROVIRAL) MEDICINE.
It is one of a group called
_protease_
_ _
_inhibitors_
. These medicines control Human Immunodeficiency Virus (HIV) infection
by stopping a
protein that the HIV needs for its multiplication. They work by
reducing the
amount of HIV in your
body and this in turn, strengthens your immune system. In this way
Atazanavir Rowex reduces the risk of
developing illnesses linked to HIV infection.
Atazanavir Rowex capsules may be used by adults and children 6 years
of age and older. Your
doctor has
prescribed Atazanavir Rowex for you because you are infected by the
HIV that
causes Acquired
Immunodeficiency Syndrome (AIDS). It is normally used in combination
with other anti-HIV
medicines. Your doctor will discuss with you which combination of
these
medicines with Atazanavir Rowex
is best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATAZANAVIR ROWEX
DO NOT TAKE
ATAZANAVIR ROWEX

IF YOU ARE ALLERGIC
to atazanavir or any of the other ingredients of this medicine (listed
in
section

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
31 August 2021
CRN00C6JJ
Page 1 of 47
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atazanavir Rowex 200 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 200 mg of atazanavir (as sulfate).
Excipient with known effect
Each hard capsule contains 87.4 mg of lactose (as monohydrate).
_ _
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Opaque, blue capsule of size 0 printed with white ink, with 200 mg on
the cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atazanavir Rowex capsules, co-administered with low dose ritonavir,
are indicated for the treatment of HIV-1 infected adults
and paediatric patients 6 years of age and older in combination with
other antiretroviral medicinal products (see section 4.2).
Based on available virological and clinical data from adult patients,
no benefit is expected in patients with strains resistant to
multiple protease inhibitors (≥ 4 PI mutations).
The choice of Atazanavir Rowex in treatment experienced adult and
paediatric patients should be based on individual viral
resistance testing and the patient's treatment history (see sections
4.4 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_Adults_
The recommended dose of Atazanavir Rowex capsules is 300 mg once daily
taken with ritonavir 100 mg once daily and with
food. Ritonavir is used as a booster of atazanavir pharmacokinetics
(see sections 4.5 and 5.1). (See also section 4.4 Withdrawal
of ritonavir only under restrictive conditions).
_Paediatric patients (6 years to less than 18 years of age and
weighing at least 15 kg)_
The dose of atazanavir capsules for paediatric patients is based on
body weight as shown in Table 1 and should not exceed the
recommended adult dose. Atazanavir Rowex capsules must be taken with
ritonavir and have to be taken with food.
TABLE 1: DOSE FOR PAEDIATRIC PATIENTS