Atazanavir Accord 300 mg hard capsules

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Atazanavir sulfate

Disponibil de la:

Accord Healthcare Ireland Ltd.

Codul ATC:

J05AE08

INN (nume internaţional):

Atazanavir sulfate

Dozare:

300 milligram(s)

Forma farmaceutică:

Capsule, hard

Zonă Terapeutică:

atazanavir

Statutul autorizaţiei:

Marketed

Data de autorizare:

2019-06-28

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATAZANAVIR 200 MG HARD CAPSULES
ATAZANAVIR 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 questions, ask your doctor, pharmacist or nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
-
The full name of this medicine is Atazanavir 200mg, 300mg hard
capsules, but within this
leaflet it will be referred to as Atazanavir capsules.
WHAT IS IN THIS LEAFLET
1.
What Atazanavir capsules are and what they are used for
2.
What you need to know before you take Atazanavir capsules
3.
How to take Atazanavir capsules
4.
Possible side effects
5.
How to store Atazanavir capsules
6.
Contents of the pack and other information
1.
WHAT
ATAZANAVIR CAPSULES ARE AND WHAT THEY ARE USED FOR
ATAZANAVIR CAPSULES ARE 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 capsules reduces the
risk of developing illnesses linked to HIV infection.
Atazanavir capsules may be used by adults and children 6 years of age
and older. Your doctor has
prescribed Atazanavir capsules 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 capsules are
best for you.
2.
WHAT YOU NEED TO KNOW BE

Caracteristicilor produsului

Health Products Regulatory Authority
11 May 2021
CRN00C62S
Page 1 of 34
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atazanavir Accord 300 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains atazanavir sulphate corresponding to 300 mg of
atazanavir.
Excipient(s) with known effect:
163 mg of lactose per capsule
0.41 mg of sunset yellow FCF (E110) per capsule
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Off white to pale yellow coloured granular powder filled in hard
gelatin capsules of approx. 23.5 mm in length with orange
opaque cap imprinted with "H" in black colour and green opaque body
imprinted with "A8" in black colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atazanavir Accord 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 Accord 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 Accord 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