Azithromycin ABR capsules hard

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

azithromycin (azithromycin dihydrate)

Disponible des:

Balkanpharma-Razgrad AD

Codi ATC:

J01FA10

Designació comuna internacional (DCI):

azithromycin (azithromycin dihydrate)

Dosis:

500mg

formulario farmacéutico:

capsules hard

Unidades en paquete:

(3/1x3/) in blister

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2023-05-13

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZITHROMYCIN ABR 500 MG HARD CAPSULES
Azithromycin
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 Azithromycin ABR is and what it is used for
2.
What you need to know before you use Azithromycin ABR
3.
How to use Azithromycin ABR
4.
Possible side effects
5.
How to store Azithromycin ABR
6.
Contents of the pack and other information
1.
WHAT AZITHROMYCIN ABR IS AND WHAT IT IS USED FOR
Azithromycin ABR contains the macrolide antibiotic azithromycin. It is
active against a large number of
pahtogens causing some common diseases in humans.
It is used to treat infections caused by certain bacteria and other
micro-organisms, which include:

chest, throat or nasal infections (such as bronchitis, pneumonia,
tonsillitis, sore throat (pharyngitis) and
sinusitis);

ear infections;

skin and soft tissue infections (such as an abscess or boil);

sexually transmitted diseases caused by organisms called Chlamydia
trachomatis and Neisseria
gonorrhoea.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AZITHROMYCIN ABR
DO NOT TAKE AZITHROMYCIN ABR
-
if you are allergic to azithromycin or any of the other ingredients of
this medicine (listed in section 6).
-
if you are allergic to erythromycin or other antibiotics in the
macrolide and ketolide group.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Azithromycin ABR if
you have or have had any of the
following conditions:

Fitxa tècnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Azithromycin ABR 500 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance in 1 capsule: azithromycin dihydrate (azithromycin
dihydrate), equiv. per 500 mg of
azithromycin (azithromycin).
Excipients with known effect: Lactose monohydrate/Corn starch (85:15).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsules, hard
Appearance of the capsules: hard gelatine capsules, white body, pink
cap.
Appearance of the contents: White to off-white powder, the presence of
conglomerates that disintegrate
under pressure is allowed.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azithromycin ABR is indicated for the treatment of the following
infections when known or likely to be due
to one or more susceptible microorganisms (see section 5.1):
-
bronchitis;
-
community-acquired pneumonia;
-
sinusitis;
-
pharyngitis/tonsillitis (see section 4.4 regarding streptococcal
infections);
-
otitis media;
-
skin and soft tissue infections;
-
uncomplicated genital infections due to _Chlamydia trachomatis_ and
_Neisseria gonorrhoeae_.
Considerations should be given to official guidance regarding the
appropriate use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The total dose of azithromycin is 1500 mg which should be given over
three days (500 mg once daily).
In uncomplicated genital infections due to _Chlamydia trachomatis_,
the dose is 1000 mg as a single oral dose.
For susceptible _Neisseria gonorrhoeae_ the recommended dose is 1000
mg or 2000 mg of azithromycin in
combination with 250 mg or 500 mg ceftriaxone according to local
clinical treatment guidelines. For patients
who are allergic to penicillin and/or cephalosporins, prescribers
should consult local treatment guidelines.
Renal impairment
No dose adjustment is required in patients with mild to moderate renal
impairment (GFR 10-80 ml/min or
creatinine clearance >40 ml/min).
In patients with severe renal impairment (GFR <10 ml/min or cr