ZITHROMAX I.V.

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AZITHROMYCIN AS DIHYDRATE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

J01FA10

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

AZITHROMYCIN AS DIHYDRATE 500 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

PFIZER PGM, FRANCE

Therapeutic group:

AZITHROMYCIN

Therapeutic area:

AZITHROMYCIN

Therapeutic indications:

Treatment of infections caused by susceptible strains of the designated microorganisms in the following conditions: community-acquired pneumonia and pelvic inflammatory disease.

Authorization date:

2011-11-30

Patient Information leaflet

מ"עב לארשי הקיטבצמרפ יא ףא יפ רזייפ
רקנש 'חר
9
.ד.ת ,
12133
לארשי ,חותיפ הילצרה
46725
:לט
972-9-9700500
:סקפ
972-9-9700501
לירפא
2019
,ה/דבכנ ת/חקור ,ה/אפור
ןולעב ןוכדע לע ךעידוהל וננוצרב
(אפורל ןולע תנוכתמב) ןכרצל
:
ZITHROMAX I.V.
:ליעפה ביכרמה
Azithromycin (as dihydrate) 500mg/vial
INDICATED FOR:
Treatment of infections caused by susceptible strains of the
designated microorganisms in the
acquired pneumonia and pelvic inflammatory disease.
-
following conditions: community ןולעב םיירקיעה םינוכדעה ןלהל
:(אפורל ןולע תנוכתמב) ןכרצל
....
......
7
DRUG INTERACTIONS
.…..
7.3
POTENTIAL DRUG-DRUG INTERACTION WITH MACROLIDES
Interactions with the following drugs listed below digoxin, colchicine
or phenytoin have not
been reported in clinical trials with azithromycin ; however,.No no
specific drug interaction
studies have been performed to evaluate potential drug-drug
interaction. However, drug
interactions have been observed with other macrolide products. Until
further data are
developed regarding drug interactions when digoxin, colchicine or
phenytoin are used with
azithromycin careful monitoring of patients is advised.
…….
8
USE IN SPECIFIC POPULATIONS
8.1
PREGNANCY
TERATOGENIC EFFECTS. Pregnancy Category B:
Risk Summary
Available data from published literature and postmarketing experience
over several decades
with azithromycin use in pregnant women have not identified any
drug-associated risks for
major birth defects, miscarriage, or adverse maternal or fetal
outcomes (see Data).
Developmental toxicity studies with azithromycin in rats, mice, and
rabbits showed no drug-
induced fetal malformations at doses up to 4, 2, and 2 times,
respectively, an adult human
daily dose of 500 mg based on body surface area. Decreased viability
and delayed
development were observed in the offspring of pregnant rats
administered azithromycin from
day 6

Summary of Product characteristics

Azenil 250mg Capsules, Azenil 200mg/5ml Suspension LPD CC 261221
1
2021-0070541
AZENIL
® CAPSULES
AZENIL
®
200 MG/5 ML SUSPENSION
NAME OF THE MEDICINAL PRODUCT
AZENIL
® CAPSULES
AZENIL
®
200 MG/5 ML SUSPENSION
QUALITATIVE AND QUANTITATIVE COMPOSITION
Azenil capsules:
Each capsule contains Azithromycin dihydrate 262.05 mg equivalent to
250 mg azithromycin base.
Azenil 200mg/5ml suspension:
Contains Azithromycin 209.64 mg/5ml equivalent to 200mg/5ml of
azithromycin base in Powder for Oral Suspension.
Excipients with known effect:
Azenil capsules: Lactose, sodium
Azenil 200mg/5ml suspension: Sucrose, sodium
For the full list of excipients, see Description (9) in this leaflet.
PHARMACEUTICAL FORM
Azenil capsules-
The capsule is printed in black ink with Pfizer on one end of shell
and “ZTM 250” on the other end.
These capsules are packed in PVC blister packs.
Azenil 200mg/5ml - Powder for suspension
is presented as a dry powder which yields, on reconstitution with
water, a
white to off-white suspension.
The powder for oral suspension is packed in polyethylene bottles.
1
INDICATIONS AND USAGE
Infections caused by susceptible organisms in lower respiratory tract
including bronchitis and pneumonia, skin and soft
tissue infections, otitis media, upper respiratory tract infections
including sinusitis and pharyngitis, tonsilitis, also in the
treatment of uncomplicated genital infections due to chlamydia
trachomatis.
1.1
LIMITATIONS OF USE
Azithromycin should not be used in patients with pneumonia who are
judged to be inappropriate for oral therapy
because of moderate to severe illness or risk factors such as any of
the following:
•
patients with cystic fibrosis,
•
patients with nosocomial infections,
•
patients with known or suspected bacteremia,
•
patients requiring hospitalization,
•
elderly or debilitated patients, or
•
patients with significant underlying health problems that may
compromise their ability to respond to their
illness (including immunodeficiency or functional asplenia).
1.2 USAGE
Azenil