ZITHROMAX I.V.

Pajjiż: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

AZITHROMYCIN AS DIHYDRATE

Disponibbli minn:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Kodiċi ATC:

J01FA10

Għamla farmaċewtika:

POWDER FOR SOLUTION FOR INFUSION

Kompożizzjoni:

AZITHROMYCIN AS DIHYDRATE 500 MG/VIAL

Rotta amministrattiva:

I.V

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

PFIZER INC, USA

Grupp terapewtiku:

AZITHROMYCIN

Żona terapewtika:

AZITHROMYCIN

Indikazzjonijiet terapewtiċi:

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

Data ta 'l-awtorizzazzjoni:

2021-11-30

Fuljett ta 'informazzjoni

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

Karatteristiċi tal-prodott

Zithromax I.V LPD CC 261221
1
0070541
-
1
202
ZITHROMAX
® I.V.
NAME OF THE MEDICINAL PRODUCT
ZITHROMAX
®
I.V.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains Azithromycin dihydrate 524.1 mg equivalent to 500
mg azithromycin base.
Excipients with known effect:
Sodium hydroxide 198.3 mg/vial
For the full list of excipients, see section _Description_ (11) in
this leaflet.
PHARMACEUTICAL FORM
Powder for solution for infusion
1
INDICATIONS AND USAGE
Treatment of infections caused by susceptible strains of the
designated microorganisms in the following conditions:
community-acquired pneumonia (CAP) and pelvic inflammatory disease
(PID).
2
DOSAGE AND ADMINISTRATION
For the treatment of adult patients with CAP due to the indicated
organisms, the recommended dose of intravenous
azithromycin is 500 mg as a single daily dose by the IV route for at
least two days. Intravenous therapy should be followed
by oral azithromycin at a single daily dose of 500 mg to complete a 7
to 10-day course of therapy. The timing of the
conversion to oral therapy should be done at the discretion of the
physician and in accordance with clinical response.
For the treatment of adult patients with PID due to the indicated
organisms, the recommended dose of intravenous
azithromycin is 500 mg as a single dose by the IV route for one or two
days. Intravenous therapy should be followed by
azithromycin by the oral route at a single daily dose of 250 mg to
complete a 7-day course of therapy. The timing of the
conversion to oral therapy should be done at the discretion of the
physician and in accordance with clinical response. If
anaerobic microorganisms are suspected of contributing to the
infection, an antimicrobial anaerobic agent may be
administered in combination with azithromycin.
After reconstitution and dilution, the recommended route of
administration for intravenous azithromycin is by IV infusion
only. DO NOT ADMINISTER AS AN INTRAVENOUS BOLUS OR AN INTRAMUSCULAR
INJECTION.
The infusate concentration and rate of infusion for azithr