Zedbac 500 mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Azithromycin dihydrate

Available from:

Morningside Healthcare (Malta) Limited

ATC code:

J01FA; J01FA10

INN (International Name):

Azithromycin dihydrate

Pharmaceutical form:

Powder for concentrate for solution for infusion

Therapeutic area:

Macrolides; azithromycin

Authorization status:

Not marketed

Authorization date:

2012-10-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZEDBAC 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Azithromycin (as dihydrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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
WHAT IS IN THIS LEAFLET:
1
What Zedbac is and what it is used for
2
What you need to know before you are given Zedbac
3
How to use Zedbac
4
Possible side effects
5
How to store Zedbac
6
Contents of the pack and other information
1.
WHAT ZEDBAC IS AND WHAT IT IS USED FOR
Zedbac belongs to a group of antibiotics called macrolides. It is used
to treat localized infections
caused by bacteria in many different parts of the body.
WHICH DISEASES ARE TREATED WITH ZEDBAC?
Zedbac is indicated for treatment of serious infections or when oral
treatment cannot be used. It is
used for treatment of pneumonia (lungs infection), and pelvic
infections (infection of the reproductive
organs) caused by susceptible organisms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZEDBAC
DO NOT USE ZEDBAC
-
if you are allergic to azithromycin or any of the ingredients of this
medicine (listed in section 6)
-
if you are allergic (hypersensitive) to any other macrolide antibiotic
(such as erythromycin or
clarithromycin) or ketolide (macrolide derivatives)
-
if you are taking any ergot derivatives such as ergotamine (used to
treat migraine) as these
medicines should not be taken together with azithromycin.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Zedbac
-
if you have an allergic reaction such as red or white spots on the
skin, itching and skin irritation,
swelling of the skin, larynx (throat) or tongue, and difficulty in
breathing, in which case you
should stop treatment with Zedbac

Summary of Product characteristics

Health Products Regulatory Authority
05 January 2024
CRN00DY5C
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zedbac 500 mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg of azithromycin (equivalent to 524.03 mg of
azithromycin dihydrate), which after reconstitution
results in a 100 mg/ml azithromycin solution. The concentrate should
be further diluted to 1 mg/ml or 2 mg/ml.
Excipient(s) with known effect:
This medicinal product contains 168.2 mg (7.31 mmol) sodium per vial.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
Free white powder, with small aggregates.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin as powder for solution for infusion is indicated for the
treatment of community-acquired pneumonia due to
susceptible microorganisms, (see section 5.1) in adult patients where
initial intravenous therapy is required.
Azithromycin as powder for solution for infusion is indicated for the
treatment of pelvic inflammatory disease (PID) due to
susceptible microorganisms (see section 5.1), in patients where
initial intravenous therapy is required.
Consideration should be given to official guidance regarding the
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Azithromycin (azithromycin as powder for
concentrate for solution for infusion) for the treatment of
adult patients with community-acquired pneumonia due to the indicated
susceptible microorganisms is of 500 mg
administered as a single intravenous daily dose for at least two
consecutive days. The intravenous therapy should be followed
by the oral administration of azithromycin in a single daily dose of
500 mg up to 7 to10 days of treatment. Transition to oral
therapy should be carried out when indicated by the doctor and
according to the clinical response.
The recommended dose of Azithromycin (azithromycin as powder f