Flagyl 0.5% w/v Solution for Infusion in Viaflex Container

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metronidazole

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

J01XD; J01XD01

INN (International Name):

Metronidazole

Dosage:

0.5 percent weight/volume

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Imidazole derivatives; metronidazole

Authorization status:

Marketed

Authorization date:

1982-04-19

Patient Information leaflet

FLAGYL™
0.5% W/V SOLUTION FOR INFUSION IN VIAFLEX CONTAINER
_METRONIDAZOLE _
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
– 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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
– If any side effects gets serious, or if you notice any side effect
not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1. WHAT FLAGYL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLAGYL
3. HOW TO TAKE FLAGYL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE FLAGYL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT FLAGYL IS AND WHAT IT IS USED FOR
Flagyl belongs to the group of medicines called anti-microbials.
Flagyl Infusion is used in the treatment and prevention of severe
infections that are caused by
anaerobic bacteria, particularly species of _Bacteroides_, anaerobic
_Streptococci_, _Fusobacteria_,
_Clostridia_, etc. It works by killing bacteria and parasites that
cause infection in your body.
If you need any further information on your illness, speak to your
doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLAGYL
DO NOT TAKE FLAGYL IF:
• If you are sensitive or allergic to metronidazole or any of the
ingredients listed below in Section 6.
Signs of an allergic reaction include: rash, swallowing or breathing
problems, swelling of your lips,
face, throat or tongue.
• If you are pregnant or breast feeding or think you might be
pregnant.
• If you are suffering or have ever suffered from any liver or
kidney disease.
• If you are suffering or have ever suffered from any diseases of
the nervous system.
WARNINGS AND PRECAUTIONS
Cases of severe liver toxicity/acute liver failure, including cases
with a fatal outcome, in patients with
Cockayne syndrome have been reported with product

Summary of Product characteristics

Health Products Regulatory Authority
03 December 2021
CRN00CKRH
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flagyl 0.5% w/v Solution for Infusion in Viaflex Container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each infusion bag contains 500mg/100ml of metronidazole. (5mg/ml).
Excipient(s) with known effect:
Sodium 310mg (see section 4.4)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion (Infusion).
A clear pale yellow sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Metronidazole is indicated in adults and children for the following
indications:
In the treatment of severe infections due to anaerobic bacteria,
particularly species of Bacteroides, anaerobic Streptococci, etc.,
and for prophylaxis against such infections, in patients for whom oral
medication is not practical.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous.
_Recommended Dosage:_
_Treatment_
_Adults and children over 12 years:_
500mg (100ml) eight hourly.
Children > 8 weeks to 12 years of age:
The usual daily dose is 20-30mg/kg/day as a single dose or divided
into 7.5mg/kg
every 8 hours. The daily dose may be increased to 40mg/kg, depending
on the
severity of the infection. Duration of treatment is usually 7 days.
Health Products Regulatory Authority
03 December 2021
CRN00CKRH
Page 2 of 7
_Children < 8 weeks of age_
15mg/kg as a single dose daily or divided into 7.5mg/kg every 12
hours.
In newborns with a gestation age < 40 weeks, accumulation of
metronidazole can occur during the
first week of life, therefore the concentrations of metronidazole in
serum should preferably be
monitored after a few days therapy.
_Prophylaxis against postoperative infections caused by anaerobic
bacteria_
_Adults and children over 12 years:_
500mg (100ml) immediatlely before, during or after operation repeated
eight hourly
thereafter.
_Children < 12 years of age_
20-30 mg/