MACO PHARMA METRONIDAZOLE 0.5 %w/v Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

METRONIDAZOLE

Available from:

Maco Pharma (UK) Ltd

ATC code:

J01XD01

INN (International Name):

METRONIDAZOLE

Dosage:

0.5 %w/v

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

Imidazole derivatives

Authorization status:

Authorised

Authorization date:

2000-06-23

Patient Information leaflet

WHAT IS IN THIS LEAFLET
1. What Metronidazole MacoPharma 0.5%w/v Solution for Infusion is and
what it is used for
2. What you need to know before you are given Metronidazole MacoPharma
0.5%w/v Solution for Infusion 
3. How Metronidazole MacoPharma 0.5%w/v Solution for Infusion is given
4. Possible side effects
5. How to store Metronidazole MacoPharma 0.5%w/v Solution for Infusion
6. Contents of the pack and other information
1. WHAT METRONIDAZOLE MACOPHARMA 0.5%W/V
SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
Metronidazole is an antibiotic used in adults and children to
treat severe infection caused by certain anaerobic bacteria, ie
bacteria which do not live or grow in the presence of oxygen. 
It may also be used to prevent infection in patients who cannot
be treated by mouth. 
The solution is mainly used in abdominal and gynaecological
surgery and will be given to you by slow injection into a vein by
a doctor or nurse.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
METRONIDAZOLE MACOPHARMA 0.5%W/V SOLUTION
FOR INFUSION
YOU MUST NOT BE GIVEN
this solution if you have ever had:
• an ALLERGY (hypersensitivity) to metronidazole or any of the
other ingredients in the solution (see Section 6)
• ACUTE PANCREATITIS, or pancreatitis as a serious side effect to
metronidazole.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse if you:
• have LIVER DISEASE (the amount of medicine you are given may
be reduced or given less often)
• have any disease or condition affecting the BRAIN OR NERVOUS
SYSTEM
• are receiving the solution intensively, or for MORE THAN 10
DAYS
– you will be closely monitored
• are PREGNANT, think you may be pregnant, or are
BREASTFEEDING
Treatment will be stopped if signs of nervous system problems
develop.
OTHER MEDICINES AND METRONIDAZOLE MACOPHARMA 0.5%W/V
SOLUTION FOR INFUSION
Tell your doctor if you are taking or have recently taken any
other medicines.
In particular, the following medicines may affect, or be affected
by, metronidazole:
• ANTI-COAGULANTS
(blood thin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metronidazole MacoPharma 0.5%w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 500mg/100ml
Excipients: contains sodium (as sodium chloride and disodium phosphate anhydrous), 15mmol (340mg) per 100ml
dose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear pale yellow infusion solution without visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Metronidazole is indicated in adults and children for the treatment of severe infections due to anaerobic bacteria 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
Metronidazole MacoPharma 0.5%w/v Solution for Infusion should be infused intravenously at a rate of approximately
5ml per minute, and should be substituted with oral medication as soon as possible.
Metronidazole MacoPharma 0.5%w/v Solution for Infusion may be administered concurrently (but separately) with
other appropriate antimicrobial agents in parenteral dosage forms.
Treatment of established anaerobic infections:
Intravenous medication can be used in patients with severe anaerobic infections for whom oral medication is precluded.
Treatment for 7 days should suffice in most cases but this period may be extended depending on clinical and
microbiological assessments and the site of infection. Regular clinical and laboratory monitoring is advised if
administration continues for more than 10 days (see section 4.4 Warnings and Precautions for Use).
Adults: Infuse 500mg (100ml) 8 hourly.
Children > 8 weeks to 12 years of age: The usual dai