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METRONIDAZOLE 500MG/100ML INTRAVENOUS INFUSION

Active substance(s): METRONIDAZOLE

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Metronidazole 500 mg/100 ml Intravenous Infusion
• Keep this leaflet. You may need to read it again




if you are suffering from liver disease
if you are actively suffering from disease of the nervous
system. In this case you should inform your doctor,
particularly if you experience poor coordination (ataxia),
01821
dizziness or confusion during the treatment
• if you are undergoing kidney dialysis
• if you are on low sodium diet as this medicine contains 13.5 mmol
(310 mg) sodium per 100 ml.
Your doctor may want to carry out some tests if you receive this medicine for
more than 10 days.

• If you have any further questions, ask your doctor
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.

In this leaflet:
1. What Metronidazole 500 mg/100 ml is and what it is used for
2. Before you are given Metronidazole 500 mg/100 ml
3. How Metronidazole 500 mg/100 ml is given
4. Possible side effects
5. How to store Metronidazole 500 mg/100 ml

Using Metronidazole 500 mg/100 ml with food and drink

What is it used for?

Do not drink any alcohol while receiving your medicine, and for 48 hours
afterwards. This might cause unpleasant side effects, such as feeling sick and
vomiting, abdominal pain, hot flushes, palpitations, and headache.

This medicine is used when oral medication is not possible, for the prevention
and treatment of infections caused by certain species of bacteria. It is used in
adults and children for:


the prevention of postoperative infections due to sensitive bacteria
in surgical procedure with a high risk of occurrence of this type of
infection



the treatment of severe established abdominal and gynaecological
infections where sensitive bacteria have been identified as the cause
or are suspected to be the cause.

Pregnancy and breast-feeding
This medicine should be avoided during pregnancy or breast-feeding unless
your doctor considers it essential.
It must not be given during the first three months of pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and Using machines
You should not drive or use machines while being treated with this medicine.

If you need any further information on your condition, please ask your doctor.

2. Before you are given Metronidazole 500 mg/100 ml

3. How Metronidazole 500 mg/100 ml is given
Your doctor will decide how much you need and when it will be given to you.

You MUST NOT receive Metronidazole 500 mg/100 ml


If you are sensitive or allergic to metronidazole or any of the other
ingredients of this medicine



if you are suffering from, or have suffered from any end stage liver
disease



if you have blood cells disorders



if you are suffering from any uncontrolled disease of the nervous
system



if you are less than 3 months pregnant or think you may be less than
3 months pregnant.

Dosage and Method of Administration
Each bag is one dose and will be administered through a plastic tube into a vein
using a drip. It will be given at a rate of approximately 5 ml/minute (equivalent
to the infusion of one bag over 20 to 60 minutes). As soon as possible after
the infusion has been completed, your treatment will be continued using oral
medication. Your doctor will decide when you can start to take oral medication
instead of the drip.
The amount you will be given depends upon
• your age
• your weight
• your clinical condition and
• the reason it is being prescribed for you.
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It is available in a plastic bag containing 100 ml.

Signature

Your medicine also contains the following inactive ingredients (excipients):
citric acid monohydrate, disodium phosphate dodecahydrate, sodium chloride
and water for injections.

Name

Your medicine contains metronidazole 500 mg per 100 ml (5 mg per ml). This
is a sterile solution for intravenous infusion free from bacterial endotoxin
(substances causing fever reactions).

Country

The active ingredient in your medicine is metronidazole. It is an antimicrobial
agent (an agent that kills micro-organisms or suppresses their multiplication
and growth).

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What is this medicine?

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1. What is Metronidazole 500 mg/100 ml and what is it
used for

3rd DRAFT

For use under medical supervision.

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Certain medicines are known to change the normal effect of this infusion.
Certain medicines can have their effect changed by this infusion. These
medicines should not be used at the same time as Metronidazole
500 mg/100 ml Intravenous Infusion. Please tell your doctor if you are taking or
have recently taken any of the following medicines:
• warfarin (oral anticoagulant) as your blood clotting time will need to
be monitored more frequently
• vecuronium
• 5-Fluoro-uracile
• Lithium as lithium treatment should be reduced or stopped before you
are given Metronidazole
• phenobarbital
• cholestyramine
• phenytoin
• cimetidine
• ciclosporin
• busulfan.
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

DATE 20 January 2014

Using other Medicines

6. Further information

EUROPEAN LABELLING CENTRE



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Take special care with Metronidazole
500 mg/100 ml

Read all of this leaflet carefully before you start using this medicine

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PACKAGE LEAFLET: INFORMATION FOR THE USER

– Prevention of infection after abdominal or gynaecological
surgery:

No symptoms developed where too much of this medicine is given to newborn
infants born prematurely.

The preventive treatment duration will be short and mostly limited to the
post-operative period (24 hours but no more than 48 hours).
Adults will usually receive
• a single dose of 1000 to 1500 mg (2 to 3 bags) up to one hour before
surgery or
• 500 mg (1 bag) immediately before, during or after the operation.
A 500 mg dose (1 bag) will then usually be repeated every 8 hours as
necessary.
Children less than 12 years will receive a smaller dose which is calculated
from their body weight as a single dose of 20 – 30 mg/kg given one to two
hours before surgery.
Newborn infants born prematurely (gestational age less than 40 weeks) will
receive one single dose of 10 mg/kg body weight prior to surgery.

– Treatment:
Please inform your doctor immediately if any of these symptoms occur.
In the event of accidental over-infusion, your doctor will stop the infusion. Your
doctor will take the appropriate measures according to the symptoms you have
developed.
If you have any further questions on the use of this medicinal product please
ask your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.

– Treatment of severe established abdominal or gynaecological
infection:

Decrease of the number of white blood cells in your blood, headache
and feeling of weakness.

Rare side effects (less than 1 person out of 1,000 but more than
1 person out of 10,000):

– Patients with advanced liver deficiency:

• fever
• itching, inflammation or swelling of the skin, skin eruption or skin
rashes all of which may sometimes be severe
• face oedema (Quincke oedema: accumulation of fluid in the skin at the
level of the face)
• pustule
• drowsiness, dizziness, or hallucinations
• clumsiness, or poor coordination
• alteration of your blood that can modify results of your blood tests
• abnormal liver test results
• yellowing of the skin and eyes (jaundice)
• unexpected infections, mouth ulcers, bruising, bleeding gums, sore
throat or mouth, upset stomach, cramps, diarrhoea, or loss of appetite
(anorexia)
• darkening of your urine
• double vision or nearsightedness.
If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor. Your doctor will take the appropriate
measures according to the side effect you have developed.

Your doctor will reduce the dosage. Your doctor will at the same time monitor
the level of metronidazole in your blood.

Duration of Treatment
Duration of treatment for ongoing infections is usually 7 to 10 days.
Depending upon your clinical condition and results of bacteriological
assessment, your doctor may decide to prolong the treatment. This is intended
to eradicate infections from parts of your body where the anti-infective
metronidazole has difficulties to access or where self-recontamination is
possible.

If you received more Metronidazole 500 mg/100 ml than you
should
– Symptoms:
If you have received more infusion than you should, the following symptoms
could appear:
• feeling sick (nausea)
• vomiting
• poor coordination (ataxia) and
• slight disorientation.

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Signature

Uncommon side effects (less than 1 person out of 100 but more than
1 person out of 1,000):

Name

There is no need to adjust the dosage if you have problems with your kidneys.
Your doctor will most probably not adjust the dosage of your medicine if you are
undergoing peritoneal dialysis. Your doctor can however take the decision to
reduce the dosage of metronidazole if excessive levels of metabolites are found
in your blood.
If you are undergoing haemodialysis your doctor will re-administer your
medicine just after haemodialysis.

Country

– Patients with renal failure:

3rd DRAFT

Metronidazole will be administered to the Elderly with caution, especially where
high doses are required. Your doctor will modify your dose as required.

feeling sick (nausea)
vomiting
unpleasant metallic taste in the mouth
inflammation of the mouth and tongue
dry mouth
pain in the muscles.

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– Elderly:

EUROPEAN LABELLING CENTRE

Common side effects (less than 1 person out of 10 but more than
1 person out of 100):

RA
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DATE 20 January 2014

The following severe side effects can occur rarely (less than 1 person out of
1,000 but more than 1 person out of 10,000):
• severe allergic reaction (which may cause sudden faintness, severe
breathlessness, abdominal pain or swelling of the tongue and throat)
• severe neurological effects: (convulsion or fits, brain disease, disorder
of the nerves which can causes loss of vision, brain fever not caused
by bacterials (aseptic meningitis)
• inflammation of your pancreas (which may cause pain in your belly
with radiation through the back)
• severe skin effects (Erythema multiforme, Serious illness with
blistering of the skin, mouth, eyes and genitals and skin peeling).
If you experience any of these severe side effects, please tell your doctor
immediately. The doctor will stop the infusion.

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Severe side effects:

This medicine will be used for the treatment of established infections when you
are unable to take the medicine by mouth.
Adults will usually receive a single daily dose of 1000 to 1500 mg (2 to 3 bags)
or 500 mg (1 bag) every 8 hours.
Children more than 8 weeks to 12 years of age will receive a smaller dose
which is calculated from their body weight as
• either a single daily dose of 20 – 30 mg/kg
• or alternatively 3 doses of 7.5 mg/kg given every 8 hours
• The daily dose may be increased to 40 mg/kg, depending on the
severity of the infection. Duration of treatment is usually 7 days.
Newborn infants (less than 8 weeks old) will receive one single daily dose of
15 mg/kg of body weight or 7.5 mg/kg every 12 hours.
Newborn infants born prematurely (gestational age less than 40 weeks) will
have their level of metronidazole in blood controlled after a few days of therapy
as accumulation of the drug substance in the blood might occur during the first
week of life.

5. How to store Metronidazole 500 mg/100 ml
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label after
Exp:. The expiry date refers to the last day of that month. You will not be given
this medicine if this date has passed.
Keep container in the outer carton in order to protect from light.
Do not remove the unit from overwrap until ready for use.
Do not use if the solution is not clear, or if the unit is damaged in any way.
Discard any unused portion.

6. Further information
This leaflet does not contain all the information about this medicine. If you have
any questions or are not sure about anything, ask your doctor or nurse.

What Metronidazole 500 mg/100 ml contains

DATE 20 January 2014

Baxter Healthcare S.A.,
Moneen Road, Castlebar, County Mayo, Ireland
Bieffe Medital Sabiñánigo,
Ctra de Biescas, Senegüé, 22666 Sabiñánigo (Huesca), Spain

The medicinal product is authorised in the Member States of
the EEA under the following names:
United Kingdom
Spain
Italy
Denmark
Norway

Metronidazole 500 mg/100 ml Intravenous Infusion
VIAFLO Metronidazol 5 mg/ml Solución para perfusión
Metronidazolo 0.5% Baxter
Metronidazol “Baxter” VIAFLO Infusionsvæske, opløsning
Metronidazol Baxter VIAFLO 5 mg/ml Infusjonsvæske, oppløsning

The leaflet was last approved in
01/2014.

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Signature

Manufacturer:
The product may be made by:

RA
PROOFREAD + APPROVED

Baxter Healthcare Ltd.
Caxton Way
Thetford
Norfolk
IP24 3SE
UK

3rd DRAFT

EUROPEAN LABELLING CENTRE

Marketing Authorisation Holder:
The company responsible for the product (also known as the marketing
authorization holder) is:

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Marketing Authorisation Holder and Manufacturer

Name

It is a clear solution for infusion intended for intravenous administration.
The solution is in 100 ml polyolefin/polyamide transparent plastic containers
protected by a transparent plastic overwrap.
The pack size is: 20 x 100 ml, 50 x 100 ml and 60 x 100 ml.

Country

What Metronidazole 500 mg/100 ml looks like and contents of
the pack

MARKETING
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It is an isotonic solution.
The active substance is Metronidazole. Each 100 ml consists of:
Metronidazole 500 mg.
The other inactive ingredients (excipients) are Disodium phosphate
dodecahydrate, Citric acid monohydrate, Sodium chloride and Water for
injections.

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Baxter and Viaflo are trademarks of Baxter International Inc.

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Signature

Name

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3rd DRAFT
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EUROPEAN LABELLING CENTRE

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DATE 20 January 2014

Metronidazole 500 mg/100 ml Intravenous Infusion
The following information is intended for medical
or healthcare professionals only:

Amoebiasis:
> 10 years: 400 to 800 mg 3 times daily for 5 – 10 days.
Children 7 to 10 years: 200 to 400 mg 3 times daily for 5 – 10 days.
Children 3 to 7 years: 100 to 200 mg 4 times daily for 5 – 10 days.
Children 1 to 3 years: 100 to 200 mg 3 times daily for 5 – 10 days.
Alternatively, doses may be expressed by body weight:
35 to 50 mg/kg daily in 3 divided doses for 5 to 10 days, not to
exceed 2400 mg/day.

Posology and method for administration:
Method of Administration
Metronidazole 500 mg/100 ml should be infused intravenously at an
approximate rate of 5 ml/minute (or one bag infused over 20 to 60 minutes).
Oral medication should be substituted as soon as feasible.

Eradication of Helicobacter pylori in paediatric patients:

Prophylaxis against postoperative infections caused by anaerobic
bacteria

As a part of a combination therapy, 20 mg/kg/day not to exceed 500 mg twice
daily for 7 – 14 days.
Official guidelines should be consulted before initiating therapy.

Primarily in the context of abdominal, (especially colorectal) and gynecological
surgery.
Antibiotic prophylaxis duration should be short, mostly limited to the post
operative period (24 hours but never more than 48 hours): Various schedules are
possible.
Adults:
Intravenous injection of single dose of 1000 mg – 1500 mg,
30 – 60 minutes preoperatively or alternatively 500 mg
immediately before, during or after operation, then 500 mg
8 hourly.
Children < 12 years:
20 – 30 mg/kg as a single dose given 1 – 2 hours before surgery.
Newborns with a gestation age < 40 weeks:
10 mg/kg body weight as a single dose before operation.

Elderly population
Caution is advised in the elderly, particularly at high doses, although there is
limited information available on modification of dosage.

Bacterial vaginosis:
Adolescents: 400 mg twice daily for 5 – 7 days or 2000 mg as a single dose.

Urogenital trichomoniasis
Adults and adolescents:
2000 mg as a single dose or 200 mg 3 times daily for 7 days or
400 mg twice daily for 5 – 7 days.
Children < 10 years:
40 mg/kg orally as a single dose or 15 – 30 mg/kg/day divided in
2 – 3 doses for 7 days; not to exceed 2000 mg/dose.

Giardiasis:
> 10 years: 2000 mg once daily for 3 days, or 400 mg three times daily for
5 days, or 500 mg twice daily for 7 to 10 days.
Children 7 to 10 years: 1000 mg once daily for 3 days.
Children 3 to 7 years: 600 to 800 mg once daily for 3 days.
Children 1 to 3 years: 500 mg once daily for 3 days.
Alternatively, as expressed in mg per kg of body weight:
15 – 40 mg/kg/day divided in 2 – 3 doses.

Baxter and Viaflo are trademarks of Baxter International Inc.

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Name

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See section 3 of this leaflet.
Use only if the solution is clear, without visible particles and if the container is
undamaged. Administer immediately following the insertion of infusion set.
Do not remove unit from overpouch until ready for use.
The inner bag maintains the sterility of the product.
Do not connect bags to each other. Such use could result in air embolism due to
residual air being drawn from the primary container before the administration of
the fluid from the secondary container is completed.
The solution should be administered with sterile equipment using an aseptic
technique. The equipment should be primed with the solution in order to prevent
air entering the system.
In patients maintained on intravenous fluids, Metronidazole 500 mg/100 ml may
be diluted with appropriate volumes of 0.9% sodium chloride solution, dextrose
5% – 0.9% sodium chloride solution, dextrose 5% w/v or potassium chloride
infusions (20 and 40 mmol/litre).
Using an incorrect administration technique might cause the appearance of
fever reactions due to the possible introduction of pyrogens. In the case of
adverse reaction, infusion must be stopped immediately.
The product should be used immediately after opening.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
1. Opening
a. Remove the VIAFLO container from the overpouch just before use.
b. Check for minute leaks by squeezing inner bag firmly. If leaks are
found, discard solution, as sterility may be impaired.
c. Check the solution for limpidity and absence of foreign matters. If
solution is not clear or contains foreign matters, discard the solution.
2. Preparation for administration
Use sterile material for preparation and administration.
a. Suspend container from eyelet support.
b. Remove plastic protector from outlet port at bottom of container:
– grip the small wing on the neck of the port with one hand,
– grip the large wing on the cap with the other hand and twist,
– the cap will pop off.
c. Use an aseptic method to set up the infusion.
d. Attach administration set. Refer to complete directions accompanying
set for connection, priming of the set and administration of the
solution.

EUROPEAN LABELLING CENTRE

Instructions for use and handling

Country

In patients with advanced hepatic insufficiency a dosage reduction with serum
level monitoring is necessary.

Intravenous route is to be used initially if patients symptoms preclude oral
therapy. Various schedules are possible.
Adults:
1000 mg – 1500 mg daily as a single dose or alternatively 500 mg
every 8 hours.
Children > 8 weeks to 12 years of age:
The usual daily dose is 20 – 30 mg/kg/day as a single dose or
divided into 7.5 mg/kg every 8 hours. The daily dose may be
increased to 40 mg/kg, depending on the severity of the infection.
Duration of treatment is usually 7 days.
Children < 8 weeks of age:
15 mg/kg as a single dose daily or divided into 7.5 mg/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 preferable be controlled after a few days
therapy.
Oral medication could be given, at the same dose regimen. Oral medication
should be substituted as soon as feasible.
Duration of Treatment
Treatment for seven to ten days should be satisfactory for most patients but,
depending upon clinical and bacteriological assessments, the physician might
decide to prolong treatment e.g.; for the eradication of infection from sites
which cannot be drained or are liable to endogenous recontamination by
anaerobic pathogens from the gut, oropharynx or genital tract.

3rd DRAFT

Patients with advanced hepatic insufficiency

Anaerobic infections

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DATE 20 January 2014

Routine adjustments of the dosage of Metronidazole are not considered
necessary in the presence of renal failure.
No routine adjustment in the dosage of Metronidazole needs to be made in
patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or
continuous ambulatory peritoneal dialysis (CAPD). However dosage reduction
may be necessary when excessive concentrations of metabolites are found.
In patients undergoing haemodialysis, Metronidazole should be re-administered
immediately after haemodialysis.

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Patients with renal failure

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3rd DRAFT
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EUROPEAN LABELLING CENTRE

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DATE 20 January 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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