Metronidazole 5 Mg/Ml Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
METRONIDAZOLE 5 MG/ML SOLUTION FOR INFUSION
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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 of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Metronidazole infusion is and what it is used for
2. Before you are given Metronidazole infusion
3. How you are given Metronidazole infusion
4. Possible side effects
5. How to store Metronidazole infusion
6. Further information
1. WHAT METRONIDAZOLE SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
Metronidazole solution for infusion contains 5 mg/ml of the active ingredient metronidazole, Metronidazole is an antibiotic.
Metronidazole is used to prevent or treat infections in adults and children caused by anaerobic bacteria (bacteria that can live without oxygen). Metronidazole infusion is used when metronidazole cannot be taken by mouth. Metronidazole is used to:
- Prevent pre- and/or post operative infections owing to sensitive bacteria in surgical procedures with a high risk of occurence of this type of infection.
- Treat severe abdominal and gynaecological infections where sensitive bacteria are suspected to be the cause.
Metronidazole infusion may be used in combination with other antibiotics.
2. BEFORE YOU ARE GIVEN METRONIDAZOLE SOLUTION FOR INFUSION Do not take Metronidazole infusion if you:
- are allergic (hypersensitive) to metronidazole or any of the other ingredients of Metronidazole infusion (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
Take special care with Metronidazole infusion (and talk to your doctor) if you:
- are having dialysis treatment (metronidazole should be re-administered immediately after dialysis)
- have a liver disorder (the dose of your metronidazole may need to be adjusted)
- are having blood tests of liver functions (metronidazole may interfere with results of some of the tests)
- have a disease of the brain or nervous system
- have had alcohol (Do not take alcohol during Metronidazole treatment and for at least 48 hours afterwards as this might cause unpleasant side effects, such as nausea and vomiting, abdominal pain, hot flushes, palpitations and headache).
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. This is especially true of the following medicines as they may interact with your Metronidazole infusion:
- oral anticoagulants ( medicines to prevent blood clots).
- lithium (a treatment for mental illness)
- phenobarbitone (a sedative or treatment for epilepsy)
- 5 fluorouracil (a treatment for cancer or skin diseases)
- ciclosporin (a drug used to prevent rejection after a transplant)
- cholestyramine (a drug used to reduce cholestrol levels in blood)
- cimetidine (a drug used in healing stomach ulcers)
It may still be all right for you to be given Metronidazole infusion and your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding
You should not be given Metronidazole infusion while pregnant or breast-feeding unless your doctor tells you to. Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
Metronidazole infusion may cause drowsiness, dizziness, confusion, hallucinations, convulsions or temporary visual disorders. If you have any of these symptoms you should not drive or operate machinery.
3. HOW YOU ARE GIVEN METRONIDAZOLE SOLUTION FOR INFUSION
The solution will be administered into a vein using a drip. It will be given at a rate of 5 ml / minute. As soon as possible after being given the injection 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 of metronidazole you will be given will depend on the reason it is being prescribed for you.
To prevent infection before or after abdominal or gynaecological surgery, adults will usually receive a single dose of 1000mg-1500mg up to one hour before surgery or 500 mg (100ml) immediately before, during or after the operation. A 500mg dose will then usually be repeated every 8 hours as necessary. Oral medication, given 8 hourly, will then replace the drip as soon as feasible.
For children the doctor will work out how much your child should be given depending on their weight. Your child will receive the dose shortly before the operation.
To treat established infections, in the event that you are unable to take medicine by mouth, adults may be given 1000-1500mg daily as a single dose or 500 mg of metronidazole (100ml) every 8 hours.
For children the doctor will work out how much your child should be given depending on their weight. Metronidazole will be administered to the elderly with caution, especially where high doses are required.
Your doctor will modify your dose as required.
Duration of treatment for ongoing infections is usually 7-10 days.
This product contains 7.90 mg/ml Sodium chloride and 0.476 mg/ml Anhydrous Disodium Hydrogen Phosphate corresponding to 13.84 mmole (or 326.02 mg) of sodium per 100 ml.
This should be taken into consideration for patients on a low sodium diet.
4. POSSIBLE SIDE EFFECTS OF METRONIDAZOLE SOLUTION FOR INFUSION
Like all medicines, Metronidazole infusion can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
The following side effects have been reported:
- Numbness, tingling, pain, or a feeling of weakness, in the arms or legs
- Convulsions or fits
- Mental problems, including confusion and hallucinations
- Temporary effects to your eyesight, such as blurred or double vision
- Unpleasant taste in the mouth
- Furred tongue
- Nausea (feeling sick)
- Vomiting
- Upset stomach
- Loss of appetite
- Itching, inflammation or swelling of the skin, or skin rashes, which may sometimes be severe
- Severe abdominal (tummy) pain
- Fever, headache or sore throat
- Yellowing of the skin and eyes (jaundice)
- Darkening of the urine
- Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness
- Drowsiness, or dizziness
- Clumsiness, or poor coordination
- Pains in the muscles or joints
- Blood disturbances
- Abnormal liver tests.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE METRONIDAZOLE SOLUTION FOR INFUSION
Your doctor or pharmacist knows how to store Metronidazole solution for infusion
100 ml glass bottle: Store below 30°C.Do not refrigerate or freeze. Keep vial in the outer carton to protect from light.
100 ml plastic bag: Store below 25°C. Do not refrigerate or freeze. Keep bag in the original package to protect from light.
6. FURTHER INFORMATION
What Metronidazole solution for infusion contains:
The active substance is metronidazole.
The other ingredients are: Citric acid, Disodium Hydrogen Phosphate, Sodium Chloride and Water for Injections
What Metronidazole infusion looks like and contents of the pack
Metronidazole 5 mg/ml Infusion (100 ml) is in glass bottles closed with a rubber stopper.
Metronidazole 5 mg/ml Infusion is also available in 100 ml plastic bag.
Marketing Authorisation Holder
Claris Lifesciences UK Limited Crewe Hall, Crewe,
Cheshire, CW1 6UL,
United Kingdom Manufacturer
Peckforton Pharmaceuticals Limited Crewe Hall, Crewe, Cheshire, CW1 6UL,
United Kingdom.
This leaflet was last revised in October 2015
Marketing Authorisation Holder :
Claris Lifesciences UK Limited
Crewe Hall, Crewe, Cheshire, CW1 6UL, United Kingdom.
Manufacturer:
Peckforton Pharmaceuticals Ltd.
Crewe Hall, Crewe, Cheshire, CW1 6UL, United Kingdom.
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