5 mg / ml solution for infusion
metronidazole
What Metronidazole Braun is and what it is used for
Metronidazole Braun belongs to a group of medicines called antibiotics. It is used to treat and prevent infections caused by bacteria that are sensitive to the active substance metronidazole.
You can get Metronidazole Braun for the treatment of the following diseases:
- infection is in the abdomen
- gynecological infection er.
Metronidazole Braun can also be given for preventive purposes before abdominal surgery.
Metronidazole contained in Metronidazole Braun may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Metronidazole Braun
Do not use Metronidazole Braun
- if you are allergic to metronidazole, other similar substances or any of the other ingredients of this medicine (listed in section 6)
- if you have abnormal blood counts or a blood disorder ( blood dyscrasia )
- if you have a disease of the nervous system.
Warnings and cautions
Talk to your doctor or nurse before receiving Metronidazole Braun:
- if you have a hereditary disease called Cockayne’s syndrome
- if you have syphilis .
Your doctor will consider very carefully if you can get Metronidazole Braun.
Tell your doctor immediately if you get any of the following symptoms during treatment:
- numbness or tingling in the skin
- coordination problem
- dizziness
- seizures.
These symptoms may be due to the medicine affecting your nervous system, especially if you have been using Metronidazole Braun for a long time.
If you have a severe allergic reaction (such as anaphylactic shock ), treatment will be stopped immediately. See section 4 for further information.
Contact a doctor immediately if you have severe diarrhea. Diarrhea can be caused by a severe disease of the colon called pseudomembranous colitis (see also section 4).
As long-term use of metronidazole may cause blood disorders (see section 4), your blood counts will be monitored if you need to use the medicine for a long time.
Metronidazole Braun may cause harmless darkening of the urine.
Other medicines and Metronidazole Braun
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You must tell your doctor if you are taking any of the following medicines:
- disulfiram (used to treat alcohol dependence): Disulfiram and metronidazole should not be taken together. Concomitant use of these two drugs can lead to confusional states and even severe mental disorder ( psychosis ).
- phenobarbital (primidone, used to treat epilepsy ): phenobarbital may reduce the effect of metronidazole.
- Birth control pills: your birth control pills may be less reliable during treatment with metronidazole.
- busulfan (used to treat cancer): the concentration of busulfan in the blood may increase, which may increase the risk of side effects of busulfan.
- carbamazepine (used to treat epilepsy ): metronidazole may increase the duration of action of carbamazepine.
- cimetidine (used to treat stomach upset): cimetidine may increase the concentration of metronidazole in the blood.
- warfarin (a medicine that prevents the blood from clotting): Metronidazole may increase the effect of warfarin . Dose one of warfarin may need to be reduced during treatment with metronidazole.
- cyclosporine (used to inhibit the immune system): Concomitant use of cyclosporine and metronidazole may lead to increased concentrations of cyclosporine in the blood. Your doctor may want you to have additional blood tests to check the concentration of ciclosporin in your blood and your kidney function.
- fluorouracil (used to treat cancer): metronidazole may increase the concentration of fluorouracil in the blood, which may increase the risk of side effects caused by fluorouracil.
- lithium (for the treatment of mental illness): Metronidazole may increase the concentration of lithium in the blood. Your doctor may want you to take additional blood tests to check the concentration of lithium and salts ( electrolytes ) in your blood and kidney function.
- phenytoin (used to treat epilepsy ): Metronidazole may increase the concentration of phenytoin in the blood. Your doctor may need to adjust the dose of phenytoin .
If you are going to have a blood test, you should tell your doctor that you are taking Metronidazole Braun. The drug may affect the test result.
Metronidazole Braun with alcohol
You must abstain from alcoholic beverages during treatment with metronidazole and for 24 hours after stopping treatment. Alcohol consumption can cause intolerance reactions such as dizziness and vomiting.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Metronidazole passes into breast milk and you should therefore not breastfeed during treatment.
Driving and using machines
Do not drive or use machines during treatment with metronidazole as metronidazole may affect your ability to react. This is especially true at the beginning of treatment.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist
Metronidazole Braun contains sodium
This medicine contains 322 mg sodium (the main ingredient in table salt/table salt) per 100 ml. This corresponds to 16% of the maximum recommended daily sodium intake for adults. If the product is diluted with sodium chloride, the added sodium should also be considered. Talk to your doctor.
3. How to use Metronidazole Braun
This medicine is given to you by a doctor or nurse. It is given as a drip directly into a vein ( intravenous infusion ).
Dosage one depends on the type and severity of your illness, on your age and body weight, and on how you respond to treatment. The doctor will decide the right dose for you.
If necessary, in addition to Metronidazole Braun, you can also be given other antibiotics.
If you take more Metronidazole Braun than you should
In case of overdose, you may experience the symptoms described under the side effects in section 4. If you get any side effects, talk to your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
High doses and long-term use increase the risk of side effects.
The following side effects can be serious. Tell your doctor or nurse immediately if you get any of the following side effects:
- severe and persistent diarrhea (may be a symptom of a severe intestinal infection called pseudomembranous colitis , occurring in an unknown number of users)
- severe inflammatory rash on mucous membranes and skin associated with fever, redness and blistering, and which in extremely rare cases can lead to skin detachment on large areas of skin ( Stevens-Johnson syndrome , toxic epidermal necrolysis , occurs in an unknown number of users)
- brain diseases, which can cause headaches, confusion, lethargy and coma (may affect up to 1 in 10,000 users)
- severe acute hypersensitivity reaction (allergic shock , angioedema , may affect up to 1 in 1,000 people)Symptoms can be:
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing
- sudden drop in blood pressure
- stomach pain, diarrhea, vomiting
- the number of white blood cells may decrease during treatment, which may affect the immune system ( agranulocytosis , pancytopenia, neutropenia , may occur in up to 1 in 1,000 users)Symptoms can be:
- fever together with severe diminished general condition
- fever with local symptoms of infection such as sore throat / mouth or difficulty urinating.
Other side effects are
Common (may affect up to 1 in 10 people)
- diffuse intolerance symptoms
- metallic taste in the mouth.
Uncommon (may affect up to 1 in 100 people)
- decreased white blood cell count ( leukopenia ).
Rare (may affect up to 1 in 1,000 people)
- decreased platelet count ( thrombocytopenia )
- mental disorders such as confusion, hallucinations
- dizziness, coordination problems, disorders of the nervous system such as numbness, pain, tingling in the arms or legs, cramps
- visual disturbances, e.g. double vision, myopia
- inflammation of the tongue, stomach pain, vomiting, nausea, diarrhea, taste changes, loss of appetite
- abnormal liver function values (detected by blood tests), hepatitis (hepatitis), jaundice
- pancreatitis
- skin rash, itching , hives
- darkening of the urine
- fever
- headache.
Has been reported (occurs in an unknown number of users):
- encephalitis not caused by bacteria (aseptic meningitis ).
How to store Metronidazole Braun
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and carton. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store the bottles in the outer carton. Sensitive to light.
This medicine is for single use only. Discard any unused solution.
From a microbiological point of view, a dilute solution should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ° C, unless dilution has taken place under controlled and validated aseptic conditions.
Use only if the solution is clear and colorless or slightly yellowish and if the bottle and closure are undamaged.
Contents of the pack and other information
Content declaration
- The active substance is metronidazole.1 ml Metronidazole Braun solution for infusion contains 5 mg metronidazole.One 100 ml vial contains 500 mg of metronidazole.
- The other ingredients are sodium chloride, disodium phosphate dodecahydrate, citric acid, water for injections.
What the medicine looks like and contents of the pack
Metronidazole Braun is a clear, colorless, or slightly yellowish aqueous solution.
Pack sizes:
Ecoflac plus plastic packaging (LDPE): 10 × 100 ml, 20 × 100 ml, 10 × 200 ml, 10 × 300 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Postal address:
34209 Melsungen
Germany
Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
or
B. Braun Medical SA
Carreterra de Terrassa 121
08191 Rubi, Barcelona
Spain
Further information on this medicine can be obtained from the representative of the marketing authorization holder:
B. Braun Medical AB
Box 110
182 12 Danderyd