METRONIDAZOLO 5 mg /Ml Инфузионный Раствор

Содержание инструкции

1. Metronidazolo B. Braun 5 mg/ml infusion solution
   1. What is Metronidazolo B. Braun 5 mg/ml and what is it used for
   2. What you need to know before using Metronidazolo B. Braun 5 mg/ml
   3. How to use Metronidazolo B. Braun 5 mg/ml
   4. Possible side effects
   5. How to store Metronidazolo B. Braun 5 mg/ml
   6. Contents of the pack and other information

Metronidazolo B. Braun 5 mg/ml infusion solution

Metronidazolo

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Metronidazolo B. Braun 5 mg/ml is and what it is used for.
• 2. What you need to know before using Metronidazolo B. Braun 5 mg/ml.
• 3. How to use Metronidazolo B. Braun 5 mg/ml.
• 4. Possible side effects.
• 5. How to store Metronidazolo B. Braun 5 mg/ml.
• 6. Contents of the pack and other information.

1. What is Metronidazolo B. Braun 5 mg/ml and what is it used for

Metronidazolo B. Braun 5 mg/ml belongs to a group of medicines known as antibiotics and used to
treat serious infections caused by bacteria that can be killed by the active ingredient metronidazole.
You may be prescribed Metronidazolo B. Braun 5 mg/ml for the treatment of any of the following
diseases:
➢ infections of the central nervous system such as abscesses (local infection with pus) in the brain,
inflammation of the meninges (lining of the brain);
➢ infections of the lungs and the lining of the lungs, such as pneumonia accompanied by destruction
of tissue, pneumonia following the entry of gastric contents into the lungs, lung abscesses;
➢ infections of the gastrointestinal tract, such as inflammation of the inner lining of the abdominal
cavity and the pelvic wall, liver abscesses, surgery of the colon or rectum, abdominal
and pelvic infections with pus;
➢ infections of the female genital organs, such as inflammation inside the uterus, following
removal of the uterus, caesarean section, spontaneous abortion accompanied by sepsis, puerperal fever;
➢ infections of ears, nose and throat, and of teeth, jaw and mouth, such as gingivitis;
➢ inflammation of the inner lining of the heart;
➢ infections of bones and joints, such as inflammation of the bone marrow;
➢ gas gangrene;
➢ sepsis caused by thrombosis and inflamed veins.
If necessary, your treatment may be supplemented with other antibiotics.
Metronidazolo B. Braun 5 mg/ml may be prescribed as preventive treatment before operations
associated with a high risk of infection from so-called anaerobic bacteria, mainly in gynecology or
surgery of the stomach and intestines.

2. What you need to know before using Metronidazolo B. Braun 5 mg/ml

Do not use Metronidazolo B. Braun 5 mg/ml
➢ if you are allergic to metronidazole, to other similar substances or to any of the other components of
this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before you are given Metronidazolo B. Braun 5 mg/ml.
Take special care with Metronidazolo B. Braun 5 mg/ml if you have:
➢ severe liver damage;
➢ a blood formation disorder or;
➢ a disease of the brain, spinal cord or nerves.
Therefore, your doctor will have to carefully determine whether you can be treated with Metronidazolo B.
Braun 5 mg/ml.
If seizures or other nervous disorders (for example, numbness of the limbs) appear during therapy, your treatment must be reviewed immediately.
As a rule, treatment with Metronidazolo B. Braun 5 mg/ml should not be prolonged for more than 10
days; the treatment period will only be extended in exceptional circumstances and if absolutely necessary. Repetition of therapy with metronidazole will be limited to cases where this is absolutely necessary.
In such cases, you will be monitored with particular attention.
Especially in the case of prolonged treatment with metronidazole or if you are immunocompromised, an imbalance of the intestinal flora may occur.
Treatment must be stopped or reviewed immediately if you experience severe diarrhea which may be
due to a serious intestinal disease called “pseudomembranous colitis” (see also section 4).
Cases of liver toxicity (severe hepatotoxicity/acute hepatic failure), including cases leading to death, have been reported with medicines containing metronidazole, in patients suffering from
Cockayne syndrome.
If you suffer from Cockayne syndrome, your doctor will also frequently check your liver function both during and after treatment with metronidazole.
Immediately inform your doctor and stop taking metronidazole if you experience:

• stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, pale and greenish-grey stools, or itching;
• severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with Metronidazolo B. Braun 5 mg/ml. Stop taking Metronidazolo B. Braun 5 mg/ml and consult your doctor immediately if you notice any of the symptoms related to these severe skin reactions, described in section 4. Because prolonged use of metronidazole can impair blood formation (see section “Possible side effects”), a blood cell count will be performed during treatment. Other medicines and Metronidazolo B. Braun 5 mg/mlTell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription.

Medicines that can cause heart rhythm disorders
Tell your doctor if you are taking medicines that can cause a heart rhythm disorder (so-called prolongation of the QT interval visible on an electrocardiogram), such as some antiarrhythmics
(medicines used to treat heart rhythm disorders such as, for example, amiodarone) and some antibiotics
(such as, for example, ciprofloxacin).
When you receive these medicines, your heart function needs to be monitored. Consult your doctor if
you notice any abnormalities in heart function, dizziness or fainting.

Barbiturates (the active ingredient of sleeping pills)
The duration of action of metronidazole is reduced by phenobarbital; for this reason, your dose of metronidazole may need to be increased.

Busulfan
Metronidazole should not be given to patients taking busulfan because it increases the
likelihood of toxic effects.

Carbamazepine (a medicine used to treat epilepsy)
This combination also requires caution because metronidazole can increase the duration of action of
carbamazepine.

Cimetidine (a medicine for the treatment of stomach conditions)
Cimetidine can reduce the elimination of metronidazole in isolated cases and consequently lead to an
increase in metronidazole concentrations in the serum.

Coumarin derivatives (medicines that inhibit blood clotting)
Metronidazole can increase the inhibitory effect on coagulation of coumarins. If you are taking a
medicine that prevents blood clotting (e.g. warfarin), you may need to reduce the dose
of this medicine during treatment with metronidazole.

Cyclosporine (a medicine used to suppress unwanted immune responses)
When cyclosporine is administered together with metronidazole, cyclosporine levels in the blood
may increase; your doctor will therefore need to adjust your dose of cyclosporine accordingly.

Disulfiram (used in alcohol detoxification therapy)
If you are taking disulfiram, you should not be prescribed metronidazole, or you should stop
taking disulfiram. The combined use of these two medicines can cause confusion which
can lead to a serious mental disorder (psychosis).

Fluorouracil (an anti-cancer drug)
The daily dose of Fluorouracil may need to be reduced if administered in conjunction with
metronidazole because metronidazole can lead to an increase in Fluorouracil levels in the blood.

Lithium (used in the treatment of mental illness)
Treatment with lithium preparations requires particularly careful monitoring during
treatment with metronidazole and it may be necessary to adjust the dose of the lithium preparation.

Mycophenolate mofetil (used to prevent rejection after organ transplantation)
Its effect may be weakened by metronidazole; therefore, careful monitoring of the effect of this medicine is recommended.

Phenytoin (a medicine for the treatment of epilepsy)
If you are taking phenytoin, your doctor will treat you with metronidazole only with particular caution,
because metronidazole can increase the duration of action of phenytoin. On the other hand, phenytoin can
reduce the effect of metronidazole.

Tacrolimus (used to suppress unwanted immune responses)
Blood levels of this agent and renal function must be checked at the beginning and end of
treatment with metronidazole.

Metronidazolo B. Braun 5 mg/ml with alcohol

Alcohol
Do not drink alcoholic beverages while taking metronidazole, as this can cause
intolerance reactions such as dizziness and vomiting.

Pregnancy, breastfeeding and fertility

Pregnancy
If you are pregnant, your doctor will not prescribe metronidazole unless he/she considers it absolutely
necessary.

Breastfeeding
Do not breastfeed during treatment with metronidazole and do not resume breastfeeding for
the next 2-3 days as metronidazole passes into breast milk.

Fertility
Animal studies have only shown a potential negative influence of metronidazole on the male reproductive system when administered at high doses well above the maximum
recommended dose for humans.

Driving and operating machinery
Do not drive or operate machinery during treatment with metronidazole, as metronidazole can
impair attention. This is more frequent at the beginning of therapy or when
taking alcohol.

Metronidazolo B. Braun 5 mg/ml contains sodium
This medicine contains 322 mg of sodium (the main component of table salt) per 100 ml. This
is equivalent to 16% of the maximum recommended daily intake of salt with the diet of an adult.

3. How to use Metronidazolo B. Braun 5 mg/ml

Dosage
The dosage depends on the nature and severity of your illness, your age and body weight, and your
individual response to treatment.
The usual recommended dosages are:
Adults and adolescents
Treatment of infections:
You will normally receive 300 ml of the medicine (equivalent to 1500 mg of metronidazole) on the first day of
treatment.
From the second day of treatment onwards, you will receive 200 ml of the medicine (equivalent to 1000 mg of metronidazole)
each day.
Alternatively, you may receive 100 ml of the medicine (equivalent to 500 mg of metronidazole) every 8 hours.
At the beginning of treatment, your doctor may administer a higher initial dose of metronidazole.
In most cases, the treatment will last 7 days. Only in exceptional cases may the treatment be
prolonged beyond this period.
The dose will be the same for patients with kidney disease.
Lower doses may be necessary for patients with liver disease.
If you have undergone haemodialysis treatment, your doctor will adjust the dosage to the days of treatment.

Prevention of infections after surgery
If used for the prevention of infections in surgical procedures, you may be given 500
mg of the medicine before the operation. The dose will be repeated 8 and 16 hours after the operation.
Use in children
In children, the dosage is based on body weight.
Treatment of infections:

Normally the treatment will last 7 days.
Prevention of infections that may occur after surgery:

Method of administration and duration of treatment
Metronidazolo B. Braun 5 mg/ml is administered via intravenous infusion.
The infusion of one vial usually takes 60 minutes, but must not be carried out in less than 20
minutes.
This medicine can be diluted in a suitable infusion vehicle solution.
The entire treatment period with metronidazole is usually 7 days and should not exceed 10 days,
unless this is absolutely necessary (see also “Pay particular attention with
Metronidazolo B. Braun 5 mg/ml”).
If you are taking other antibiotics at the same time, your doctor will administer these drugs separately.

If you use more Metronidazolo B. Braun 5 mg/ml than you should
Undesirable effects, described in the following section, may appear as signs or symptoms of an
overdose.
There is no specific antidote or known specific treatment in case of massive overdose,
but metronidazole can be removed from the body by dialysis (artificial kidney treatment).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are mainly manifested following use of high doses or with long-term use.
To describe the frequency of side effects, the following terminology is used:
“Very common” occurs in more than 1 in 10 treated patients
“Common” occurs in 1-10 patients per 100 treated
“Uncommon” occurs in 1-10 patients per 1,000 treated
“Rare” occurs in 1-10 patients per 10,000 treated
“Very rare” occurs in less than 1 patient per 10,000 treated
“not known” the frequency cannot be defined based on available data

Stop taking Metronidazolo B. Braun 5 mg/ml and consult your doctor immediately if
you notice any of the following symptoms:
Rare:
➢ Severe, persistent diarrhea (probably a symptom of a serious intestinal infection called pseudomembranous colitis, see below).
➢ Severe acute hypersensitivity reactions up to and including anaphylactic shock.
Very rare:
White blood cell and platelet counts may decrease during treatment (granulocytopenia,
agranulocytosis, pancytopenia, thrombocytopenia). Regular monitoring of blood cell counts is necessary in case of prolonged use.
➢ Hepatitis (inflammation of the liver), jaundice, inflammation of the pancreas (sporadic reports)
➢ Cerebral disorders, lack of coordination.
Not known:
➢ Hypersensitivity reactions from mild to moderate, swelling of the face, mouth, throat and/or tongue (angioedema).
➢ Spasm of the gaze, damage or inflammation of the optic nerves.
➢ Reduced white blood cell count (leukopenia), severe anemia (aplastic anemia).
➢ Seizures, nervous system pathologies such as numbness, pain, a furry tongue sensation
(whitish-yellow coating) or tingling in arms or legs.
➢ Bacterial-free cerebral fever (aseptic meningitis).

➢ Acute liver failure in patients suffering from Cockayne syndrome (see section 2
“Warnings and precautions”).
➢ Hearing impairment, hearing loss.
➢ Ringing in the ears (tinnitus).
➢ Skin rash, blisters, fever or other signs and symptoms of hypersensitivity reactions.
➢ Reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome,
toxic epidermal necrolysis).
➢ Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or
drug hypersensitivity syndrome).
➢ Widespread, red and scaly rash, with the formation of pustules under the skin and blisters,
accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Other side effects include

Common:
➢ Yeast and bacterial superinfections.

Uncommon:
➢ Dark urine (due to a metronidazole metabolite).

Rare:
➢ ECG changes.

Very rare:
➢ Psychotic disorders including confusion, hallucinations.
➢ Headache, dizziness, drowsiness, fever, visual and motor disturbances, vertigo, speech defects,
convulsions.
➢ Visual disturbances, double vision, myopia.
➢ Liver function pathologies (such as elevated serum levels of certain enzymes and bilirubin).
➢ Allergic skin reactions such as itching, hives.
➢ Joint and muscle pain.

Not known:
➢ Stomach pain, nausea, diarrhea, inflammation of the tongue and mouth, belching and a bitter taste, metallic taste, feeling of heaviness in the stomach, furry tongue (whitish-yellow coating).
➢ Difficulty swallowing.
➢ Anorexia.
➢ Depressed mood.
➢ Drowsiness or insomnia, muscle spasms.
➢ Redness and itching of the skin (erythema multiforme).
➢ Irritation of the vein wall (up to inflammation of the veins and thrombosis) after intravenous administration, feeling of weakness, fever.

Emergency management of pseudomembranous enterocolitis
In case of severe, persistent diarrhea, you should immediately inform your doctor as the cause may be
due to pseudomembranous colitis, a serious condition that must be treated immediately. The
doctor will stop the metronidazole and prescribe you appropriate treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects helps to provide more information on the safety of
this medicine.

5. How to store Metronidazolo B. Braun 5 mg/ml

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 container and the vial. The expiry date
refers to the last day of that month.
Keep the vials in the outer packaging to protect them from light.
This medicine is for single use only. Discard any unused content.
From a microbiological point of view, dilutions must be used immediately. If not used
immediately, the shelf life after opening and the conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the
dilution has been carried out under controlled and validated aseptic conditions.
Use only if the solution is clear and free from visible particles, and if the vial and closure are intact.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Metronidazolo B. Braun 5 mg/ml contains
➢ The active ingredient is metronidazole.
1 ml of Metronidazolo B. Braun 5 mg/ml solution for infusion contains 5 mg of metronidazole.
One 100 ml polyethylene bottle contains 500 mg of metronidazole.
➢ The excipients are sodium chloride, disodium phosphate dodecahydrate, citric acid, water for
injections.

Description of the appearance of Metronidazolo B. Braun 5 mg/ml and contents of the pack
Metronidazolo B. Braun 5 mg/ml is a clear, colorless to slightly yellowish aqueous solution.
Metronidazolo B. Braun 5 mg/ml is supplied in 100 ml polyethylene bottles.
The solution is supplied in packs of 10 or 20 bottles.
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 Tel. +49-5661-71-0 Fax +49-5661-71-4567 Manufacturer(s)
• B. Braun Melsungen AG B. Braun Medical, S.A. Carl-Braun-Straße 1 Carretera de Terrassa 121 34212 Melsungen, Germany 08191 Rubí, Barcelona, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following names: