METRONIDAZOLO <500 mg/100 ml Infusion solution

Зміст інструкції

1. METRONIDAZOLO BAXTER S.P.A. 500 mg/100 ml solution for intravenous infusion
   1. What is METRONIDAZOLO BAXTER S.P.A. and what is it used for
   2. What you need to know before you take METRONIDAZOLO BAXTER S.P.A.
   3. How to take METRONIDAZOLO BAXTER S.P.A.
   4. Possible side effects
   5. How to store METRONIDAZOLO BAXTER S.P.A.
   6. Package contents and other information

METRONIDAZOLO BAXTER S.P.A. 500 mg/100 ml solution for intravenous infusion

Read this leaflet carefully before you start this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What METRONIDAZOLO BAXTER S.P.A. is and what it is used for
• 2. What you need to know before you are given METRONIDAZOLO BAXTER S.P.A.
• 3. How METRONIDAZOLO BAXTER S.P.A. is given
• 4. Possible side effects
• 5. How to store METRONIDAZOLO BAXTER S.P.A.
• 6. Contents of the pack and other information

1. What is METRONIDAZOLO BAXTER S.P.A. and what is it used for

The active substance contained in the medicine is metronidazole. Metronidazole is an antibacterial
(also known as an antibiotic), meaning a medicine that kills bacteria or stops their multiplication and
growth.
This medicine is used for the treatment and prevention of serious infections caused by
certain species of bacteria.
It is used in adults and children for:

• treating infections caused by anaerobic bacteria on which metronidazole exerts a bactericidal action (kills bacteria). Metronidazole may be administered to treat one of the following infections in which bacteria sensitive to metronidazole have been identified:
• generalized infections of the blood (septicemia),
• presence of bacteria in the blood (bacteremia),
• infections of the central nervous system such as brain abscesses (cerebral abscesses),
• lung infections, such as pneumonia accompanied by tissue destruction (necrotizing pneumonia),
• bone infections, such as inflammation of the bone marrow (osteomyelitis),
• infections of the female genital organs, such as inflammation inside the uterus, following childbirth, cesarean section or spontaneous abortion (puerperal fever),
• infections of the gastrointestinal tract, such as inflammation of the inner lining of the abdominal cavity (peritonitis) and the pelvic wall (pelvic abscesses),
• sores that occur in the post-operative period.
• preventing post-operative infections (which can occur following surgery) associated with a high risk of infection from anaerobic bacteria.

2. What you need to know before you take METRONIDAZOLO BAXTER S.P.A.

Do not use METRONIDAZOLOBAXTERS.P.A.:

• if you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking METRONIDAZOLO BAXTER S.P.A.
Cases of liver toxicity have been reported with medicines containing metronidazole
(severe hepatotoxicity/acute hepatic failure), including cases that have led to death,
in patients suffering from Cockayne syndrome.
If you suffer from Cockayne syndrome, your doctor will also frequently monitor 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.

Your doctor will be particularly careful with this medicine if you:

• suffer from severe liver disease.
• are currently suffering from a disease of the nervous system. In this case, inform your doctor, especially if you experience poor coordination (ataxia), partial hearing loss (hypoacusis), dizziness or confusion during treatment.
• suffer from blood cell disorders
• are undergoing renal dialysis

Your doctor may ask you to undergo some control tests if this medicine is administered to you for more than 10 days.

Other medicines and METRONIDAZOLOBAXTERS.P.A.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are taking:

• warfarin and other drugs that inhibit blood coagulation (oral anticoagulants); in case of concomitant treatment with metronidazole, your doctor may adjust the doses of these drugs.
• busulfan (used to treat leukemia, which is a cancer of the blood cells): in case of concomitant treatment with metronidazole, severe toxic effects to busulfan may occur.
• disulfiram (to treat alcohol dependence)
• medicines to treat epilepsy, such as phenobarbital, phenytoin and carbamazepine
• cimetidine (used to treat stomach ulcers)
• medicines used to correct irregular heartbeats, such as amiodarone and quinidine
• medicines used after organ transplants, such as cyclosporine and tacrolimus

METRONIDAZOLO BAXTER S.P.A. with alcohol
Do not drink alcohol during treatment with this medicine and for 72 hours afterwards, as
unpleasant side effects may occur, such as feeling unwell and vomiting, abdominal pain,
hot flushes, palpitations and headache.

Pregnancy and breastfeeding
This medicine should be avoided during pregnancy or breastfeeding, unless your doctor
considers it essential. If you are pregnant, suspect or are planning a
pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.

Driving and operating machinery
During treatment with this medicine you may experience some side effects
(including, for example, drowsiness, dizziness, headache, incoordination of movements, transient
loss of consciousness and uncontrolled body movements) that may impair your ability
to drive vehicles or use machinery. Therefore, you should not drive vehicles or use machinery during
treatment with this medicine

METRONIDAZOLO BAXTER S.P.A. contains sodium
Talk to your doctor or pharmacist if you need 2 or more vials a day for a prolonged
period, especially if you have been advised to follow a low-sodium diet.

3. How to take METRONIDAZOLO BAXTER S.P.A.

This medicine will be administered to you following the doctor's instructions exactly. If you
have any doubts, consult your doctor or pharmacist.
The doctor will decide what dose you need and when to administer it.
Each vial is for single use only and will be administered to you by slow intravenous infusion at a
rate of approximately 5 ml/minute.
The amount that will be administered to you will depend on:

• your age
• your weight
• your clinical condition
• the reason why it was prescribed to you

If you take more METRONIDAZOLO BAXTER S.P.A. than you should
Since the administration will be carried out by an experienced and qualified person, it is
unlikely that you will be given more METRONIDAZOLO BAXTER S.P.A. than you should.
If this were to happen, the administration will be stopped immediately and, if necessary, the
doctor will administer appropriate therapy.

4. Possible side effects

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

Serious side effects:
Rarely (may affect up to 1 in 1,000 people) the following serious side effects may occur:

• severe allergic reaction (which may cause sudden fainting, severe shortness of breath, abdominal pain or swelling of the face and/or tongue and throat);
• serious neurological effects: convulsions or seizures, brain diseases, nerve disorders, which may cause loss of vision, brain fever not caused by bacteria (aseptic meningitis)
• inflammation of the pancreas, which can cause stomach pain that radiates to the back (pancreatitis);
• severe effects on the skin (erythema, severe disease with blistering on the skin, in the mouth and genitals and exfoliation of the skin);
• unexpected infections, mouth ulcers, bruising, bleeding gums or severe fatigue. These effects may be caused by a blood problem.

Not Known (frequency cannot be estimated from available data):

• Acute liver failure in patients with Cockayne syndrome (see section 2 “Warnings and precautions”)
• speech disorder

If you experience any of these serious side effects, tell your doctor immediately who will stop the infusion.

Other side effects:
Common (may affect up to 1 in 10 people):

• unpleasant metallic taste, inflammation of the mouth and/or tongue, dry mouth;
• muscle pain

Not Common (may affect up to 1 in 100 people):

• decrease in the number of leukocytes (white blood cells) detected in blood tests
• headache,
• lack of energy or strength

Rare (may affect up to 1 in 1000):

• reduction in the number of some blood cells detected in blood tests (agranulocytosis, pancytopenia, neutropenia, thrombocytopenia).
• drowsiness
• dizziness, hallucinations
• feeling unwell (nausea, malaise), vomiting, diarrhea
• double vision or myopia.
• yellowing of the skin and whites of the eyes (jaundice);
• darkening of the urine;
• fever
• Jarisch-Herxheimer reaction (a whole-body reaction that occurs within the first 24 hours after starting antibiotic therapy during the treatment of some types of infections)
• weakness, numbness and pain, usually in the hands and feet
• loss of muscle control or poor coordination
• pain in the upper part of the abdomen
• swelling of the skin
• inflammation of the mucous membranes
• reaction at the injection site

Very rare (may affect up to 1 in 10,000):

• infection that is added to another one already existing (superinfection with candida)
• decreased sexual desire (libido)
• vertigo
• inflammation of the urinary bladder (cystitis)
• increased amount of urine (polyuria)
• presence of pus in the urine (pyuria)

Not known (frequency cannot be estimated from available data):

• constipation, decreased or loss of appetite;
• confusion;
• depressed mood,
• poor quality sleep
• numbness, tingling;
• muscle stiffness, muscle contraction
• joint pain
• painful urination
• itching, inflammation, swelling, rash, which can occasionally all be severe; sweating,
• chest pain
• chills
• alteration of the blood, which may change the results of blood tests, abnormal liver function test results;
• hypersensitivity
• rapid or irregular heartbeat;
• change in the color of the tongue
• feeling unwell, malaise
• partial loss of hearing (hypoacusis)
• recurrence of a rash at the same site after exposure to the drug (fixed drug eruption)
• decreased sensitivity and especially skin sensitivity
• difficulty breathing

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

5. How to store METRONIDAZOLO BAXTER S.P.A.

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 pack after Exp. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Keep the vials in the outer packaging to protect the medicine from light.
Use only if the solution is clear and if the vial and closure are intact. Use immediately after
opening the vial.
Each vial is to be used for a single and uninterrupted administration, any remaining contents must not
be used again.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What METRONIDAZOLOBAXTERS.P.A. contains

• The active ingredient is metronidazole (100 ml of Metronidazolo BAXTER S.P.A. 500 mg/100 ml solution for intravenous infusion contains 500 mg of metronidazole)
• The other ingredients are sodiumchloride, sodiumdibasic phosphate dodecahydrate (see paragraph Metronidazolo BAXTER S.P.A. contains sodium), citric acid monohydrate, water for injections q.s. to 100 ml.

Description of the appearance of Metronidazolo BAXTER S.P.A. and contents of the pack
Metronidazolo BAXTER S.P.A. is presented as a clear, colourless or slightly straw-yellow solution, free from visible particles, intended for administration by
intravenous infusion.
The solution is contained in glass vials of 100 ml placed in a cardboard box.
The following pack sizes are available:
1 vial of 100 ml
25 vials of 100 ml

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxter S.p.A. – Via Del Serafico 89 – 00142 Rome

Manufacturer
Bieffe Medital S.p.A. - Via Nuova Provinciale - Grosotto (So)
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The following information is intended exclusively for doctors or healthcare professionals:
This section contains practical information relating to administration. Read the SmPC for
complete information on dosage, method of administration, contraindications,
warnings etc.

Dosage and administration
The medicine must be used only for slow intravenous infusion.
This type of administration is particularly useful in emergency cases and is indicated in
surgical patients when:

• pre-operatively, an anaerobic infection is present or suspected, e.g. septicaemia, peritonitis, subphrenic or pelvic abscess;
• during surgery, signs of a septic state caused by anaerobic germs appear;
• during surgery, there is a possibility of contamination by anaerobes, originating from the gastro-intestinal tract, female genital tracts, or the oropharynx. In patients already undergoing infusion therapy, the medicine may be diluted with adequate volumes of physiological saline, isotonic dextrose solution, 5% dextrose solution or potassium chloride (20 mmol/l and 40 mmol/l). Avoid adding other drugs, besides metronidazole, to the solution to be infused.

Treatment

• Adults and children over 12 years: 100 ml for intravenous infusion (at a rate of 5 ml per minute) every 8 hours. In the majority of patients, 7 days of therapy are sufficient, but in some cases (regions inaccessible to drainage, new contamination, etc.) the treatment needs to be continued for longer.
• Children under 12 years: Infusion of 1.5 ml/kg of weight (7.5 mg of metronidazole/kg of weight) every 8 hours.

Prophylaxis

• Adults and children over 12 years: 100 ml for intravenous infusion immediately before, during or after surgery, followed by the same dose every 8 hours.
• Children under 12 years: As in adults, but with infusion at a dose of 1.5 ml/kg of weight (7.5 mg of metronidazole/kg of weight) every 8 hours.

Special warnings and precautions for use
Metronidazole has demonstrated carcinogenic properties in animals under particular
experimental conditions.
Regular clinical and biological monitoring is recommended if treatment is continued for
more than 10 days. The doctor intending to use the medicine for periods longer than those
recommended (treatment of chronic forms) must consider the possible benefit versus the
risk of peripheral neuropathy.
Patients with renal insufficiency
Patients undergoing peritoneal dialysis should be monitored for signs of toxicity due to
potential accumulation of metronidazole metabolites

Instructions for use and handling
Use immediately after opening the container (100 ml vial). The solution must be clear,
colourless or slightly straw-yellow and free from visible particles.
Each 100 ml vial must be used for a single and uninterrupted administration and
any residue must not be reused.
Avoid adding other drugs, besides metronidazole, to the solution to be infused.
Do not use plastic containers in series connections. Such use could cause
gaseous embolism due to aspiration of residual air from the primary container before
completion of the fluid administration from the secondary container.
The use of a vented intravenous administration set with the vent in the open position could
cause a gaseous embolism. Vented intravenous administration sets with the vent in
the open position must not be used with flexible plastic containers.

Additives:
Additives known to be incompatible or for which incompatibility is determined must not be used.
Before adding a substance or medicinal product, verify that it is soluble and stable in
metronidazole and that the pH range of metronidazole is appropriate. Additives may
be incompatible. When introducing additives, it is necessary to consult the instructions for use
of the medicinal product to be added and other relevant literature (see paragraph 6.2).
Mix the solution thoroughly when additives have been introduced.
Do not use if the colour changes and/or precipitates, insoluble complexes or crystals appear after addition.
Do not store solutions containing additives.

Further information relating to the onset of adverse effects
During intensive and prolonged treatments, some cases of peripheral neuropathies have been reported, in
generally with a favourable outcome after discontinuation of treatment or dose reduction.

Overdosage
Symptoms:
neurotoxic effects, including ataxia, mild disorientation, confusion, seizures and
peripheral neuropathy.