METRONIDAZOLO 500 mg /100 Ml Roztwór Do Infuzji
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METRONIDAZOLO Bioindustria L.I.M. 500 mg/100 ml solution for intravenous infusion
Metronidazolo
Generic Medicine
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 or nurse.
- If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.
Contents of this leaflet:
- 1. What is METRONIDAZOLO Bioindustria L.I.M. and what it is used for
- 2. What you need to know before you use METRONIDAZOLO Bioindustria L.I.M.
- 3. How to use METRONIDAZOLO Bioindustria L.I.M.
- 4. Possible side effects
- 5. How to store METRONIDAZOLO Bioindustria L.I.M.
- 6. Contents of the pack and other information
1. What is METRONIDAZOLO Bioindustria L.I.M. and what is it used for?
METRONIDAZOLO Bioindustria L.I.M. contains the active ingredient metronidazole which belongs to a
group of medicines called antibiotics, used for infections caused by bacteria.
This medicine is indicated for the treatment of severe infections (septicemia, bacteremia), in adults and
children, caused by the following bacteria Bacteroides fragilis, Fusobacteria, Eubacteria, Clostridiaand Gram-positive anaerobic Cocci.
METRONIDAZOLO Bioindustria L.I.M. is particularly indicated for:
- the treatment of infections such as infections causing accumulation of infected material (brain and pelvic abscesses), severe lung infections (necrotizing pneumonia), affecting bones and joints (osteomyelitis), the uterus (puerperal fever), the peritoneum (peritonitis) and infections causing sores following surgical operations.
- prevention of infections caused by bacteria (Bacteroidesand Gram-positive anaerobic Cocci) that occur following surgical operations (in the pre- and post-operative phase).
2. What you need to know before using METRONIDAZOLO Bioindustria L.I.M.
Do not use METRONIDAZOLO Bioindustria L.I.M.
- if you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from any blood or bone marrow disease (blood dyscrasias);
- if you suffer from problems with the nervous system (active central nervous system diseases);
- if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Consult your doctor or nurse before you are administered METRONIDAZOLO Bioindustria
L.I.M.
METRONIDAZOLO Bioindustria L.I.M. will always be administered to you under strict medical supervision.
METRONIDAZOLO Bioindustria L.I.M. will be administered to you with great caution and at reduced doses if:
- you have serious kidney problems (impaired renal function);
- you have serious liver problems (severe liver diseases).
If METRONIDAZOLO Bioindustria L.I.M. is administered to you for a period longer than 10 days:
- the doctor will assess the risk of developing problems with the peripheral nervous system (peripheral neuropathy).
- you will be subjected to regular checks of your clinical condition.
Cases of liver toxicity (severe hepatotoxicity/acute hepatic failure), including cases leading to death, have been reported with medicines containing metronidazole in patients with
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, soft or greyish-green stools, or itching.
Other medicines and METRONIDAZOLO Bioindustria L.I.M.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines:
- oral anticoagulants and coumarins(warfarin, and similar medicines), used to reduce blood clotting because it may increase the anticoagulant effect.
- medicines that interfere with the metabolismof metronidazole, such as phenytoin and phenobarbital, used as antiepileptics.
If you have taken disulfiram, a medicine used to treat alcoholism, in the last two weeks, do not
take METRONIDAZOLO Bioindustria L.I.M.
METRONIDAZOLO Bioindustria L.I.M. with alcohol
Do not drink alcohol if you have been administered METRONIDAZOLO Bioindustria L.I.M. because you may
experience symptoms such as nausea, vomiting and abdominal cramps.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or nurse for advice before you are administered this medicine.
If you are pregnant or breastfeeding, do not use METRONIDAZOLO Bioindustria L.I.M..
Driving and using machines
This medicine does not impair the ability to drive and operate machines.
METRONIDAZOLO BIOINDUSTRIA L.I.M. contains sodium
This medicine contains 332.6 mg (14.46 mmol) of sodium per 100 ml of solution. This should be taken into
account in people with impaired renal function or who are on a low-sodium diet.
3. How to use METRONIDAZOLO Bioindustria L.I.M.
Use this medicine following the instructions of your doctor or nurse exactly. If you have any doubts
consult your doctor or nurse.
If you use more METRONIDAZOLO Bioindustria L.I.M. than you should
This medicine will be administered by trained personnel, so it is unlikely that you will be
administered an excessive dose. However, if you are administered an excessive dose, contact
your doctor who will indicate an appropriate therapy for your symptoms.
If you have been administered an excessive amount of this medicine, contact immediately
your doctor or nurse.
If you have any doubts about the use of this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known(the frequency cannot be estimated from available data)
- unpleasant metallic taste, presence of scaling on the tongue (coated tongue), loss of appetite (anorexia), nausea, vomiting, stomach and intestinal pain (gastro-intestinal disturbances);
- drowsiness, dizziness, headache, loss of muscle coordination (ataxia), fever, formation of spots and skin irritation (skin rashes), itching, dark urine, kidney problems (dysuria, cystitis, polyuria, pyuria), decreased libido, Candidainfections;
- problems with the peripheral nervous system (peripheral neuropathies);
- decrease in the number of white blood cells in the blood (leukopenia);
- transient seizures.
If you experience neurological problems (neuropathies, seizures) stop treatment.
Side effects in children
The frequency, type and severity of side effects in children are the same as in adults.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store METRONIDAZOLO Bioindustria L.I.M.
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 packaging after the words “EXP.”.
The expiry date refers to the last day of that month and the product in intact packaging and
correctly stored.
Store at a temperature not exceeding 25°C. Store in the original container and in the outer
packaging. Keep the medicine away from light as it is light-sensitive.
Do not dispose of any medicine in 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 Bioindustria L.I.M. contains
- The active ingredient is metronidazole. Each 100 ml vial contains 500 mg of metronidazole.
- The other ingredients are sodium chloride, disodium phosphate dihydrate, anhydrous citric acid, water for injections.
Description of the appearance of METRONIDAZOLO Bioindustria L.I.M. and contents of the pack
METRONIDAZOLO Bioindustria L.I.M. is presented in a pack of 25 vials of 100 ml.
Marketing Authorisation Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A. (Bioindustria L.I.M. S.p.A.) - Via De Ambrosiis, 2 -
15067 Novi Ligure (AL)
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The following information is intended exclusively for doctors or healthcare professionals
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 infection due to anaerobes is present or suspected, for example, septicemia, 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 from the gastro-intestinal tract, the female genital tract, or the oropharynx. In patients already undergoing infusion therapy, the medicine can be diluted with adequate volumes of physiological solution, 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 of age: 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 aged between 8 weeks and 12 years: The usual daily dose is 20-30 mg/kg/day in 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. The duration of treatment is usually 7 days.
- Children under 8 weeks of age: 15 mg/kg in a single daily dose or divided into 7.5 mg/kg every 12 hours.
- In neonates with a gestational age of less than 40 weeks, accumulation of metronidazole may occur during the first week of life; for this reason, metronidazole concentrations in the serum should preferably be monitored after a few days of therapy.
- Bacterial vaginosis: Adolescents: 400 mg twice a day for 5-7 days or 2000 mg in a single dose Prophylaxis
- Adults and children over 12 years of age: 100 ml for intravenous infusion immediately before, during or after surgery, followed by the same dose every 8 hours.
- Children under 12 years of age:
20-30 mg/kg in a single dose given 1-2 hours before surgery.
- Neonates with a gestational age of less than 40 weeks: 10 mg/kg of body weight in a single dose before surgery
Interactions with other medicines and other forms of interaction
Metronidazole potentiates the activity of warfarin and other coumarinic oral anticoagulants, resulting in
a prolongation of prothrombin time; it is appropriate to modify the doses in cases of patients treated
simultaneously with these drugs and metronidazole. Simultaneous administration of drugs that
induce hepatic microsomal enzymes (e.g. phenytoin, phenobarbital) may accelerate the elimination of
metronidazole with a consequent reduction in drug blood levels.
Metronidazole should not be administered to patients who have taken disulfiram in the two
weeks prior to treatment.
Incompatibilities
Avoid adding other drugs to the solution to be infused. No additives should be added to the
metronidazole solution.
Shelf life
36 months.
Special precautions for storage
Store at a temperature not exceeding 25°C. Store in the original container and in the outer
packaging. Sensitive to light.
For further information, consult the Summary of Product Characteristics.
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- Kraj rejestracji
- Postać farmaceutycznaInfusion solution, 500 MG/100 ML
- Kod ATCJ01XD01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki METRONIDATSOLO BIOINDUSTRIA LIMPostać farmaceutyczna: Infusion solution, 5 MG/MLSubstancja czynna: metronidazoleProducent: B. BRAUN MELSUNGEN AGWymaga receptyPostać farmaceutyczna: Infusion solution, <500 mg/100 mlSubstancja czynna: metronidazoleProducent: BAXTER S.P.A.Wymaga receptyPostać farmaceutyczna: Infusion solution, 5 MG/MLSubstancja czynna: metronidazoleProducent: NORIDEM ENTERPRISES LTDWymaga recepty
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METRONIDATSOLO BIOINDUSTRIA LIM wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w METRONIDATSOLO BIOINDUSTRIA LIM jest metronidazole. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
METRONIDATSOLO BIOINDUSTRIA LIM jest produkowany przez BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie METRONIDATSOLO BIOINDUSTRIA LIM jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić METRONIDATSOLO BIOINDUSTRIA LIM w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (metronidazole) to m.in. METRONIDATSOLO B. BRAUN, METRONIDATSOLO BAXTER S.P.A., METRONIDATSOLO NORIDEM. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
