FLAGYL Suppositories, Oral suspension (2022)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Sanofi-aventis Α.Ε.Β.Ε. |
|---|---|
| Διεύθυνση | Λεωφ. Συγγρού 348, Κτήριο Α', 17674, Καλλιθέα, Αθήνα |
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Περιεχόμενα
1. Name of the medicinal product
Flagyl 500 mg suppositories. Flagyl-S 200 mg/5 mL oral suspension.
2. Qualitative and quantitative composition
Flagyl suppositories contain 500 mg metronidazole. Flagyl-S suspension contains 320 mg metronidazole benzoate, equivalent to 200 mg metronidazole, in each 5 mL. Flagyl-S suspension also contains 3.01 g ...
3. Pharmaceutical form
Suppository and oral suspension. Flagyl suppositories are creamy in colour, smooth faced and torpedo shaped. Flagyl-S is a white to cream-yellow (buff) coloured suspension easily dispersible with gentle ...
4.1. Therapeutic indications
The prevention of post-operative infections due to anaerobic bacteria, particularly species of bacteroides and anaerobic streptococci. The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, ...
4.2. Posology and method of administration
Flagyl suppositories are unsuitable for initiating treatment of serious conditions owing to slower absorption and lower plasma concentrations of metronidazole. Flagyl suspension should be taken at least ...
4.3. Contraindications
Patients with evidence of or a history of blood dyscrasias should not receive the drug since upon occasion a mild leucopenia has been observed during its administration. However, no persistent haematological ...
4.4. Special warnings and precautions for use
Alcohol Alcoholic beverages and drugs containing alcohol, should not be consumed by patients being treated with metronidazole and for at least a day after treatment as nausea, vomiting, abdominal cramps, ...
4.5. Interaction with other medicinal products and other forms of interaction
Some potentiation of anticoagulant effect (and increased haemorrhagic risk caused by decreased hepatic catabolism) has been reported when metronidazole has been used with the warfarin type oral anticoagulants. ...
4.6. Fertility, pregnancy and lactation
Pregnancy Category B2 There is inadequate evidence of the safety of metronidazole in pregnancy. However, as Flagyl crosses the placental barrier it, like other medicines, should not be given during pregnancy ...
4.7. Effects on ability to drive and use machines
Patients should be warned about the potential for confusion, dizziness, vertigo, hallucinations, convulsions or transient visual disorders and advised not to drive or operate machinery if these symptoms ...
4.8. Undesirable effects
Serious adverse reactions occur very rarely with standard recommended regimens. Gastrointestinal disorders When given orally, metronidazole is well tolerated. The most common adverse reactions refer to ...
4.9. Overdose
Symptoms of overdosage are limited to vomiting, ataxia and slight disorientation. Uneventful recovery has followed attempts at suicide and accidental overdoses with quantities of 30 and 60 200 mg tablets, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antibacterials for systemic use <b>ATC code:</b> J01XD01 Microbiology Antiprotozoal agent; anaerobic antibacterial agent. Flagyl is active against a wide range of pathogenic ...
5.2. Pharmacokinetic properties
Absorption The bioavailability of metronidazole in Flagyl suppositories is 60-80%. Effective blood concentrations are achieved 5-12 hours after the first suppository and are maintained by the recommended ...
5.3. Preclinical safety data
Carcinogenicity / Mutagenicity Metronidazole has been shown to be carcinogenic in the mouse and in the rat. However, similar studies in the hamster have given negative results and extensive human epidemiological ...
6.1. List of excipients
Flagyl suppositories contain hard fat as the excipient. Flagyl-S oral solution contains the following excipients: sucrose ethanol monobasic sodium phosphate dihydrate aluminium magnesium silicate methyl ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. Dilution of Flagyl-S suspension, if necessary, should be carried out with syrup B.P. The diluted suspension has a shelf life of 14 days.
6.4. Special precautions for storage
Store at or below 25°C. Protect from light.
6.5. Nature and contents of container
Suppositories <u>Pack size:</u> blister pack 10 suppositories. Suspension <u>Pack size:</u> 100 mL glass bottle.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, PO Box 62027, Sylvia Park Auckland 1644, Freecall: 0800 283 684, Email: medinfo.australia@sanofi.com
9. Date of first authorization / renewal of the authorization
Flagyl suppositories: 25 August 1977 Flagyl-S oral suspension: 22 December 1980
10. Date of revision of the text
20 June 2022
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Σχετικά φαρμακευτικά σκευάσματα
| Κωδικός | Όνομα | Κ | Ν.Τ. | Χ.Τ. | Λ.Τ. | Κάτοχος άδειας |
|---|---|---|---|---|---|---|
| 07613.05.01 | FLAGYL 500MG/SUP VAG.SUP ΒΤx10 | 1,24 | 1,42 | 2,00 | Sanofi-Aventis Α.Ε.Β.Ε. |