| Flagyl suspension SPC:
Section 4.1- wording changed to Flagyl is indicated in adults and children for the following indications…. The indications remain the same.
And following text added: Considerations should be given to official guidance on the appropriate use of antibacterial agents.
Section 4.2- further more specific guidance has been added for children;
Children and infants - Children > 8 weeks to 12 years of age: The usual daily dose is 20-30mg/kg/day as a single dose or divided into 7.5mg/kg every 8 hours. The daily dose may be increased to 40mg/kg, depending on the severity of the infection. Duration of treatment is usually 7 days.
Children < 8 weeks of age: 15mg/kg as a single dose daily or divided into 7.5mg/kg every 12 hours.
In newborns with a gestation age < 40 weeks, accumulation of metronidazole can occur during the first week of life, therefore the concentrations of metronidazole in serum should preferable be monitored after a few days therapy.
Prophylaxis against postoperative infections caused by anaerobic bacteria:
Children < 12 years: 20-30 mg/kg as a single dose given 1-2 hours before surgery
Newborns with a gestation age <40 weeks: 10mg/kg body weight as a single dose before operation
Changes have been made to the dosages table;
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Duration of dosage in
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Adults and children over
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Children
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days
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10 years
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7 to 10 years
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3 to 7 years
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1 to 3 years
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Urogenital trichomoniasis
Where re-infection
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7
or
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200 mg three times daily
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100 mg three times daily
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100 mg twice daily
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50 mg three times daily
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is likely, in adults
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|
|
|
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the consort should receive a similar course of treatment concurrently
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2
or
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800 mg in the morning and 1,200 mg in the evening
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|
|
|
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2.0 g as a single dose
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Non-specific vaginitis
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7
or
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400 mg twice daily
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|
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1
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2.0g as a single dose
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|
|
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Giardiasis
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3
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2000mg once daily
or
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1000mg once daily
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600-800 mg once daily
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500 mg once daily
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5
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400mg three times daily
or
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7-10
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500mg twice daily
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Alternatively, as expressed in mg per kg of body weight: 15-40 mg/kg/day divided in 2-3 doses.
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Sectin 4.5- following wording added: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
4.9 – wording changed to the following;
Single oral doses of metronidazole, up to 12g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosage. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.
Section 10- date changed to 04/11/2011
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