ROVAMYCIN Film-coated tablet Ref.[8592] Active ingredients: Spiramycin

Publisher: Sanofi-aventis Israel ltd, P.O.B. 8090 Netanya 4250499

Therapeutic indications

Respiratory tract infections, infections caused by clamydia, cryptosporidiosis pregnancy toxoplasmosis.

Posology and method of administration

Posology

In patients with normal renal function:

Routine dose:

Adults: 6 to 9 million IU/24 hours, i.e. 4 to 6 tablets per day in 2 to 3 intakes.

Children: 1.5 to 3 million IU per 10 kg of body weight per day in 2 to 3 intakes.

Sore throats should be treated for 10 days.

Meningococcal meningitis prophylaxis

Adults: 3 million IU/12 hours.

Children: 75,000 IU/kg/12 hours.

For 5 days.

In patients with renal insufficiency

No dose adjustment is necessary.

Method of Administration

Tablets should be swallowed whole with a glass of water

Overdose

There is no known toxic dose for spiramycin.

Expected signs of overdose are gastrointestinal: nausea, vomiting, diarrhea.

Due to the risk of QT prolongation, ECG monitoring is advised.

In the event of overdose, the QT interval should be determined, especially where other risk factors are present (hypokalemia, congenital lengthening of QT interval, other medicinal products lengthening QT interval and/or inducing torsades de pointes).

There is no specific antidote.

Symptomatic treatment is recommended.

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