ROVAMYCIN Film-coated tablet
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
ROVAMYCIN.
Qualitative and quantitative composition
<u>Active ingredient:</u> each tablet contains 1.5 MIU Spiramycin. Excipients: Microcrystalline cellulose, Gelifiable maize starch, Hydroxypropylcellulose, Sodium croscarmellose, Hypromellose, Magnesium ...
Pharmaceutical form
Film-coated tablet.
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: <u>Adults:</u> 6 to 9 million IU/24 hours, i.e. 4 to 6 tablets per day in 2 to 3 intakes. <u>Children:</u> 1.5 to 3 million IU per 10 kg of ...
Contraindications
Hypersensitivity to spiramycin , other macrolids or any of the excipients (see section 2 Qualitative and Quantitave composition). It is not recommended for breast-feeding mothers (see 4.6 Pregnancy and ...
Special warnings and precautions for use
QT interval prolongation Cases of QT interval prolongation have been reported in patients taking macrolides, including spiramycin. Caution should be exercised when using spiramycin, in patients with known ...
Interaction with other medicinal products and other forms of interaction
Interactions requiring precautions for use Levodopa (associated with carbidopa) Inhibition of carbidopa absorption with decreased plasma concentrations of levodopa. Clinical monitoring and possible adjustment ...
Pregnancy and lactation
Pregnancy Spiramycin can be used during pregnancy if necessary. Extensive use of spiramycin during pregnancy has shown no evidence of malformation or fetotoxicity to date. Lactation Spiramycin is excreted ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
<u>Gastrointestinal system:</u> Gastralgia, nausea, vomiting, diarrhea and, very rarely, pseudo-membranous colitis. <u>Skin and appendages:</u> Rash, urticaria, pruritis. Very rarely angioedema, anaphylactic ...
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 ...
Pharmacodynamic properties
Pharmacotherapeutic class: SYSTEMIC ANTIBACTERIAL AGENT ATC code: J01FA02 Antibacterial antibiotic belonging to the macrolides family. Antibacterial activity spectrum Critical concentrations differentiate ...
Pharmacokinetic properties
Absorption Spiramycin is rapidly but incompletely absorbed and is not modified by food intake. Distribution After oral administration of 6 million IU of spiramycin, the peak serum concentration is 3.3 ...
Preclinical safety data
Not relevant.
Marketing authorization holder
Sanofi-aventis Israel ltd, P.O.B. 8090 Netanya 4250499
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