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Drug Rovas 1.5M have composition Spiramycin 1.5M, Indication treatment of Lower, Upper respiratory tract infections : otitis, sore throat, acute bronchitis, non-malignant skin infections such as impetigo skin ulcer

CHLORAMPHENICOL 250mg treatment of severe infections caused by susceptible bacteria

Zidocin DHG Treatment of acute, chronic or recurrent stomatological infections

COMPOSITION:

Spiramycin 1.500.000 IU

Excipients.q.s  1 tablet

(Tapioca starch, sodium starch glycolate. talc, magnesium stearate, aerosil, PVP. HPMC, PEG 6000, titanium dioxide)

ROVAS 1.5M IU - Spiramycin 1.500.000 IU

DOSAGE FORM:

Film coated tablets.

PRESENTATION:

Box of 2 blisters x 8 tablets.

PHARMACODYNAMICS:

Rovas 1.5M contains Spiramycin – a macrolide antibiotic. At serum concentrations Rovas is bacteriostatic but at tissue concentrations the drug is bactericidal.

Action mechanism: Rovas acts on 50S subunit of the bacterial ribosome, prevents protein synthesis by bacteria.

Organisms being sensitive to Rovas: Streptococcus, meticillin-sensitive Staphylococcus. Pneumococcus. Meningococcus. Gonococcus. Rhodococcus equi, Corynebacterium diphteriae. Bordetella pertussis. Leptospira. Moraxella. Branhamella catarrhalis. Helicobacter pylon. Campylobacter jejuni. Borrelia burgdorferi, Coxielia. Mycoplasma pneumoniae. Chlamydia trachomatis. Treponema pallidum. Acbnomyces. Propionibacterium acnes. Mycoplasma hominis, Mobiluncus. Eubacterium, Porphyromonas. Toxoplasma gondii. Some organisms being medium-sensitive: Neisseria gonorrhoeae, Vibrio, Ureaplasma, Legionella pneumophila. Some bacteria that have to be made a bacterial-graph to determine the sensitivity: Campylobacter coli, Streptococcus pneumoniae. Peptostreptococcus, Enterococcus. Clostridium pertringens.

PHARMACOKINETICS:

Rovas 1.5M is well dispersed into the body. The drug’s concentration is highly obtained in lung, tonsil, bronchi and sinuses. The elimination half-life of Spiramycin is between 5 and 8 hrs. The drug is not excreted in active form through kidney: thus, it is not necessary to adjust the dose in case of renal impairment.

INDICATIONS: For treatment of Rovas 1.5M :

– Upper respiratory tract infections: otitis, sore throat, tonsillitis, acute sinusitis; stomatological infections.

– Lower respiratory tract infections: acute bronchitis, acute course of chronic bronchitis, public pneumonia (in patients without risky elements, without clinical symptoms). In case of doubting about an atypical pneumonia. Rovas is indicated in any cases of serious or non-serious diseases.

– Treatment of non-malignant skin infections such as impetigo, skin ulcer, erysipela.

– Treatment of genital infections not caused by gonococcus.

– Prophylaxis of meningitis caused by meningococcus when patients contra-indicated in the prescription of rifamptcin.

– Prophylaxis of innate toxoplasmosis in pregnancy.

– Replacement therapy in case of patients allergic to penicillin.

– Prophylaxis of recurrences of acute rheumatism in patients allergic to penicillin.

CONTRAINDICATIONS:

Hypersensitivity to macrolide antibiotics.

PRECAUTIONS:

Patients with hepatic disorders. Breast-feeding should be discontinued when taking the drug.

INTERACTIONS:

Spiramycin inactivates contraceptives.

ADVERSE EFFECTS:

Frequently: Nausea, vomiting, diarrhoea, Rarely: fatigue, sweating, allergic skin reactions.

Inform your physician about any adverse effects occur during the treatment.

OVER DOSAGE:

No documents have been reported.

DOSAGE 4 ADMINISTRATION:

Rovas 1.5M should be taken at least 2 hrs prior or 3 hrs after meals.

The therapy process must be completely pursued.

Oral doses

Adults: 1 – 2 tablets x 3 times /day.

Prophylaxis of meningitis caused by meningococcus

Adults: 2 tablets/time, each 12 hours for one time.

– Prophylaxis ot innate toxoplasmosis in pregnancy: 6 tablets/day. in many divided doses, within 3 weeks, repeat the dose every 2 weeks.

Or as directed by the physician

Read the directions carefully before use Consult the physician for more information This drug is for prescriptions only

Shelf-life: 36 months from the manufacturing date.

Storage conditions: store in dry places, not exceeding 30°C.

Specifications: Manufacturer’s

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