Wilprafen tablets film-coated

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

josamycin

Pieejams no:

Dragenopharm Apotheker Puschl GmbH

ATĶ kods:

J01FA07

SNN (starptautisko nepatentēto nosaukumu):

josamycin

Deva:

500mg

Zāļu forma:

tablets film-coated

Vienības iepakojumā:

(10/1x10/) in blister

Receptes veids:

Prescription

Autorizācija statuss:

Registered

Autorizācija datums:

2016-12-30

Produkta apraksts

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Wilprafen 500 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of josamycin
The full list of excipients is given in Section 6.1.
3. DOSAGE FORM
film-coated tablets
4. CLINICAL INFORMATION
4.1. THERAPEUTIC INDICATIONS
Dental infections, E.N.T. infections, respiratory infections,
infections of superficial soft tissue, mammary
glands, genital organs or bile ducts caused by microorganisms
sensitive to the active substance. Wilprafen is
also indicated for individuals allergic to penicillin and carriers of
infections sensitive to josamycin.
4.2. DOSAGE AND ROUTE OF ADMINISTRATION
Adults
In adults, the most common dosage regimen and dosing is 1.5 - 2 g per
day, divided into multiple doses. In
severe cases, dosing may be increased to 3 g per day or more.
Pediatric patients
In children, the dosing is 40 - 50 mg/kg per day, divided into
multiple doses.
In young children, the product should only be prescribed in case of
serious need and should only be used
under medical supervision.
It is recommended to take tablets between meals. Treatment should be
continued for 48 hours after clinical
symptoms disappear and the body temperature goes back to normal.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients, or
to chemically related substances.
Severe hepatobiliary disease.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with liver impairment may show increased plasma levels of the
drug.
Thus, caution should be exercised when using josamycin in patients
with liver impairment.
2
It is generally recommended to monitor liver function in patients with
hepatobiliary disease when treatment
lasts longer than 15 days. Although there is no conclusive evidence,
it cannot be ruled out that treatment
(especially prolonged treatment) with josamycin and other macrolide
antibiotics may cause proliferation of
resistant bacteria and fungi. In such cases, treatment should be
discontinued a