Roxithromycin Sandoz 150mg tablets film-coated

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

roxithromycin

Sẵn có từ:

S.C. Sandoz S.R.L.

Mã ATC:

J01FA06

INN (Tên quốc tế):

roxithromycin

Liều dùng:

150mg

Dạng dược phẩm:

tablets film-coated

Các đơn vị trong gói:

(10/1x10/), in blister

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2016-02-16

Đặc tính sản phẩm

_Acc. To CDS Roxithromycin oral v02_05_2013_
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ROXITHROMYCIN SANDOZ® 150 MG
ROXITHROMYCIN SANDOZ® 300 MG
FILM-COATED TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of roxithromycin.
Each film-coated tablet contains 300 mg of roxithromycin.
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
150 mg tablets are white, round, convex film-coated tablets, scored on
one face
embossment on one side: R 150.
300 mg tablets are white, round, biconvex film-coated tablets, scored
on one face
embossment on one side: R 300.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Infections caused by roxithromycin- susceptible microorganisms:
- infections of ear-nose-throat (tonsillitis, pharyngitis, acute
sinusitis, otitis media)
- infections of airways : bronchitis, pneumonia (also caused by
Chlamydiae, Mycoplasms,
Legionellae), and whooping cough
- skin and soft tissue infections (furunculosis, pyoderma, impetigo,
erysipelas, acne
vulgaris, odontogenic infections)
- urogenital infections such as urethritis, cervicitis,
cervicovaginitis caused Chlamydiae and
Mycoplasms
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents when using Roxithromycin Sandoz®.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage and method of administration depend on the severity of the
infection, the
sensitivity of the pathogen and the patient’s general condition.
_DOSAGES _
Adults and children/adolescents weighing above 40 kg
The usual dose for patients above 40 kg body weight is 300 mg daily
i.e. one 150 mg
tablet every 12 hours, in the morning and in the evening or 1 300 mg
film-coated tablet
daily in the morning
Dosage in case of hepatic dysfunctions
In patients with severe hepatic dysfunctions, the daily dose is to be
halved (cf. section 4.4
"Special warnings and precautions for use").
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_page 1 of 10 _
_Acc. To CDS Roxithromycin oral v02_05_2013_
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Dos