Dalacin capsules

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

clindamycin (clindamycin hydrochloride)

Sẵn có từ:

Fareva Amboise

Mã ATC:

J01FF01

INN (Tên quốc tế):

clindamycin (clindamycin hydrochloride)

Liều dùng:

150mg

Dạng dược phẩm:

capsules

Các đơn vị trong gói:

(16/2x8/) in blister

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2023-12-08

Đặc tính sản phẩm

1
1.
NAME(S) OF THE MEDICINAL PRODUCT
Dalacin 150 mg hard capsules
Dalacin 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dalacin 150 mg hard capsules:
Each capsule contains 150 mg clindamycin (equivalent to 177.515 mg of
clindamycin hydrochloride).
Dalacin 300 mg hard capsules:
Each capsule contains 300 mg clindamycin (equivalent to 355.03 mg of
clindamycin hydrochloride).
Excipients with known effect
_Dalacin 150 mg hard capsule _
Each capsule contains 209.485 mg lactose-monohydrate.
_Dalacin 300 mg hard capsule _
Each capsule contains 253.97 mg lactose-monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Dalacin 150 mg hard capsules _
Approximately 440 mg of white powder is filled in each capsule, which
is made from hard gelatine that consists
of a white upper and lower half designated with black “CLIN 150”
and “Pfizer” signs.
_ _
_Dalacin 300 mg hard capsules _
Approximately 650 mg of white powder is filled in each capsule, which
is made from hard gelatine that consists
of a white upper and lower half designated with black “CLIN 300”
and “Pfizer” signs.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of infections caused by susceptible _anaerobic_ bacteria or
susceptible strains of _Gram positive aerobic_
bacteria, for example, streptococci, staphylococci and pneumococci;
and susceptible strains of _Chlamydia _
_trachomatis_.
Treatment of patients with penicillin sensitive infections, who are
allergic to penicillin.
1.
Upper respiratory infections including tonsillitis, pharyngitis,
sinusitis, otitis media/chronic suppurative
otitis media and scarlet fever.
2.
Lower respiratory infections including bronchitis, pneumonia, empyema
and lung abscess.
3.
Skin and soft tissue infections including acne, furuncles, cellulitis,
impetigo, abscesses, and wound
infections. For specific skin and soft tissue infections like
erysipelas and paronychia (panaritium), it
would seem logical that these conditions would respond very well to
clindamyc