Dalacin capsules

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

下载 产品特点 (SPC)
08-12-2023

有效成分:

clindamycin (clindamycin hydrochloride)

可用日期:

Fareva Amboise

ATC代码:

J01FF01

INN(国际名称):

clindamycin (clindamycin hydrochloride)

剂量:

150mg

药物剂型:

capsules

每包单位数:

(16/2x8/) in blister

处方类型:

Prescription

授权状态:

Registered

授权日期:

2023-12-08

产品特点

                                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
                                
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