Dalacin C

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Clindamycin hydrochloride 177.515mg Equivalent to 150 mg clindamycin base, based on 84.5% potency.;  ;  ; Clindamycin hydrochloride 177.515mg Equivalent to 150 mg clindamycin base, based on 84.5% potency.

Disponible depuis:

Pfizer New Zealand Limited

DCI (Dénomination commune internationale):

Clindamycin hydrochloride 177.515 mg (Equivalent to 150 mg clindamycin base, based on 84.5% potency.)

Dosage:

150 mg

forme pharmaceutique:

Capsule

Composition:

Active: Clindamycin hydrochloride 177.515mg Equivalent to 150 mg clindamycin base, based on 84.5% potency.     Excipient: Erythrosine Gelatin Indigo carmine Ink Lactose monohydrate Magnesium stearate Maize starch Purified talc Titanium dioxide Active: Clindamycin hydrochloride 177.515mg Equivalent to 150 mg clindamycin base, based on 84.5% potency. Excipient: Gelatin Ink Lactose monohydrate Magnesium stearate Maize starch Purified talc Titanium dioxide

Unités en paquet:

Blister pack, 16 capsules

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Chongqing Carelife Pharmaceutical Co Ltd

indications thérapeutiques:

Clindamycin hydrochloride has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram positive bacteria such as streptococci, staphylococci and pneumococci: 1. Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever. 2.Lower respiratory infections including bronchitis, pneumonia, emphysema 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 clindamycin therapy. 4. Bone and joint infections including osteomyelitis and septic arthritis. 5. Pelvic infections including endometritis, cellulitis, vaginal cuff infection tubo-ovarian abscesses salpingitis and pelvic inflammatory disease when given in conjunction with an antibiotic of appropriate gram negative aerobic spectrum. In cases of cervicitis due to Chlamydia trachomatis, mono therapy with clindamycin has been shown to be effective in eradicating the organism. 6. Intra-abdominal infections including peritonitis and abdominal abscess when given in conjunction with an antibiotic of appropriate gram negative aerobic spectrum. 7. Septicemia and endocarditis - the effectiveness of clindamycin in the treatment of selected cases of endocarditis has been documented when clindamycin is determined to be bactericidal to the infecting organism by in vitro testing of appropriate achievable serum concentrations. 8. Dental infections such as periodental abscess and periodonitis. 9. As an alternative therapy when used in combination with quinine or amodiaquine for the treatment of multi-drug resistant Plasmodium falciporum infection.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, - 16 capsules - 60 months from date of manufacture stored at or below 25°C - Blister pack, - 24 capsules - 60 months from date of manufacture stored at or below 25°C - Blister pack, - 100 capsules - 60 months from date of manufacture stored at or below 25°C

Date de l'autorisation:

1972-08-24

Résumé des caractéristiques du produit

Version: pfddalcc11223
Supersedes: pfddalcc10122
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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DALACIN
®
C 150 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each DALACIN C 150 mg capsule contains 177.515 mg clindamycin
hydrochloride equivalent
to 150 mg clindamycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules.
The capsules consist of a white cap and white body imprinted with
‘Clin 150’ and ‘Pfizer’ in
edible black ink.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clindamycin hydrochloride has been shown to be effective in the
treatment of the following
infections when caused by susceptible anaerobic bacteria or
susceptible strains of Gram-
positive bacteria such as streptococci, staphylococci and pneumococci:
1.
Upper respiratory infections including tonsillitis, pharyngitis,
sinusitis, 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).
4.
Bone and joint infections including osteomyelitis and septic
arthritis.
5.
Pelvic infections including endometritis, cellulitis, vaginal cuff
infection tubo-ovarian
abscesses, salpingitis and pelvic inflammatory disease when given in
conjunction with an
antibiotic of appropriate Gram-negative aerobic spectrum. In cases of
cervicitis due to
_Chlamydia trachomatis_
, monotherapy with clindamycin has been shown to be effective in
eradicating the organism.
6.
Intra-abdominal infections including peritonitis and abdominal abscess
when given in
conjunction with an antibiotic of appropriate Gram-negative aerobic
spectrum.
Version: pfddalcc11223
Supersedes: pfddalcc10122
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7.
Septicaemia and endocarditis - the effectiveness of clindamycin in the
treatment of selected
cases of endocarditis has been documented when clindamycin is
dete