Clindamycin-hameln

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clindamycin phosphate 178.23 mg/mL equivalent to clindamycin 150mg/mL

Available from:

Max Health Limited

Dosage:

600 mg/4mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Clindamycin phosphate 178.23 mg/mL equivalent to clindamycin 150mg/mL Excipient: Benzyl alcohol Disodium edetate Nitrogen Sodium hydroxide Water for injection

Prescription type:

Prescription

Therapeutic indications:

Clindamycin phosphate 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.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type 1 clear 4 mL x 10 - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2021-06-13

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Clindamycin-hameln, 150mg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of solution contains 178.22 mg/mL
clindamycin
phosphate equivalent to 150 mg
clindamycin.
Each ampoule with 2 mL of solution contains clindamycin phosphate
equivalent to 300 mg of
clindamycin.
Each ampoule with 4 mL of solution contains clindamycin phosphate
equivalent to 600 mg of
clindamycin.
Excipients with known effect:
Each mL of solution contains 9 mg of benzyl alcohol – see section
4.4.
Each mL of solution contains up to 8.6 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, sterile solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clindamycin phosphate 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.
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6.
Intra-abdominal infections including peritonitis and abdominal abscess
when given in
conjunction with an antibiotic of ap