Dalacin C

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Clindamycin phosphate 178.22 mg/mL Equivalent to clindamycin base 150 mg/mL;  ;  ;  

Saatavilla:

Pfizer New Zealand Limited

INN (Kansainvälinen yleisnimi):

Clindamycin phosphate 178.22 mg/mL (Equivalent to clindamycin base 150 mg/mL)

Annos:

600mg/4mL

Lääkemuoto:

Solution for injection

Koostumus:

Active: Clindamycin phosphate 178.22 mg/mL Equivalent to clindamycin base 150 mg/mL       Excipient: Benzyl alcohol Disodium edetate dihydrate Hydrochloric acid Sodium hydroxide Water for injection

Kpl paketissa:

Ampoule, 4mL, 1 dose unit

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Zhejiang Hisoar Pharmaceutical Co. Ltd

Käyttöaiheet:

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.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Ampoule, 4mL - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, 4mL - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Valtuutus päivämäärä:

1974-07-12

Pakkausseloste

DALACIN
®
C INJECTION
1
DALACIN® C INJECTION
_Clindamycin phosphate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dalacin C Injection.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given Dalacin
C Injection against the benefits this
medicine is expected to have for you.
Dalacin C Injection should only be
given to you by a health professional.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DALACIN C
INJECTION IS USED FOR
Dalacin C Injection is an antibiotic. It
is used to treat infections in different
parts of the body caused by bacteria.
This medicine works by killing or
stopping the growth of bacteria
causing your infection.
It will not work against viral
infections such as colds or flu.
Dalacin C Injection is recommended
for patients who are allergic to
penicillin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DALACIN C
INJECTION HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed
Dalacin C Injection for another
reason.
This medicine is available only with
a doctor's prescription.
Dalacin C Injection is not addictive.
BEFORE YOU ARE GIVEN
DALACIN C INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN DALACIN C
INJECTION IF YOU HAVE AN ALLERGY TO:
•
clindamycin or lincomycin
•
any of the other ingredients listed
at the end of this leaflet (see
'Product Description').
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF THE EXPIRY DATE PRINTED
ON THE PACK HAS PASSED OR IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
If it has expired or is d

Valmisteyhteenveto

Version: pfddacpi10122
Supersedes: pfddacpi10821
Page 1 of 15
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DALACIN
®
C 600 mg/4 mL solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
1 mL
of
DALACIN C
solution
contains
178.22 mg/mL
clindamycin
phosphate
equivalent to 150 mg clindamycin.
Excipients with known effect:
Each 1 mL of solution contains 9.45 mg benzyl alcohol.
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.
6.
Intra-abdominal infections including peritonitis and abdominal abscess
when given in
conjunction with an antibiotic of appropriate Gram-negative aerobic
spectrum.
Version: pfddacpi10122
Supersedes: pfddacpi10821
Page 2 of 15
7.
Septicaemia and endocarditis - the effectiveness of clindamycin in the
treatment of
selected cases of endocarditis has been do