Dalacin V

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Clindamycin phosphate

Disponível em:

Pfizer Australia Pty Ltd

Classe:

Medicine Registered

Folheto informativo - Bula

DALACIN
®
 V CREAM

_Clindamycin phosphate_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dalacin V Cream. 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 using Dalacin V
Cream against the benefits it is
expected to have for you.
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 V CREAM
IS USED FOR
Dalacin V Cream is an antibiotic. It
is used to treat vaginal infection.
Dalacin V Cream works by stopping
the growth of the bacteria causing the
vaginal infection.
Your doctor may have prescribed
Dalacin V Cream for another
purpose. Ask your doctor or
pharmacist if you have any questions
about why Dalacin V Cream has
been prescribed for you.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
DALACIN V CREAM
_WHEN YOU MUST NOT USE IT_
DO NOT USE DALACIN V CREAM IF YOU
HAVE AN ALLERGY TO CLINDAMYCIN OR
LINCOMYCIN OR ANY OF THE
INGREDIENTS IN DALACIN V CREAM
LISTED AT THE END OF THIS LEAFLET.
DO NOT USE DALACIN V CREAM IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT USE DALACIN V CREAM IF THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK HAS PASSED.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START USING DALACIN V
CREAM, CONTACT YOUR DOCTOR.
_BEFORE YOU START TO USE IT_
YOU MUST TELL YOUR DOCTOR IF:
1. YOU HAVE ANY ALLERGIES TO ANY
OTHER MEDICINES OR ANY OTHER
SUBSTANCES, SUCH AS FOODS,
PRESERVATIVES OR DYES
2. YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT
 Your doctor will discuss the risks
and benefits of using Dalacin V
Cream when pregnant.
3. YOU ARE BREAST-FEEDING OR PLAN
TO BREAST-FEED
 Your doctor will discuss the risks
and benefits of using Dalacin V
Cream when breastfeeding.
4. YOU HAVE OR HAVE HAD ANY OTHER
MEDICAL CONDITIONS, INCLUDING
INFLAMMAT

Características técnicas

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Supersedes: pfpdalvm10708 
Commercial/Non-Commercial 
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APPROVED PRODUCT INFORMATION 
DALACIN® V CREAM 2% 
(CLINDAMYCIN PHOSPHATE INTRAVAGINAL CREAM) 
DESCRIPTION 
DALACIN
® 
V Cream 2% contains the equivalent of 2% (20 mg/g) free
clindamycin as a 
water soluble ester of clindamycin and phosphoric acid
(clindamycin phosphate).  Each unit 
dose of DALACIN
® 
V Cream 2% (approximately 5 grams) represents 100 mg of
clindamycin. 
DALACIN
® 
V Cream 2% also contains: sorbitan monostearate,
polysorbate 60, propylene 
glycol, stearic acid, cetostearyl alcohol, cetyl ester
wax, paraffin liquid and purified water.  
Each 5 g contains 50 mg benzyl alcohol as preservative. 
Clindamycin is a semi-synthetic antibiotic produced by a
7(S)-chloro-substitution of the 7(R)-
hydroxyl group of the parent compound lincomycin.  The MW of

clindamycin phosphate is 
504.96 and its structure is represented below: 

ACTIONS 
MICROBIOLOGY: 
Clindamycin is an antimicrobial agent which has been shown to be
effective in the treatment 
of infection caused by susceptible anaerobic bacteria or
susceptible strains of Gram positive 
aerobic bacteria.  Biological activity of clindamycin from this
formulation is inferred from the 
efficacy demonstrated in the clinical studies of the treatment
of Bacterial Vaginosis.  
Clindamycin has been shown to have _in vitro_ activity against the
following organisms which 
are associated with Bacterial Vaginosis: _Gardnerella vaginalis,
Mobiluncus_ spp, _Bacteroides_ 
spp_, Mycoplasma hominis, Peptostreptococcus_ spp. 

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PHARMACOLOGY 
Following a once a day (for seven days) dosing of approximately
5 grams of DALACIN
® 
V 
Cream, containing the equivalent of 100 mg clindamycin, peak
serum clindamycin levels 
averaged  20 ng/mL  (range  3 to 93 ng/mL