DALACIN V clindamycin 2% (20mg/g) (as phosphate) cream tube

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

clindamycin phosphate, Quantity: 22.8 mg/g (Equivalent: clindamycin, Qty 20 mg/g)

Disponible depuis:

Pfizer Australia Pty Ltd

DCI (Dénomination commune internationale):

Clindamycin phosphate

forme pharmaceutique:

Cream

Composition:

Excipient Ingredients: purified water; polysorbate 60; benzyl alcohol; stearic acid; cetyl esters wax; propylene glycol; liquid paraffin; sorbitan monostearate; cetostearyl alcohol

Mode d'administration:

Vaginal

Unités en paquet:

7.5 grams, 40 gram

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Dalacin V Cream 2% is indicated for the treatment of symptomatic Bacterial Vaginosis. Note: For the purposes of this indication Bacterial Vaginosis is usually defined by positive results to at least three of the four following criteria: 1. Vaginal discharge with pH > 4.5; 2. Vaginal discharge demonstrating an amine ("fishy") odour with the addition of 10% potassium hydroxide; 3. Vaginal discharge with "clue cells" on microscopy, and; 4. A gram stain consistent with a diagnosis of Bacterial Vaginosis (Lactobacillus morphotype absent or markedly decreased; Gardnerella morphotype predominant flora; white blood cells absent or few; Mobiluncus morphotype may or may not be present). Other pathogens which may be associated with genital infection such as Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and Neisseria gonorrhoeae should be ruled out by appropriate laboratory means.

Descriptif du produit:

Visual Identification: Semi-solid white cream.; Container Type: Tube; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statut de autorisation:

Registered

Date de l'autorisation:

1994-04-08

Notice patient

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
INFLAMMATION OF THE BOWEL OR
SEVERE

Résumé des caractéristiques du produit

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AUSTRALIAN PRODUCT INFORMATION - DALACIN
® V CREAM 2%
(CLINDAMYCIN PHOSPHATE) INTRAVAGINAL CREAM
1. NAME OF THE MEDICINE
Clindamycin phosphate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
For the full list of excipients, see section 6.1, List of Excipients.
3. PHARMACEUTICAL FORM
Intravaginal cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DALACIN
V Cream 2% is indicated for the treatment of symptomatic Bacterial
Vaginosis.
NOTE:
For the purposes of this indication Bacterial Vaginosis is usually
defined by positive
results to at least three of the four following criteria:
1.
Vaginal discharge with pH > 4.5,
2.
Vaginal discharge demonstrating an amine ("fishy") odour with the
addition of
10% potassium hydroxide,
3.
Vaginal discharge with "clue cells" on microscopy, and
4.
A gram stain consistent with a diagnosis of Bacterial Vaginosis (
_Lactobacillus_
morphotype
absent
or
markedly
decreased;
_Gardnerella_
morphotype
predominant flora; white blood cells absent or few;
_Mobiluncus_
morphotype may
or may not be present).
Other pathogens which may be associated with genital infection such as
_Trichomonas vaginalis_
,
_Candida albicans_
,
_Chlamydia trachomatis_
and
_Neisseria gonorrhoeae_
should be ruled out by
appropriate laboratory means.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dose of DALACIN
V Cream 2% is one applicator-full (approximately
5 grams) of cream intravaginally at bedtime for seven (7) consecutive
days.
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4.3 CONTRAINDICATIONS
Clindamycin phosphate cream is contraindicated in patients with a
history of hypersensitivity
to clindamycin, lincomycin or other components of the cream (see
section 6.1, List of
Exc