Duac Once Daily Gel

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Benzoyl peroxide 66.7 mg/g; Clindamycin phosphate 12.8 mg/g;  

Dostupné s:

GlaxoSmithKline NZ Limited

INN (Mezinárodní Name):

Benzoyl peroxide 66.7 mg/g

Dávkování:

1%w/w, 5%w/w

Léková forma:

Topical gel

Složení:

Active: Benzoyl peroxide 66.7 mg/g Clindamycin phosphate 12.8 mg/g   Excipient: Carbomer 940 Colloidal silicon dioxide Dimeticone Disodium edetate dihydrate Disodium lauryl sulfosuccinate Glycerol Poloxamer Purified water Sodium hydroxide

Jednotky v balení:

Tube, aluminium, 5 g

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

Arkema Inc

Terapeutické indikace:

For the topical treatment of comedo, papular and pustular acne vulgaris.

Přehled produktů:

Package - Contents - Shelf Life: Tube, aluminium, - 5 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 6 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, Physican's samples 10 x 6g - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 25 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 30 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 45 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 50 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 55 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 60 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 70 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze)

Datum autorizace:

2004-03-25

Informace pro uživatele

DUAC
®
1
DUAC
®
_ONCE DAILY GEL _
_Active ingredients: clindamycin 1% w/w (as phosphate) and benzoyl
peroxide 5% w/w _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Duac Once Daily
Gel. It does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
benefits of you using Duac Once
Daily Gel against the risks he expects
it may have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. YOU MAY NEED TO READ IT
AGAIN.
WHAT IS DUAC ONCE
DAILY GEL AND WHAT IS
IT USED FOR?
Duac Once Daily Gel contains
clindamycin and benzoyl peroxide.
Clindamycin is an antibiotic, which
prevents the growth of bacteria
which are involved in acne. Benzoyl
peroxide acts to reduce comedones
(blackheads and whiteheads). It is
also effective at killing the bacteria,
which are involved in acne, and
makes the skin less oily.
Duac Once Daily Gel is used on the
skin to treat acne. It helps to:
•
reduce the bacteria or germs,
which are implicated in acne;
•
reduce the number of acne spots;
•
reduce the likelihood of new
blackheads and whiteheads from
forming; and
•
make your skin less oily.
Your doctor may have prescribed
Duac Once Daily Gel for another
purpose. Ask your doctor if you have
any questions about why Duac Once
Daily Gel has been prescribed for
you.
Duac Once Daily Gel is for use by
adults and adolescents (aged 12 and
above) with acne.
Duac Once Daily Gel is not
addictive.
Duac Once Daily Gel is only
available with a doctor's prescription.
BEFORE YOU USE DUAC
ONCE DAILY GEL
_WHEN YOU MUST NOT USE IT _
DO NOT USE DUAC ONCE DAILY GEL:
•
IF YOU HAVE AN ALLERGY TO DUAC
ONCE DAILY GEL OR ANY OF THE
INGREDIENTS IN DUAC ONCE DAILY
GEL LISTED AT THE END OF THIS
LEAFLET.
•
IF YOU HAVE A KNOWN SENSITIVITY
TO BENZOYL PEROXIDE,
CLINDAMYCIN OR LINCOMYCIN.
•
YOU HAVE OR HAVE EVER HAD:
−

Charakteristika produktu

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Duac Once Daily Gel contains 1% w/w clindamycin (as phosphate) and 5%
w/w benzoyl
peroxide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Duac Once Daily Gel contains 1% w/w clindamycin (as phosphate) and 5%
w/w benzoyl
peroxide.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Gel
Duac Once Daily Gel is a white to slightly yellow homogenous gel for
topical use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the topical treatment of comedo, papular and pustular acne
vulgaris, in adults and
adolescents aged 12 years and above.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
Dose
Duac Once Daily Gel is for topical use only.
Duac Once Daily Gel is recommended for a maximum duration of 11 weeks.
Australian Therapeutic Guidelines, Antibiotics, Version 12 recommend
addition of topical
antibiotics (topical clindamycin) if there is insufficient response to
topical keratolytics alone in
the treatment of acne vulgaris of moderate severity.
Adults and Adolescents (aged 12 years and above)
Duac Once Daily Gel should be applied once daily as a thin film in the
evening, to affected
areas after the skin has been thoroughly washed, rinsed with warm
water, and gently patted
dry.
If excessive dryness or peeling occurs, frequency of application
should be reduced or
application temporarily interrupted.
Patients should be advised that excessive application will not improve
efficacy, but may
increase the risk of skin irritation.
Paediatric population
The safety and efficacy of Duac Once Daily Gel has not been
established in prepubescent
children (under 12 years of age), since acne vulgaris rarely presents
in this age group
.
2
4.3
CONTRAINDICATIONS
Duac Once Daily Gel is contraindicated in:

patients who have demonstrated hypersensitivity to lincomycin,
clindamycin, benzoyl
peroxide or any components of the formulation.

Patients with, or with a history of regional enteritis, ulcerative
colitis, or antibiotic-
associated colitis (including pseudome