SALOFALK FOAM mesalazine 1g/application aerosol can

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

mesalazine, Quantity: 1 g

متاح من:

Dr Falk Pharma Australia Pty Ltd

الشكل الصيدلاني:

Foam

تركيب:

Excipient Ingredients: propane; cetostearyl alcohol; disodium edetate; propylene glycol; butane; polysorbate 60; isobutane; sodium metabisulfite

طريقة التعاطي:

Rectal

الوحدات في الحزمة:

14 actuations/can

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Salofalk foam enemas are indicated in the treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance treatment of ulcerative colitis.

ملخص المنتج:

Visual Identification: White-greyish to slightly reddish violet, creamy firm foam; Container Type: Aerosol Can; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Licence status A

تاريخ الترخيص:

2004-10-05

نشرة المعلومات

SALOFALK
®
foam (1 g/application) – Consumer Medicine Information _ _
Page 1 of 5
_ _
SALOFALK
®
FOAM
_mesalazine (1 g/application) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
SALOFALK foam. It does not
contain all of the available
information. Reading this leaflet
does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the possible risks of
using SALOFALK foam against
the expected benefits.
ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT USING
SALOFALK FOAM.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may want to read it again.
WHAT SALOFALK
FOAM IS USED FOR
SALOFALK foam contains the
active ingredient, mesalazine
(5-aminosalicylic acid), which is
used to treat, and prevent
relapses of mild to moderate
attacks of ulcerative colitis
(inflammation of the large
bowel).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
SALOFALK FOAM HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed SALOFALK foam for
another reason.
SALOFALK foam is not
addictive.
SALOFALK foam is only
available on a doctor’s
prescription.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE SALOFALK FOAM
IF:
•
you are allergic to
mesalazine or aspirin-like
medicines, sulfites or any of
the ingredients listed at the
end of this leaflet. Signs of
allergic reactions may
include itchy skin rash,
shortness of breath and
swelling of the face or
tongue.
•
you suffer from a severe
kidney or liver problem.
•
the expiry date (EXP)
printed on the pack has
passed. If you use this
medicine after the expiry
date has passed, it may not
work as well.
•
the package is torn or
shows signs of tampering.
DO NOT GIVE SALOFALK FOAM
TO A CHILD 12 YEARS OLD OR
UNDER.
The safety and effectiveness of
SALOFALK foam in this age
group has not been
established.
TALK TO YOUR DOCTOR IF YOU ARE
NOT SURE WHETHER YOU SHOULD
START TO USE SALOFALK FOAM.
_BEFORE YOU START TO USE IT _
TELL YOUR DOCTOR IF:
•
Y

خصائص المنتج

SALOFALK
®
foam - Product Information
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
SALOFALK
®
FOAM
(MESALAZINE)
1
NAME OF THE MEDICINE
Mesalazine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SALOFALK foam contains 1 g/application mesalazine as the active
ingredient.
Excipients with known effect: sulphites
See section 4.4 Special warnings and precautions for use
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SALOFALK foam is a white-greyish to slightly reddish violet, creamy
firm foam.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SALOFALK foam is indicated in the treatment of acute ulcerative
colitis of mild to
moderate severity and for the maintenance treatment of ulcerative
colitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Unless otherwise advised a dose of 2 g or 4 g mesalazine as SALOFALK
foam once
a day is used for the treatment of acute ulcerative colitis or
maintenance of remission.
A dose of 2 g SALOFALK foam is equivalent to 2 applications.
SALOFALK foam should be used at room temperature, 20 – 25°C (please
also see
section 6.4 Special Precautions for Storage). The canister is first
fitted with an applicator
and then shaken for about 15 seconds before the applicator is inserted
into the rectum
as far as comfortable. To administer a dose of SALOFALK foam, the pump
dome is fully
pushed down and released. Note the spray can will only work properly
when held with
the pump dome pointing down. Following the second activation, the
applicator should be
held in position for 10-15 seconds before being withdrawn from the
rectum. The best
results are achieved if the bowels are evacuated prior to instillation
of SALOFALK foam.
The dosage should be adjusted to suit the progress of the condition.
Discontinuation of
treatment should be under supervision of the physician.
Due to the considerable variation in the severity of the ulcerative
colitis and the extent
of the affected area it is not possible to recommend a uniform dose of
mesalazine
which will provide optimal effe