BUDENOFALK budesonide foam 2 mg cans

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

budesonide, Quantity: 2 mg

Tersedia dari:

Dr Falk Pharma Australia Pty Ltd

INN (Nama Internasional):

Budesonide

Bentuk farmasi:

Foam

Komposisi:

Excipient Ingredients: propylene glycol; purified water; emulsifying wax; cetyl alcohol; citric acid monohydrate; disodium edetate; butane; isobutane; propane; steareth-10

Rute administrasi :

Rectal

Unit dalam paket:

2 can pack, 1 can pack

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

BUDENOFALK foam is indicated in the treatment of active rectal and rectosigmoid disease in ulcerative colitis.

Ringkasan produk:

Visual Identification: Aluminium canisters with metering valve; Container Type: Jar/Can; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

2012-06-12

Selebaran informasi

BUDENOFALK foam – Consumer Medicine Information
Page 1 of 5
BUDENOFALK
® FOAM
_BUDESONIDE _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
BUDENOFALK foam. 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
BUDENOFALK foam against
the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the
medicine. You may need to
read it again.
WHAT BUDENOFALK
FOAM IS USED FOR
BUDENOFALK foam contains
the active ingredient,
budesonide. Budesonide
belongs to a group of
medications called
corticosteroids. BUDENOFALK
foam is used to treat ulcerative
colitis (inflammation) of the
rectum (back passage) and the
lower part of the large bowel.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another reason.
This medicine is not addictive.
This medicine is not expected
to affect your ability to drive a
car or operate machinery.
BUDENOFALK foam is only
available on a doctor’s
prescription.
There is not enough information
to recommend the use of this
medicine for children or
adolescents.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE BUDENOFALK
FOAM IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing
budesonide
•
any of the ingredients listed
at the end of this leaflet.
Some 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.
DO NOT USE BUDENOFALK
FOAM IF YOU SUFFER FROM A
SEVERE LIVER DISEASE (LIVER
CIRRHOSIS).
DO NOT USE THIS MEDICINE
AFTER THE EXPIRY DATE PRINTED
ON THE PACK OR IF THE
PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged,
return it to your pharma

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION
BUDENOFALK® (BUDESONIDE) FOAM
1
NAME OF THE MEDICINE
Budesonide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BUDENOFALK® foam contains the active ingredient budesonide.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Foam
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BUDENOFALK® foam is indicated in the treatment of active rectal and
rectosigmoid disease
in ulcerative colitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
For adults aged >18 years of age: Apply one actuation of 2 mg
budesonide daily.
BUDENOFALK® 2 mg foam can be applied in the morning or evening.
BUDENOFALK® 2 mg foam should be in room temperature when applied.
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. Note
that the dose is only
sufficiently accurate when the pump dome is held downwards as
vertically as possible. To
administer a dose of BUDENOFALK® 2 mg foam , the pump dome is fully
pushed down
and very slowly released. Following the activation the applicator
should be held in
position for 10-15 seconds before being withdrawn from the rectum.
The best results are obtained when the intestine is evacuated prior to
administration of
BUDENOFALK® 2mg foam.
The attending physician determines the duration of use. An acute
episode generally
subsides after 6 to 8 weeks.
Treatment may be continued in patients showing progressive
improvement, but it should
not be persisted with if the response has been inadequate. Continuous
treatment beyond 8
2
weeks has not been assessed. BUDENOFALK® 2 mg foam should not be used
after this
time.
Topical steroids including BUDENOFALK® have not been shown to be
effective in the
maintenance of remission of ulcerative colitis.
Do not use BUDENOFALK® foam after 4 weeks of first opening the
container.
4.3
CONTRAINDICATIONS
BUDENOFALK® foam is contraindicated in patients with the following:
•
hypersensitivity to budesonide or any of