COLIFOAM (10% w/w Hydrocortisone Acetate) Rectal Foam Cream aerosol can

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

hydrocortisone acetate, Quantity: 10 % w/w

Διαθέσιμο από:

Viatris Pty Ltd

INN (Διεθνής Όνομα):

Hydrocortisone acetate

Φαρμακοτεχνική μορφή:

Enema

Σύνθεση:

Excipient Ingredients: cetyl alcohol; emulsifying wax; methyl hydroxybenzoate; propyl hydroxybenzoate; steareth-10; propylene glycol; trolamine; purified water; propane; isobutane

Οδός χορήγησης:

Rectal

Μονάδες σε πακέτο:

21.1g

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

This product approved for registraiton as a variation of a product accepted for inclusion in the ARTG as 'currently supplied' at the commencement of the Act. Indications are held in ARTG paper records. Previous Product Number AUST R 15654. Product Information not reviewed. INDICATIONS AS AT 21 AUGUST 1998: Topical treatment of inflammation occurring in the rectal mucosa, eg ulcerative colitis, proctosigmoiditis and granular proctitis.

Περίληψη προϊόντος:

Visual Identification: White, aerosol foam.; Container Type: Jar/Can; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1993-02-10

Φύλλο οδηγιών χρήσης

COLIFOAM
®
_Hydrocortisone Acetate 10% w/w_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COLIFOAM. 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 COLIFOAM
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 COLIFOAM IS
USED FOR
COLIFOAM is a type of cortisone
and belongs to the group of
medicines called corticosteroids.
COLIFOAM is used to treat
inflammation of the lower bowel.
These diseases can produce severe
diarrhoea and pain.
Your doctor may have prescribed
COLIFOAM for another purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
COLIFOAM HAS BEEN PRESCRIBED
FOR YOU.
There is no evidence that
COLIFOAM is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
COLIFOAM
_WHEN YOU MUST NOT USE IT_
DO NOT USE COLIFOAM IF YOU
HAVE:
1.
An allergy to:
•
Hydrocortisone Acetate and/
or
•
to any of the ingredients at the
end of this leaflet
2.
Viral skin infection (such as cold
sores, shingles, chicken pox or
anal warts).
3.
Fungal skin infection (such as
thrush, tinea or ringworm).
4.
Peritonitis, bowel obstruction,
abscess, perforation, fresh
intestinal anastomoses, or
extensive fistulae
ASK YOUR DOCTOR TO BE SURE YOU DO
NOT HAVE ANY OF THESE CONDITIONS.
DO NOT BREASTFEED WHILE YOU ARE
USING COLIFOAM UNLESS YOUR
DOCTOR SAYS IT IS SAFE.
DO NOT USE COLIFOAM JUST
BEFORE HAVING A BATH, SHOWER OR
GOING SWIMMING.
If you do, you may reduce the
effectiveness of COLIFOAM.
DO NOT USE COLIFOAM IF 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.
DO NOT USE COLIFOAM IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERI

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION
COLIFOAM
®
_Hydrocortisone acetate _
1
NAME OF THE MEDICINE
Hydrocortisone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
COLIFOAM contains hydrocortisone acetate 10% w/w.
Excipients with known effect:
COLIFOAM also contains methyl hydroxybenzoate and propyl
hydroxybenzoate.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
COLIFOAM is an enema, formulated as a lump free viscous, muco-adherent
foam for rectal administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of inflammation occurring in the rectal mucosa, e.g.
ulcerative colitis, proctosigmoiditis and
granular proctitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dosage is one applicator full containing approximately 90 to 100
mg hydrocortisone acetate, as directed by
the doctor. The usual dosage rate is one applicator full once or twice
daily for two to three weeks, and every
second day thereafter, applied as directed above into the rectum.
DIRECTIONS FOR USE
Shake aerosol can vigorously for 60 seconds before each use. Hold
aerosol can upright and insert its nozzle into
the tip of the applicator. As a result the applicator will be on top
of the aerosol can. Be sure the plunger is drawn
all the way out. The aerosol can must be held upright to obtain proper
flow of medication.
COLIFOAM – PRODUCT INFORMATION
2
2
To fill the applicator, hold it by the barrel and press down gently on
top of aerosol can until the foam has filled
up approximately one quarter of the applicators body. Keep the plunger
withdrawn during this procedure. Only
a short press is needed to do this. Wait for few seconds until the
foam has stopped expanding. These steps may
be repeated until the foam has reached the fill line. When foam
reaches fill line of the applicator, it is ready for
use.
CAUTION:
The aerosol can nozzle should never be inserted directly into the
anus.
Remove applicator from aerosol can. Allow some foam to remain on the
applicator tip. Hold applicator by barrel
and