GLENBEX Calcipotriol (as monohydrate) 50 microgram/g and Betamethasone (as dipropionate) 500 microgram/g Foam Aerosol Can

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

betamethasone dipropionate, Quantity: 643 microgram/g (Equivalent: betamethasone, Qty 500 microgram/g); calcipotriol monohydrate, Quantity: 52.2 microgram/g

Dostępny od:

Freyr Australia Pty Ltd

Forma farmaceutyczna:

Foam

Skład:

Excipient Ingredients: propane; polyoxypropylene-11 stearyl ether; isobutane; d-alpha-tocopherol; isopropyl alcohol; butane; white soft paraffin; liquid paraffin

Droga podania:

Topical

Sztuk w opakowaniu:

60 g, 2 x 60 g

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Topical treatment of psoriasis vulgaris in adults.

Podsumowanie produktu:

Visual Identification: White to off-white opalescent liquid in a pressurised aluminium spray can with a valve and actuator. At administration it is a white to off-white foam; Container Type: Aerosol Can; Container Material: Al; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autoryzacji:

Registered

Data autoryzacji:

2023-06-02

Ulotka dla pacjenta

Glenbex
®
1
Glenbex
®
Foam Spray
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1. WHY AM I USING Glenbex® ?
Glenbex
®
contains the active ingredients calcipotriol monohydrate and
betamethasone dipropionate. Glenbex® is used to treat
Psoriasis.
For more information, see Section 1. Why am I using Glenbex®? in the
full CMI.
2. What should I know before I use Glenbex
®
?
Do not use if you have ever had an allergic reaction to calcipotriol
monohydrate and betamethasone dipropionate or any of
the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
Glenbex®? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Glenbex® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4. How do I use Glenbex
®
?
•
Glenbex® is for topical use (on the skin). Glenbex® is designed for
direct application (spray on) to your skin, where it is
affected by psoriasis.
More instructions can be found in Section 4. How do I use Glenbex®?
in the full CMI.
5. What should I know while using Glenbex
®
?
Things you
should do
• Remind any doctor, dentist or pharmacist you visit that you are
using Glenbex®.
Things you
should not do
• Do not stop using this medicine suddenly. Except for psoriasis, do
not use Glenbex® on skin affected by
viral, bacterial or parasitic infections and other skin diseases.
Looking after
your medicine
• Extremely flammable Pressurised container: May burst if heated.
Protect from sunlight and do not
expose to temperatures above 50°C. Do not pierce or burn, even after
use. Do not spray on an open
flame or other ignition source. Keep away from sparks, open flames and

Charakterystyka produktu

AUSTRALIAN PRODUCT INFORMATION – GLENBEX
®
(CALCIPOTRIOL
MONOHYDRATE AND BETAMETHASONE DIPROPIONATE) FOAM SPRAY
1. NAME OF THE MEDICINE
Calcipotriol monohydrate
Betamethasone dipropionate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Glenbex
®
contains 50 micrograms of calcipotriol (as monohydrate) and 500
micrograms of
betamethasone (as dipropionate) per gram.
Excipients with known effect: butylated hydroxytoluene.
For the full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
The Foam Spray in the can is a white to off-white opalescent liquid.
After spraying, a white to off white foam is formed. The foam has the
appearance of non-
expanding foam that gradually collapses after spraying.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of psoriasis vulgaris in adults.
4.2 DOSE AND METHOD OF ADMINISTRATION
Glenbex
®
is for TOPICAL USE ONLY. Do not use if the pack shows signs of damage
or
tampering.
Adults:
Flare treatment
Glenbex
®
should be applied to the affected area once daily. The recommended
treatment period
is 4 weeks. If it is necessary to continue or restart treatment after
this period, treatment should
be continued after medical review and under regular medical
supervision.
Maximum dose
The maximum daily dose of Glenbex
®
should not exceed 15 g, i.e. one 60 g can should last for
at least 4 days
of treatment. 15 g corresponds to the amount administered from the can
if the
actuator is fully depressed for approximately one minute. A two-second
application delivers
approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of
skin roughly
corresponding to the surface area of an adult hand.
The maximum weekly dose of Glenbex
®
should not exceed 100 g. If using other calcipotriol
containing products concomitantly, the total dose of all calcipotriol
containing medical
products, including Glenbex
®
, should not exceed 15 g per day and 100 g per week.
The total body surface area treated should not exceed 30%.
Method of administration
The can should