Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
betamethasone dipropionate, Quantity: 643 microgram/g (Equivalent: betamethasone, Qty 500 microgram/g); calcipotriol monohydrate, Quantity: 52.2 microgram/g
Freyr Australia Pty Ltd
Foam
Excipient Ingredients: propane; polyoxypropylene-11 stearyl ether; isobutane; d-alpha-tocopherol; isopropyl alcohol; butane; white soft paraffin; liquid paraffin
Topical
60 g, 2 x 60 g
(S4) Prescription Only Medicine
Topical treatment of psoriasis vulgaris in adults.
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
Registered
2023-06-02
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 Læs hele dokumentet
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 Læs hele dokumentet