देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
lauromacrogol 400, Quantity: 60 mg
Accelagen Pty Ltd
Injection, solution
Excipient Ingredients: ethanol; dibasic sodium phosphate dihydrate; monobasic potassium phosphate; water for injections
Intravenous
5 ampoules
(S4) Prescription Only Medicine
INDICATIONS: The solutions are indicated for the treatment of varicose veins (up to 6mm diameter) of the lower limbs by compression sclerotherapy.
Visual Identification: Clear, colourless to weakly yellowish-greenish solution; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2001-07-27
Aethoxysklerol ® 1 AETHOXYSKLEROL® 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 I AM GIVEN AETHOXYSKLEROL? Aethoxysklerol contains the active ingredient lauromacrogol 400. Aethoxysklerol is used to treat varicose veins. For more information, see Section 1. Why I am given Aethoxysklerol? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN AETHOXYSKLEROL? Do not use if you have ever had an allergic reaction to Aethoxysklerol 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 am given Aethoxysklerol? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Aethoxysklerol may interfere with some medicines and affect how they work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS AETHOXYSKLEROL GIVEN? • Your doctor injects Aethoxysklerol into the varicose vein and selects the appropriate dose. • After injection, a firm compression bandage or elastic stocking will be applied. More information can be found in Section 4. How is Aethoxysklerol given? in the full CMI. 5. AFTER AETHOXYSKLEROL INJECTION THINGS YOU SHOULD DO • Keep a record of your injections. • Keep follow-up appointments with your doctor or clinic. THINGS TO BE CAREFUL OF • Make sure you tell your doctor if you think you may be having an allergic reaction to Aethoxysklerol. • Make sure the bandage does not slip down. LOOKING AFTER YOUR MEDICINE • Keep it in the original pack, at room temperature (below 30°C), and do not expose to excessive heat. Keep it where young children cannot reach it. For more information, see Section 5. After Aethoxysklerol injection in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? All medicines can have पूरा दस्तावेज़ पढ़ें
Aethoxysklerol Injection Product Information Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION - AETHOXYSKLEROL ® (LAUROMACROGOL 400) 1. NAME OF THE MEDICINE Lauromacrogol 400. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aethoxysklerol is a sterile solution of lauromacrogol 400 available in four strengths 0.5%, 1%, 2%, 3% buffered to pH 6.5 – 8.0. Aethoxysklerol 0.5% contains 10 mg lauromacrogol 400 in 2 mL ampoule. Aethoxysklerol 1% contains 20 mg lauromacrogol 400 in 2 mL ampoule. Aethoxysklerol 2% contains 40 mg lauromacrogol 400 in 2 mL ampoule. Aethoxysklerol 3% contains 60 mg lauromacrogol 400 in 2 mL ampoule. Not all presentations are distributed in Australia. List of excipients with known effect: ethanol. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to very faintly greenish yellow solution. 4. CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS The solutions are indicated for the treatment of varicose veins (up to 6 mm diameter) of the lower limbs by compression sclerotherapy. 4.2 D OSE AND METHOD OF ADMINISTRATION Dosage and selection of the Aethoxysklerol concentration depends on the size of the varices to be sclerosed. Sclerotherapy is followed by compression bandaging of the limb. Extensive varicosis should always be treated in several sessions. When first treating a patient prone to hypersensitivity reactions, no more than one injection should be given. Depending on the outcome and size of the area to be sclerosed, several injections may be given at subsequent treatment sessions, provided that the maximum dosage 2 mg/kg body weight per day is not exceeded. METHOD OF ADMINISTRATION • Aethoxysklerol is to be injected into the lumen of the affected vein. • Aethoxysklerol is for single use in one patient only. Any unused product should be disposed of appropriately. • Only inject into a leg placed horizontally or elevated 30-45° above the horizontal. The most appropriate syringe and needle size for each vein size sh पूरा दस्तावेज़ पढ़ें