Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
sumatriptan, Quantity: 200 mg/mL
Aspen Pharmacare Australia Pty Ltd
Spray, solution
Excipient Ingredients: dibasic sodium phosphate; purified water; monobasic potassium phosphate; sulfuric acid; sodium hydroxide
Nasal
1 spray, 2 sprays
(S4) Prescription Only Medicine
Imigran Nasal Spray is indicated for the acute relief of migraine attacks with or without aura. There is no information available on the use of Imigran in the treatment of basilar or hemiplegic migraine.
Visual Identification: Clear pale yellow to dark yellow liquid; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
1998-02-26
1 IMIGRAN NASAL SPRAY IMIGRAN S NASAL SPRAY _(Sumatriptan) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Unless explained differently, the information for "_Imigran_ nasal spray" in this leaflet applies to both _Imigran_ S nasal spray 10 mg and _Imigran_ nasal spray 20 mg (refer to the "Product description" section near the end of the leaflet for a description of these two products). Please read this leaflet carefully before you start using _Imigran _nasal spray. This leaflet answers some common questions about _Imigran _nasal spray. It does not contain all of 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 expected benefits of you taking _Imigran _nasal spray against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS_ IMIGRAN _NASAL SPRAY USED FOR? _Imigran_ nasal spray contains the active ingredient sumatriptan. This medicine belongs to a group of drugs called serotonin agonists. _Imigran_ nasal spray is used to relieve a migraine attack. It should not be used to prevent migraine attacks from occurring. _Imigran_ nasal spray may be used for migraine headaches with or without what is known as 'aura'. It is thought that migraine headache is due to widening of certain blood vessels in the head. _Imigran_ nasal spray works by making those vessels normal again and eases the symptoms of migraine. Your _Imigran_ nasal spray does not work in other types of headache which are not a migraine. _Imigran_ nasal spray is not addictive. BEFORE YOU USE _IMIGRAN _NASAL SPRAY _ _ _DO NOT USE IF: _ You must not use _Imigran_ nasal spray if: YOU HAVE EVER HAD AN ALLERGIC REACTION TO SUMATRIPTAN (SEE “SIDE- EFFECTS”) OR ANY OF THE INGREDIENTS LISTED TOWARD THE END OF THIS LEAFLET. (SEE “INGREDIENTS”). YOU HAVE OR HAVE HAD: - heart dise Прочитать полный документ
1 AUSTRALIAN PRODUCT INFORMATION IMIGRAN (SUMATRIPTAN) TABLETS, INJECTION AND NASAL SPRAY 1 NAME OF THE MEDICINE Sumatriptan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sumatriptan is the therapeutically active ingredient in Imigran nasal spray and sumatriptan succinate is the therapeutically active ingredient in Imigran tablets and injection. Excipients with known effect: Imigran 50mg and 100mg tablets contain sugars (as lactose) IMIGRAN TABLETS 50 MG Each tablet contains 50 mg sumatriptan base as the succinate salt. The tablets also contain: lactose, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry YS-1-1441-G. IMIGRAN TABLETS 100 MG Each tablet contains 100 mg sumatriptan base as the succinate salt. The tablets also contain: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry white OY-S-7393. IMIGRAN FDT 50 MG Each tablet contains 50 mg sumatriptan base as the succinate salt. Imigran FDT also contains: calcium hydrogen phosphate anhydrous, microcrystalline cellulose, sodium bicarbonate, croscarmellose sodium, magnesium stearate and Opadry YS- 1-1441-G. IMIGRAN FDT 100 MG Each tablet contains 100 mg sumatriptan base as the succinate salt. Imigran FDT also contains: calcium hydrogen phosphate anhydrous, microcrystalline cellulose, sodium bicarbonate, croscarmellose sodium, magnesium stearate and Opadry white OY-S-7322. INJECTION Imigran MK II injection is available in pre-filled syringes containing 6 mg of sumatriptan base as the succinate salt, in an isotonic solution containing sodium chloride and water for injections (total volume 0.5 mL). 2 IMIGRAN NASAL SPRAY Each nasal spray is a single dose unit of sumatriptan base in 0.1 mL aqueous solution containing sulfuric acid, monobasic potassium phosphate, dibasic anhydrous sodium phosphate, sodium hydroxide and purified water. The pH of the nasal spray solution is 5.5. 3 PHARMACEUTICAL FORM TABLETS Sumatriptan tablets are presented in two formulations: Imigran tablets Прочитать полный документ