Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
Desmopressin acetate
Ferring Pharmaceuticals Pty Ltd
Medicine Registered
MINIRIN ® NASAL SPRAY _Desmopressin acetate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Minirin Spray. It does not contain all the available information. It does not replace of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Minirin Spray against the benefits they expect it will 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 MINIRIN IS USED FOR The active ingredient, desmopressin acetate in Minirin Spray is a synthetic version of a naturally occurring substance produced in the brain called vasopressin. It has a number of different actions on the body including an action on the kidney to reduce the amount of urine produced. This means that Minirin Spray can be used for several different conditions including: • primary nocturnal enuresis (bedwetting) in patients over 6 years of age, who have a normal ability to concentrate urine and who have not responded to treatment with an enuresis alarm or in patients in whom an enuresis alarm is contraindicated or inappropriate • cranial diabetes insipidus (large amounts of urine being produced day and night and constant thirst) • as a diagnostic test to establish if the kidneys have the ability to concentrate urine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. It is available only with a doctor's prescription. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU TAKE MINIRIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE MINIRIN SPRAY IF YOU HAVE AN ALLERGY TO: • any medicine containing desmopressin or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: Lire le document complet
PRODUCT INFORMATION #152-v14A _ _ _MINIRIN_ _®_ _ NASAL SPRAY _ NAME OF THE MEDICINE: Desmopressin Acetate Synonyms: DDAVP 1-desamino-8-D-Arginine vasopressin. Desamino-cys-1-D-Arginine-8 vasopressin. CAS No. 62357-86-2 (trihydrate) DESCRIPTION: The active substance is a synthetic structural analogue of the natural hormone arginine vasopressin. Early treatment of central diabetes insipidus used a more or less purified extract from bovine or porcine posterior pituitaries. These caused unpleasant complications of use. When vasopressin became known, two forms were found - Arginine Vasopressin (found in humans) and lysine vasopressin (found in pig pituitaries). Two chemical changes have been made to the natural hormone: a. desamination of the N-terminal of cysteine-1 b. substitution of 8-D-arginine for 8-L-arginine SCH 2 CH 2 CO-Tyr-Phe-Gln-Asn-Cys-Pro-D-Arg-Gly-NH 2 Minirin Nasal Spray contains desmopressin acetate, sodium chloride, citric acid monohydrate, sodium phosphate-dibasic dihydrate, benzalkonium chloride solution 50% as preservative and purified water. PHARMACOLOGY: According to results from antidiuretic and pressor tests in rats these changes increase antidiuretic activity three to five fold while pressor activity is reduced to 0.1% of that of antidiuretic hormone. Pharmacokinetics a. Absorption: Using i.v. or i.m. doses, 100% is available. Used intranasally, it is estimated that 10% is available. Thus i.v. or i.m. doses are one tenth that of the intranasal route. The extent of absorption is similar for the spray and the rhinyle with a trend towards higher absorption associated with the spray. Mean C max and AUC values are approximately 40% highe Lire le document complet