Երկիր: Նոր Զելանդիա
Լեզու: անգլերեն
Աղբյուրը: Medsafe (Medicines Safety Authority)
Desmopressin acetate trihydrate 4 µg/mL equivalent to 3.56 µg/mL desmopressin base
Pharmaco (NZ) Ltd
Desmopressin acetate trihydrate 4 µg/mL (Equiv to 3.56 µg/mL desmopressin base)
4 mcg/mL
Solution for injection
Active: Desmopressin acetate trihydrate 4 µg/mL equivalent to 3.56 µg/mL desmopressin base Excipient: Hydrochloric acid Sodium chloride Water for injection
Ampoule, 1mL, 10 dose units
Prescription
Prescription
PolyPeptide Laboratories AB
· Treatment of central diabetes insipidus and for establishing renal concentration capacity testing.
Package - Contents - Shelf Life: Ampoule, 1mL - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1980-04-11
______________________________________________________________________________ MINIRIN ® Injection 1 MINIRIN INJECTION _DESMOPRESSIN ACETATE_ CONSUMER MEDICINE INFORMATION IMPORTANT: PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING MINIRIN ® INJECTION. THIS LEAFLET IS INTENDED TO ANSWER QUESTIONS YOU MAY HAVE ABOUT MINIRIN ® INJECTION. IT DOES NOT REPLACE THE ADVICE FROM YOUR DOCTOR OR PHARMACIST. IF YOU HAVE ANY QUESTIONS BEFORE, DURING OR AFTER USING THIS MEDICATION BE SURE TO ASK YOUR DOCTOR OR PHARMACIST. WHAT IS MINIRIN ® INJECTION? MINIRIN Injection contains 4 micrograms of the active ingredient, desmopressin acetate, in 1mL solution. It is a clear colourless solution for injection packed in 1mL ampoules. The ampoules are available in boxes of 10. MINIRIN Injection also contains the inactive ingredients, sodium chloride, hydrochloric acid to adjust the acid/alkali balance and Water for Injections. WHAT IS MINIRIN ® INJECTION USED FOR AND HOW DOES IT WORK? The active ingredient of MINIRIN ® Injection (desmopressin acetate) is a synthetic version of a natural hormone in the body, called antidiuretic hormone (ADH). It has a number of different actions on the body including an action on the kidneys to reduce the amount of urine produced. This means that MINIRIN ® Injection can be used for several different conditions. MINIRIN ® Injection may be used for treatment of antidiuretic hormone (ADH)-sensitive Central Diabetes Insipidus (CDI) where intranasal administration is inconvenient. It may also be used in adults by intramuscular administration for testing if the kidneys have the ability to concentrate urine and for control of prolonged bleeding or von Willebrand’s/haemophilia during surgery. BEFORE USING MINIRIN ® INJECTION _WHEN SHOULD MINIRIN_ _®_ _INJECTION NOT BE USED?_ MINIRIN ® Injection is not suitable f Կարդացեք ամբողջական փաստաթուղթը
NEW ZEALAND DATA SHEET MINIRIN INJ 003 Nov 2017 Page 1 of 10 MINIRIN 4 MICROGRAM/ML SOLUTION FOR INJECTION Desmopressin acetate 1 PRODUCT NAME MINIRIN solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml MINIRIN solution for injection contains desmopressin acetate 4 micrograms equivalent to desmopressin 3.56 micrograms. Excipients with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium- free. _ _ For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MINIRIN injection is indicated for: Treatment of central diabetes insipidus and for establishing renal concentration capacity testing. Shortening or normalisation of prolonged bleeding time prior to an invasive therapeutic or diagnostic operation, or for therapeutic control of bleeding in patients with prolonged bleeding time as a consequence of congenital or substance-induced thrombocyte dysfunction, uremia, cirrhosis of the liver or in patients with prolonged bleeding time of unknown etiology. For the therapeutic control of bleeding and bleeding prophylaxis in connection with minor surgical procedures in patients with mild haemophilia A and von Willebrand’s disease who respond positively to a test dose. In exceptional cases, even moderate forms of the disease can be treated. MINIRIN must not be used in patients with von Willebrand’s disease type IIB. 4.2 DOSE AND METHOD OF ADMINISTRATION _ _ _CENTRAL DIABETES INSIPIDUS _ The injection may be used when the intranasal administration is considered unsuitable. Individual dosage after testing of the effect on urine osmolality and diuresis at different dose levels. In the event of signs of water retention/hyponatremia treatment should be interrupted and the dose should be adjusted. Adults: 1-4mcg (0.25-1ml) in 1-2 divided doses (maximum 4mcg per day). _ _ _RENAL FUNCTION TESTING _ To establish renal concentration c Կարդացեք ամբողջական փաստաթուղթը