MINIRIN INJECTION 4 mcg/ml

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING PHARMACEUTICALS PRIVATE LIMITED

Therapeutic

Prescription Only

INJECTION

**POSOLOGY AND METHOD OF ADMINISTRATION** **Posology** Central diabetes insipidus The injection may be used when the intranasal or oral administration is considered unsuitable. Individual dosage is determined after testing of the effect on urine osmolality and diuresis at different dose levels. In the event of signs of water retention/hyponatraemia treatment should be interrupted and the dose should be adjusted. Normal dosage, intravenous injection: Adults: 1–4 mcg (0.25–1 ml) 1–2 times daily. Children above the age of 1 year: 0.4–1 mcg (0.1–0.25 ml) 1–2 times daily. Children below the age of 1 year: 0.2–0.4 mcg (0.05–0.1 ml) 1–2 times daily. For patients who have been controlled on intranasal MINIRIN® and who must be switched to the injection form, either because of poor intranasal absorption, or because of the need for surgery, the comparable antidiuretic dose of the injection is about 10% of the intranasal dose. Renal concentrating capacity test Normal adult dose by intramuscular or subcutaneous injection is 4 mcg (1 ml). For children above the age of 1 year the dose is 1 to 2 mcg (0.25 to 0.5 ml). For children below the age of 1 year the dose is 0.4 mcg (0.1 ml). For children it is recommended to use primarily the intranasal presentation. After administration of MINIRIN® injection, any urine collected within 1 hour is discarded. During the next 8 hours 2 portions of urine are collected for measurement of osmolality. Fluid restriction should be observed, see section Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. The reference level for normal urine osmolality after MINIRIN® administration is 800 mOsm/kg for most patients. With values under this level, the test should be repeated. A repeated low result indicates an impaired ability to concentrate urine and the patient should be referred for further examination into the underlying cause of the malfunction. Haemophilia A and von Willebrand’s Disease MINIRIN® injection is administered as an intravenous infusion at a dose of 0.3 mcg/kg bodyweight diluted in sterile physiological saline and infused slowly over 15–30 minutes. In adults and children weighing 10 kg or more, 50 ml of diluent is used; in children weighing 10 kg or less, 10 ml of diluent is used. If a positive effect is obtained, the initial MINIRIN® dose may be repeated 1–2 times with intervals of 6–12 hours. Further repetition of the dose may result in a reduced effect. In patients with haemophilia the desired increase of VIII:C is appraised by the same criterion as in the treatment with factor VIII-concentrate. The VIII:C-concentration must be followed up regularly since in a few cases the effect has been seen to decrease with repeated doses. If the MINIRIN®-infusion does not lead to the desired increase of the VIII:C-concentration in plasma, the treatment may be complemented with a supply of factor VIII-concentrate. The treatment of patients with haemophilia should be conducted in consultation with each patient’s coagulation laboratory. Determination of the coagulation factor and bleeding time before MINIRIN®-treatment: Plasma levels of VIII:C and vWF:Ag increase substantially after desmopressin administration. However, it has not been possible to establish any correlation between the plasma concentration of these factors and the bleeding time, either before or after desmopressin. The effect of desmopressin on the bleeding time should therefore, if possible, be tested in the individual patient. The bleeding time test should be as standardized as possible, e.g. with the use of Simplate II. Determination of bleeding time and plasma levels of the coagulation factors should be conducted in cooperation or consultation with a coagulation laboratory. Posology for special populations Renal impairment MINIRIN® injection should be used with caution in patients with moderate and severe renal insufficiency (see section Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Hepatic impairment No studies have been performed in this population. It is unlikely that desmopressin will interact with drugs affecting hepatic metabolism, since desmopressin has been shown not to undergo significant liver metabolism in in vitro studies with human microsomes. **Method of administration** The injection is normally administered intravenously but may, if needed, also be given intramuscularly or subcutaneously, depending on the indications.