OCTOSTIM Solution for injection (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Name of the medicinal product
OCTOSTIM Desmopressin acetate injection.
Summary product information
Route of Administration Dosage Form / Strength Nonmedicinal Ingredients Intravenous, subcutaneous 15 mcg/mL Hydrochloric acid, purified water, sodium chloride
Indications and clinical use
OCTOSTIM (desmopressin acetate injection) is indicated for: The prevention of bleeding in patients with mild hemophilia A and mild von Willebrands disease Type I. The prevention or treatment of bleeding ...
Contraindications
OCTOSTIM is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the excipients. Because of the risk of platelet aggregation and thrombocytopenia, OCTOSTIM should ...
Warnings and precautions
OCTOSTIM (desmopressin acetate) treatment without concomitant restriction of water intake may lead to water retention/hyponatremia with or without accompanying signs and symptoms (reduced serum sodium, ...
Adverse reactions
Adverse Drug Reaction Overview The most serious adverse reaction with desmopressin is hyponatremia/water retention, which is associated with headache, nausea, vomiting, water intoxication, decreased serum ...
Drug interactions
Overview Although the pressor activity of desmopressin acetate is very low, its use with other pressor agents should be done only with careful patient monitoring. Desmopressin acetate injection has been ...
Dosage and administration
Administration OCTOSTIM is administered by subcutaneous injection or as an intravenous infusion over 20 to 30 minutes to provide a dose of 0.3 mcg/kg. The maximum intravenous dose is 20 mcg. If OCTOSTIM ...
Overdosage
OCTOSTIM (desmopressin acetate) at excessive doses may cause headaches, abdominal cramps, nausea and facial flushing. In such cases the dosage should be reduced, frequency of administration decreased, ...
Action and clinical pharmacology
Mechanism of Action OCTOSTIM (desmopressin acetate) is a synthetic structural analogue of the natural human hormone, arginine vasopressin with deamination of 1-cysteine and substitution of 8-L-arginine ...
Storage and stability
OCTOSTIM should be stored at refrigerator temperature 2-8°C. Do not freeze.
Special handling instructions
Diluted solutions. Continuous intravenous infusion For intravenous infusion of OCTOSTIM in adults and children weighing 10 kg or more, a dose of 0.3 mcg/kg should be drawn up into a syringe, and added ...
Dosage forms, composition and packaging
Composition Each mL of OCTOSTIM contains desmopressin acetate 15 mcg, with sodium chloride and hydrochloric acid to adjust the pH to 3.5, in water for injection. Availability OCTOSTIM is available in a ...
Pharmaceutical information
Drug Substance Proper name: Desmopressin Acetate Chemical name: 1-Desamino-8-arginine-vasopressin acetate trihydrate 1-(3-mercaptopropionic acid)-8-D-arginine-vasopressin monoacetate (salt) trihydrate ...
Toxicology
Acute toxicity The acute toxicity of desmopressin acetate is low (Table 2). Mice tolerate IV doses of 2 mg/kg. At IV doses of 30 mcg/kg in rates and 40 mcg/kg in rabbits, only transient changes in clinical ...
Marketing authorization holder
Ferring Inc., 200 Yorkland Blvd., Suite 500, North York, Ontario, M2J 5C1
Submission control number
244562
Date of revision
March 17, 2021