DURATOCIN Solution for injection (2018)
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
Περιεχόμενα
Name of the medicinal product
DURATOCIN (Carbetocin Injection). 1mL vial 100 mcg/mL Injection.
Summary product information
Route of Administration Dosage Form/Strength Clinically Relevant Nonmedicinal Ingredients Intravenous 100 mcg/mL solution L-methionine, mannitol, sodium hydroxide, succinic acid, water for injection ...
Indications and clinical use
DURATOCIN (carbetocin injection) is indicated for the prevention of uterine atony and postpartum hemorrhage following cesarean section under epidural or spinal anaesthesia. DURATOCIN has not been studied ...
Contraindications
Because of its long duration of action relative to oxytocin, uterine contractions produced by carbetocin cannot be stopped by simply discontinuing the medication. Therefore carbetocin should <b>not</b> ...
Warnings and precautions
General Duratocin should only be used at well-equipped specialist obstetrics units. Some patients may not have an adequate uterine contraction after a single injection of DURATOCIN (carbetocin injection). ...
Adverse reactions
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed ...
Drug interactions
During clinical trials, carbetocin has been administered in association with a number of analgesics, spasmolytics and agents used for epidural or spinal anaesthesia, and no drug interactions have been ...
Dosage and administration
A single intravenous dose of 100 mcg (1 mL) of DURATOCIN (carbetocin injection) is administered by bolus injection, slowly over 1 minute, only when delivery of the infant has been completed by cesarean ...
Overdosage
Overdosage of carbetocin can be expected to produce enhanced pharmacological effects. Therefore, when carbetocin is administered postpartum, overdosage may be associated with uterine hyperactivity and ...
Action and clinical pharmacology
DURATOCIN (carbetocin injection) is a long-acting synthetic nonapeptide analogue of oxytocin with agonist properties. It can be administered intravenously as a single dose immediately following delivery ...
Storage and stability
Store at room temperature (15°C to 30°C). Once the vial has been opened, the product should be used immediately
Dosage forms, composition and packaging
DURATOCIN (carbetocin injection) is available in 1 mL vials as a sterile solution. Each vial contains 100 mcg carbetocin. Boxes contain 5 vials each. Each vial contains 100 mcg (0.1 mg) of carbetocin, ...
Pharmaceutical information
Drug Substance Proper name: Carbetocin (INN) Chemical name: 1-desamino-1-monocarba-2-(0-methyl)-tyrosine oxytocin Molecular formula and molecular mass: C<sub>45</sub>H<sub>69</sub>N<sub>11</sub>O<sub> ...
Clinical trials
Three pivotal randomised controlled clinical trials were conducted in support of the use of carbetocin in healthy pregnant women undergoing elective cesarean section. Elective Cesarean Section <b>Table ...
Toxicology
In acute toxicology studies, the LD<sub>50</sub> was estimated at 10 mg/kg in an intravenous rat study. Marked clinical signs (lethargy, hunched posture, piloerection, rapid breathing and uncoordinated ...
Marketing authorization holder
Ferring Inc., 200 Yorkland Boulevard, Suite 500, North York, ON, M2J 5C1
Submission control number
207085
Date of revision
February 28, 2018
References
1. Aizawa T, Yasuda N, Greer MA, Sawyer WH. In vivo adrenocorticotropic-releasing activity of neurohypophysial hormones and their analogues. Endocrinology 1982:110:98. 2. Amico JA, Ulbrecht JS, Robinson ...
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
