NADROPARIN SODIUM Solution for injection
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
Nadroparin calcium Aspen 15,200 I.U. anti-Xa/0.8ml double strength solution for injection in a pre-filled syringe.
Qualitative and quantitative composition
1 Pre-filled syringe with 0.8 ml solution for injection contains 15,200 I.U. anti-Xa nadroparin calcium derived from porcine intestinal mucosa. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection in pre-filled syringe. The solution is sterile and clear, pH 4.5 to 7.5.
Therapeutic indications
Treatment of deep venous thrombosis.
Posology and method of administration
Posology Treatment of deep venous thrombosis Nadroparin 19,000 I.U. should be injected subcutaneously once daily for the duration of 10 days in a dosage appropriately adjusted for the patients body weight ...
Contraindications
Nadroparin 19,000 I.U. should not be used in patients with: hypersensitivity to the active substance(s), heparin, or to any of the excipients listed in section 6.1. history of, or current heparin-associated ...
Special warnings and precautions for use
Thrombocytopenia and platelet function disorders Heparin-induced thrombocytopenia Because of the possibility of heparin-induced thrombocytopenia, the platelet count should be monitored throughout the course ...
Interaction with other medicinal products and other forms of interaction
Oral anticoagulants, system (gluco-) corticosteroids, and dextran Nadroparin should be administered with caution in patients who receive oral anticoagulants, systemic (gluco-) corticosteroids and dextrans. ...
Fertility, pregnancy and breastfeeding
Pregnancy Animal studies have not shown any teratogenic or fetotoxic effects. However, there is only limited clinical data concerning transplacental passage of nadroparin. Experiences based on a limited ...
Effects on ability to drive and use machines
There are no data on the effects on the ability to drive and use machines.
Undesirable effects
The most common adverse effects include haemorrhagic manifestations, minor hematomas at the injection site, open or hidden bleeding complications (particularly affecting the skin, mucous membranes, lesions, ...
Overdose
Symptoms and Signs In the treatment of deep venous thrombosis, prolongation of the activated Partial Thromboplastin Time (aPTT) value should only be considered as an indication of overdose. Dose-escalations ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antithrombotic ATC-Code: B01AB06 Nadroparin 19,000 I.U. is the calcium salt of nadroparin, a low-molecular weight heparin with a mean molecular weight of about 4,500 Daltons. ...
Pharmacokinetic properties
The pharmacokinetic properties have been determined by measuring the anti-Xa activity in plasma. Absorption Following subcutaneous injection, the maximum anti-Xa activity (C<sub>max</sub>) was reached ...
Preclinical safety data
Not relevant.
List of excipients
Calcium hydroxide or Hydrochloric acid 10% (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
The prefilled syringe consists of a Type-I glass cylinder with stainless steel needle and needle guard made of natural and/or styrene-butadiene-rubber, a safety cylinder made of polypropylene and a piston ...
Special precautions for disposal and other handling
Prior to administration, visually inspect for particulate matter and discoloration. Discard the injection solution if any visual change has occurred. For single use only. Discard any unused solution. ...
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
