ELDISINE Powder for 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
Eldisine Powder for Solution for Injection 5.0 mg.
Qualitative and quantitative composition
Eldisine Powder 5mg contains 5mg vindesine sulphate per 5ml when reconstituted. For a full list of excipients, see section 6.1.
Pharmaceutical form
Powder for Solution for Injection. A clear glass vial containing a lyophilised plug of white crystalline powder.
Therapeutic indications
Eldisine is an anti-neoplastic drug for intravenous use which can be used alone or in combination with other oncolytic drugs. Information available at present suggests that Eldisine as a single agent may ...
Posology and method of administration
This preparation is for intravenous use only. It should be administered only by individuals experienced in vindesine administration. FOR INTRAVENOUS USE ONLY FATAL IF GIVEN BY OTHER ROUTES. See special ...
Contraindications
FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES. See special warnings in section 4.4 for the treatment of patients given intrathecal vindesine sulphate. Use in patients who have drug-induced ...
Special warnings and precautions for use
This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of vindesine sulphate. The intrathecal administration of vindesine sulphate usually ...
Interaction with other medicinal products and other forms of interaction
When chemotherapy is being given in conjunction with radiation therapy through portals, which include the liver, the use of vindesine should be delayed until radiation therapy has been completed. Acute ...
Pregnancy and lactation
Usage in pregnancy or lactation The safety of this product for use during pregnancy has not been established. Animal studies with vindesine suggest that teratogenic effects may occur. The benefit-to-risk ...
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
Prior to the use of the drug, patients and/or their parents/guardians should be advised of the possibility of untoward symptoms. Acute toxicity appears to be dose related and is more likely to occur if ...
Overdose
Side effects following the use of vindesine are dose related. Therefore, following administration of more than the recommended dose, patients can be expected to experience these effects in an exaggerated ...
Pharmacodynamic properties
Pharmacotherapeutic group: Cytostatic agent from the group of vinca alkaloids; mitosis inhibitor ATC code: L01CA03 Vindesine sulphate is an antineoplastic agent derived from vinblastine, like the other ...
Pharmacokinetic properties
The pharmacokinetics of vindesine is similar to those of the other vinca alkaloids. After intravenous administration, elimination from the blood is triphasic, and the drug is rapidly distributed to body ...
Preclinical safety data
Animal studies with vindesine suggest that teratogenic effects may occur.
List of excipients
Mannitol Sulphuric acid (diluted) Sodium hydroxide (diluted)
Incompatibilities
Eldisine should never be mixed with any other drug.
Shelf life
5 years.
Special precautions for storage
Vials of Eldisine should be stored in a refrigerator between 2° and 8°C. After reconstitution: After a portion of the solution has been removed from a vial, the remainder of the contents of the vial may ...
Nature and contents of container
Single vials comprising Type I glass each with a rubber stopper, an aluminium sealing ring and a polypropylene cap.
Special precautions for disposal and other handling
Guidelines for the safe handling of antineoplastic agents Cytotoxic preparations should not be handled by pregnant staff. Trained personnel should reconstitute the drug. This should be performed in a designated ...
Marketing authorization holder
Genus Pharmaceuticals Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK
Marketing authorization number(s)
PL 06831/0117
Date of first authorization / renewal of the authorization
17/03/2009
Date of revision of the text
30/10/2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
