CISPLATIN Concentrate for solution for infusion (2019)
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
Cisplatin 1mg/ml Injection BP. Cisplatin 1 mg/ml Concentrate for solution for infusion.
Qualitative and quantitative composition
1 ml contains 1 mg cisplatin. 1 vial of 10 ml concentrate for solution for infusion contains 10 mg cisplatin. 1 vial of 20 ml concentrate for solution for infusion contains 20 mg cisplatin. 1 vial of 50 ...
Pharmaceutical form
Concentrate for solution for infusion. The concentrate is a clear and colourless to yellowish solution.
Therapeutic indications
To be used as mono-therapy, or as part of an existing chemotherapy for advanced or metastatic tumours: testicular carcinoma (palliative and curative poly-chemotherapy) and ovary carcinoma (stages III and ...
Posology and method of administration
Posology Adults and children The cisplatin dosage depends on the primary disease, the expected reaction, and on whether cisplatin is used for monotherapy or as a component of a combination chemotherapy. ...
Contraindications
Hypersensitivity to the active substance or other platinum containing compounds, or to any of the excipients listed in section 6.1. in dehydrated condition (pre- and post-hydration is required to prevent ...
Special warnings and precautions for use
Cisplatin reacts with metallic aluminum to form a black precipitate of platinum. All aluminum containing IV sets, needles, catheters and syringes should be avoided. Cisplatin must be administered under ...
Interaction with other medicinal products and other forms of interaction
Nephrotoxic substances Concomitant administration of nephrotoxic (e.g. cephalosporins, aminoglycosides, amphotericin B or contrast media) or ototoxic (e.g. aminoglycosides) medicinal products will potentiate ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of cisplatin in pregnant women, but based on its pharmacological properties Cisplatin is suspected to cause serious birth defects. Studies in animals have ...
Effects on ability to drive and use machines
Due to the possible side effects cisplatinhas minor or moderate influence on the ability to drive and use machines. Patients who suffer from these effects (eg feeling sleepy or vomiting) must avoid driving ...
Undesirable effects
Undesirable effects depend on the used dose and may have cumulative effects. The most frequently reported adverse events (>10%) of Cisplatin were haematological (leukopenia, thrombocytopenia and anaemia), ...
Overdose
CAUTION IS ESSENTIAL IN ORDER TO PREVENT AN INADVERTENT OVERDOSE. An acute overdose of cisplatin may result in renal failure, liver failure, deafness, ocular toxicity (including detachment of the retina), ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents / Platinum compounds ATC code: L01XA01 Mechanism of action Cisplatin is an anorganic substance containing a heavy metal [cis-diamminedichloroplatinum(II)]. ...
Pharmacokinetic properties
Distribution After intravenous administration, cisplatin is rapidly distributed among all tissues. Following cisplatin doses of 20 to 120 mg/m², the concentrations of platinum are highest in liver, prostate ...
Preclinical safety data
Chronic toxicity Chronic toxicity models indicate kidney damage, bone marrow depression, gastro-intestine disorders and ototoxicity. Mutagenity and carcinogenity Cisplatin is mutagenic in numerous in vitro ...
List of excipients
Sodium chloride Hydrochloric acid, dilute Water for injections
Incompatibilities
Cisplatin reacts with aluminium which results in production of a black platinum precipitate. Therefore any device containing aluminium that may come in contact with cisplatin (sets for intravenous infusion, ...
Shelf life
Shelf life Medicinal product as packaged for sale: 2 years. Solution for infusion after dilution (see section 6.6): Chemical and physical in-use stability has been demonstrated for 48 hours at 2 to 8°C ...
Special precautions for storage
Medicinal product as packaged for sale: Do not store above 25°C. Do not refrigerate or freeze. Keep the vial in the outer carton. For storage conditions of the diluted medicinal product, see section 6.3. ...
Nature and contents of container
Amber type I glass vial with chlorobutyl rubber stopper with aluminium overseal. Packs of 1, 5 or 10 vial(s) containing 10ml, 20 ml, 50 ml or 100 ml concentrate for solution for infusion each. Not all ...
Special precautions for disposal and other handling
Cisplatin 1 mg/ml concentrate for solution for infusion is to be diluted before use. For preparation of solution for infusion, any device containing aluminium that may come in contact with cisplatin (sets ...
Marketing authorization holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Marketing authorization number(s)
PL 04416/1597
Date of first authorization / renewal of the authorization
Date of first authorisation: 12.07.2002
Date of revision of the text
07/10/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
