TOMUDEX Powder 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
Tomudex 2 mg powder for solution for infusion.
Qualitative and quantitative composition
One vial contains 2 mg raltitrexed. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for infusion. White to cream coloured powder.
Therapeutic indications
The palliative treatment of advanced colorectal cancer where 5-fluorouracil and folinic acid based regimens are either not tolerated or inappropriate.
Posology and method of administration
Posology Adults The dose of raltitrexed is calculated on the basis of the body surface area. The recommended dose is 3 mg/m² given intravenously, as a single short, intravenous infusion in 50 to 250 ml ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Raltitrexed should not be used in pregnant women, in women who may become pregnant during treatment or women ...
Special warnings and precautions for use
Raltitrexed must only given by or under the supervision of a physician who is experienced in cancer chemotherapy, and in the management of chemotherapy-related toxicity. Patients undergoing therapy should ...
Interaction with other medicinal products and other forms of interaction
No specific clinical drug drug interaction studies have been conducted in man. Leucovorin (folinic acid), folic acid or vitamin preparations containing these agents must not be given immediately prior ...
Fertility, pregnancy and lactation
Pregnancy Pregnancy should be avoided if either partner is receiving raltitrexed. It is also recommended that conception should be avoided for at least 6 months after cessation of treatment. Raltitrexed ...
Effects on ability to drive and use machines
Raltitrexed may cause malaise or asthenia following infusion and the ability to drive/use machinery could be impaired whilst such symptoms continue.
Undesirable effects
As with other cytotoxic drugs, raltitrexed may be associated with certain adverse drug reactions. These mainly include reversible effects on the haemopoietic system, liver enzymes and gastrointestinal ...
Overdose
There is no clinically proven antidote available. In the case of inadvertent or accidental administration of an overdose, preclinical data suggest that consideration should be given to the administration ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, antimetabolites ATC code: L01BA03 Raltitrexed is a folate analogue belonging to the family of anti-metabolites and has potent inhibitory activity against ...
Pharmacokinetic properties
Following intravenous administration at 3.0 mg/m², the concentration-time profile in patients was triphasic: Peak concentrations, found at the end of the infusion, were followed by a rapid initial decline ...
Preclinical safety data
Perivascular tolerance in studies in animals did not reveal any significant irritant reaction. Acute toxicity The approximate LD<sub>50</sub> values for the mouse and rat are 875-1249 mg/kg and >500 mg/kg ...
List of excipients
Mannitol Dibasic sodium phosphate (heptahydrate or dodecahydrate) Sodium hydroxide
Incompatibilities
In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
Shelf life
Unopened Vial: 3 years. Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, ...
Special precautions for storage
Unopened vial: Do not store above 25°C. Keep container in the outer carton to protect from light. For storage conditions after reconstitution of the medical product, see section 6.3.
Nature and contents of container
5 ml clear neutral type I glass vials, with a bromobutyl rubber closure and aluminium crimp seal with a plastic flip-off cover. The vials are packed in individual cartons to protect the product from light. ...
Special precautions for disposal and other handling
There is no preservative or bacteriostatic agent present in Tomudex or the materials specified for reconstitution or dilution. Tomudex must therefore be reconstituted and diluted under aseptic conditions ...
Marketing authorization holder
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
Marketing authorization number(s)
PL 04515/0225
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 June 2000
Date of revision of the text
03/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
