MITOMYCIN Powder for solution for injection or infusion (2017)
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Περιεχόμενα
Name of the medicinal product
Mitomycin 2 mg powder for solution for injection/infusion or intravesical use.
Qualitative and quantitative composition
Each vial contains Mitomycin 2 mg. For full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection/infusion or intravesical use. Blue-violet cake or powder.
Therapeutic indications
Mitomycin is used in palliative tumour therapy. Mitomycin is administered intravenously as monochemotherapy or in combined cytostatic chemotherapy in the case of: advanced metastatic gastric carcinoma ...
Posology and method of administration
Posology Mitomycin should only be used by doctors experienced in this therapy if there is a strict indication and with continual monitoring of the haematological parameters. It is essential that the injection ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breastfeeding (see section 4.6) Systemic therapy Pancytopenia or isolated leucopoenia/thrombopenia, haemorrhagic ...
Special warnings and precautions for use
Due to the toxic effects on the bone marrow of mitomycin, other myelotoxic therapy modalities (in particular other cytostatics, radiation) must be administered with particular caution in order to minimise ...
Interaction with other medicinal products and other forms of interaction
Myelotoxic interactions with other bone marrow-toxic treatment modalities (especially other cytotoxic medicinal products, radiation) are possible. Combination with vinca alkaloids or bleomycin may reinforce ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of mitomycin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Mitomycin has a mutagenic, teratogenic and carcinogenic effect ...
Effects on ability to drive and use machines
Even when used in accordance with instructions these medicinal products may cause nausea and vomiting and thereby reduce reaction times to such an extent that the ability to drive a motor vehicle or operate ...
Undesirable effects
Undesirable effects are listed below by system organ class and frequency. Frequencies below are defined as: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 ...
Overdose
In case of overdose severe myelotoxicity or even myelophthisis must be expected, with the full-blown clinical effect only appearing after approximately 2 weeks. The period until which the number of leucocytes ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agent, Other cytotoxic antibiotics ATC Code: L01DC03 The antibiotic mitomycin is a cytostatic medicinal product from the group of alkylating agents. Mitomycin ...
Pharmacokinetic properties
After the intravenous administration of 10-20 mg/m² of mitomycin, maximum plasma levels of 0.4-3.2 µg/ml have been measured. The biological half-life is short and is between 40 and 50 minutes. The serum ...
Preclinical safety data
In animals, mitomycin is toxic to all proliferating tissues, particularly the cells of the bone marrow and the mucous membrane of the gastrointestinal tract, resulting in the inhibition of spermiogenesis. ...
List of excipients
Mannitol E421
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Unopened vial: 2 years The reconstituted product should be used immediately. The contents of the vials are intended for single use only. Unused solutions must be discarded.
Special precautions for storage
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Mitomycin is contained within a amber colored, type I glass vial with a bromo butyl rubber stopper and an aluminium seal. The 2 mg vials are packaged into cartons containing 1, 5 or 10 vials. Not all pack ...
Special precautions for disposal and other handling
Intravenous use Mitomycin 2 mg, powder for solution for injection/infusion or intravesical use may not be reconstituted in water. The contents of the vial should be reconstituted with saline or 20% glucose ...
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0387
Date of first authorization / renewal of the authorization
Date of first authorization: 11<sup>th</sup> January 2016
Date of revision of the text
04/02/2017
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