OXALIPLATIN Concentrate for solution (2019)
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Περιεχόμενα
Name of the medicinal product
Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion.
Qualitative and quantitative composition
1 ml concentrate for solution for infusion contains 5 mg oxaliplatin. 10 ml of concentrate for solution for infusion contains 50 mg of oxaliplatin. 20 ml of concentrate for solution for infusion contains ...
Pharmaceutical form
Concentrate for solution for infusion. Clear, colourless liquid. pH: 4.5 – 6.5 Osmolarity: approximately 8mOsmol/kg
Therapeutic indications
Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid (FA) is indicated for: Adjuvant treatment of stage III (Dukes C) colon cancer after complete resection of primary tumor Treatment ...
Posology and method of administration
The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medical product used, in conditions that guarantee the integrity of ...
Contraindications
Oxaliplatin is contraindicated in patients who have a known history of hypersensitivity to oxaliplatin or to any of the excipients. are breast feeding. have myelosuppression prior to starting first course, ...
Special warnings and precautions for use
Oxaliplatin should only be used in specialised departments of oncology and should be administered under the supervision of an experienced oncologist. Renal impairment Due to limited information on safety ...
Interaction with other medicinal products and other forms of interaction
In patients who have received a single dose of 85 mg/m² of oxaliplatin, immediately before administration of 5-fluorouracil (5-FU), no change in plasma levels of 5-fluorouracil (5-FU) has been observed. ...
Fertility, pregnancy and lactation
Pregnancy/Women of childbearing potential To date there is no available information on safety of use in pregnant women. In animal studies, reproductive toxicity was observed. Consequently, oxaliplatin ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However oxaliplatin treatment resulting in an increased risk of dizziness, nausea and vomiting and other neurological ...
Undesirable effects
The most frequent adverse events of oxaliplatin in combination with 5-fluorouracil and folinic acid (5-FU and FA) were of gastrointestinal (diarrhoea, nausea, vomiting and mucositis), haematological (neutropenia, ...
Overdose
There is no known antidote to oxaliplatin. In cases of overdose, exacerbation of adverse events can be expected. Monitoring of haematological parameters should be initiated and symptomatic treatment given. ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antineoplastic agents, platinum compounds ATC-Code: L01XA03 Oxaliplatin is an antineoplastic active substance belonging to a new class of platinum-based compounds in which ...
Pharmacokinetic properties
The pharmacokinetics of individual active compounds have not been determined. The pharmacokinetics of ultrafiltrable platinum, representing a mixture of all unbound, active and inactive platinum species, ...
Preclinical safety data
The target organs identified in preclinical species (mice, rats, dogs, and/or monkeys) in single- and multiple-dose studies included the bone marrow, the gastrointestinal system, the kidney, the testes, ...
List of excipients
Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. DO NOT mix with alkaline medicinal products or solutions, in particular 5-fluorouracil, trometamol ...
Shelf life
Medicinal product as packaged for sale: 24 months. In-use stability after dilution: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage ...
Special precautions for storage
Keep the vial in the outer carton in order to protect from light. Do not freeze. Do not store above 25°C. For storage conditions of the diluted medicinal product, see section 6.3.
Nature and contents of container
Colourless glass vials with grey Halobutyl rubber stoppers and aluminium seals with plastic flip-off caps, with or without a protective plastic overwrap (Onco-Safe). Pack sizes: 50mg/10ml: 1 vial, 5 vials, ...
Special precautions for disposal and other handling
As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions. Instructions for Handling The handling of this cytotoxic agent by healthcare personnel ...
Marketing authorization holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Marketing authorization number(s)
PL 04416/1604
Date of first authorization / renewal of the authorization
17/12/2010
Date of revision of the text
25/10/2019
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