ERBITUX Solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Erbitux 5 mg/mL solution for infusion.
Qualitative and quantitative composition
Each mL of solution for infusion contains 5 mg cetuximab. Each vial of 20 mL contains 100 mg cetuximab. Each vial of 100 mL contains 500 mg cetuximab. Cetuximab is a chimeric monoclonal IgG1 antibody produced ...
Pharmaceutical form
Solution for infusion. Colourless solution.
Therapeutic indications
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer: in combination with irinotecan-based chemotherapy, ...
Posology and method of administration
Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Close monitoring is required during the infusion and for at least 1 hour after ...
Contraindications
Erbitux is contraindicated in patients with known severe (grade 3 or 4) hypersensitivity reactions to cetuximab. The combination of Erbitux with oxaliplatin-containing chemotherapy is contraindicated for ...
Special warnings and precautions for use
Infusion-related, including anaphylactic, reactions Severe infusion-related reactions, including anaphylactic reactions, may commonly occur, in some cases with fatal outcome. Occurrence of a severe infusion-related ...
Interaction with other medicinal products and other forms of interaction
In combination with platinum-based chemotherapy, the frequency of severe leukopenia or severe neutropenia may be increased, and thus may lead to a higher rate of infectious complications such as febrile ...
Fertility, pregnancy and lactation
Pregnancy EGFR is involved in foetal development. Limited observations in animals are indicative of a placental transfer of cetuximab, and other IgG1 antibodies have been found to cross the placental barrier. ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. If patients experience treatment-related symptoms affecting their ability to concentrate and react, it is recommended ...
Undesirable effects
The main undesirable effects of cetuximab are skin reactions, which occur in more than 80% of patients, hypomagnesaemia which occurs in more than 10% of patients and infusion-related reactions, which occur ...
Overdose
There is limited experience with single doses higher than 400 mg/m² body surface area to date or weekly administrations of doses higher than 250 mg/m² body surface area. In clinical studies with doses ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC06 Mechanism of action Cetuximab is a chimeric monoclonal IgG1 antibody that is specifically directed against the ...
Pharmacokinetic properties
Cetuximab pharmacokinetics were studied when cetuximab was administered as monotherapy or in combination with concomitant chemotherapy or radiation therapy in clinical studies. Intravenous infusions of ...
Preclinical safety data
Dose-dependent skin alterations, starting at dose levels equivalent to those used in humans, were the major findings observed in toxicity studies with Cynomolgus monkeys (a chronic repeat-dose toxicity ...
List of excipients
Sodium chloride Glycine Polysorbate 80 Citric acid monohydrate Sodium hydroxide Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 4 years. Chemical and physical in-use stability of Erbitux 5 mg/mL has been demonstrated for 48 hours at 25°C, if the solution is prepared as described in section 6.6. Erbitux does not contain ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). For storage conditions after opening, see section 6.3.
Nature and contents of container
20 mL or 100 mL of solution in a vial (Type I glass) with a stopper (halobutyl rubber) and a seal (aluminium/polypropylen). Pack size of 1 vial. Not all vial sizes may be marketed.
Special precautions for disposal and other handling
Erbitux may be administered via a gravity drip, an infusion pump or a syringe pump. A separate infusion line must be used for the infusion, and the line must be flushed with sterile sodium chloride 9 mg/mL ...
Marketing authorization holder
Merck KGaA, 64271, Darmstadt, Germany
Marketing authorization number(s)
EU/1/04/281/003 EU/1/04/281/005
Date of first authorization / renewal of the authorization
Date of first authorisation: 29/06/2004 Date of latest renewal: 29/06/2009
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