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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Erbitux 5mg/ml solution for infusion (2012)

Εκδότης

Εκδότης Merck Serono
Διεύθυνση Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
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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. ...

Pharmaceutical form

Solution for infusion. Colourless solution.

Therapeutic indications

Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, ...

Posology and method of administration

Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic ...

Contraindications

Erbitux is contraindicated in patients with known severe (grade 3 or 4) hypersensitivity reactions to ...

Special warnings and precautions for use

Infusion-related reactions If the patient experiences a mild or moderate infusion-related reaction, the ...

Interaction with other medicinal products and other forms of interaction

In combination with platinum-based chemotherapy, the frequency of severe leukopenia or severe neutropenia ...

Fertility, pregnancy and lactation

Pregnancy EGFR is involved in foetal development. Limited observations in animals are indicative of a ...

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 ...

Undesirable effects

The main undesirable effects of cetuximab are skin reactions, which occur in more than 80% of patients, ...

Overdose

There is limited experience with single doses higher than 400 mg/m2 body surface area to date or weekly ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC06 Mechanism of ...

Pharmacokinetic properties

Cetuximab pharmacokinetics were studied when cetuximab was administered as monotherapy or in combination ...

Preclinical safety data

Dose-dependent skin alterations, starting at dose levels equivalent to those used in humans, were the ...

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 ...

Shelf life

3 years. Chemical and physical in-use stability of Erbitux 5 mg/ml has been demonstrated for 48 hours ...

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). ...

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 ...

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 renewal: 29/06/2009

Date of revision of the text

08/2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.