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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: MabCampath 30mg/ml concentrate for solution for infusion (2012)

Εκδότης

Εκδότης Genzyme Therapeutics
Διεύθυνση 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

MabCampath 30 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

One ml contains 30 mg of alemtuzumab. Each vial contains 30 mg of alemtuzumab. Alemtuzumab is a genetically ...

Pharmaceutical form

Concentrate for solution for infusion. Colourless to slightly yellow concentrate.

Therapeutic indications

MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) ...

Posology and method of administration

MabCampath should be administered under the supervision of a physician experienced in the use of cancer ...

Contraindications

Hypersensitivity to alemtuzumab, to murine proteins or to any of the excipients. Active systemic infections. ...

Special warnings and precautions for use

Acute adverse reactions, which may occur during initial dose escalation and some of which may be due ...

Interaction with other medicinal products and other forms of interaction

Although no formal drug interaction studies have been performed with MabCampath, there are no known clinically ...

Pregnancy and lactation

Pregnancy MabCampath is contraindicated during pregnancy. Human IgG is known 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. However, caution ...

Undesirable effects

The tables below report adverse reactions by MedDRA system organ classes (MedDRA SOCs). The frequencies ...

Overdose

Patients have received repeated unit doses of up to 240 mg of MabCampath. The frequency of grade 3 or ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC04 Alemtuzumab ...

Pharmacokinetic properties

Pharmacokinetics were characterised in MabCampath-naive patients with B-cell chronic lymphocytic leukaemia ...

Preclinical safety data

Preclinical evaluation of alemtuzumab in animals has been limited to the cynomolgus monkey because of ...

List of excipients

Disodium edetate Polysorbate 80 Potassium chloride Potassium dihydrogen phosphate Sodium chloride Dibasic ...

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

Unopen vial: 3 years. Reconstituted solution: MabCampath contains no antimicrobial preservative. MabCampath ...

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from ...

Nature and contents of container

Clear type I glass vial, closed with a rubber stopper, containing 1 ml of concentrate. Pack size: carton ...

Special precautions for disposal and other handling

The vial contents should be inspected for particulate matter and discolouration prior to administration. ...

Marketing authorization holder

Genzyme Europe BV Gooimeer 10 1411 DD Naarden Netherlands

Marketing authorization number(s)

EU/1/01/193/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 06/07/2001 Date of latest renewal: 10/07/2011

Date of revision of the text

05/2011
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.