SPC, UK: MabCampath 30mg/ml concentrate for solution for infusion
||4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU
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συνδρομή διάρκειας 30 ημερών.
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 ...
Concentrate for solution for infusion. Colourless to slightly yellow concentrate.
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 ...
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 ...
The tables below report adverse reactions by MedDRA system organ classes (MedDRA SOCs). The frequencies ...
Patients have received repeated unit doses of up to 240 mg of MabCampath. The frequency of grade 3 or ...
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC04 Alemtuzumab ...
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 ...
This medicinal product must not be mixed with other medicinal products except those mentioned in section ...
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)
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
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.