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

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Genzyme Therapeutics
Διεύθυνση :
4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU
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Δωρεάν εγγραφή

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 engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface ...

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) for whom fludarabine combination chemotherapy is not appropriate.

Posology and method of administration

MabCampath should be administered under the supervision of a physician experienced in the use of cancer therapy. Posology During the first week of treatment, MabCampath should be administered in escalating ...

Contraindications

Hypersensitivity to alemtuzumab, to murine proteins or to any of the excipients. Active systemic infections. HIV. Active second malignancies. Pregnancy.

Special warnings and precautions for use

Acute adverse reactions, which may occur during initial dose escalation and some of which may be due to the release of cytokines, include hypotension, chills/rigors, fever, shortness of breath and rashes. ...

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 significant interactions of MabCampath with other medicinal products. Because MabCampath is ...

Pregnancy and lactation

Pregnancy MabCampath is contraindicated during pregnancy. Human IgG is known to cross the placental barrier; MabCampath may cross the placental barrier as well and thus potentially cause foetal B and T ...

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 should be exercised as confusion and somnolence have been reported.

Undesirable effects

The tables below report adverse reactions by MedDRA system organ classes (MedDRA SOCs). The frequencies are based on clinical trial data. The most appropriate MedDRA term is used to describe a certain ...

Overdose

Patients have received repeated unit doses of up to 240 mg of MabCampath. The frequency of grade 3 or 4 adverse events, such as fever, hypotension and anaemia, may be higher in these patients. There is ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC04 Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte ...

Pharmacokinetic properties

Pharmacokinetics were characterised in MabCampath-naive patients with B-cell chronic lymphocytic leukaemia (B-CLL) who had failed previous therapy with purine analogues. MabCampath was administered as ...

Preclinical safety data

Preclinical evaluation of alemtuzumab in animals has been limited to the cynomolgus monkey because of the lack of expression of the CD52 antigen on non-primate species. Lymphocytopenia was the most common ...

List of excipients

Disodium edetate Polysorbate 80 Potassium chloride Potassium dihydrogen phosphate Sodium chloride Dibasic sodium phosphate Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. There are no known incompatibilities with other medicinal products. However, other medicinal ...

Shelf life

Unopen vial: 3 years. Reconstituted solution: MabCampath contains no antimicrobial preservative. MabCampath should be used within 8 hours after dilution. Solutions may be stored at 15°C-30°C or refrigerated. ...

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 light. For storage conditions of the reconstituted medicinal product, see section 6.3.

Nature and contents of container

Clear type I glass vial, closed with a rubber stopper, containing 1 ml of concentrate. Pack size: carton of 3 vials.

Special precautions for disposal and other handling

The vial contents should be inspected for particulate matter and discolouration prior to administration. If particulate matter is present or the concentrate is coloured, then the vial should not be used. ...

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