MYLOTARG Powder for concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
MYLOTARG 5 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial of powder for concentrate for solution for infusion contains 5 mg gemtuzumab ozogamicin. After reconstitution (see section 6.6), the concentrated solution contains 1 mg/mL gemtuzumab ozogamicin. ...
Pharmaceutical form
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white cake or powder.
Therapeutic indications
MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid ...
Posology and method of administration
MYLOTARG should be administered under the supervision of a physician experienced in the use of anticancer medicinal products and in an environment where full resuscitation facilities are immediately available. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hepatotoxicity, including hepatic ...
Interaction with other medicinal products and other forms of interaction
No clinical drug interaction studies have been conducted with MYLOTARG. See section 5.2 for available data from in vitro studies.
Pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving MYLOTARG. Women of childbearing potential, ...
Effects on ability to drive and use machines
MYLOTARG has moderate influence on the ability to drive and use machines. Patients should be advised they may experience fatigue, dizziness and headache during treatment with MYLOTARG (see section 4.8). ...
Undesirable effects
Summary of the safety profile The overall safety profile of MYLOTARG is based on data from patients with acute myeloid leukaemia from the combination therapy study ALFA-0701, monotherapy studies, and from ...
Overdose
No cases of overdose with MYLOTARG were reported in clinical experience. Single doses higher than 9 mg/m² in adults were not tested. Treatment of MYLOTARG overdose should consist of general supportive ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC05 Mechanism of action Gemtuzumab ozogamicin is a CD33-targeted ADC. Gemtuzumab is a humanised immunoglobulin class ...
Pharmacokinetic properties
Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of CD33-directed monoclonal antibody (hP67.6) that is covalently linked to the cytotoxic agent N-acetyl-gamma calicheamicin. The pharmacokinetics ...
Preclinical safety data
Repeat-dose toxicity The main toxicities occurred in the liver, bone marrow and lymphoid organs, haematology parameters (decreased RBC mass and WBC counts, mainly lymphocytes), kidney, eye and male and ...
List of excipients
Dextran 40 Sucrose Sodium chloride Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate anhydrous
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life Unopened vial: 5 years. Reconstituted and diluted solution: Following reconstitution and dilution, the solution should be protected from light and should be used immediately. If the product ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store the vial in the original carton to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, see section ...
Nature and contents of container
Amber Type 1 glass vial, with butyl rubber stopper and crimp seal with flip-off cap containing 5 mg gemtuzumab ozogamicin. Each carton contains 1 vial.
Special precautions for disposal and other handling
Use appropriate aseptic technique for the reconstitution and dilution procedures. MYLOTARG is light sensitive and should be protected from ultraviolet light during reconstitution, dilution, and administration. ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Marketing authorization number(s)
EU/1/18/1277/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 April 2018
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