ALYMSYS Concentrate for solution for infusion (2021)
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Περιεχόμενα
1. Name of the medicinal product
Alymsys 25 mg/mL concentrate for solution for infusion.
2. Qualitative and quantitative composition
Each mL of concentrate contains 25 mg of bevacizumab*. Each 4 mL vial contains 100 mg of bevacizumab. Each 16 mL vial contains 400 mg of bevacizumab. For dilution and other handling recommendations, see ...
3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Colourless to yellowish or brownish liquid with opalescence.
4.1. Therapeutic indications
Alymsys in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Alymsys in combination with paclitaxel is ...
4.2. Posology and method of administration
Alymsys must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Posology Metastatic carcinoma of the colon or rectum (mCRC) The recommended ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies. ...
4.4. 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. Gastrointestinal (GI) perforations ...
4.5. Interaction with other medicinal products and other forms of interaction
Effect of antineoplastic agents on bevacizumab pharmacokinetics No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population ...
4.6. Pregnancy and lactation
Women of childbearing potential/Contraception Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment. Pregnancy There are no clinical trial data ...
4.7. Effects on ability to drive and use machines
Bevacizumab has no or negligible influence on the ability to drive and use machines. However, somnolence and syncope have been reported with bevacizumab use (see Table 1 in section 4.8). If patients are ...
4.8. Undesirable effects
Summary of the safety profile The overall safety profile of bevacizumab is based on data from over 5,700 patients with various malignancies, predominantly treated with bevacizumab in combination with chemotherapy ...
4.9. Overdose
The highest dose tested in humans (20 mg/kg of body weight, intravenous every 2 weeks) was associated with severe migraine in several patients.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies <b>ATC code:</b> L01XC07 Alymsys is a biosimilar ...
5.2. Pharmacokinetic properties
The pharmacokinetic data for bevacizumab are available from ten clinical trials in patients with solid tumours. In all clinical trials, bevacizumab was administered as an intravenous infusion. The rate ...
5.3. Preclinical safety data
In studies of up to 26 weeks duration in cynomolgus monkeys, physeal dysplasia was observed in young animals with open growth plates, at bevacizumab average serum concentrations below the expected human ...
6.1. List of excipients
Trehalose dihydrate Monobasic sodium phosphate monohydrate Disodium phosphate Polysorbate 20 Water for injections
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. A concentration dependent degradation profile of bevacizumab was observed when diluted with ...
6.3. Shelf life
<u>Unopened vial:</u> 30 months. <u>Diluted medicinal product:</u> Chemical and physical in-use stability has been demonstrated for 30 days at 2ºC to 8ºC plus an additional 48 hours at temperature not ...
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
6.5. Nature and contents of container
4 mL solution in a vial (Type I glass) with a stopper (chlorobutyl rubber) containing 100 mg of bevacizumab. 16 mL solution in a vial (Type I glass) with a stopper (chlorobutyl rubber) containing 400 mg ...
6.6. Special precautions for disposal and other handling
Alymsys should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution. A sterile needle and syringe should be used to prepare Alymsys. The necessary ...
7. Marketing authorization holder
Mabxience Research SL, C/ Manuel Pombo Angulo 28 3a y 4a Planta, 28050 Madrid, Spain
8. Marketing authorization number(s)
EU/1/20/1509/001 – 100 mg/4 ml EU/1/20/1509/002 – 400 mg/16 ml
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 26 March 2021
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