ONTRUZANT Powder for concentrate for solution for infusion (2022)
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Περιεχόμενα
Name of the medicinal product
Ontruzant 150 mg powder for concentrate for solution for infusion. Ontruzant 420 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
<u>Ontruzant 150 mg powder for concentrate for solution for infusion:</u> One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White to pale yellow lyophilised powder.
Therapeutic indications
Breast cancer Metastatic breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who ...
Posology and method of administration
HER2 testing is mandatory prior to initiation of therapy (see sections 4.4 and 5.1). Ontruzant treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy ...
Contraindications
Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded. HER2 testing must be performed ...
Interaction with other medicinal products and other forms of interaction
No formal drug interaction studies have been performed. Clinically significant interactions between trastuzumab and the concomitant medicinal products used in clinical trials have not been observed. Effect ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should be advised to use effective contraception during treatment with trastuzumab and for 7 months after treatment has concluded (see section ...
Effects on ability to drive and use machines
Ontruzant has a minor influence on the ability to drive or use machines (see section 4.8). Dizziness and somnolence may occur during treatment with Ontruzant (see section 4.8). Patients experiencing infusion-related ...
Undesirable effects
Summary of the safety profile Amongst the most serious and/or common adverse reactions reported in Ontruzant usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular ...
Overdose
There is no experience with overdose in human clinical trials. Single doses of trastuzumab alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic agents, monoclonal antibodies <b>ATC code:</b> L01XC03 Trastuzumab is a recombinant humanised IgG1 monoclonal antibody against the human epidermal growth ...
Pharmacokinetic properties
The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2-positive MBC, EBC, AGC or other tumour ...
Preclinical safety data
There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies. ...
List of excipients
L-histidine hydrochloride monohydrate L-histidine α,α-trehalose dihydrate Polysorbate 20
Incompatibilities
This medicinal product must not be mixed or diluted with other medicinal products except those mentioned under section 6.6. Do not dilute with glucose solutions since these cause aggregation of the protein. ...
Shelf life
Shelf life <u>Unopened vials:</u> 4 years. <u>After reconstitution and dilution:</u> After aseptic reconstitution with sterile water for injections, chemical and physical stability of the reconstituted ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze the reconstituted solution. For storage conditions of the reconstituted and diluted medicinal product, see section 6.3 and 6.6.
Nature and contents of container
Ontruzant 150 mg powder for concentrate for solution for infusion: One 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab. Each ...
Special precautions for disposal and other handling
Ontruzant is provided in sterile, preservative-free, non-pyrogenic, single use vials. Appropriate aseptic technique should be used for reconstitution and dilution procedures. Care must be taken to ensure ...
Marketing authorization holder
Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands
Marketing authorization number(s)
EU/1/17/1241/001 EU/1/17/1241/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 November 2017 Date of latest renewal: 19 July 2022
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