KEYTRUDA Concentrate for solution for infusion (2025)
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Περιεχόμενα
Name of the medicinal product
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Qualitative and quantitative composition
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab. Each mL of concentrate contains 25 mg of pembrolizumab. Pembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody ...
Pharmaceutical form
Concentrate for solution for infusion. Clear to slightly opalescent, colourless to slightly yell ow solution, pH 5.2–5.8.
Therapeutic indications
Melanoma KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. KEYTRUDA as monotherapy is indicated ...
Posology and method of administration
Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. PD-L1 testing If specified in the indication, patient selection for treatment with KEYTRUDA based ...
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. Assessment of PD-L1 status When ...
Interaction with other medicinal products and other forms of interaction
No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. Pregnancy ...
Effects on ability to drive and use machines
Pembrolizumab has a minor influence on the ability to drive and us e machines. In some patients, dizziness and fatigue have been reported following administration of pembrolizumab (see section 4.8).
Undesirable effects
Summary of the safety profile Pembrolizumab is most commonly associated with immune -mediated adverse reactions. Most of these, including severe reactions, resolved following initiation of appropriate ...
Overdose
There is no information on overdose with pembrolizumab. In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic agents, PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors <b>ATC code:</b> L01FF02 Mechanism of action KEYTRUDA is a humanised monoclonal ...
Pharmacokinetic properties
The pharmacokinetics of pembrolizumab was studied in 2 993 patients with metastatic or unresectable melanoma, NSCLC, or carcinoma who received doses in the range: of 1 to 10 mg/kg bw every 2 weeks, 2 to ...
Preclinical safety data
The safety of pembrolizumab was evaluated in a 1-month and a 6-month repeat-dose toxicity study in Cynomolgus monkeys administered intravenous doses of 6, 40 or 200 mg/kg bw once a week in the 1-month ...
List of excipients
L-histidine L-histidine hydrochloride monohydrate Sucrose Polysorbate 80 (E433) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
<u>Unopened vial:</u> 2 years. <u>After preparation of infusion:</u> Chemical and physical in-use stability has been demonstrated for up to 42 days at 2°C to 8°C or at 23°C to 27°C. Protect from light. ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Store in the original carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
4 mL of concentrate in a 10 mL Type I clear glass vial, with a coated grey chlorobutyl or bromobutyl stopper and an aluminium seal with a dark blue coloured flip -off cap, containing 100 mg pembrolizumab. ...
Special precautions for disposal and other handling
<u>Preparation and administration of the infusion:</u> Do not shake the vial. Equilibrate the vial to room temperature (at or below 25°C). Prior to dilution, the vial of liquid can be out of refrigeration ...
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/15/1024/002 EU/1/15/1024/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 July 2015 Date of latest renewal: 24 March 2020
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