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SPC: KEYTRUDA Powder for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

KEYTRUDA 50 mg powder for concentrate for solution for infusion.

Qualitative and quantitative composition

One vial of powder contains 50 mg of pembrolizumab. After reconstitution, 1 mL of concentrate contains 25 mg of pembrolizumab. Pembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) ...

Pharmaceutical form

Powder for concentrate for solution for infusion. White to off-white lyophilised powder.

Therapeutic indications

KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with Stage ...

Posology and method of administration

Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. PD-L1 testing for patients with NSCLC, urothelial carcinoma, or HNSCC Testing for PD-L1 tumour ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

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 assessing the ...

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 ...

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 may have a minor influence on the ability to drive and use machines. Fatigue has been reported following administration of pembrolizumab (see section 4.8).

Undesirable effects

Summary of the safety profile Pembrolizumab is most commonly associated with immune-related adverse reactions. Most of these, including severe reactions, resolved following initiation of appropriate medical ...

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

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC18 Mechanism of action KEYTRUDA is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) ...

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 every 2 weeks, 2 to 10 ...

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 once a week in the 1-month study ...

List of excipients

L-histidine L-histidine hydrochloride monohydrate Sucrose Polysorbate 80

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

Shelf life Unopened vial: 3 years. After reconstitution: From a microbiological point of view, the reconstituted or diluted solution should be used immediately. The reconstituted or diluted solution must ...

Special precautions for storage

Store in a refrigerator (2°C–8°C). For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.

Nature and contents of container

15 mL Type I glass vial, with a grey bromobutyl stopper and an aluminium seal with an avocado coloured flip-off cap, containing 50 mg pembrolizumab. Each carton contains one vial.

Special precautions for disposal and other handling

Preparation and administration: Prior to reconstitution, the vial of lyophilised powder can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours. Aseptically add 2.3 mL of water for ...

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization number(s)

EU/1/15/1024/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 17 July 2015

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