KENGREXAL Powder for concentrate solution (2020)
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Περιεχόμενα
Name of the medicinal product
Kengrexal 50 mg powder for concentrate for solution for injection/infusion.
Qualitative and quantitative composition
Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor. After reconstitution 1 mL of concentrate contains 10 mg cangrelor. After dilution 1 mL of solution contains 200 micrograms cangrelor. ...
Pharmaceutical form
Powder for concentrate for solution for injection/infusion. White to off-white lyophilised powder.
Therapeutic indications
Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary ...
Posology and method of administration
Kengrexal should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures and is intended for specialised use in an acute and hospital setting. Posology ...
Contraindications
Active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension. Any history ...
Special warnings and precautions for use
Risk of bleeding Treatment with Kengrexal may increase the risk of bleeding. In pivotal studies conducted in patients undergoing PCI, GUSTO (Global Use of Strategies to Open Occluded Arteries), moderate ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Oral P2Y12 agents (clopidogrel, prasugrel, ticagrelor) When clopidogrel is administered during infusion of cangrelor, the expected inhibitory effect ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of Kengrexal in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Kengrexal is not recommended during ...
Effects on ability to drive and use machines
Kengrexal has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common adverse reactions with cangrelor include mild and moderate bleeding and dyspnoea. Serious adverse reactions associated with cangrelor in patients with coronary ...
Overdose
In clinical studies, healthy volunteers received up to two times the proposed daily dose. In clinical trials, the maximum accidental overdose was 10 times (bolus) or 3.5 times the infusion dose normally ...
Pharmacodynamic properties
Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin ATC code: B01AC25 Mechanism of action Kengrexal contains cangrelor, a direct P2Y12 platelet receptor antagonist that blocks ...
Pharmacokinetic properties
Absorption The bioavailability of cangrelor is complete and immediate. Cangrelor is rapidly distributed reaching C<sub>max</sub> within two minutes after administration of an intravenous bolus followed ...
Preclinical safety data
Non-clinical data reveal no special safety risk for humans based on studies of safety pharmacology, mutagenicity and clastogenic potential. Carcinogenicity studies have not been performed. The primary ...
List of excipients
Mannitol Sorbitol Sodium hydroxide (for pH-adjustment)
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years. The powder should be reconstituted immediately prior to dilution and use. Do not refrigerate. From a microbiological point of view, unless the method of reconstitution/dilution precludes ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions after reconstitution and dilution of the medicinal product see section 6.3.
Nature and contents of container
Powder in 10 mL glass vials (Type 1) closed with a Flurotec coated butyl rubber stopper and sealed with crimped aluminium seal. Kengrexal is available in packs of 10 vials.
Special precautions for disposal and other handling
Instructions for preparation Aseptic procedures should be used for the preparation of Kengrexal. The vial should be reconsituted immediately prior to dilution and use. Reconstitute each 50 mg/vial by adding ...
Marketing authorization holder
Chiesi Farmaceutici S.p.A., Via Palermo, 26/A, 43122, Parma, Italy
Marketing authorization number(s)
EU/1/15/994/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 March 2015
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