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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Exembol 100 mg/ml concentrate for solution for infusion (2012)

Εκδότης

Εκδότης Mitsubishi Pharma Europe
Διεύθυνση Dashwood House, 69 Old Broad Street, London, EC2M 1QS
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Περιεχόμενα

Name of the medicinal product

Exembol 100 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

1 ml concentrate for solution for infusion contains argatroban as 100 mg argatroban monohydrate. 1 Vial ...

Pharmaceutical form

Concentrate for Solution for Infusion. Clear colourless to pale yellow solution.

Therapeutic indications

Anticoagulation in adult patients with heparin-induced thrombocytopenia type II who require parenteral ...

Posology and method of administration

Initial Dosage Treatment with Exembol should be initiated under the guidance of a physician with experience ...

Contraindications

Exembol is contraindicated in patients with uncontrolled bleeding. Hypersensitivity to argatroban or ...

Special warnings and precautions for use

Exembol causes a generally increased tendency to bleeding. An unexplained fall in haematocrit, fall in ...

Interaction with other medicinal products and other forms of interaction

Concomitant use with antiplatelet agents, thrombolytics, and other anticoagulants may increase the risk ...

Pregnancy and lactation

There are no adequate data from the use of Exembol in pregnant women. The effect of argatroban on reproduction ...

Effects on ability to drive and use machines

In theory, the presence of ethanol in the formulation (1g per vial) may impair the patients ability to ...

Undesirable effects

Bleeding complications, as is to be expected given the pharmacological properties, constitute the main ...

Overdose

Excessive anticoagulation, with or without bleeding, may be controlled by discontinuing Exembol or by ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic agents, direct thrombin inhibitors ATC code: B01AE03 Argatroban, ...

Pharmacokinetic properties

Steady-state levels of both argatroban and anticoagulant effect are typically attained within 1-3 hours ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology ...

List of excipients

Sorbitol (E 420i) Anhydrous ethanol Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

3 years. Diluted solution: chemical and physical in-use stability has been demonstrated for up to 14 ...

Special precautions for storage

Keep vial in the outer carton in order to protect from light. Diluted solutions should not be exposed ...

Nature and contents of container

Clear 5 mL type I glass vial sealed with a teflon-coated chlorobutylrubber stopper and an aluminium crimp-seal ...

Special precautions for disposal and other handling

Exembol should be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion, glucose 50 mg/ml (5%) ...

Marketing authorization holder

Mitsubishi Pharma Europe Ltd 6 th Floor Dashwood House 69 Old Broad Street London EC2M 1QS United Kingdom ...

Marketing authorization number(s)

PL 20012/0008

Date of first authorization / renewal of the authorization

11/05/2012

Date of revision of the text

11/05/2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.