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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Angiox 250mg powder for concentrate for solution for injection or infusion (2012)

Εκδότης

Εκδότης The Medicines Company UK Ltd
Διεύθυνση 115L Milton Park, Abingdon, Oxfordshire, OX14 4SA, UK
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Περιεχόμενα

Name of the medicinal product

Angiox 250 mg powder for concentrate for solution for injection or infusion.

Qualitative and quantitative composition

Each vial contains 250 mg bivalirudin. After reconstitution 1 ml contains 50 mg bivalirudin. After dilution ...

Pharmaceutical form

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

Therapeutic indications

Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention ...

Posology and method of administration

Angiox should be administered by a physician experienced in either acute coronary care or in coronary ...

Contraindications

Angiox is contraindicated in patients with: a known hypersensitivity to the active substance or to any ...

Special warnings and precautions for use

Angiox is not intended for intramuscular use. Do not administer intramuscularly. Haemorrhage Patients ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have been conducted with platelet inhibitors, including acetylsalicylic acid, ticlopidine, ...

Pregnancy and lactation

Pregnancy There are no or limited data from the use of bivalirudin in pregnant women. Animal studies ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

Adverse reactions for bivalirudin from HORIZONS, ACUITY, REPLACE-2 trials and post-marketing experience ...

Overdose

Cases of overdose of up to 10 times the recommended dose have been reported in clinical trials. Single ...

Pharmacodynamic properties

Pharmacotherapeutic group: Direct thrombin inhibitors ATC code: B01AE06 Angiox contains bivalirudin, ...

Pharmacokinetic properties

The pharmacokinetic properties of bivalirudin have been evaluated and found to be linear in patients ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, ...

List of excipients

Mannitol Sodium hydroxide solution (for pH adjustment)

Incompatibilities

The following medicinal products should not be administered in the same intravenous line as bivalirudin ...

Shelf life

4 years. Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 ...

Special precautions for storage

Lyophilised powder: Do not store above 25°C. Reconstituted solution: Store in a refrigerator (2–8°C). ...

Nature and contents of container

Angiox is supplied as a lyophilised powder in 10 ml single use glass vials (Type 1) closed with a butyl ...

Special precautions for disposal and other handling

Instructions for preparation Aseptic procedures should be used for the preparation and administration ...

Marketing authorization holder

The Medicines Company UK Ltd 115L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM

Marketing authorization number(s)

EU/1/04/289/001

Date of first authorization / renewal of the authorization

20.09.2004/20.09.2009

Date of revision of the text

02/2012
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.