Angiox 250mg powder for concentrate for solution for injection or infusion (2012)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

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

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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 1 ml contains 5 mg bivalirudin. For a full list of excipients see section 6.1.

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 (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary ...

Posology and method of administration

Angiox should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures. Posology Patients undergoing PCI, including primary PCI The recommended dose ...

Contraindications

Angiox is contraindicated in patients with: a known hypersensitivity to the active substance or to any of the excipients, or to hirudins active bleeding or increased risk of bleeding because of haemostasis ...

Special warnings and precautions for use

Angiox is not intended for intramuscular use. Do not administer intramuscularly. Haemorrhage Patients must be observed carefully for symptoms and signs of bleeding during treatment particularly if bivalirudin ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have been conducted with platelet inhibitors, including acetylsalicylic acid, ticlopidine, clopidogrel, abciximab, eptifibatide, or tirofiban. The results do not suggest pharmacodynamic ...

Pregnancy and lactation

Pregnancy There are no or limited data from the use of bivalirudin in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or ...

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 are listed by system organ class in Table 1. In all clinical studies bleeding data were collected ...

Overdose

Cases of overdose of up to 10 times the recommended dose have been reported in clinical trials. Single bolus doses of bivalirudin up to 7.5 mg/kg have also been reported. Bleeding has been observed in ...

Pharmacodynamic properties

Pharmacotherapeutic group: Direct thrombin inhibitors ATC code: B01AE06 Angiox contains bivalirudin, a direct and specific thrombin inhibitor that binds both to the catalytic site and the anion-binding ...

Pharmacokinetic properties

The pharmacokinetic properties of bivalirudin have been evaluated and found to be linear in patients undergoing Percutaneous Coronary Intervention and in patients with ACS. Absorption: The bioavailability ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, or toxicity to reproduction. Toxicity in animals upon ...

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 since they result in haze formation, micro-particulate formation or gross precipitation; alteplase, ...

Shelf life

4 years. Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2‑8°C. Diluted 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). Do not freeze. Diluted solution: Do not store above 25°C. Do not freeze.

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 rubber stopper and sealed with a crimped aluminum seal. Angiox 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 and administration of Angiox. Add 5 ml sterile water for injections to one vial of Angiox and swirl gently until completely ...

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