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AstraZeneca

Angiox
bivalirudin

PACKAGE LEAFLET: INFORMATION FOR THE USER


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

bivalirudin


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


50 ml] of glucose solution or sodium chloride solution) 1 ml contains 5 mg bivalirudin. The other ingredients are mannitol and sodium hydroxide 2% (for pH adjustment)


What Angiox looks like and contents of the pack


Angiox is a powder for concentrate for solution for injection or infusion (powder for concentrate). Angiox is a white to off-white powder in a glass vial.

Angiox is available in cartons containing 10 vials.


Marketing Authorisation Holder and Manufacturer


The Medicines Company UK Limited 115L Milton Park

Abingdon

Oxfordshire OX14 4SA

UNITED KINGDOM

Manufacturer


Hälsa Pharma GmbH Nikolaus Dürkopp-Str. 4A 33602 Bielefeld GERMANY


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien

The Medicines Company UK Ltd

Tél/Tel : +32 (0) 80081522

ou/oder +32 (0) 27006752 Email/E-Mail :

medical.information@themedco.com

Lietuva

The Medicines Company UK Ltd

Tel. Nr.: +370 880031794

arba +370 852140678

El. paštas: medical.information@themedco.com


България

The Medicines Company UK Ltd Teл.: 00800 1103246

или +359(0) 24916041

e-mail: medical.information@themedco.com

Luxembourg/Luxemburg

The Medicines Company UK Ltd Tél/Tel : +352 80028211

ou/oder +352 24871691 Email/E-Mail :

medical.information@themedco.com


Česká republika

The Medicines Company UK Ltd Tel.: +420 800050070

Medicinal product no longer authorised

nebo +420 239018449

E-mail: medical.information@themedco.com

Magyarország

The Medicines Company UK Ltd Tel. : +36 (0) 680986235

vagy +36 (0) 617777410

E-mail : medical.information@themedco.com


Danmark

The Medicines Company UK Ltd

Tlf.nr.: +45 80251618

eller +45 43314966

E-mail : medical.information@themedco.com

Malta

The Medicines Company UK Ltd

Tel : +356 80062399

jew +356 27780987

Email : medical.information@themedco.com


Deutschland

The Medicines Company UK Ltd Tel : +49 (0) 8007238819

oder +49 (0) 69299571318

E-Mail : medical.information@themedco.com

Nederland

The Medicines Company UK Ltd Tel : +31 (0) 8003712001

of +31 (0) 707709201

Email : medical.information@themedco.com


Eesti

The Medicines Company UK Ltd

Tel. : +372 8000044560

või +372 8801076

E-mail: medical.information@themedco.com

Norge

The Medicines Company UK Ltd

Tlf.: +47 80056935

eller +47 22310956

E-post: medical.information@themedco.com

Ελλάδα

Ferrer-Galenica A.E. Τηλ: +30 210 5281700

Österreich

The Medicines Company UK Ltd Tel : +43 (0) 800070265

oder +43 (0) 1206092417

E-Mail : medical.information@themedco.com


España

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94 08028-Barcelona

Tel.: +34 93 600 37 00

Polska

The Medicines Company UK Ltd

Tel.: +48 800702695

lub +48 223060790

E-mail: medical.information@themedco.com


France

The Medicines Company France SAS Tél : +33 (0)805542540

ou + 33 (0)1 41 29 75 75

ou + 33 (0)1 57 32 92 42

Email : medical.information@themedco.com

Portugal

Ferrer Portugal, S.A. Tel.: +351 21 444 96 00


Hrvatska

The Medicines Company UK Ltd Tel: 00800 843 633 26

ili +41 44 828 1084

Email: medical.information@themedco.com

România

The Medicines Company UK Ltd Tel: 00800 843 633 26

sau +41 44 828 1084

E-mail : medical.information@themedco.com


Ireland

The Medicines Company UK Ltd

Medicinal product no longer authorised

Tel : +353 1800812065

or +353 (0)19075583

Email : medical.information@themedco.com

Slovenija

The Medicines Company UK Ltd

Tel : +386 (0) 80080631

ali +386 (0) 18888602

E-pošta: medical.information@themedco.com


Ísland

The Medicines Company UK Ltd Sími : +354 8007260

eða +41 44 828 1084

Netfang : medical.information@themedco.com

Slovenská republika

The Medicines Company UK Ltd Tel : +421 (0 )268622610

alebo +421 (0) 268622610

Email : medical.information@themedco.com


Italia

The Medicines Company UK Ltd

Tel: +39 800979546

o +39 (0)291294790

Email: medical.information@themedco.com

Suomi/Finland

The Medicines Company UK Ltd

Puh./tel. +358 (0) 800774218

tai +358 (0) 972519943

S-posti: medical.information@themedco.com


Κύπρος

THESPIS PHARMACEUTICAL LtdΤηλ: Τηλ:

+357-22677710

Sverige

The Medicines Company UK Ltd

Tfn : +46 (0) 20100527

eller +46 (0) 859366368

E-post : medical.information@themedco.com


Latvija

The Medicines Company UK Ltd Tālr. +371 80004842

vai +371 67859709

E-pasts: medical.information@themedco.com

United Kingdom

The Medicines Company UK Ltd Tel : +44 (0)800 587 4149

or +44 (0)203 684 6344

Email : medical.information@themedco.com

This leaflet was last revised in:


.eu


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The following information is intended for healthcare professionals only:


Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information.


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 PCI.


Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention.


Angiox should be administered with acetylsalicylic acid and clopidogrel.


Instructions for preparation


Aseptic procedures should be used for the preparation and administration of Angiox.


Medicinal product no longer authorised

Add 5 ml sterile water for injections to one vial of Angiox and swirl gently until completely dissolved and the solution is clear.


Withdraw 5 ml from the vial, and further dilute in a total volume of 5% 50 ml of glucose solution for injection, or sodium chloride 9 mg/ml (0.9%) solution for injection to give a final bivalirudin concentration of 5 mg/ml.


The reconstituted/diluted solution should be inspected visually for particulate matter and discolouration. Solutions containing particulate matter should not be used.


The reconstituted/diluted solution will be a clear to slightly opalescent, colourless to slightly yellow solution.


Any unused product or waste material should be disposed of in accordance with local requirements.


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, amiodarone HCl, amphotericin B, chlorpromazine hydrochloride (HCl), diazepam, prochlorperazine edisylate, reteplase, streptokinase and vancomycin HCl.


The following six medicinal products show dose-concentration incompatibilities with bivalirudin. See section 6.2 for the summary of compatible and incompatible concentrations of these compounds. The medicinal products incompatible with bivalirudin at higher concentrations are: dobutamine hydrochloride, famotidine, haloperidol lactate, labetalol hydrochloride, lorazepam and promethazine HCl.

Contraindications


Angiox is contraindicated in patients with:


Posology


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


The recommended dose of bivalirudin for patients undergoing PCI is an intravenous bolus of

0.75 mg/kg body weight followed immediately by an intravenous infusion at a rate of 1.75 mg/kg body weight/hour for at least the duration of the procedure. The infusion of 1.75 mg/kg body weight/hour may be continued for up to 4 hours post-PCI and at a reduced dose of 0.25 mg/kg body weight/hour for an additional 4 – 12 hours as clinically necessary. In STEMI patients the infusion of

1.75 mg/kg body weight/hour should be continued for up to 4 hours post-PCI and continued at a reduced dose of 0.25 mg/kg/h for an additional 4 – 12 hours as clinically necessary (see section 4.4).


Medicinal product no longer authorised

Patients should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischaemia.


Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI)


The recommended starting dose of bivalirudin for medically managed patients with acute coronary syndrome (ACS) is an intravenous bolus of 0.1 mg/kg followed by an infusion of 0.25 mg/kg/h. Patients who are to be medically managed may continue the infusion of 0.25 mg/kg/h for up to 72 hours.

If the medically managed patient proceeds to PCI, an additional bolus of 0.5 mg/kg of bivalirudin should be administered before the procedure and the infusion increased to 1.75 mg/kg/h for the

duration of the procedure.

Following PCI, the reduced infusion dose of 0.25 mg/kg/h may be resumed for 4 to 12 hours as clinically necessary.


For patients who proceed to coronary artery bypass graft (CABG) surgery off pump, the intravenous infusion of bivalirudin should be continued until the time of surgery. Just prior to surgery, a 0.5 mg/kg bolus dose should be administered followed by a 1.75 mg/kg/h intravenous infusion for the duration of the surgery.


For patients who proceed to CABG surgery on pump, the intravenous infusion of bivalirudin should be continued until 1 hour prior to surgery after which the infusion should be discontinued and the patient treated with unfractionated heparin (UFH).


To ensure appropriate administration of bivalirudin, the completely dissolved, reconstituted and diluted product should be thoroughly mixed prior to administration (see section 6.6). The bolus dose should be administered by a rapid intravenous push to ensure that the entire bolus reaches the patient before the start of the procedure.


Intravenous infusion lines should be primed with bivalirudin to ensure continuity of drug infusion after delivery of the bolus.

The infusion dose should be initiated immediately after the bolus dose is administered, ensuring delivery to the patient prior to the procedure, and continued uninterrupted for the duration of the procedure. The safety and efficacy of a bolus dose of bivalirudin without the subsequent infusion has not been evaluated and is not recommended even if a short PCI procedure is planned.


An increase in the activated clotting time (ACT) may be used as an indication that a patient has received bivalirudin.


Renal insufficiency

Angiox is contraindicated in patients with severe renal insufficiency (GFR<30 ml/min) and also in dialysis-dependent patients (see section 4.3).


In patients with mild or moderate renal insufficiency, the ACS dose (0.1 mg/kg bolus/0.25 mg/kg/h infusion) should not be adjusted.


Patients with moderate renal impairment (GFR 30-59 ml/min) undergoing PCI (whether being treated with bivalirudin for ACS or not) should receive a lower infusion rate of 1.4 mg/kg/h. The bolus dose should not be changed from the posology described under ACS or PCI above.


Hepatic impairment

No dose adjustment is needed.

(For full information on posology see section 4.2 of SmPC)


Shelf life


4 years


Medicinal product no longer authorised

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8oC. Store in a refrigerator (2 oC –8oC). Do not freeze.


Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25oC. Do not store above 25C. Do not freeze.