Bivalirudin 250mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bivalirudin

Available from:

Accord-UK Ltd

ATC code:

B01AE06

INN (International Name):

Bivalirudin

Dosage:

250mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080100; GTIN: 5055565730751 5055565745533

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BIVALIRUDIN 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
.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Bivalirudin is and what it is used for
2.
What you need to know before you use Bivalirudin
3.
How to use Bivalirudin
4.
Possible side effects
5.
How to store Bivalirudin
6.
Contents of the pack and other information
1.
WHAT BIVALIRUDIN IS AND WHAT IT IS USED FOR
Bivalirudin contains a substance called bivalirudin which is an
antithrombotic medicine.
Antithrombotics are medicines which prevent the formation of blood
clots (thrombosis).
Bivalirudin is used to treat patients
:

with chest pain due to heart disease (acute coronary syndromes - ACS)

who are having surgery to treat blockages in their blood vessels
(angioplasty and/or
percutaneous coronary intervention - PCI).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BIVALIRUDIN DO NOT USE BIVALIRUDIN
-
if you are allergic to bivalirudin or any of the other ingredients of
this medicine (listed in
section
6) or hirudins (other blood thinning medicines).
-
if you have, or have recently had, any bleeding from your stomach,
intestines, bladder or other
organs, for example, if you have noticed abnormal blood in your stools
or urine (except from
menstrual bleeding).
-
if you have, or have had, difficulty with your blood clotting (a low
platelet count).
-
if you have severe high blood pressure.
-
if you have an infection of the heart tissue.
-
if you have severe kidney problems or if you need kidney dialysis.
Check with the doctor if you are unsure.
WARNINGS AND PRECAUTIONS
Talk to your doctor before usi

Summary of Product characteristics

OBJECT 1
BIVALIRUDIN 250 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INJECTION OR INFUSION
Summary of Product Characteristics Updated 03-Jun-2016 | Accord
Healthcare Limited
1. Name of the medicinal product
Bivalirudin 250 mg powder for concentrate for solution for injection
or infusion
2. 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.
Excipient(s) with known effect: Sodium - Less than 1 mmol (23 mg) per
vial
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for injection or infusion (powder
for concentrate).
Sterile, white to off-white lyophilised powder.
Reconstituted concentrate for solution for injection or infusion
pH in the range of the 4.6 to 6.0 and osmolality in the range of 250
to 450 mOsmol/Kg of the
reconstituted solution (concentration 50 mg/ml).
4. Clinical particulars
4.1 Therapeutic indications
Bivalirudin 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.
Bivalirudin 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.
Bivalirudin should be administered with acetylsalicylic acid and
clopidogrel.
4.2 Posology and method of administration
Bivalirudin 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 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