Bivalirudin Cipla 250 mg Pulver till koncentrat till injektions-/infusionsvätska, lösning

Země: Švédsko

Jazyk: švédština

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktivní složka:

bivalirudin

Dostupné s:

Cipla Europe NV

ATC kód:

B01AE06

INN (Mezinárodní Name):

bivalirudin

Dávkování:

250 mg

Léková forma:

Pulver till koncentrat till injektions-/infusionsvätska, lösning

Složení:

bivalirudin 250 mg Aktiv substans; mannitol Hjälpämne

Druh předpisu:

Receptbelagt

Přehled produktů:

Förpacknings: Injektionsflaska, 1 st; Injektionsflaska, 10 x 1 st

Stav Autorizace:

Avregistrerad

Datum autorizace:

2016-08-24

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
BIVALIRUDIN CIPLA 250 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/ 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.

If you get any side effects talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Bivalirudin Cipla is and what it is used for
2. What you need to know before you use Bivalirudin Cipla
3. How to use Bivalirudin Cipla
4. Possible side effects
5. How to store Bivalirudin Cipla
6. Contents of the pack and other information
1.
WHAT BIVALIRUDIN CIPLA IS AND WHAT IT IS USED FOR
Bivalirudin Cipla contains a substance called bivalirudin which is an
antithrombotic medicine.
Antithrombotics are medicines which prevent the formation of blood
clots (thrombosis).
Bivalirudin Cipla 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 CIPLA
DO NOT USE BIVALIRUDIN CIPLA

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 not sure.
WARNINGS AND PRECAUTIONS

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bivalirudin Cipla 250 mg powder for concentrate for solution for
injection/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.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for injection/infusion
White to off white lyophilized powder/cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bivalirudin Cipla 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 Cipla 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 Cipla should be administered with acetylsalicylic acid and
clopidogrel.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Bivalirudin Cipla should be administered by a physician experienced in
either acute coronary care
or in coronary intervention procedures.
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 clinical 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 body weight/hour for an
additional 4 – 12 hours as
clinically necessary (