INTEGRILIN 2 MGML

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

EPTIFIBATIDE

Tillgänglig från:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC-kod:

B01AC16

Läkemedelsform:

SOLUTION FOR INJECTION

Sammansättning:

EPTIFIBATIDE 2 MG/ML

Administreringssätt:

I.V

Receptbelagda typ:

Required

Tillverkad av:

SCHERING-PLOUGH LABO. N.V , BELGIUM

Terapeutisk grupp:

EPTIFIBATIDE

Terapiområde:

EPTIFIBATIDE

Terapeutiska indikationer:

Integrilin is indicated for the prevention of death and myocardial infarction in patients presenting with high risk unstable angina or non-Q-wave myocardial infarction. Integrilin is indicated in patients who are managed with standard medical therapies and/or with percutaneous coronary intervention. Integrilin is also indicated as an adjunct to percutaneous transluminal coronary angioplasty (PTCA) balloon angioplasty, directional atheretomy, transluminal extraction catheter atherectomy, rotational ablation angioplasty, or excimer laser angioplasty for the prevention of abrupt closure of the treated coronary vessel and related acute ischemic cardiac complications (death, myorardial infarction, need for urgent intervention). Integrilin is intended for use with aspirin and heparin.

Tillstånd datum:

2013-10-31

Bipacksedel

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה :ךיראת
12 רבמבונב
2014
:תילגנאב רישכת םש
INTEGRILIN 0.75 MG/ML. 2 MG/ML :םושיר רפסמ
112-71-29528-11
,
112-72-29529-11 :םושירה לעב םש
-לארשי( םהודו פראש קרמ תרבח
1996
מ"עב )
תושקובמה תורמחהה
אפורל ןולעב קרפ
יחכונ טסקט
שדח טסקט
CONTRAINDICATIONS
Known hypersensitivity to any
component of the product.
Hypersensitivity to INTEGRILIN or
any component of the product
hypersensitivity reactions that
occurred included anaphylaxis and
urticaria).
WARNINGS AND
PRECAUTIONS-
_Bleeding_
Because eptifibatide inhibits platelet
aggregation, caution should be
employed when it is used with other
drugs that affect hemostasis,
including thrombolytics, oral
anticoagulants, nonsteroidal anti-
inflammatory drugs, and
dipyridamole. To avoid potentially
additive pharmacologic effects,
concomitant treatment with other
inhibitors of platelet receptor GP
IIb/IIIa should be avoided
_Use of Thrombolytics, _
_Anticoagulants, and Other _
_Antiplatelet Agents-_
Risk factors for bleeding include
older age, a history of bleeding
disorders, and concomitant use of
drugs that increase the risk of
bleeding (thrombolytics, oral
anticoagulants, nonsteroidal anti-
inflammatory drugs, and P2Y
12
inhibitors). Concomitant treatment
with other inhibitors of platelet
receptor glycoprotein (GP) IIb/IIIa
should be avoided. In patients
treated with heparin, bleeding can
be minimized by close monitoring of
the aPTT and ACT _[see Dosage _
_and Administration (2)]_.
WARNINGS AND
PRECAUTIONS-
_Thrombocytopenia_
In the event of acute profound
thrombocytopenia or a confirmed
platelet decrease to <100,000/mm
3
,
discontinue INTEGRILIN and
heparin (unfractionated or low-
molecular-weight). Monitor serial
platelet counts, assess the
presence of drug-dependent
antibodies, and treat as appropriate
(see ADVERSE REACTIONS,
Immunogenicity).
There has been no clinical
experience with eptifibat

Produktens egenskaper

1
PRESCRIBING INFORMATION
INTEGRILIN
® 0.75 MG/ML SOLUTION FOR I.V. INFUSION
INTEGRILIN
® 2 MG/ML SOLUTION FOR I.V. INJECTION
(
EPTIFIBATIDE)
1 INDICATIONS AND USAGE
INTEGRILIN is indicated for the prevention of death and myocardial
infarction in patients presenting with high risk
unstable angina or non-Q-wave myocardial infarction.
INTEGRILIN is indicated in patients who are managed with standard
medical therapies and/or with percutaneous
coronary intervention.
INTEGRILIN is also indicated as an adjunct to percutaneous
transluminal coronary angioplasty (PTCA) balloon
angioplasty, directional atherectomy, transluminal extraction catheter
atherectomy, rotational ablation angioplasty, or
excimer laser angioplasty for the prevention of abrupt closure of the
treated coronary vessel and related acute ischemic
cardiac complications (death, myocardial infarction, need for urgent
intervention).
INTEGRILIN is intended for use with aspirin and heparin.
2
DOSAGE AND ADMINISTRATION
Before infusion of INTEGRILIN, the following laboratory tests should
be performed to identify pre-existing
hemostatic abnormalities: hematocrit or hemoglobin, platelet count,
serum creatinine, and PT/aPTT. In patients
undergoing PCI, the activated clotting time (ACT) should also be
measured.
The activated partial thromboplastin time (aPTT) should be maintained
between 50 and 70 seconds unless PCI is
to be performed. In patients treated with heparin, bleeding can be
minimized by close monitoring of the aPTT and ACT.
2.1
DOSAGE IN ACUTE CORONARY SYNDROME (ACS)
INDICATION
NORMAL RENAL FUNCTION
CREATININE CLEARANCE LESS THAN 50 ML/MIN
Patients with
ACS
180 mcg/kg intravenous (IV) bolus
as soon as possible after diagnosis,
followed by continuous infusion of
2 mcg/kg/min
180 mcg/kg IV bolus as soon as possible after
diagnosis, followed by continuous infusion of
1 mcg/kg/min
•
Infusion should continue until hospital discharge or initiation of
coronary artery
bypass graft surgery (CABG), up to 72 hours
•
If a patient is to undergo PCI, the infusion