Tirofiban 50 micrograms/ml solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TIROFIBAN

Available from:

Ibigen S.r.L Via Fossignano, 2, 04011 Aprilia (LT), Italy

ATC code:

B01AC17

INN (International Name):

TIROFIBAN 50 µg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

TIROFIBAN 50 µg/ml

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2016-04-14

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TIROFIBAN 50 MICROGRAMS/ML SOLUTION FOR INFUSION
TIROFIBAN
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 nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Tirofiban is and what it is used for
2. What you need to know before you use Tirofiban
3. How to use Tirofiban
4. Possible side effects
5. How to store Tirofiban
6. Contents of the pack and other information
1. WHAT TIROFIBAN IS AND WHAT IT IS USED FOR
Tirofiban is used to help assist the blood flow to your heart and to
help prevent chest pain and heart
attacks. It works by preventing platelets, cells found in the blood,
from forming blood clots.
This medicine may also be used in patients whose heart vessels are
dilated with a balloon
(percutaneous coronary intervention or PCI). This is a procedure,
possibly with implantation of a
small tube (stent), to improve the blood flow to the heart.
Tirofiban is intended for use with aspirin and unfractionated heparin.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TIROFIBAN
DO NOT USE TIROFIBAN
•
If you are allergic to tirofiban or any of the other ingredients of
this medicine (listed in section
6)
•
If you are bleeding internally or have a history of bleeding
internally within the last 30 days
•
If you have a history of bleeding in the brain, brain tumor or
abnormal blood vessels in the
brain
•
If you have severe uncontrolled high blood pressure (malignant
hypertension)
•
If you have a low blood platelet count (thrombocytopenia) or problems
with blood clotting
•
If you developed thro

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tirofiban 50 micrograms/ml solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for infusion contains 50 micrograms of tirofiban.
One bag of 250 ml contains 12.5 mg of tirofiban.
Excipient with known effect
Each 250 ml bag contains approximately 39.8 mmol (916.28 mg) sodium.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for Infusion.
A clear, colourless solution, pH 5.5-6.5 and Osmolarity 270-330
mOsmol/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tirofiban is indicated for the prevention of early myocardial
infarction in adult patients
presenting with acute coronary syndromes without ST elevation
(NSTE-ACS) with the last
episode of chest pain occurring within 12 hours and with ECG changes
and/or elevated
cardiac enzymes.
Patients most likely to benefit from Tirofiban treatment are those at
high risk of developing
myocardial infarction within the first 3-4 days after onset of acute
angina symptoms
including for instance those that are likely to undergo an early
percutaneous coronary
intervention (PCI). Tirofiban is also indicated for the reduction of
major cardiovascular
events in patients with acute myocardial infarction (STEMI) intended
for primary PCI (see
sections 4.2 and 5.1).
Tirofiban is intended for use with acetylsalicylic acid (ASA) and
unfractionated heparin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This product is for hospital use only, by specialist physicians
experienced in the
management of acute coronary syndromes.
Tirofiban should be administered with unfractionated heparin and oral
antiplatelet therapy,
including ASA.
Posology
In patients who are managed with an early invasive strategy for
NSTE-ACS but not planned
to undergo angiography for at least 4 hours and up to 48 hours after
diagnosis, tirofiban is
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given intravenously at an initial infusion rate of 0.4
microgram/kg/min for 30 minutes. At
the end of the initial infusion, tirof