Aggrastat
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
11-09-2012
Summary of Product characteristics
(SPC)
11-09-2012
Active ingredient:
Tirofiban hydrochloride monohydrate 0.281 mg/mL equivalent to 0.25 mg/mL tirofiban;
Available from:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
INN (International Name):
Tirofiban hydrochloride monohydrate 0.281 mg/mL (equivalent to 0.25 mg/mL tirofiban)
Dosage:
0.25 mg/mL
Pharmaceutical form:
Concentrate for infusion
Composition:
Active: Tirofiban hydrochloride monohydrate 0.281 mg/mL equivalent to 0.25 mg/mL tirofiban Excipient: Citric acid Hydrochloric acid Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water for injection
Units in package:
Vial, glass, 50 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Cadila Healthcare Ltd
Product summary:
Package - Contents - Shelf Life: Vial, glass, - 50 mL - 36 months from date of manufacture stored at or below 30°C
Authorization date:
1997-11-18
Patient Information leaflet
CONSUMER MEDICINE INFORMATION
AGGRASTAT
®
I N F
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_SINGLE DOSE VIAL _
_TIROFIBAN HYDROCHLORIDE _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about AGGRASTAT. It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All
medicines have risks and benefits. Your doctor has weighed the risks of you using AGGRASTAT against
the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
WHAT AGGRASTAT IS USED FOR
AGGRASTAT, in combination
with heparin (another medicine used to prevent blood clots), is used to
prevent
complications that may occur in people who have unstable
angina (a type of chest pain) or are having a heart
attack.
AGGRASTAT belongs to a group of medicines called platelet aggregation inhibitors.
It works by preventing cells in
the blood, called platelets, from sticking together to form blood clots. If blood
clots are not treated or prevented, they can block blood vessels. This can
lead to complications such as
angina or heart attacks.
BEFORE YOU ARE GIVEN AGGRASTAT
_WHEN YOU MUST NOT BE GIVEN IT _
Do not use AGGRASTAT if you have an
allergy to AGGRASTAT or any of the ingredients listed at the end of
this leaflet.
DO NOT USE AGGRASTAT IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS:
l
bleeding inside your body
l
a
Read the complete document
Summary of Product characteristics
NAME OF MEDICINE
AGGRASTAT
_tirofiban hydrochloride _
®
50mL Vial
PRESENTATION
Concentrate: (0.25 mg/mL) 50mL
glass vial containing 12.5mg of tirofiban (as 14.05mg
tirofiban hydrochloride monohydrate) in 50mL of iso-osmotic citrate
buffer solution.
THERAPEUTIC CLASS
AGGRASTAT (tirofiban hydrochloride, MSD), a non-peptide
antagonist of the platelet GP
IIb/IIIa receptor, is a platelet aggregation inhibitor.
INDICATIONS
AGGRASTAT, in combination with heparin, is indicated
for patients with unstable angina
or non-Q-wave myocardial infarction to
prevent cardiac ischaemic events.
DOSAGE AND ADMINISTRATION
THE VIAL OF AGGRASTAT (CONCENTRATE) MUST BE DILUTED PRIOR TO
ADMINISTRATION (SEE
INSTRUCTIONS FOR USE).
_AGGRASTAT is for intravenous use only using sterile
equipment. _AGGRASTAT may be
co-administered with heparin through the same line.
AGGRASTAT is recommended for use with a calibrated infusion
device. Care should be
taken to avoid a prolonged loading infusion. Care should also be
taken in calculating the
bolus dose and infusion rates based on patient weight.
In clinical studies patients received
aspirin, unless contraindicated.
UNSTABLE ANGINA PECTORIS OR NON-Q-WAVE MYOCARDIAL INFARCTION:
AGGRASTAT should be administered intravenously, in combination with
heparin, at the
initial infusion rate of 0.4mcg/kg/min for 30 minutes. Upon
completion of the initial
infusion, AGGRASTAT should be continued at a maintenance infusion
rate of 0.1
mcg/kg/min.
The table below is provided as a guide to dosage
adjustment by weight.
Most Patients
Severe Renal Insufficiency
Patient
Weight
(kg)
30 Min
Loading
Infusion
Rate
(mL/hr)
Maintenance
Infusion
Rate
(mL/hr)
30 Min
Loading
Infusion Rate
(mL/hr)
Maintenance
Infusion
Rate
(mL/hr)
30-37
16
4
8
2
38-45
20
5
10
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