TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5mg/50mL Concentrated Injection for infusion Vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
06-10-2020
Summary of Product characteristics
(SPC)
06-10-2020
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
tirofiban hydrochloride, Quantity: 14.05 mg (Equivalent: tirofiban, Qty 12.5 mg)
Available from:
Juno Pharmaceuticals Pty Ltd
INN (International Name):
tirofiban hydrochloride
Pharmaceutical form:
Injection, concentrated
Composition:
Excipient Ingredients: mannitol; sodium hydroxide; hydrochloric acid; dibasic sodium phosphate dihydrate; water for injections
Administration route:
Intravenous
Units in package:
1 vial
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
TIROFIBAN JUNO, in combination with heparin, is indicated for patients with unstable angina or non-Q-wave myocardial infarction to prevent cardiac ischaemic events. (See PHARMACOLOGY and DOSAGE AND ADMINISTRATION.)
Product summary:
Visual Identification: A clear, colourless sterile solution. Practically free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-05-09
Patient Information leaflet
_Tirofiban Juno concentrate for injection CMI _
_ _
_Juno Pharmaceuticals Pty Ltd _
TIROFIBAN JUNO
_tirofiban hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TIROFIBAN JUNO.
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 TIROFIBAN JUNO 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 TIROFIBAN JUNO
IS USED FOR
TIROFIBAN JUNO, 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.
TIROFIBAN JUNO 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
TIROFIBAN JUNO
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT USE TIROFIBAN JUNO IF
YOU HAVE AN ALLERGY TO TIROFIBAN
JUNO OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
DO NOT USE TIROFIBAN JUNO IF
YOU HAVE ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
∗
BLEEDING INSIDE YOUR BODY, OR A
HISTORY OF INCREASED TENDENCY
TO BLEEDING, ESPECIALLY WITHIN
THE LAST 30 DAYS
∗
A HISTORY OF BLEEDING IN THE
BRAIN OR BRAIN TUMOUR
∗
A HISTORY OF ABNORMAL OR
DEFORMED ARTERIES OR VEINS
∗
A HISTORY OF SWELLING AND
WEAKENING OF A PART OF A BLOOD
VESSEL, ALSO CALLED ANEURSYM
∗
A HISTORY OF STROKE, ESPECIALLY
WITHIN THE LAST 30 DAYS, OR ANY
HISTORY OF STROKE DUE TO
BLEEDING IN THE BRAIN
∗
MAJOR SURGERY OR PHYSICAL
TRAUMA, INCLUDING FALLS OR
BLOWS TO THE BODY OR HEAD,
ESPECIALL
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Summary of Product characteristics
Juno Pharmaceuticals Pty Ltd
Australian Product Information
Tirofiban
Page | 1
_ _
_ _
AUSTRALIAN PRODUCT INFORMATION
TIROFIBAN JUNO 12.5 MG / 50 ML_ (TIROFIBAN (AS HYDROCHLORIDE)) _
_ _
1 NAME OF THE MEDICINE
Tirofiban hydrochloride.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TIROFIBAN JUNO Concentrate for Infusion is a sterile concentrated
solution for intravenous
infusion after dilution and is supplied in a 50 mL glass vial. Each 50
mL vial contains 14.05
mg of tirofiban hydrochloride monohydrate equivalent to 12.5 mg of
tirofiban and the following
inactive ingredients: 78.0 mg dibasic sodium phosphate dihydrate, 2.25
g mannitol and water
for injections The pH ranges from 5.5 to 6.5 and may have been
adjusted with hydrochloric
acid and/or sodium hydroxide.
3. PHARMACEUTICAL FORM
TIROFIBAN JUNO Concentrate for Infusion is a clear, colourless sterile
solution, practically
free from visible particles, in glass vials.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TIROFIBAN JUNO, in combination with heparin, is indicated for patients
with unstable angina
or non-Q-wave myocardial infarction to prevent cardiac ischaemic
events. (See SECTION 5.1
Pharmacodynamic Properties and SECTION 4.2 Dose and Method of
Administration.)
4.2 DOSE AND METHOD OF ADMINISTRATION
THE VIAL OF TIROFIBAN JUNO (CONCENTRATE) MUST BE DILUTED PRIOR TO
ADMINISTRATION (SEE
INSTRUCTIONS FOR USE)
_TIROFIBAN JUNO is for intravenous use only using sterile equipment.
_TIROFIBAN JUNO
may be co-administered with heparin through the same line. TIROFIBAN
JUNO should not
be administered in the same intravenous line as diazepam.
TIROFIBAN JUNO 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.
TIROFIBAN JUNO should be administered intravenously at the initial
infusion rate of
0.4µg/kg/min for 30 minutes. Upon completi
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