TIROFIBAN

Main information

  • Trade name:
  • TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5mg/50mL Concentrated Injection for infusion Vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5mg/50mL Concentrated Injection for infusion Vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209216
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209216

TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5mg/50mL Concentrated Injection for infusion Vial

ARTG entry for

Medicine Registered

Sponsor

Juno Pharmaceuticals Pty Ltd

Postal Address

Level 2 6 Bond Street,South Yarra, VIC, 3141

Australia

ARTG Start Date

9/05/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5mg/50mL Concentrated Injection for infusion Vial

Product Type

Single Medicine Product

Effective date

20/08/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

3 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5mg/50mL Concentrated Injection for infusion Vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

A clear, colourless sterile solution. Practically free from visible particles

Active Ingredients

tirofiban hydrochloride

14.05 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 10:42:46 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

TIROFIBAN AC 20 January 2014

TIROFIBAN AC

tirofiban hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about TIROFIBAN AC.

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 AC 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 AC

is used for

TIROFIBAN AC, 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 AC belongs to a group

medicines

called

platelet

aggregation inhibitors.

It works by preventing cells in the

blood, called platelets, from sticking

together to form blood clots.

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 AC

When you must not be given

it

Do not use TIROFIBAN AC if

you have an allergy to

TIROFIBAN AC or any of the

ingredients listed at the end of

this leaflet

Do not use TIROFIBAN AC 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,

especially within the last month

*

a history, symptoms or signs of

aortic dissection, a disease of a

large blood vessel

* severe, uncontrolled high blood

pressure

* pericarditis, a condition which

involves swelling of the lining

that surrounds the heart.

If you are not sure whether you

should start receiving TIROFIBAN

AC, talk to your doctor.

Do not use TIROFIBAN AC if

you have received TIROFIBAN

AC before and developed a low

platelet count.

If you are not sure whether you have

received TIROFIBAN AC

before

developed a low platelet count,

ask your doctor.

Do not use TIROFIBAN AC if

you are already receiving an

injection of another 'platelet

aggregation inhibitor' medicine.

Do not use TIROFIBAN AC if

you are breast-feeding or intend

to breast-feed.

TIROFIBAN AC is not

recommended for use while breast-

feeding. It is not known whether it

passes into breast milk.

Do not use TIROFIBAN AC

in children.

The safety and effectiveness in

children have not been established.

Before you are given it

Tell your doctor if:

1. you are pregnant Like most

medicines, TIROFIBAN AC is

generally not recommended

during pregnancy.

However, if there is a need to

consider using TIROFIBAN AC

during pregnancy, your doctor

will discuss the possible risks and

benefits to you and your unborn

baby.

2. you have or have had any

medical conditions, especially

the following:

* any bleeding problems, including

stomach bleeding, or blood in

your urine or stools, within the

TIROFIBAN AC 20 January 2014

last year

* blood clotting problems or

platelet diseases, including low

platelet count

* disease of the blood vessels of

the brain, including stroke,

within the last year

* problems with the blood vessels

in the back of your eye/s

* kidney disease, or are undergoing

dialysis

3. you have received platelet

aggregation inhibitors before

4. you recently had an epidural

(spinal) procedure

5. you have any allergies to any

How TIROFIBAN AC

is given

TIROFIBAN AC is given as a

slow injection into a vein.

TIROFIBAN AC must only be

given by a doctor or nurse.

Your doctor will decide what dose

and how long you will receive

TIROFIBAN AC. This depends

your condition and other

factors, such as your weight and

kidney function.

Side Effects

difficulty in swallowing or

breathing

* chills, dizziness, or wheezing

If you have them, you may be having

an allergic reaction to

TIROFIBAN AC. You may

need urgent medical attention.

Tell your doctor or nurse if you

notice any of the following and

they worry you:

* fever

* nausea

* headache

These are usually mild side effects of

TIROFIBAN AC.

Other side effects not listed above

other medicines or any other

may also occur in some patients.

substances, such as foods,

preservatives or dyes.

If you have not told your doctor

about any of the above, tell them

before you are given

TIROFIBAN AC.

Taking other medicines

Tell your doctor, nurse, or

pharmacist as soon as possible if

you do not feel well while you are

being given TIROFIBAN AC.

TIROFIBAN AC helps most

people, but it may have unwanted

side-effects in a few people. All

medicines can have side effects.

Tell your doctor if you notice any

other effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Storage

Tell your doctor if you are taking

any other medicines, including

Sometimes they are serious, most of

the time they are not. You may need

TIROFIBAN AC will be stored in the

medicines that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines and TIROFIBAN

AC may interfere with each other.

This includes:

medicines used to dissolve or

prevent blood clots, including

warfarin

These medicines may be affected by

TIROFIBAN AC, or may affect how

well it works. You may need

different amounts of your medicine,

or you may need to take different

medicines.

Your doctor or pharmacist has more

information on medicines to be

careful with or to avoid while being

given TIROFIBAN AC.

medical treatment if you get some of

the side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or nurse

immediately if you notice any

unusual bleeding or bruising.

This includes bleeding gums, nose

bleeds, blood in your urine, bloody

or black, tarry stools, coughing up

blood, vomiting blood or material

that looks like coffee grounds.

These may be serious side effects of

TIROFIBAN AC. You may need

urgent medical attention.

Also, tell your doctor or nurse

immediately if you notice any of

the following:

* rash

* pinkish, itchy swellings on the

skin, also called hives or

nettlerash

* swelling of the face, lips, mouth

or throat which may cause

pharmacy or on the ward.

It is kept in a cool, dry place where it

is protected from light and where the

temperature stays below 25°C.

Product Description

What it looks like

TIROFIBAN AC comes in a glass

vial, containing 50 mL of solution.

Ingredients

Active ingredient:

* 0.25 mg of tirofiban per mL

Inactive ingredients:

* sodium phosphate - dibasic

dehydrate

* mannitol

* water for injections.

* The pH may have been adjusted with

hydrochloric acid and/or sodium

hydroxide.

TIROFIBAN AC 20 January 2014

Supplier

TIROFIBAN AC is supplied in

Australia by:

Actavis Pty Ltd

Level 5, 117 Harrington Street

The Rocks NSW 2000

Phone 1800 554 414

This leaflet was prepared in January 2014.

Australian Register Number:

AUST R 209216

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11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety