Dobutamine-Claris

Main information

  • Trade name:
  • Dobutamine-Claris dobutamine (as hydrochloride) 250 mg/ 20 mL concentrated solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Dobutamine-Claris dobutamine (as hydrochloride) 250 mg/ 20 mL concentrated solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212837
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212837

Dobutamine-Claris dobutamine (as hydrochloride) 250 mg/ 20 mL concentrated solution for injection

ampoule

ARTG entry for

Medicine Registered

Sponsor

AFT Pharmaceuticals Pty Ltd

Postal Address

PO Box 748,North Ryde,Sydney, NSW, 1670

Australia

ARTG Start Date

11/07/2014

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. Dobutamine-Claris dobutamine (as hydrochloride) 250 mg/ 20 mL concentrated solution for injection

ampoule

Product Type

Single Medicine Product

Effective date

14/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery.???

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

20 mL per ampoule, 5 ampoules per pack

(S4) Prescription Only Medicine

Components

1. Dobutamine-Claris dobutamine (as hydrochloride) 250 mg/ 20 mL concentrated solution for injection ampoule

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

Colourless to pale yellow solution

Active Ingredients

dobutamine hydrochloride

14.01 mg/mL

© 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 26.11.2017 at 11:57:36 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

Dobutamine-Claris

Dobutamine hydrochloride equivalent to dobutamine 250 mg/20 mL,

Concentrated Solution for Injection

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Dobutamine-Claris. It does not contain all the

available information and does not take the place of talking with your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given

Dobutamine-Claris 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 with the medicine. You may need to read it again.

What Dobutamine-Claris is used for

This medicine contains dobutamine (as dobutamine hydrochloride) as the active ingredient. It

belongs to a group of medicines called catecholamines, which are a synthetic version of a naturally

occurring chemical, adrenaline.

Dobutamine-Claris is used to treat patients who need short-term treatment of heart failure following

a heart attack or heart surgery. It works by strengthening the pumping action of the heart,

increasing the amount of blood flowing to the body and by expanding both veins and arteries, so the

heart can more easily propel the blood. It helps your heart work more effectively.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor’s prescription. There is no evidence that it is addictive.

There is not enough safety and efficacy information available to recommend the use of Dobutamine-

Claris in children.

Before you are given it

When you must not be given it

You must not be given Dobutamine-Claris if you have ever had an allergic reaction to:

any medicine containing dobutamine hydrochloride

any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty

breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the

skin.

You must not be given this medicine if you have a condition called idiopathic hypertrophic sub

aortic stenosis (i.e. a narrowing of the artery coming from your heart).

Before you are given it

Tell your doctor if you are allergic to any other medicines, or any foods, preservative or dyes.

Tell your doctor if you have or have had any of the following conditions:

hypokalaemia (i.e. low potassium levels)

high blood pressure

fast or irregular heart beat

other heart problems.

Tell your doctor if you are pregnant or intend to become pregnant or are breast-feeding. Your

doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start being given

Dobutamine-Claris.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get from your

pharmacy, supermarket or health food shop.

Some medicines may interfere with Dobutamine-Claris. These include:

some general anaesthetics, such as halothane

nitroprusside and nitroglycerin

other adrenergic agents (adrenaline-like agents).

These medicines may be affected by Dobutamine-Claris or may affect how well it works. You may

need different amounts of your medicines or you may need to take different medicines. Your doctor

or pharmacist have more information on medicines to be careful with or avoid while having this

medicine.

How it is given

Dobutamine-Claris is a sterile concentrated solution for injection which is diluted with suitable

sterile fluids prior to use. It is given as a slow injection into a vein, known as a continuous infusion or

a ‘drip’. Your doctor or nurse will prepare the infusion of Dobutamine-Claris for you.

How much to be given

Your doctor will decide the dose of Dobutamine-Claris you will be given and will adjust the flow rate

and duration accordingly.

If you are given too much (overdose)

As you will be given Dobutamine-Claris under the supervision of your doctor, it is unlikely that you

will receive too much.

However, if you experience any side effects after being given Dobutamine-Claris, immediately tell

your doctor or nurse or call the Poisons Information Centre (telephone 13 11 26 Australia, 0800 764

766 New Zealand) for advice. Do this even if there are no signs of discomfort or poisoning. You may

need urgent medical attention.

Symptoms of overdose may include loss of appetite, nausea, vomiting, tremor, anxiety, fast or

irregular heartbeats, headache, shortness of breath and chest pain.

While you are using it

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you are having

Dobutamine-Claris, especially if you are being started on any new medicines.

Tell your surgeon or anaesthetist if you are having Dobutamine-Claris if you are about to undergo

surgery or an operation. It may affect other medications used during surgery.

If you are about to have any blood tests tell your doctor that you are having Dobutamine-Claris. It

may interfere with the results of some tests.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are having

Dobutamine-Claris. This medicine helps most people with heart failure but it may have unwanted

side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You

may need medical attention 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 if you notice any of the following side effects and they worry you:

nausea

fever

headache.

These side effects are usually mild.

Tell your doctor or nurse as soon as possible if you notice any of the following:

pain where the needle went into your vein or pain along the vein following injection

fast or irregular heartbeat

non-specific chest pain

difficulty in breathing, wheezing or coughing

redness or itching of the skin

bleeding or bruising more easily than normal

feeling faint.

The above list includes serious side effects which may require medical attention. These side effects

are rare.

Do not be alarmed by this list of side effects. You may not experience any of them.

Other side effects not listed above may also occur in some people. Tell your doctor or pharmacist if

you notice anything that is making you feel unwell.

Storage

Dobutamine-Claris will be stored in the pharmacy or on the ward. The solution for injection should

be kept in a cool place, protected from light where the temperature stays below 25

Product description

What it looks like

Dobutamine-Claris is a clear, colourless or slightly yellow solution.

Ingredients

Active ingredient: dobutamine hydrochloride

Other ingredients: sodium metabisulphite, sodium hydroxide and/or hydrochloric acid for pH

adjustment, water for injections

Dobutamine-Claris

does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Australia

AFT Pharmaceuticals Pty. Ltd

113 Wicks Road

North Ryde

NSW 2113

New Zealand

AFT Pharmaceuticals Ltd

Auckland

Australian Registration Number:

AUST R 212837

Date of Preparation

15 October 2015

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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