BAXTER

Main information

  • Trade name:
  • BAXTER 0.22% POTASSIUM CHLORIDE and HARTMANN'S SOLUTION injection AHB2954
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BAXTER 0.22% POTASSIUM CHLORIDE and HARTMANN'S SOLUTION injection AHB2954
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 19468
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

19468

BAXTER 0.22% POTASSIUM CHLORIDE and HARTMANN'S SOLUTION 1000mL injection bag AHB2954

ARTG entry for

Medicine Registered

Sponsor

Baxter Healthcare Pty Ltd

Postal Address

PO Box 88,TOONGABBIE, NSW, 2146

Australia

ARTG Start Date

30/09/1991

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

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 February 1992.

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 February 1992.

Products

1. BAXTER 0.22% POTASSIUM CHLORIDE and HARTMANN'S SOLUTION injection AHB2954

Product Type

Single Medicine Product

Effective date

13/01/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. Indications held in ARTG paper records. (Old

code)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Not recorded

24 Months

Store below 30

degrees Celsius

Not recorded

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1000mL x 12

Not scheduled. Not considered by committee

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Clear colourless solution

Active Ingredients

calcium chloride dihydrate

270 mg/L

potassium chloride

2.2 g/L

sodium chloride

6 g/L

sodium lactate

3.22 g/L

© 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 01.12.2017 at 09:58:51 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

CMI Mar14

BAXTER

Page 1 of 2

COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION

(HARTMANN’S SOLUTION)

Consumer Medicine Information

What is in this leaflet?

This leaflet answers some

common questions about

Compound Sodium Lactate

Intravenous Infusion

(Hartmann’s Solution). It does

not contain all of the available

information. All medicines have

risks and benefits. Your doctor

has weighed the risks of you

using Hartmann's Solution IV

Infusion against the benefit

they expect it will have for you.

It does not take the place of

talking to your doctor, nurse or

pharmacist.

If you have any concerns about

taking this medicine, ask your

doctor, nurse or pharmacist.

What Hartmann’s Solution

is used for

This medicine is used to

replace and balance body fluid

and mineral salts that may be

lost for a variety of medical

reasons.

Before you are given

Hartmann’s Solution

Hartmann’s Solution should

not be given to you if:

you have an allergy to any

ingredient listed at the end

of this leaflet;

you have congestive heart

failure (constant wheezing,

shortness of breath);

you have severely reduced

kidney function;

you have too much sodium

and chloride in your blood

that is not being corrected

with medication;

it is intended to be

administered at the same

time and through the same

injection equipment as blood

preparations (citrate

anticoagulated/preserved

blood) or ceftriaxone, an

antibiotic (if a baby < 1

month of age is to be

treated, administration at the

same time as ceftriaxone

must never occur)

the expiry date printed on

the pack on the bottom of

the bag has passed, or if the

packaging is torn or shows

any signs of tampering.

You must tell your doctor if

you:

have heart problems;

have kidney problems

including kidney stones;

you have too much

potassium or calcium in your

blood that is not being

corrected with medication

have diabetes;

are taking any other

medicines including those

you can buy without a

prescription, in particular

digoxin (a medicine for heart

problems), medicines for

high blood pressure

(diuretics, ACE inhibitors or

ARAs), immunosuppressant

medicines (tacrolimus or

cyclosporine), potassium

supplements,

corticosteroids, lithium or

vitamin D;

are pregnant

are breast-feeding

How Hartmann’s Solution

is given

How much is given:

Your doctor will decide how

much Hartmann’s Solution will

be given to you, which depends

on your need and condition.

The medicine is given by a slow

rate (drip) injection, therefore it

should be given by using

special equipment and

attended by a health

professional (doctor, trained

nurse).

How it is given:

Hartmann’s Solution will be

given at a slow rate of injection

(drip) by a health professional.

Usually, you will need to stay in

a health institution (hospital,

clinic, nursing home, etc.) but in

some cases at home, as it

requires a special medical

equipment to deliver the

medicine into your circulation.

This delivery should be

attended by a health

professional. A cannula

(administration needle) is

placed in a vein by your doctor

or nurse.

The infusion is for single use,

and for one person only. Any

unused portion must be

CMI Mar14

BAXTER

Page 2 of 2

discarded and not used later,

either for you or anyone else.

Case of overdose

The doctor or nurse giving you

the Hartmann’s Solution has

had experience in the use of

this sort of medicine, so it is

unlikely that you will be given

an overdose. However, in case

of an overdose, the infusion will

be discontinued and another

treatment may be needed. You

may experience some of the

effects listed under “Side

Effects” below.

While you are receiving

Hartmann’s Solution

Discuss with your doctor the

progress you have experienced

after the treatment, and

whether any complication has

occurred, especially during the

first few days of therapy.

Frequent clinical evaluation and

laboratory tests may be

required. As Hartmann’s

Solution is normally given in a

hospital, your nurse will take

records of your progress and

any unexpected reactions.

Side effects

As with any medicines, some

side effects may occur. Your

body may also retain sodium

and this may result in a build-up

of fluid and swelling of the

hands, ankles and feet.

Additionally, as with other

preparations similar to

Hartmann’s Solution, pain,

irritation, inflammation, swelling

or abnormal clotting at the site

of injection is also possible.

Always tell your doctor or nurse

if you have any unexpected

effects during or after receiving

Hartmann’s Solution and they

worry you.

In rare circumstances, more

serious side effects may occur

such as chest pain, fast or slow

heartbeat, or fluid on the lungs

or swelling of the face, lips or

mouth causing breathing

difficulties. If these occur, tell

your health professional on

duty immediately. These may

be symptoms of a serious

allergic reaction. Your health

professional will take

appropriate action promptly,

such as stopping the infusion.

Product descriptions

What Hartmann’s Solution

looks like

It is a clear, colourless solution

filled in plastic bags.

What is in Hartmann’s

Solution

The active components are:

sodium lactate, potassium

chloride, sodium chloride and

calcium chloride, formulated

and dissolved in water for

injection.

How to store Hartmann’s

Solution

Hartmann’s Solution will be

stored in the pharmacy or the

hospital ward. It is

recommended that the product

be stored below 30°C.

Where can you get more

information?

You can get more information

from your doctor or pharmacist.

Name and address of the

sponsor

Baxter Healthcare Pty Ltd

1 Baxter Drive

Old Toongabbie NSW 2146

Australia

Date of preparation: March

2014

Australian registration

numbers

AUST R 19468

Potassium Chloride (0.22%),

Sodium

Chloride

(0.6%),

Sodium lactate (0.322 %) &

Calcium

chloride

(0.027%)

[Modified

Hartmann]

AHB2954

AUST R 19425

Potassium Chloride (0. 04%),

Sodium

Chloride

(0.6%),

Sodium

lactate

(0.322%)

&

Calcium

Chloride

(0.027%)

[Hartmann] - AHB2323

AUST R 48510

Potassium Chloride (0.04%),

Sodium

Chloride

(0.6%),

Sodium

lactate

(0.322%)

&

Calcium

Chloride

(0.027%)

[Hartmann] - AHB2324

Baxter and Viaflex are

registered trademarks of

Baxter International, Inc.

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Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names (Active substance: Diclofenac sodium) - Community Referrals - Art 29 - Commission Decision (2019)589 of Mon, 21 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1467

Europe -DG Health and Food Safety

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

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

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2104 (Novartis Europharm Limited)

EU/3/18/2104 (Novartis Europharm Limited)

EU/3/18/2104 (Active substance: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1))) - Orphan designation - Commission Decision (2018)9019 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/157/18

Europe -DG Health and Food Safety

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

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

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

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

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

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

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

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): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

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

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety