Hartmann's Solution for Infusion, PE bottle

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate solution 50%
Available from:
Fresenius Kabi Deutschland GmbH
ATC code:
B05BB; B05BB01
INN (International Name):
Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate solution 50%
Pharmaceutical form:
Solution for infusion
Therapeutic area:
Solutions affecting the electrolyte balance; electrolytes
Authorization status:
Not marketed
Authorization number:
PA2059/057/005
Authorization date:
2009-07-24

U15720/A IE

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hartmann's Solution

For Infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor or nurse.

- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

What HARTMANN’S SOLUTION is and what it is used for?

What you need to know before you receive Hartmann's solution

How you are given HARTMANN’S SOLUTION?

Possible side effects

How to store HARTMANN’S SOLUTION?

6. Contents of the pack and other information

1. WHAT HARTMANN’S SOLUTION IS AND WHAT IT IS USED FOR ?

HARTMANN’S SOLUTION is a sterile, colourless solution for infusion.

It is used for the treatment of extracellular dehydration (water loss), hypovolaemia (sudden drop in volume of circulating blood) and metabolic acidosis

(increased acid in the body).

2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE HARTMANN'S SOLUTION

You should not receive HARTMANN’S SOLUTION if you have:

hyperhydration (too much fluid)

decompensated congestive cardiac failure (your heart can't pump enough blood throughout the body)

hyperkalemia (too much potassium in your blood),

hypercalcemia (too much calcium in your blood),

metabolic alkalosis (too much alkalis such as bicarbonate in the blood),

in combination with digitalis (medicine used as cardiac stimulant) (see "Using other medicines" section).

Your doctor will check these.

Special care will be taken if you:

- suffer from swelling with sodium retention.

- suffer from acute illness, pain, post-operative stress, infections, burns, or diseases of the central nervous system

- have any type of heart, liver or kidney disease

- have been treated with a medicine increasing the effect of vasopressin (a hormone regulating the body's water retention) because this may increase the risk

of hospital-acquired low sodium levels in the blood (hyponatraemia)

Especially in these situations, your doctor or nurse will take samples of blood and urine.

Your doctor or nurse will make sure that the solution is given to you properly.

Warnings and precautions

All patients should be closely monitored. In cases where normal regulation of the water content of the blood is disturbed due to increased secretion of

vasopressin, also known as Antidiuretic Hormone (ADH), the infusion of fluids with a low concentration of sodium chloride (hypotonic fluids) may result in a low

level of sodium in the blood (hyponatraemia). This can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain (cerebral oedema) and death;

therefore these symptoms (acute symptomatic hyponatraemic encephalopathy) are considered a medical emergency.

Children, women in the fertile age and patients with brain diseases such as meningitis, brain bleeding, brain contusion and brain oedema are at particular risk of

the severe and life-threatening brain swelling caused by acute hyponatraemia.

Children and adolescents

Children are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

Other medicines and Hartmann's Solution

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines such as:

digitalis (medicine used as cardiac stimulant)

diuretics given alone or in combination (such as spironolactone, triamterene, amiloride) - medicines that increase water loss in the urine

ACE inhibitors and angiotensin II receptor antagonists– medicines that are mainly used for controlling blood pressure, treating heart failure

tacrolimus and cyclosporine- medicine used to prevent organ rejection

Medicines leading to an increased vasopressin effect (see also section “Warnings and precautions” above), e.g.:

Medicines potentiating vasopressin action (e.g. non-steroidal anti-inflammatory drugs)

Medicines acting as vasopressin, so-called vasopressin analogues

Other medicinal products increasing the risk of hyponatraemia including diuretics in general and antiepileptics.

Pregnancy and breast-feeding

HARTMANN’S SOLUTION can be used during pregnancy or breast-feeding. However, you should tell your doctor if you are pregnant, if you think you are

pregnant or if you are breast-feeding.

This medicine should be given with special caution for pregnant women during labour particularly if combined with oxytocin (a hormone which may be given to

induce labour and to control bleeding) due to the risk of hyponatraemia.

3. HOW YOU ARE GIVEN HARTMANN’S SOLUTION ?

You will receive your medicine by slow intravenous infusion ('IV drip'). The rate at which the infusion is given and the volume infused will depend on your own

specific requirements. Your doctor will decide on the correct dose for you to receive.

If you are given more HARTMANN’S SOLUTION than you should:

It is very unlikely that you will receive more infusion than you should as your doctor or nurse will monitor you during the treatment. However, if you think that you

have received too much solution, inform your doctor or nurse immediately.

Signs of overdose include: fluid overload with tightened skin, venous stasis and swelling. Extra renal dialysis may be necessary.

If overdose does occur, your infusion will be stopped and appropriate treatment will be given.

The following information is intended for medical or healthcare professionals only:

Posology

General advice

Fluid balance, serum electrolytes and acid-base balance may need to be monitored before and during administration, with particular attention to serum sodium

in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated

with vasopressin agonist drugs, due to the risk of hospital acquired hyponatraemia. Monitoring of serum sodium is particularly important for physiologically

hypotonic fluids.

For paediatric patients the dose and rate of administration should be determined by the consulting physician experienced in paediatric intravenous fluid therapy.

Warnings

This solution must not be given by intramuscular injection.

Keep to a slow infusion rate.

The infusion must be stopped if any abnormal sign develops.

Risk of complications related to volume and amount of electrolytes administered.

Risk of overload of cardiovascular system with pulmonary oedema, especially in predisposed individuals. Infusion of Hartmann's solution may cause metabolic

alkalosis because of the presence of lactate ions. Hartmann's solution may not produce its alkalinizing action in patients with hepatocellular insufficiency since

lactate metabolism may be impaired.

In case of concomitant blood transfusion and because of the presence of calcium, Hartmann's solution must not be administered via the same infusion system

because of the risk of coagulation.

Precautions for use

The patients clinical status and laboratory parameters (blood and using electrolytes) must be monitored during use of this solution, especially in the following

situations:

congestive cardiac failure,

severely impaired renal function,

oedema with sodium retention.

Precautions for using bag:

do not use an air entry;

flush the infusion system in order to avoid any passage of air,

do not connect in series since the residual of the first container might be carried on by the solution coming from the second container, with the risk of air

embolism.

for single use only; do not reconnect partially used container.

Physico-chemical incompatibilities:

It is up to the physician to determine the incompatibility of an added medicine regarding Hartmann's solution, by checking for any possible colour change and/or

possible formation of precipitate, insoluble complex or crystals.

There is physical-chemical incompatibility with certain antibiotics when they are given intravenously : chlortetracycline, amphotericin B, oxytetracycline.

Before adding any medicine, check that the pH zone in which it is effective corresponds to that of Hartmann's solution.

Also check the package leaflet of the medicine to be added.

Check the colour and clarity of the solution, as well as that the container is not damaged before use. Discard any damaged or partially used container.

Once a medicine is added to Hartmann's solution, the mixture must be administered immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, HARTMANN’S SOLUTION can cause side effects, although not everybody gets them.

The following side effects have been reported if the solution is given too quickly:

Swelling

Water or sodium overload

Headache, nausea, seizures, lethargy. This can be caused by a low level of sodium in the blood. When sodium levels in the blood become very low, water

enters the brain cells and causes them to swell. This results in increased pressure in the skull and causes hyponatraemic encephalopathy

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel@353 1 6764971; Fax +353 1 6762517; Website:www.hpra.ie; Email:medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE HARTMANN’S SOLUTION ?

Keep out of sight and reach of children.

Do not use HARTMANN'S SOLUTION after the expiry date which is stated on the bottle.

Glass bottles and bags: Do not store above 25

PE bottles: No special precautions for storage.

Your doctor or nurse will ensure the solution is clear and free from particles before use.

Any solution remaining after treatment should be discarded.

After opening or mixture with other drugs, the product should be used immediately.

6. FURTHER INFORMATION

What HARTMANN’S SOLUTION contains?

The active substances are:

Molar formula

Osmolarity : 279 mOsm/l

Osmolality : 255 mOsm/kg

pH: 5.5 to 6.3

The other ingredients are : hydrochloric acid, sodium hydroxide, water for injections.

What HARTMANN’S SOLUTION looks like and contents of the pack?

Hartmann's solution is a clear and colourless solution for infusion.

1 and 40 x 50 ml, 1 and 40 x 100 ml, 1 and 20 x 250 ml, 1 and 15 x 500 ml or 1, 8 and 10 x 1000 ml in polyester-polyethylene copolymer - polypropylene /

styrene, ethylene, butadiene bag with overwrap.

1 and 40 x 250 ml, 1 and 20 x 500 ml or 1 and 10 x 1000 ml in polyester-polyethylene copolymer-polypropylene/styrene, ethylene, butadiene bag without

overwrap.

1, 10, 20, 30 x 250 ml, 1, 10, 20 x 500 ml or 1, 10 x 1000 ml polyethylene bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Deutschland GmbH

Else-Kroener Strasse 1, Bad Homburg

v.d.H 61352, Germany

Manufacturer :

FRESENIUS KABI POLSKA Sp. z o.o.

25 ul. Sienkiewicza,

P-99-300 Kutno

This medicinal product is authorised in the Member States of the EEA under the following names:

Ireland: Hartmann's solution for infusion

Portugal: Lactato de Ringer Fresenius

Luxembourg: Ringer-lactat Lösung

This leaflet was last approved in 08/2019

V002-IE/KT

Bag or bottle:

Sodium chloride (g)

Potassium chloride (g)

Dihydrated calcium chloride (g)

50% sodium lactate solution (g)

50 ml

0.30

0.02

0.01

0.32

100 ml

0.60

0.04

0.03

0.63

250 ml

1.50

0.10

0.07

1.59

500 ml

3.00

0.20

0.14

3.17

1000 ml

6.00

0.40

0.27

6.34

Bag or bottle:

50 ml

100 ml

250 ml

500 ml

1000 ml

Sodium (mmol)

Potassium (mmol)

Calcium (mmol)

Chloride (mmol)

Lactate (mmol)

6.55

0.27

0.09

5.59

1.42

13.09

0.54

0.18

11.17

2.83

32.73

1.35

0.46

27.93

7.08

65.45

2.70

0.92

55.85

14.15

130.90

5.40

1.84

111.70

28.30

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Hartmann's Solution for Infusion, PE bottle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Bag :

50 ml

100 ml

250 ml

500 ml

1000 ml

Sodium chloride (g)

0.30

0.60

1.50

3.00

6.00

Potassium chloride (g)

0.020

0.040

0.10

0.20

0.40

Dihydrated calcium chloride (g)

0.01

0.03

0.07

0.14

0.27

50% sodium lactate solution (g)

0.32

0.63

1.59

3.17

6.34

For full list of excipients, see section 6.1.

Molar formula

Bag :

50 ml

100 ml

250 ml

500 ml

1000 ml

Sodium (mmol)

6.55

13.09

32.73

65.45

130.90

Potassium (mmol)

0.27

0.54

1.35

2.70

5.40

Calcium (mmol)

0.09

0.18

0.46

0.92

1.84

Chloride (mmol)

5.59

11.17

27.93

55.85

111.70

Lactate (mmol)

1.42

2.83

7.08

14.15

28.30

3 PHARMACEUTICAL FORM

Solution for infusion.

Osmolarity: 279 mOsm/l

Osmolarity: 255 mOsm/kg

pH: 5.5 to 6.3

Clear and colourless solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

- Predominantly extracellular dehydration, regardless of cause (vomiting, diarrhea, fistulas, etc.).

- Hypovolemia regardless of cause: hemorrhagic shock, burns, peri-operative water and electrolyte loss.

- Mild metabolic acidosis.

4.2 Posology and method of administration

Posology:

This is determined by the physician according to clinical status, age and weight of the patient and according to laboratory

findings.

Method of administration:

This solution must be given by slow intravenous infusion under strictly aseptic conditions.

Fluid balance, serum electrolytes and acid-base balance may need to be monitored before and during administration, with

particular attention to serum sodium in patients with increased non-osmotic vasopressin release (syndrome of inappropriate

antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs, due to the risk of hospital

acquired hyponatraemia (see sections 4.4, 4.5 and 4.8).

Monitoring of serum sodium is particularly important for products with lower sodium concentration compared to serum

sodium concentration.

Paediatric patients:

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The infusion rate and volume depend on the age, weight, clinical condition (e.g. burns, surgery, head-injury, infections), and

concomitant therapy and should be determinded by the consulting physician experienced in paediatric intravenous fluid

therapy (see section 4.4 and 4.8)

4.3 Contraindications

This medicine is contraindicated in the following situations :

- Hypervolaemia (predominantly extracellular hyperhydration),

- decompensated congestive cardiac failure,

- hyperkalemia,

- hypercalcemia,

- metabolic alkalosis,

as well as in combination with digitalis (see "Interaction with other medicinal products and other forms of interaction" section).

4.4 Special warnings and precautions for use

Warnings

This solution must not be given by intramuscular injection.

Keep to a slow infusion rate.

The infusion must be stopped if any abnormal sign develops.

Risk of complications related to volume and amount of electrolytes administered.

Risk of overload of cardiovascular system with pulmonary edema, especially in predisposed individuals.

High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure, and in patients

with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatraemia (see below).

Hyponatraemia:

Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress, infections, burns, and CNS

diseases), patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists (see section 4.5) are at

particular risk of acute hyponatraemia upon infusion of hypotonic fluids.

Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterized by headache, nausea,

seizures, lethargy and vomiting. Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening

brain injury.

Children, women in fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, cerebral

contusion and brain oedema) are at particular risk of the severe and life-threatening complications, because these patients are

particularly vulnerable to the effects of brain swelling caused by acute hyponatraemia.

Infusion of Hartmann's solution may cause metabolic alkalosis because of the presence of lactate ions.

Hartmann's may not produce its alkalinizing action in patients with hepatocellular insufficiency since lactate metabolism may

be impaired.

Check the color and clarity of the solution, as well as that the container is not damaged before use. Discard any damaged or

partially used container.

In case of concomitant blood transfusion and because of the presence of calcium, Hartmann's solution must not be

administered via the same infusion system because of the risk of coagulation.

Precautions for use

The patient's clinical status and laboratory parameters (blood and urine electrolytes) must be monitored during use of this

solution, especially in the following situations:

- congestive cardiac failure,

- severely impaired renal function,

- edema with sodium retention.

Since this solution contains potassium, combination with hyperkalaemic diuretics is not recommended, plasma potassium must

be particularly closely monitored in patients at risk of hyperkalemia, e.g. in the presence of severe chronic renal failure.

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It is inadvisable to use this medicine in combination with angiotensin converting enzyme inhibitors, angiotensin II receptor

antagonists, or with tacrolimus (see "Interaction with other medicinal products and other forms of interaction" section).

Precautions for using bag:

- use immediately once opened;

- do not use an air entry;

- do not connect in series since the residual of the first container might be carried on by the solution coming from the second

container, with the risk of air embolism.

4.5 Interaction with other medicinal products and other forms of interactions

Drugs leading to an increased vasopressin effect

The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and increase

the risk of hospital acquired hyponatraemia following inappropriately balanced treatment with i.v. fluids (see sections 4.2, 4.4

and 4.8).

Drugs stimulating vasopressin release, e.g.: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective

serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics

Drugs potentiating vasopressin action, e.g.: Chlorpropamide, NSAIDs, cyclophosphamide

Vasopressin analogues, e.g.: Desmopressin, oxytocin, vasopressin, terlipressin

Other medicinal products increasing the risk of hyponatraemia also include diuretics in general and antiepileptics such as

oxcarbazepine.

Interactions related to the presence of calcium

Contraindicated combination:

+ digitalis preparations : serious or even fatal cardiac arrhythmias, especially in the presence of hypokalemia.

- Combination needing to be taken into account:

+ thiazide diuretics: risk of hypercalcemia via decreased urinary calcium excretion.

Interactions related to the presence of potassium

- Inadvisable combinations:

+ hyperkalemic diuretics:

amiloride, spironolactone, triamterene, alone or in association : potentially fatal hyperkalemia,

notably in the presence of renal failure (addition of hyperkalemic effects).

+

angiotensin

converting

enzyme

inhibitors

(ACEi)

and,

by

extrapolation,

angiotensin

II

receptor

antagonists

potentially fatal hyperkalemia, notably in the presence of renal failure (addition of hyperkalemic effects).

+ tacrolimus: potentially fatal hyperkalemia, notably in the presence of renal failure (addition of hyperkalemic effects).

4.6 Fertility, pregnancy and lactation

This solution can be used during pregnancy or lactation if necessary.

RINGER LACTATE FRESENIUS should be administrated with special caution for pregnant women during labour particularly as to

serum-sodium if administered in combination with oxytocin (see section 4.4, 4.5 and 4.8).

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Potential undesirable effects may occur in poor conditions of use or if administration is too fast.

During administration of Hartmann's Solution for Infusion, the following undesirable effects have been reported:

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General disorders and administration site conditions: oedema due to water/sodium overload (unknown frequency).

Metabolism and nutrition disorders: Hospital acquired hyponatremia*

Nervous system disorders : Acute hyponatremic encephalopathy*

*Hospital acquired hyponatraemia may cause irreversible brain injury and death, due to development of acute hyponatraemic

encephalopathy, frequency unknown (see sections 4.2. 4.4, 4.5).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions in Ireland to HPRA Pharmacovigilance

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

IRL-Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

medsafety@hpra.ie

4.9 Overdose

Poor conditions of use, such as an overdose, may lead to signs of hypervolemia with tightened skin, venous stasis, oedema –

possibly also lung – or brain oedema, disturbed acid-base balance and electrolyte balance and serum hyperosmolarity.

The infusion should be interrupted immediately.

Overdose should be treated in a specialist unit.

Extra-renal dialysis may be necessary.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

SOLUTION MODIFYING ELECTROLYTE BALANCE (ATC Code: BO5 BB 01).

This is an isotonic crystalloid solution to be used for vascular filling and restoration of water/electrolyte balance and which has

an ionic composition very close to that of extracellular fluid.

The correction of extracellular dehydration and/or of blood volume deficit is accompanied by hemodilution.

Pharmacological properties are those of the constituents of the solution (sodium, potassium, calcium, chloride).

Hartmann’s Solution for Infusionis neutral and has an excess of chloride ions over sodium ions because of the presence of

potassium chloride and calcium chloride.

Lactate ion is a bicarbonate precursor buffer anion, i.e. participating in the regulation of acid-base balance. This conversion

may be impaired in the presence of hepatocellular insufficiency.

Metabolic alkalosis may result from excess intake of lactate ions.

If lactate metabolism is blocked (type B lactic acidosis), the intake of lactate results in accumulation of the anion in the blood.

In contrast, during the correction of hypovolemic shock (with type A lactic acidosis), improvement in circulatory status, and

hence in hepatic perfusion, enables the restoration of normal lactate metabolism which corrects the process.

5.2 Pharmacokinetic properties

This solution disseminates in the extracellular compartment, with a matching increase in the volume of the latter. Lactate ion is

quickly metabolized by the liver, where it is converted to pyruvate, used in the Krebs cycle with the production of bicarbonate.

5.3 Preclinical safety data

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Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose

toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hydrochloric acid (pH adjustment)

Sodium hydroxide (pH adjustment)

Water for injections

6.2 Incompatibilities

Physical-chemical incompatibilities:

It is up to the physician to determine the incompatibility of an added medicine regarding Hartmann’s solution, by checking for

any possible color change and/or possible formation of precipitate, insoluble complex or crystals.

There is physical-chemical incompatibility with certain antibiotics when they are given intravenously: chlortetracycline,

amphotericin B, oxytetracycline.

Before adding any medicine, check that the pH zone in which it is effective corresponds to that of Hartmann’s Solution for

Infusion.

Also check the package leaflet of the medicine to be added.

Once a medicine is added to Hartmann’s Solution for Infusion, the mixture must be administered immediately.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

3 years

After opening or mixture with other drugs, the product should be used immediately.

6.4 Special precautions for storage

No special precaution for storage.

6.5 Nature and contents of container

1, 10, 20, 30 x 250 ml, 1, 10, 20 x 500 ml or 1, 10 x 1000 ml polyethylene bottles.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Check the color and clarity of the solution, as well as that the container is not damaged before use. Discard any damaged or

partially used container.

Precautions for using bag:

- use immediately once opened;

- do not use an air entry;

- do not connect in series since the residual of the first container might be carried on by the solution coming from the second

container, with the risk of air embolism.

The chemical and physical stability of any additive at the pH of solution Hartmann’s, introduced into the Hartmann’s, must be

established before use.

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Once a medicine is added to Hartmann’s Solution for Infusion, the mixture must be administered immediately.

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7 MARKETING AUTHORISATION HOLDER

Fresenius Kabi Deutschland GmbH

Else-Kroener Strasse 1

Bad Homburg v.d.H 61352

Germany

8 MARKETING AUTHORISATION NUMBER

PA2059/057/005

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 24th July 2009

10 DATE OF REVISION OF THE TEXT

July 2020

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