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STEROFUNDIN ISO SOLUTION FOR INFUSION

Active substance: SODIUM CHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
B. Braun Melsungen AG · 34209 Melsungen, Germany

1 NAME OF THE MEDICINAL PRODUCT

Sterofundin ISO
solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml Sterofundin ISO solution for infusion contain:
Sodium chloride
6.80 g
Potassium chloride
0.30 g
Magnesium chloride hexahydrate
0.20 g
Calcium chloride dihydrate
0.37 g
Sodium acetate trihydrate
3.27 g
L-Malic acid
0.67 g
Electrolyte concentrations:
mmol/l
Sodium
145.0
Potassium
4.0
Magnesium
1.0
Calcium
2.5
Chloride
127.0
Acetate
24.0
Malate
5.0
Excipients with known effect:
1000 ml Sterofundin ISO solution contain 0.2 g Sodium hydroxide
(0.115 g Sodium).
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless aqueous solution
pH:
5.1 – 5.9
Theoretical osmolarity:
309 mosm/l.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Replacement of extracellular fluid losses in the case of isotonic dehydration, where acidosis is present or imminent.
4.2. Posology and method of administration
Posology
Adults, the elderly, adolescents and children:
The dosage depends on the age, weight, clinical and biological conditions
of the patient and concomitant therapy.
Recommended dosage:
The recommended dosage is:
• for adults, the elderly and adolescents : 500 ml to 3 litres /24h, corresponding to 1 to 6 mmol sodium / kg / 24 h and 0.03 to 0.17 mmol
potassium / kg / 24 h.
• for toddlers, infants and children : 20 ml to 100 ml / kg / 24 h, corresponding to 3 to 14 mmol sodium / kg / 24 h and 0.08 to 0.40 mmol
potassium / kg / 24 h.
Administration rate:
The maximum infusion rate depends on the needs of the patient in fluid
replacement and electrolytes, his weight, clinical condition, and biological
status.
In paediatric patients the infusion rate is 5 ml/kg/h on average but the
value varies with age: 6-8 ml/kg/h for infants, 4-6 ml/kg/h for toddlers,
and 2-4 ml/kg/h for children.
Note:
• infants and toddlers: age ranges from about 28 days to 23 months (a
toddler is an infant who can walk)
• children: age ranges from about 2 years to 11 years.
Paediatric population
The safety and efficacy of Sterofundin in newborn infants (below the age
of 28 days) has not been established.
Method of administration
For intravenous use as infusion only.
Sterofundin ISO can be infused into peripheral veins (see section 3 for pH
and theoretical osmolarity).
If administration is by rapid infusion under pressure, all air must be withdrawn from the plastic container and infusion set prior to infusion, as otherwise there is a risk of producing air embolism during infusion.
Fluid balance, plasma electrolyte concentrations and pH must be monitored during administration.
Sterofundin ISO may be administered as long as there is an indication for
fluid replacement.
4.3 Contraindications
Sterofundin ISO must not be administered in the following situations:
- Hypervolaemia
- Severe congestive cardiac failure
- Renal failure with oliguria or anuria
- Severe general oedema
- Hyperkalaemia
- Hypercalcaemia
- Metabolic alkalosis

4.4 Special warning and precautions for use
High volume infusion must be used under specific monitoring in patients
with mild to moderate cardiac or pulmonary failure (for more severe conditions: see Section 4.3).
Solutions containing sodium chloride should be administered with caution
to patients with
- mild to moderate cardiac insufficiency, peripheral or pulmonary oedema
or extracellular hyperhydration (for more severe conditions: see Section
– 4.3),
- hypernatraemia, hyperchloraemia, hypertonic dehydration, hypertension, impaired renal function, present or imminent eclampsia, aldosteronism or other conditions or treatment (e. g. corticoids/steroids) associated with sodium retention (see also Section 4.5).
Solutions containing potassium salts should be administered with caution
to patients with cardiac disease, or conditions predisposing to hyperkalaemia such as renal or adrenocortical insufficiency, acute dehydration,
or extensive tissue destruction as occurs with severe burns.
Because of the presence of calcium:
- Care should be taken to prevent extravasation during intravenous infusion
- The solution should be given cautiously to patients with impaired renal
function or diseases associated with elevated vitamin D concentrations
such as sarcoidosis.
- In case of concomitant blood transfusion, the solution must not be
administered via the same infusion set
Solutions containing metabolizable anions should be administered cautiously to patients with respiratory impairment.
Monitoring of the serum electrolytes, fluid balance, and pH is necessary.
During long-term parenteral treatment, a convenient nutritive supply
must be given to the patient.
This medicinal product contains 145 mmol sodium per 1000 ml. To be
taken into consideration by patients on a controlled sodium diet.
4.5 Interaction with other medicinal products and other forms of
interaction
Sodium, potassium, calcium, and magnesium are present in Sterofundin
ISO in the same concentrations as in plasma. Hence, the administration of
Sterofundin ISO in accordance with the recommended indications and
contraindications does not increase the plasma concentrations of said
electrolytes. In case there is a rise of any electrolyte’s concentration due
to other reasons the following interactions should be considered.
Related to sodium:
Corticoids/steroids and carbenoxolone may be associated with the retention of sodium and water (with oedema and hypertension).
Related to potassium:
- Suxamethonium,
- Potassium-sparing diuretics (amiloride, spironolactone, triamterene,
alone or in association),
- Tacrolimus, cyclosporine
may increase the concentration of potassium in the plasma and lead to
potentially fatal hyperkalaemia notably in case of renal failure increasing
the hyperkalaemic effect.
Related to calcium:
Digitalis glycosides (digitalis cardiotonics) may undergo enhancement of
their effects during hypercalcaemia and lead to serious or fatal cardiac
arrhythmia.
Vitamin D may induce hypercalcaemia.
4.6 Fertility, pregnancy and lactation
There are no data from the use of Sterofundin ISO in pregnant and lactating women. In the intended indication no risks have to be expected,
when volume, electrolyte and acid/base levels are carefully monitored (see
section 5.3).
Sterofundin ISO should be used with caution in toxaemia of pregnancy.
4.7 Effects on ability to drive and use machines
Sterofundin ISO has no influence on the ability to drive and use machines.
4.8 Undesirable effects
Signs of overdose may occur, see section 4.9.
Definition of frequency terms used in this section:
Rare: ≥ 1/10,000 to < 1/1,000
Not known: Frequency cannot be estimated from the available data
Immune system disorders
Frequency not known: Hypersensitivity reactions characterized by
urticaria have been occasionally described after the intravenous administration of magnesium salts.
Gastrointestinal disorders
Although oral magnesium salts stimulate peristalsis, paralytic ileus has
been rarely reported after intravenous infusion of magnesium sulphate.

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Package leaflet: Information for the user

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B. Braun Melsungen AG · 34209 Melsungen, Germany

Sterofundin ISO
solution for infusion

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

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- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet.

What is in this leaflet
1. What Sterofundin ISO is and what it is used for
2. What you need to know before you receive Sterofundin ISO
3. How to use Sterofundin ISO
4. Possible side effects
5. How to store Sterofundin ISO
6. Contents of the pack and other information

1. What Sterofundin ISO is and what it is used for
Sterofundin ISO is a solution for infusion into a vein.
This solution replaces fluid that has been lost from the circulation. It can
be used in conditions where your blood may become or has become slightly acidic.

3. How to use Sterofundin ISO
Route of administration
This medicine is given into a vein by a drip.

Dosage
Your doctor will determine the amount of solution you need.
In adults, elderly patients and adolescents this may be 500 millilitres – 3
litres per day. The daily dose for babies and children may be between 20
– 100 millilitres per kg body weight per day.

Rate of administration
Your doctor will also determine how fast the solution will be infused,
depending on your body weight and your condition.

Duration of treatment
Your doctor will determine how long you will receive this solution.

2. What you need to know before you receive Stero- While you receive the infusion, your fluid and salt levels and your blood
fundin ISO
acid-base balance will be controlled.
You will not be given Sterofundin ISO

If you receive more Sterofundin ISO than you should

if you have
- too much fluid in the circulation,
- severe heart disease with shortness of breath and swelling of the feet or
the legs,
- severe kidney disease and you are unable or almost unable to pass urine,
- swelling of your body tissues due to fluid accumulation,
- high levels of potassium or calcium in your blood,
- or if your blood is too alkaline.

As your dose is controlled by a doctor or nurse, it is unlikely that you will
be given too much of this solution.
However, if accidentally you did receive too much or the solution has run
in too fast, you might get symptoms such as
- increase of skin tension
- congestion in veins and swelling
- accumulation of fluid in the lungs
- shortness of breath
- abnormalities in the water and salt composition of body fluids.
Excessively high blood levels of one the individual components of Sterofundin ISO may be associated with specific symptoms which your doctor
will pay attention to.
In cases of overdose the infusion is stopped instantly and appropriate corrective therapy is started.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using Sterofundin ISO.
Special care will be taken with Sterofundin ISO Solution for infusion, if
you have
- any disease that makes it necessary to reduce your salt intake, such as
mild or moderately impaired heart function, tissue swelling or fluid
accumulation in the lungs
- sarcoidosis (a chronic immune system disorder involving the lymph
nodes and the connective tissue)
- mildly or moderately increased blood pressure
- acute water deficit e.g. following extensive tissue destruction as occurs
with severe burns or due to impaired function of the adrenal glands
- high levels of sodium or chloride in your blood
- eclampsia (a complication occurring during pregnancy)
- mild or moderate impairment of your kidney function
- breathing problems
- any disease or if you receive any medicine that may lead to reduced
excretion of sodium.
If any of the above mentioned applies to you, your doctor will decide very
carefully whether this solution is suitable for you.
Your body fluid level and the salt concentrations in your blood will be controlled while you receive Sterofundin ISO to make sure that they are normal.

Other medicines and Sterofundin ISO
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
It is particularly important that your doctor knows if you take, use or
receive:
• Drugs that make your body retain sodium and water such as
- steroid hormones or
- carbenoxolone
If these are used together with Sterofundin ISO your body water level and
your blood sodium level may increase, leading to swelling and increased
blood pressure.
• Drugs with an influence on your blood potassium level such as
- suxamethonium
- some diuretics (water tablets) that lower your potassium excretion, e.g.
amiloride, spironolactone, triamterene
- tacrolimus, ciclosporin (drugs used e.g. to suppress the rejection of
transplanted organs)If these are used together with Sterofundin ISO
your blood potassium level could rise, which may lead to adverse
effects on your heart function. This is more likely to happen if you suffer from impaired kidney function.
• Digitalis preparations (i.e. digoxin), which are used to treat heart weakness
The effect of these will become stronger when the blood calcium level
rises and adverse effects such as irregular heartbeat may occur. Therefore your doctor will need to re-adjust your digoxin dose.
• Vitamin D; this may lead to an increased blood calcium level.
Your doctor will know about the adverse effects that may be brought
about by the combination of Sterofundin ISO and the aforementioned
drugs. He will take care that the infusion you receive is dosed correctly.
Some drugs do not mix with Sterofundin ISO. Doctors only add drugs to
Sterofundin ISO if they are sure they are safe to mix.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Some side effects may be caused by the administration technique. These
may include feverish reactions, infection at the site of injection, local pain
or reaction, vein irritation, blood clots in veins or inflammation of veins
extending from the site of injection.
Allergic reactions to infused magnesium salts, presenting as rash, have
been reported occasionally. The frequency of these reactions cannot be
estimated from the available data.
Bowel paralysis has rarely been reported after infusion of magnesium sulphate. This may affect up to 1 in 1,000 people.
If you get any side effects, talk to your doctor or pharmacist. This includes
any side effects not listed in this leaflet.

5. How to store Sterofundin ISO
Keep this medicine out of the sight and reach of children.
Glass bottles: Do not refrigerate or freeze.
Plastic bags, polyethylene plastic bottles: Do not store above 25ºC. Do not
refrigerate or freeze.
The medicinal product will not be used if there are particles in the solution or the solution is cloudy or discoloured. The product will not be used
if the container is leaking or otherwise damaged. This product is for single-use only, partially used containers will not be reconnected.
Do not use this medicine after the expiry date which is stated on the label
or the carton after EXP.

6. Contents of the pack and other information
What Sterofundin ISO contains
• The active substances in Sterofundin ISO solution for infusion are:
Per 1000 ml this medicine contains:
Sodium chloride
6.8 g
Potassium chloride
0.3 g
Magnesium chloride hexahydrate
0.2 g
Calcium chloride dihydrate
0.37 g
Sodium acetate trihydrate
3.27 g
Malic acid
0.67 g

• The other ingredients are
Water for injections, Sodium Hydroxide

What Sterofundin ISO looks like and contents of the pack

Sterofundin ISO is a solution for infusion (for administration by a vein
drip). It is a clear colourless solution.
It comes in
• Plastic bottles containing 250 ml, 500 ml, 1000ml,
available in packs of 10 × 250 ml, 10 × 500 ml, 10 × 1000ml
Pregnancy and breast-feeding
• Plastic bags containing 250 ml, 500 ml, 1000ml,
If you are pregnant or breast-feeding, think you may be pregnant or are
available in packs of 20 × 250 ml, 20 × 500 ml, 10 × 1000ml
planning to have a baby, ask your doctor or pharmacist for advice before
• Glass bottles containing 250 ml, 500 ml, 1000ml,
taking this medicine.
available in packs of 10 × 250 ml, 10 × 500 ml, 6 × 1000ml
Your doctor will decide whether this solution is suitable for you when you
Marketing Authorisation Holder and Manufacturer
are pregnant.
This medicine will be used with caution in so-called toxaemia of preg- B. Braun Melsungen AG
Carl-Braun-Straße 1
Postal address:
nancy, a special complication that may occur during pregnancy.
34212 Melsungen
34209 Melsungen
Driving and using machines
Sterofundin ISO has no influence on the ability to drive or use machines. Tel.: +49-5661-71-0
Fax: +49-5661-71-4567

Sterofundin ISO contains sodium

B|BRAUN

Schwarz
210x980 mm
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Lätus: 1206
Großbritannien
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If you are on a controlled sodium diet, please note that this medicinal
product contains 145 mmol sodium per 1000 ml.

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General disorders and administration site conditions
Adverse reactions may be associated with the technique of administration
including febrile response, infection at the site of injection, local pain or
reaction, vein irritation, venous thrombosis or phlebitis extending from the
site of injection and extravasation. Adverse reactions may be associated
to the medications added to the solution; the nature of the additive will
determine the likelihood of any other undesirable effects.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via Yellow Card Scheme,
Tel: Freephone 0808 100 3352, Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Overuse or too fast administration may lead to water and sodium overload
with a risk of oedema, particularly when there is a defective renal sodium
excretion. In this case extra renal dialysis may be necessary.
Excessive administration of potassium may lead to the development of
hyperkalaemia, especially in patients with renal impairment. Symptoms
include paresthesia of the extremities, muscle weakness, paralysis, cardiac
arrhythmias, heart block, cardiac arrest, and mental confusion. Treatment
of hyperkalaemia involves the administration of calcium, insulin (with
glucose) sodium bicarbonate, exchange resins or dialysis.
Excessive parenteral administration of magnesium salts leads to the
development of hypermagnesaemia, important signs of which are loss of
deep tendon reflexes and respiratory depression, both due to neuromuscular blockade. Other symptoms of hypermagnesaemia may include nausea, vomiting, flushing of the skin, thirst, hypotension due to peripheral
vasodilatation, drowsiness, confusion, muscle weakness, bradycardia,
coma, and cardiac arrest.
Excessive administration of chloride salts may cause a loss of bicarbonate
with an acidifying effect.
Excessive administration of compounds, such as acetate and malate,
which are metabolised to form the bicarbonate anion may lead to metabolic alkalosis, especially in patients with impaired renal function. Symptoms may include mood changes, tiredness, shortness of breath, muscle
weakness, and irregular heartbeat. Patients with additional hypocalcaemia
may develop muscle hypertonicity, twitching, and tetany. Treatment of
metabolic alkalosis associated with an increase in bicarbonate consists
mainly of appropriate correction of fluid and electrolyte balance.
Excessive administration of calcium salts may lead to hypercalcaemia.
Symptoms of hypercalcaemia may include anorexia, nausea, vomiting,
constipation, abdominal pain, muscle weakness, mental disturbances,
polydipsia, polyuria, nephrocalcinosis, renal calculi, and, in severe cases,
cardiac arrhythmias and coma. Too rapid intravenous injection of calcium
salts may also lead to many of the symptoms of hypercalcaemia as well as
to a chalky taste, hot flushes, and peripheral vasodilation. Mild asymptomatic hypercalcaemia will usually resolve on stopping administration of
calcium and other contributory drugs such as vitamin D. If hypercalcaemia
is severe, urgent treatment (such as loop diuretics, haemodialysis, calcitonin, bisphosphonates, trisodium edetate) is required.
When overdose is related to medications added to the solution infused,
the signs and symptoms of overinfusion will be related to the nature of
the additive being used. In the event of accidental overinfusion, treatment
should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the drug administered. The relevant
symptomatic and supportive measures should be provided as necessary.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Solutions affecting the electrolyte balance,
electrolytes
ATC code: B05BB01
This medicinal product is an isotonic electrolyte solution with electrolyte
concentrations adapted to plasma electrolyte concentrations. It is used to
correct extracellular fluid losses (i.e. losses of water and electrolytes in
proportional amounts). The supply of the solution is aimed to restore as
well as maintain normal osmotic conditions in the extracellular and intracellular space.
The anion pattern represents a balanced combination of chloride, acetate,
and malate which counteracts metabolic acidosis.
5.2 Pharmacokinetic properties
Absorption
Since the ingredients of Sterofundin ISO are infused intravenously their
bioavailability is 100 %.
Distribution and Elimination
Sodium and chloride mainly distribute in the extracellular space, whereas
the preferential distribution of potassium, magnesium and calcium is
intracellular. The kidneys are the main route of excretion for sodium,
potassium, magnesium, and chloride but small amounts are lost via the
skin and intestinal tract. Calcium is excreted in approximately equal
amounts in urine and endogenous intestinal secretion.

During the infusion of acetate and malate, their plasma levels rise and
appear to reach a steady state. Following termination of the infusion, the
acetate and malate concentrations rapidly diminish. Acetate and malate
excretion in urine rises during the infusion. However, their metabolism by
body tissues is so rapid that only a small fraction appears in urine.
5.3 Preclinical safety data
No preclinical studies have been conducted with Sterofundin ISO. There
are no data of relevance to the prescriber additional to those already
included elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections,
sodium hydroxide (for pH adjustment)
6.2 Incompatibilities
Admixture of the medicinal product with medications containing carbonates, phosphates, sulphates or tartrates may lead to precipitation.
6.3 Shelf life
Shelf life of the medicinal product as packaged for sale :
in glass bottles and polyethylene plastic bottles: 3 years
in plastic bags: 2 years
Shelf life after first opening of the container:
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior
to use are the responsibility of the user and would normally not be longer
than 24 hours at 2 to 8 °C unless reconstitution / dilution (etc) has taken
place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
Glass bottles: Do not refrigerate or freeze.
Plastic bags, polyethylene plastic bottles: Do not store above 25°C. Do not
refrigerate or freeze.
6.5 Nature and contents of container
The solution for infusion is packed in type II glass bottles with butyl rubber stoppers, in polyethylene plastic bottles or in plastic bags with outer
protective bags. The primary bag consists of a three layer plastic laminate
with a polypropylene inner layer and a polyamide outer layer.
Glass bottle: 1 x / 10 x 250 ml
1 x / 10 x 500 ml
1 x / 6 x 1,000 ml
Polyethylene plastic bottle: 1 x / 10 x 250 ml
1 x / 10 x 500 ml
1 x / 10 x 1,000 ml
Plastic bag: 1 x / 20 x 250 ml
1 x / 20 x 500 ml
1 x / 10 x 1,000 ml
Not all package sizes may be marketed.
6.6 Special precautions for disposal and other handling
Only for intravenous use.
Single use only.
Do not reconnect partially used containers.
Unused solution should be discarded.
Do not use if container or closure is damaged. Only clear solutions practically free from particles should be used.
The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order
to prevent air entering the system.
If using plastic bags, surrounding bag must only be removed immediately
before use.
For further information please refer to section 4.2.
7 MARKETING AUTHORISATION HOLDER
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
8 MARKETING AUTHORISATION NUMBER(S)
PL 03551/0100
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 15th July 2005
Date of latest renewal: 18th January 2010
10 DATE OF REVISION OF THE TEXT
17/04/2013

B|BRAUN

B. Braun Melsungen AG
34209 Melsungen, Germany

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Greece
Sterofundin ISO
Hungary
Ringerfundin B. Braun infúzio
Italy
Sterofundin
Latvia
Sterofundin ISO
Lithuania
Sterofundin ISO infuzinis tirpalas
Luxembourg
Sterofundin Iso solution pour perfusion
Malta
Sterofundin ISO
Netherlands
Sterofundin ISO
This medicinal product is authorised in the Member States of Norway
Ringerfundin infusjonsvaeske
the EEA under the following names:
Poland
Sterofundin ISO
Austria
Sterofundin ISO Infusionslösung
Portugal
Isofundin
Belgium
Sterofundin ISO oplossing voor infusie
Romania
Sterofundin ISO soluţie perfuzabilă
Bulgaria
Sterofundin ISO
Slovenia
Sterofundin ISO raztopina za infundiranje
Cyprus
Sterofundin ISO
Slovakia
Ringerfundin
Czech Republic
Ringerfundin B. Braun
Spain
Isofundin, solución para perfusión
Denmark
Ringerfundin
Sweden
Ringerfundin infusionsvästka, lösning
Estonia
Sterofundin ISO
United Kingdom
Sterofundin ISO solution for infusion
Finland
Ringerfundin infuusioneste, liuos
This leaflet was last revised in April 2013.
France
Isofundine, solution pour perfusion
Germany
Sterofundin ISO Infusionslösung
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
B. Braun Medical S. A.
Carretera de Terrassa 121
08191 Rubí (Barcelona), Spain

• Symptoms of excessive overdose of acetate and malate:
Metabolic alkalosis, which may lead to mood changes, tiredness, dyspnoea, muscle weakness, and cardiac arrythmia, in the presence of low calcium levels also twitching and cramps.
Handling
The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order
to prevent air entering the system.
If using plastic bags, surrounding bag must only be removed immediately
before use.
If administration is by rapid infusion under pressure, all air must be withdrawn from the plastic container and infusion set prior to infusion, as otherwise there is a risk of producing air embolism during infusion.
Fluid balance, plasma electrolyte concentrations and pH must be monitored during administration. Sterofundin ISO may be administered as long
as there is an indication for fluid replacement.

B|BRAUN

Schwarz
210x980 mm
85/12607589/0913
Lätus: 1206
Großbritannien
Font size 9

B. Braun Melsungen AG
34209 Melsungen
Germany

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The following information is intended for healthcare professionals only:
Symptoms associated with excessive overdose of the individual components of the solution
• Symptoms of hyperkalaemia
paraesthesia in extremities, muscle weakness, paralysis, cardiac arrythmia,
asystole, mental confusion.
• Symtoms of hypermagnesaemia:
loss of tendon reflexes and dyspnoea, nausea, vomiting, flushing of the
skin, thirst, drop of blood pressure, drowsiness, confusion, muscle weakness, bradycardia, coma, cardiac arrest.
• Symptoms of hyperchloraemia:
loss of bicarbonate, acidosis.
• Symptoms of hypercalcaemia:
anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuria, nephrocalcinosis, and, in
severe cases, cardiac arrhythmia and coma. Too rapid injection of calcium
salts my lead to chalky taste and hot flushes.

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Manufacturers

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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