STEROFUNDIN ISO SOLUTION FOR INFUSION

Active substance: SODIUM CHLORIDE

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85/12607589/1108

B. Braun Melsungen AG · 34209 Melsungen, Germany

Sterofundin ISO
solution for infusion
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
Potassium chloride
Magnesium chloride hexahydrate
Calcium chloride dihydrate
Sodium acetate trihydrate
L-Malic acid
Electrolyte concentrations:
Sodium
Potassium
Magnesium
Calcium
Chloride
Acetate
Malate
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless aqueous solution
pH:
Theoretical osmolarity:

6.80 g
0.30 g
0.20 g
0.37 g
3.27 g
0.67 g
mmol/l
145.0
4.0
1.0
2.5
127.0
24.0
5.0

5.1 - 5.9
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
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 babies 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
schoolchildren.
Note:
- infants and toddlers: age ranges from about 28 days to 23 months (a toddler is an
infant who can walk)
- children and schoolchildren: age ranges from about 2 years to 11 years.
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If administration is by rapid infusion under pressure, all air must be withdrawn from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 - Contraindications).
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 Contraindications),
- 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 - Interactions with other medicinal products and other forms of interaction).
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.
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 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 5.3 Preclinical safety data).
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.

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany

Sterofundin ISO
solution for infusion
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
- 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.
In this leaflet:
1. What Sterofundin ISO is and what it is used for
2. Before you will receive Sterofundin ISO
3. How to use Sterofundin ISO
4. Possible side effects
5. How to store Sterofundin ISO
6. Further 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.

2. BEFORE YOU RECEIVE STEROFUNDIN ISO
YOU WILL NOT BE GIVEN STEROFUNDIN ISO
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,
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.
TAKING OR USING OTHER MEDICINES
Tell your doctor if you are taking any medicine, even those not prescribed.
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.
PREGNANCY AND BREAST FEEDING.
If you are pregnant or breast feeding, please inform your doctor.
Your doctor will decide whether this solution is suitable for you when you are pregnant.
This medicine will be used with caution in so-called toxaemia of pregnancy, a special complication that may occur during pregnancy.
DRIVING AND USING MACHINES
Sterofundin ISO has no influence on the ability to drive or use machines.

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.
While you receive the infusion, your fluid and salt levels and your blood acid-base
balance will be controlled.
IF YOU HAVE RECEIVED MORE STEROFUNDIN ISO THAN YOU SHOULD:
As your dose is controlled by a doctor or nurse, it is unlikely that you will be given
too much of this solution.

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SUMMARY OF PRODUCT CHARACTERISTICS

85/12607589/1108

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 containers: 3 years
in plastic bags: 2 years
Shelf life after first opening 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 containers: 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 containers 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 container:
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 Instructions for use and handling
Only for intravenous use.
Single use only.
Unused solution should be discarded.
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 "Posology and method of administration".
7 MARKETING AUTHORISATION HOLDER
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
GERMANY
Phone: +49 5661 71 0
Fax: +49 5661 71 4567
8 MARKETING AUTHORISATION NUMBER(S)
RVG 27041
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29.10.2003
10 DATE OF REVISION OF THE TEXT
December 2008

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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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Some side effects may rarely 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.
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.
Bowel paralysis has rarely been reported after infusion of magnesium sulphate.

5. HOW TO STORE STEROFUNDIN ISO
Sterofundin ISO should be stored out of the reach and sight of children.
Glass bottles: Do not refrigerate or freeze.
Plastic bags, polyethylene plastic containers: Do not store above 25ºC. Do not refrigerate.
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.
Sterofundin ISO will not be used after the expiry date stated on the label or the carton.

6. FURTHER INFORMATION
What Sterofundin ISO contains
- The active substances in Sterofundin ISO solution for infusion:
Per 1000 ml this medicine contains:
Sodium chloride
Potassium chloride
Magnesium chloride hexahydrate
Calcium chloride dihydrate
Sodium acetate trihydrate
Malic acid
- The other ingredients are
Water for injections, Sodium Hydroxide

6.8 g
0.3 g
0.2 g
0.37 g
3.27 g
0.67 g

The following information is intended for medical or 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.

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B. Braun Melsungen AG
34209 Melsungen, Germany

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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, 1000 ml,
available in packs of 10 x 250 ml, 10 x 500 ml, 10 x 1000 ml
- Plastic bags containing 250 ml, 500 ml, 1000 ml,
available in packs of 20 x 250 ml, 20 x 500 ml, 10 x 1000 ml
- Glass bottles containing 250 ml, 500 ml, 1000 ml,
available in packs of 10 x 250 ml, 10 x 500 ml, 6 x 1000 ml
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Straße 1
Postal address:
34212 Melsungen
34209 Melsungen
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567
Manufacturers
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
B. Braun Medical S. A.
Carretera de Terrassa 121
08191 Rubí (Barcelona), Spain
This medicinal product is authorised in the Member States of the EEA under the
following names:
Sterofundin ISO
Austria
Sterofundin ISO
Belgium
Ringerfundin B. Braun
Czech Republic
Sterofundin ISO
Germany
Ringerfundin
Denmark
Isofundin
Spain
Ringerfundin
Finland
Isofundine, solution pour perfusion
France
Sterofundin ISO
United Kingdom
Ringerfundin B. Braun infúzio
Hungary
Sterofundin
Italy
Sterofundin ISO
Luxembourg
Sterofundin ISO
Netherlands
Ringerfundin
Norway
Isofundin
Portugal
Ringerfundin infusionsvästka, lösning Sweden
The leaflet was approved in January 2009

- 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.
- 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.

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B. Braun Melsungen AG
34209 Melsungen
Germany

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4.8 Undesirable effects
Signs of overdose may occur, see section 4.9.
Hypersensitivity reactions characterized by urticaria have been occasionally
described after the intravenous administration of magnesium salts.
Although oral magnesium salts stimulate peristalsis, paralytic ileus has been rarely
reported after intravenous infusion of magnesium sulphate.
Adverse reactions may be associated to 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.
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 vasodilation, 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 from 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 effecting 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
Since the ingredients of Sterofundin ISO are infused intravenously their bioavailability is 100 %.
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

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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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