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SODIUM CHLORIDE GRIFOLS 0 9% W/V SOLUTION FOR INFUSION

Active substance(s): SODIUM CHLORIDE / SODIUM CHLORIDE

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Package leaflet: Information for the user

Sodium Chloride Grifols 0.9% w/v
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.
What is in this leaflet
1. What Sodium Chloride Grifols 0.9% w/v is and what it is used for
2. What you need to know before you use Sodium Chloride Grifols 0.9% w/v
3. How to use Sodium Chloride Grifols 0.9% w/v
4. Possible side effects
5. How to store Sodium Chloride Grifols 0.9% w/v
6. Contents of the pack and other information

1. What Sodium Chloride Grifols 0.9% w/v is and what it is used for
Sodium Chloride Grifols 0.9% w/v belongs to the group of medicines named
intravenous solutions affecting the electrolyte balance – electrolytes (used
to keep the body fluids in the right balance).
This medicine supplies sodium, chloride (both electrolytes) and water, and
is indicated for:
- Dehydration states with salt loss
- Hypochloremic metabolic alkalosis
- The management of hypovolemia (a decrease in the amount of body
blood)
- As a vehicle for the administration of compatible drugs and electrolytes.

2. What you need to know before you use Sodium Chloride Grifols 0.9% w/v
Do not use Sodium Chloride Grifols 0.9% w/v:
- if the levels of chlorides and/or sodium in your blood are high
(hyperchloremia and hypernatremia respectively) or if you suffer from
hyperhydration (excess of water in your body)
- if you suffer from acidosis (level of pH lower than normal range)
Warnings and precautions
Sodium Chloride Grifols 0.9% w/v is an isotonic solution.
Talk to your doctor or nurse before using Sodium Chloride Grifols 0.9% w/v.
This medicine should be administered with caution if you suffer from
hypertension including pre-eclampsia (development of hypertension during
pregnancy)/eclampsia (complication of severe pre-eclampsia), congestive
heart failure, pulmonary or peripheral edema, severe renal insufficiency,
decompensated cirrhosis (liver disease with life-threatening symptoms
and complications), primary hyperaldosteronism (excessive production of
the hormone aldosterone) as well as if you are receiving corticosteroids
or adrenocorticotropic hormone (hormone that stimulates the secretion of
cortisol and other steroid hormones) (see next subsection).
This medicine should be administered with caution if the levels of
potassium in your blood are low (hypokalaemia) because pre-existing
electrolyte imbalance may get worse leading to cardiovascular
complications, especially if you suffer from heart problems.
It also should be administered with special care if you are elderly because
you may have problems with your heart and kidneys.
During prolonged therapies or whenever your doctor deems necessary, as in
case of existing or imminent acid-base imbalance, periodic monitoring of
the fluid balance, serum electrolyte concentrations, and acid base balance
must be performed.
Sodium re-equilibration should not be performed at a too rapid
rhythm, especially due to the risk of occurrence of serious neurological
complications such as osmotic demyelination syndrome (brain disease
caused by severe damage of the myelin sheath of brain cells) (see section 3).
This medicine should be administered only for short period therapy as a
prolonged administration could lead to a metabolic acidosis.
Because of the administration technique, you may experience extravasation
(a discharge or escape of fluid from a vein into the tissues) and/or
thrombophlebitis (inflammation of the vein with clot formation) during
intravenous infusion (see section 4). Extravasation may lead to tissue
damage (local pain, erythema, burning, itching, swelling and ulceration) at
the site of injection or along the vein. Thrombophlebitis might occur if the
administration in the same site of injection is prolonged. In these cases,
your doctor or nurse should stop the intravenous infusion and institute
appropriate therapeutic measures. They must check periodically possible
signs of inflammation at the injection site.

Due to the risk of air embolism (when one or more gas bubbles enter a vein
or artery) your doctor or nurse must take particular care in the handling of
the administration sets.
When adding a medicinal product to the solution, your doctor or nurse must
check compatibility, clarity and colour before use. The mixture cannot be
stored.
Children and adolescents
In preterm and breast-feeding neonates, sodium chloride administration
should only be performed after determining sodium levels in blood.
There are no other specific warnings or precautions to children and
adolescents.
Other medicines and Sodium Chloride Grifols 0.9% w/v
Some medicines may interact with Sodium Chloride Grifols 0.9% w/v. In
this case, a change of dosage or a treatment disruption of some of the
medicines might be required.
It is important to tell your doctor if you are using some of the following
medicines:
- lithium carbonate, since the administration of sodium chloride
accelerates renal lithium excretion, leading to a decrease in the
therapeutic action of lithium.
- corticosteroids or adrenocorticotropic hormone, since they favour water
and sodium retention.
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before using this
medicine.
There is no evidence indicating that maternal infusion of sodium chloride
0.9% during pregnancy has any harmful effects on the fetus or the
newborn.
Precautions must be taken during pregnancy in pre-eclampsia situations
(see Warnings and precautions).
Sodium chloride is excreted in human milk but taking into account that it
is a natural constituent of human milk, no side effects on the breastfed
infant are expected following maternal intravenous administration of
therapeutic doses. Nevertheless, it is recommended to use with caution
during these periods.
There are no data regarding fertility and use of sodium chloride solutions
but no side effects are anticipated.
When this medicine is used as a vehicle for the administration of
compatible drugs and electrolytes, the nature of the additive and its use
during pregnancy and lactation should be evaluated separately.
In any case, the doctor must evaluate if the treatment is advisable.
Driving and using machines
Not relevant.

3. How to use Sodium Chloride Grifols 0.9% w/v
This medicine will be administered by healthcare professionals.
It is intended for intravenous administration by means of infusion.
Your doctor will decide the amount of fluid and the rate and duration of
the infusion that you should receive depending on your age, weight and
medical condition. In general, it is recommended to administer the solution
at an average infusion rate of 40 to 60 drops per minute (120-180 mL/h).
When administering this solution, the total daily fluid requirement must be
considered. The daily recommended dose of fluid is the following:
- adults: between 25-35 mL/kg
- children: - less than 10 kg body weight: 100 mL/kg

- between 10-20 kg body weight: 1000 mL + 50 mL/kg for
every kg over 10 kg

- more than 20 kg body weight: 1500 mL + 20 mL/kg for
every kg over 20 kg
In adults, the maximum daily dose of fluid is 40 mL/kg (corresponding to
6 mmol of sodium/kg) not exceeding 3000 mL, and the maximum infusion
rate is 5 mL/kg/h. Children rarely need more than 2500 mL for males and
2000 mL for females.
In case of acute plasma volume depletion (e.g. imminent or evident
hypovolemic shock) the amount of solution should be 3 or 4 times the lost
blood volume.
When this medicine is used as a vehicle for the administration of
compatible drugs and electrolytes, the administered dosage and the speed
of the infusion will depend on the nature and the dose of the prescribed
medicinal product.

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If you receive more Sodium Chloride Grifols 0.9% w/v than you should
The excessive administration of 0.9% sodium chloride solution may result
in fluid overload (hypervolemia, hyperhydration) and/or salt overload
(hypernatremia and hyperchloremia) (see section 4). In these cases,
administration should be discontinued and appropriate therapeutic
countermeasures should be instituted.
If fluid overdose occurs (hypervolemia, hyperhydration) you may experience
pulmonary and/or peripheral edema and their consequent effects (heart
failure).
With an excessive intravenous administration of sodium you may develop
hypernatremia leading to intracellular dehydration (loss of water from
inside to outside the cells that could lead to cellular desiccation), which
should be treated in specialised area. If it occurs you may experience
nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced salivation
and lacrimation, fever, sweating, tachycardia, hypertension, headache,
dizziness, restlessness, irritability, weakness, lipothymia (transient loss of
consciousness), muscular twitching and rigidity, somnolence, confusion
progressing to convulsions, coma, renal failure, cerebral, peripheral and
pulmonary edema, respiratory failure and death.
Serious neurological complications such as osmotic demyelination
syndrome (brain disease caused by severe damage of the myelin sheath
of brain cells) can occur several days after too important and/or too
rapid correction of hyponatremia (see section 2). If it occurs you may
experience the following progressive clinical signs: confusion, speech and/
or swallowing disorders, weakness of the limbs, tetraplegia, delirium and
finally coma.
Excessive administration of chloride may cause hyperchloremia and hence,
there is a loss of bicarbonate and acidosis. Often hyperchloremia does not
produce any symptoms. In cases where symptoms develop, they are similar
to those of hypernatremia.
When this medicine is used as vehicle for the administration of compatible
drugs and electrolytes, other signs and symptoms of excessive injection
may arise from the added medicinal product. If it occurs, treatment
should be stopped and you should be monitored for any clinical signs
and symptoms associated with the medication given. You should receive
symptomatic treatment and appropriate support.
If you have any further questions on the use of this medicine, ask your
doctor or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Hyperhydration, hypernatremia, hyperchloremia, hypervolemia (excess
of body water, plasma sodium, plasma chloride and blood volume
respectively) and related signs, such as formation of edemas (abnormal
accumulation of fluid in tissues between the body’s cells) or metabolic
acidosis due to the decrease of bicarbonate concentration (increase in
plasma acidity because there is not enough bicarbonate to effectively
neutralize the effects of the acid), may occur following an inadequate or
excessive administration of this medicine.
Side effects derived from the prolonged administration by intravenous
route in the same infusion site may also occur. These effects include pain
or reaction in the injection site, fever, infection, extravasation, venous
thrombosis (formation of a blood clot inside a vein obstructing the flow of
blood) and phlebitis (inflammation of a vein) extending from the site of
injection.
If it is used as a vehicle for the administration of other compatible drugs,
other side effects attributable to the nature of these added drugs may also
occur.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme, Website:
https://yellowcard.mhra.gov.uk or telephone 0808 100 3352. By reporting
side effects, you can help provide more information on the safety of this
medicine.

5. How to store Sodium Chloride Grifols 0.9% w/v
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
container. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Once the container is opened, the solution must be used immediately.
Do not use this medicine if you notice that the solution is not clear or
contains particles, or if the container has been damaged.

6. Contents of the pack and other information
What Sodium Chloride Grifols 0.9% w/v contains
The active substance is sodium chloride. Each 100 mL of solution contains
0.9 g of sodium chloride.
The other ingredient (excipient) is water for injections.
The calculated osmolarity of the solution is 308 mOsm/L and pH is 4.5-7.0.
The theoretical sodium and chloride content is 154 mmol/L.
What Sodium Chloride Grifols 0.9% w/v looks like and contents of the
pack
Sodium Chloride Grifols 0.9% w/v is a solution for infusion. It is a clear and
colourless aqueous solution.
This medicine is available in polypropylene flexible bags (Fleboflex) of
500 mL (in boxes containing 20 bags).
Marketing Authorisation Holder and Manufacturer
LABORATORIOS GRIFOLS, S.A.
Can Guasch, 2
08150 Parets del Vallès, Barcelona (SPAIN)
This medicinal product is authorised in the Member States of the EEA
under the following names:
Spain:
Cloruro de Sodio Grifols 0,9% Solución para perfusión
Czech Republic: Chlorid sodný Grifols 0,9%
France:
Chlorure de Sodium 0,9% Grifols Solution pour perfusion
Germany:
Natriumchlorid Grifols 0,9% Infusionslösung
Italy:
Sodio Cloruro Grifols
Slovakia:
Chlorid sodný Grifols 0,9 %
United Kingdom: Sodium Chloride Grifols 0.9% w/v Solution for infusion
This leaflet was last revised in May 2017
Other sources of information
Detailed information on this medicine is available on the web site
www.medicines.org.uk.
------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Before administration of Sodium Chloride Grifols 0.9% w/v, it must be
checked that:
- There is no leakage (by squeezing the bag firmly)
- The solution is clear and without particles.
Do not administer otherwise (see section 5).
Do not remove unit from overwrap until ready for use. The inner bag
maintains the sterility of the product.
Once the container is opened, the solution must be used immediately.
To connect the infusion set, separate the protecting tab from the infusion
port so that the membrane of access to the bag is exposed. Remove all
air from the syringe and associated tubing prior to infusion to avoid air
embolism.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
The compatibility of additives with Sodium Chloride Grifols 0.9% w/v
should be checked before adding a medicinal product.
It is the responsibility of the physician to determine the incompatibility
of an additive medicinal product with respect to the Sodium Chloride
Grifols 0.9% w/v and the container by monitoring any discoloration and/or
formation of precipitates, insoluble complexes or crystals. The Instructions
for Use of the medication to be added must be consulted.
Before adding a medicinal product, verify it is soluble and stable in water
at the pH of Sodium Chloride Grifols 0.9% w/v.
When introducing additives to sodium chloride 0.9% solution as well as
administering the solution, aseptic technique must be used.
Mix the solution thoroughly when additives have been introduced.
When a compatible medication is added to Sodium Chloride Grifols 0.9% w/v,
the solution must be administered immediately. Do not store solutions
containing additives.
This medicinal product is physically incompatible with amphotericin B, an
antifungal chemotherapic agent.
This medicinal product must not be mixed with other medicinal products
unless their compatibility is verified.
Because of the administration technique, extravasation and/or
thrombophlebitis may occur during intravenous infusion (see section 4).
In these cases, intravenous infusion should be stopped and appropriate
therapeutic measures should be instituted. Possible signs of inflammation
at the injection site must be checked periodically.
P-6
Laboratorios Grifols, S.A. Can Guasch, 2 - Parets del Vallès 08150 Barcelona - SPAIN

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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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