Patient leaflet - Sodium Chloride 0.9% and Glucose 5% solution for infusion BP
1. What Sodium Chloride 0.9
& Glucose 5 Infusion is and what it is used for
Sodium Chloride 0.9 & Glucose 5 Infusion is a solution of the following substances in water: • sugar (glucose)
- sodium chloride (salt)
Glucose is one of the body’s sources of energy. This solution for infusion provides 200 kilocalories per litre.
Sodium and chloride are chemical substances found in the blood.
Sodium Chloride 0.9 & Glucose 5 Infusion is used: • as a source of carbohydrate (sugar) • to treat a loss of sodium from the blood and the body (sodium depletion)
- to treat a loss of body water, for example after being sick or having diarrhoea (extracellular dehydration)
- to treat you, if the volume of blood in your blood vessels is low (hypovolaemia)
2. What you need to know before you are given Sodium Chloride 0.9 & Glucose 5 Infusion
Do NOT receive Sodium Chloride 0.9 & Glucose 5 Infusion if you are suffering from any of the following conditions
- when you know you are allergic to the product • when there is too much fluid
Read all of thi are given this important info
Keep this l
again.
If you have
doctor or n • If you get a
or nurse. T effects not This medicine w/v & Glucose but will be refe Glucose 5 Infu this leaflet.
s leaflet carefully before you medicine because it contain rmation for you.
eaflet. You may need to read
any further questions, ask y urse.
ny side effects, talk to your his includes any possible sid listed in this leaflet. See sec is called ‘Sodium Chloride 0. 5% w/v Solution for Infusion rred to as ‘Sodium Chloride 0 sion’ throughout the remaind
Sodium Chloride 0.9 & Glucose 5 Infusion can be used during breastfeeding.
If another medicine is to be added to your solution for infusion during pregnancy or breast-feeding you should:
- consult your doctor
- read the Package Leaflet of the medicine that is to be added.
Driving and using machines
Sodium Chloride 0.9 & Glucose 5 Infusion does not affect your ability to drive or use machines.
3. How you will be given Sodium Chloride 0.9 & Glucose 5 Infusion
You will be given Sodium Chloride 0.9 & Glucose 5 Infusion by a doctor or nurse. Your doctor will decide on how much you need and when it is to be given. This will depend on your age, weight, condition and the reason for treatment. The amount you are given may also be affected by other treatments you are receiving.
You should NOT be given Sodium Chloride 0.9 & Glucose 5 Infusion if there are particles floating in the solution or if the pack is damaged in any way.
Sodium Chloride 0.9 & Glucose 5 Infusion will usually be given to you through a plastic tube attached to a needle in a vein. However, your doctor may use another method to give you the medicine.
Any unused solution should be thrown away. You should NOT be given an infusion of Sodium Chloride 0.9 & Glucose 5 Infusion from a bag that has been partly used.
Before and during the infusion, your doctor will monitor:
- the amount of fluid in your body
the acidity of your blood and urine • the amount of electrolytes in your body
(particularly sodium, in patients with high levels of the hormone vasopressin, or are taking other medicines which increase the effects of vasopressin).
If you receive more Sodium Chloride 0.9 & Glucose 5 Infusion than you should
If you are given too much Sodium Chloride 0.9 & Glucose 5 Infusion (over-infusion) or if it is given too fast, this may lead to the following symptoms: • high levels of sugar in the blood
(hyperglycaemia) Symptoms include: - dry mouth due to lack of water in body
tissues (dehydration)
- thirst
- fatigue
frequent urination due to increased urine
production (osmotic diuresis)
- blurred vision
low levels of sodium in the blood
(hyponatraemia). Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain (cerebral oedema) and death
high blood levels of sodium (hypernatraemia).
If this occurs, the most serious effect is a reduction in the water content of the brain (dehydration of the brain). This causes drowsiness and confusion and may lead to fits (convulsions), unconsciousness (coma), stopping breathing (respiratory failure) and even death.
Other symptoms include:
- thirst
- dry mouth and eyes
- fever
- rapid heart rate (tachycardia) - high blood pressure (hypertension) - headache
- dizziness
- restlessness
- irritability
- weakness.
build-up of fluid in the body causing swelling
(oedema).
If you develop any of these symptoms you must inform your doctor immediately. Your infusion will be stopped and you will be given treatment depending on the symptoms.
If a medicine has been added to your Sodium Chloride 0.9 & Glucose 5 Infusion before over-infusion occurs, that medicine may also cause symptoms. You should read the Package Leaflet
of the added medicine for a list of possible symptoms.
Stop receiving your Sodium Chloride 0.9 & Glucose 5 Infusion
Your doctor will decide when to stop giving you this infusion.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, Sodium Chloride 0.9 & Glucose 5 Infusion can cause side effects, although not everybody gets them.
The side effects can be related to Sodium Chloride 0.9 & Glucose 5 Infusion itself. This includes: • hypersensitivity reactions, including a serious allergic reaction called anaphylaxis (potential manifestation in patients with allergy to corn) • higher levels of sodium in the blood than normal (hypernatraemia)
- higher levels of sugar in the blood than normal (hyperglycaemia)
- low levels of sodium in the blood that may be acquired during hospitalization (nosocomial hyponatraemia) and related neurological disorders (acute hyponatremic encephalopathy). Hyponatraemia can lead to irreversible brain injury and death due to cerebral oedema/swelling (see also section 2 “Warnings and precautions”).
The side effects can be related to the administration technique. This includes: • fever (febrile response)
- chills
- itching (pruritus) or rash
- local pain or reaction (pain or vesicles at the site of infusion)
- irritation and inflammation of the vein into which the solution is infused (phlebitis). This can cause redness, pain or burning and swelling along the path of the vein into which the solution is infused.
If a medicine has been added to the solution for infusion, the added medicine may also cause side effects. These side effects will depend on the medicine that has been added.
You should read the Package Leaflet of the added medicine for a list of possible symptoms. 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. If any side effects occur, the infusion must be stopped.
You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom:
Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
Ireland:
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
5. How to store Sodium Chloride 0.9 & Glucose 5 Infusion
Keep this medicine out of the sight and reach of children.
Sodium Chloride 0.9 & Glucose 5 Infusion does not require special storage conditions.
Sodium Chloride 0.9 & Glucose 5 Infusion should NOT be given to you after the expiry date which is stated on the bag after EXP. The expiry date refers to the last day of that month.
You should not be given Sodium Chloride 0.9 & Glucose 5 Infusion, if there are particles floating in the solution or if the unit is damaged in any way.
6. Contents of the pack and other information
What Sodium Chloride 0.9 & Glucose 5 Infusion contains
The active substances are:
sugar (glucose): 50 g per litre
- sodium chloride: 9 g per litre
The only other ingredient is water for injections.
What Sodium Chloride 0.9 & Glucose 5 Infusion looks like and contents of the pack
Sodium Chloride 0.9 & Glucose 5 Infusion is a clear solution, free from visible particles. It is supplied in polyolefin/polyamide plastic bags (Viaflo). Each bag is wrapped in a sealed, protective, outer plastic overpouch.
The bag sizes are:
- 250 ml
- 500 ml
- 1000 ml
The bags are supplied in cartons. Each carton contains one of the following quantities: • 30 bags of 250 ml
- 20 bags of 500 ml
- 10 bags of 1000 ml
- 12 bags of 1000 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
United Kingdom
Baxter Healthcare Ltd
Caxton Way, Thetford,
Norfolk, IP24 3SE
United Kingdom
Ireland and Malta
Baxter Holding B.V.
Kobaltweg 49,
3542CE Utrecht,
Netherlands
Manufacturers in Great Britain:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital Sabiñanigo
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain
This leaflet was revised May 2025
For information about Sodium Chloride 0.9 & Glucose 5 Infusion or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder:
Tel: +44 (0)01635 206345.
Baxter and Viaflo are trademarks of Baxter International lnc.
Manufacturers In Ireland: Baxter SA
Boulevard René Branquart, 80 7860 Lessines
Belgium
Bieffe Medital Sabiñanigo Ctra de Biescas, Senegüé 22666 Sabiñanigo (Huesca) Spain
immediately and not stored.
Paediatric population
In order to avoid potentially fatal over infusion of intravenous fluids to the neonate, special attention needs to be paid to the method of administration. When using a syringe pump to administer intravenous fluids or medicines to neonates, a bag of fluid should not be left connected to the syringe.
When using an infusion pump all clamps on the intravenous administration set must be closed before removing the administration set from the pump, or switching the pump off. This is required regardless of whether the administration set has an anti free flow device.
The intravenous infusion device and administration equipment must be frequently monitored.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags. 1. Opening
a. Remove the Viaflo container from the overpouch just before use.
b. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. c. Check the solution for limpidity and absence of foreign matters. If solution is not clear or contains foreign matters, discard the solution.
- 2. Preparation for administration
Use sterile material for preparation and administration.
a. Suspend container from eyelet support. b. Remove plastic protector from outlet port at bottom of container:
- grip the small wing on the neck of the port with one hand,
- grip the large wing on the cap with the other hand and twist,
Sodium Chloride 0.9% w/v & Glucose 5% w/v
Solution for Infusion BP The following information is intended for healthcare professionals only:
Handling and Preparation
Use only if the solution is clear, without visible particles and if the container is undamaged. Administer immediately following the insertion of infusion set.
Do not remove unit from overwrap until ready for use.
The inner bag maintains the sterility of the product.
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.
Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. 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. Additives may be introduced before infusion or during infusion through the re-sealable medication port.
When additive is used, verify tonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used 
- the cap will pop off.
c. Use an aseptic method to set up the
infusion.
d. Attach administration set. Refer to
complete directions accompanying set for connection, priming of the set and administration of the solution.
- 3. Techniques for injection of additive medications
Warning: Additives may be incompatible (see Paragraph 5 “Incompatibilities of additive medications” below).
To add medicinal products before administration a. Disinfect medication port.
b. Using syringe with 19 gauge (1.10 mm) to
22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject. c. Mix solution and medication thoroughly. For
high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.
Caution: Do not store bags containing added medications.
To add medication during administration a. Close clamp on the set.
b. Disinfect medication port.
c. Using syringe with 19 gauge (1.10 mm) to
22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject. d. Remove container from IV pole and/or turn
to an upright position.
e. Evacuate both ports by tapping gently while
the container is in an upright position. f. Mix solution and medication thoroughly. g. Return container to in use position, re-open
the clamp and continue administration. 4. In-use shelf-life: Additives
The chemical and physical stability of any additive at the pH of Sodium Chloride 0.9 &
Glucose 5 Infusion in the Viaflo container should be established prior to use.
From a microbiological point of view, the diluted product must 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 dilution has taken place in controlled and validated aseptic conditions. 5. Incompatibilities of additive
medications
As with all parenteral solutions, before adding medications, compatibility of these additives with the solution in Viaflo container must be assessed. It is the responsibility of the physician to judge the incompatibility of an additive medication with the Sodium Chloride 0.9 & Glucose 5 Infusion by checking for eventual colour change and/or eventual appearance of precipitate, insoluble complexes or crystals. The Instructions for Use of the medication to be added must be consulted.
Before adding a drug, verify it is soluble and stable in water at the pH of Sodium Chloride 0.9 & Glucose 5 Infusion (pH 3.5 – 6.5).
When a compatible medication is added to the Sodium Chloride 0.9 & Glucose 5 Infusion, the solution must be administered immediately. As a guidance the following medications are incompatible with the Sodium Chloride 0.9 & Glucose 5 Infusion (non-exhaustive listing): • Ampicillin sodium
- Mitomycin
- Amphotericin B
- Erythromycin lactobionate.
Because of the presence of glucose, Sodium Chloride 0.9 & Glucose 5 Infusion should not be administered through the same infusion equipment as whole blood, as haemolysis and clumping can occur.
Those additives known to be incompatible should not be used.
Baxter and Viaflo are trademarks of Baxter International lnc.