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STERILE SODIUM CHLORIDE CONCENTRATE 30% W/V BP

Active substance(s): SODIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sterile Sodium Chloride Concentrate BP 30% w/v
(Concentrate for Solution for Infusion)
Sodium Chloride
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, please ask your doctor or nurse.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Sterile Sodium Chloride Concentrate is and what it is used for
Before you are given Sterile Sodium Chloride Concentrate
How Sterile Sodium Chloride Concentrate will be given
Possible side effects
How to store Sterile Sodium Chloride Concentrate
Further information

1. What Sterile Sodium Chloride Concentrate is
and what it is used for
Sodium Chloride belongs to a group of medicines called electrolytes.
The balance of the electrolytes in the body is essential for normal
function of our cells and our organs.
Sterile Sodium Chloride Concentrate, when diluted, is used to put
electrolytes back into your body. Electrolytes are lost through too
much sweating, prolonged diarrhoea or vomiting. This can
eventually lead to excess water loss from the body (dehydration).

2. Before you are given Sterile Sodium Chloride
Concentrate
You should not be given Sterile Sodium Chloride Concentrate if:
• you are allergic (hypersensitive) to sodium chloride
• you suffer from liver or kidney problems
• you suffer from heart disease or other heart problems
• you suffer from high blood pressure
• you are suffering from a serious complication of pregnancy
known as pre-eclampsia
• you suffer from water retention
• you are taking any sodium-retaining drugs such as corticosteroids,
non- steroidal anti-inflammatory drugs or carbenoxolone.
If you are unsure about being given this medicine or you have any
questions, talk to your doctor or nurse.
Take special care with Sterile Sodium Chloride Concentrate if:
• you suffer from water on the lungs (peripheral and pulmonary
oedema)
Special care should be taken when Sterile Sodium Chloride
Concentrate is given to children and the elderly.
If any of the above apply to you or your child please tell your doctor
before you are given Sterile Sodium Chloride Concentrate.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Medicines which are not compatible with Sterile Sodium Chloride
Concentrate include:
• streptomycin sulphate, a medicine used to treat tuberculosis
and other bacterial infections
• medicines that retain sodium such as corticosteroids, nonsteroidal anti-inflammatory drugs or carbenoxolone
If you have any doubts about whether this medicine should be
administered to you, consult your doctor or nurse.
Pregnancy and breast-feeding
Sterile Sodium Chloride Concentrate is usually suitable for use whilst
you are pregnant or breast-feeding however you should ask your
doctor for advice before you are given this medicine.
Driving and using machines
There are no known effects of having Sterile Sodium Chloride
Concentrate on driving or using machines.

3. How Sterile Sodium Chloride Concentrate will be
given
Adults, the elderly and children:
Your doctor will decide the amount of Sterile Sodium Chloride
Concentrate you need depending on your age, weight and general
health. You will be given Sterile Sodium Chloride Concentrate into a
vein (intravenously), once it has been diluted, as an infusion (drip).
If you think you have been given too much Sterile Sodium
Chloride Concentrate.
As this medicine will be given to you whilst you are in hospital, it is
unlikely that you will be given too little or too much, however, tell
your doctor or nurse if you have any concerns.

4. Possible side effects
Like all medicines, Sterile Sodium Chloride Concentrate can cause
side effects, although not everybody gets them.
Possible side effects include:
• feeling or being sick
• stomach pains
• diarrhoea
• a dry mouth, throat or eyes
• feeling thirsty
• sweating
• fever
• a fast or irregular heartbeat
• high or low blood pressure
• kidney problems
• water on the lungs
• water retention
• breathing difficulties
• headache
• dizziness
• feeling restless or irritable
• feeling weak
• muscle twitching and stiffness
• fits
Rarely you may experience:
• feeling sleepy or confused
• fits
• breathing difficulties
These are signs that you have too much sodium in your body. If you
experience any of these side effects you should tell your doctor or
nurse immediately.
Infants may experience the following side effects:
• fits
• breathing quickly
• flared nostrils (caused by difficulty breathing)
• coma
If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or nurse.
Continued overleaf

TECHNICAL LEAFLET

C*****

Sterile Sodium Chloride Concentrate BP 30% w/v
(Concentrate for Solution for Infusion)
Sodium Chloride
Qualitative and Quantitative Composition
Sodium Chloride 300mg per ml 15 g in 50ml.
The solution is equivalent to approximately 5.13 mmol/ml of sodium
ions. The solution is equivalent to approximately 5.13 mmol/ml of
chloride ions.
Pharmaceutical Form
Concentrate for solution for infusion
CLINICAL PARTICULARS
Therapeutic Indications
Concentrated sodium chloride Injection is used for rehydration only
when diluted. Before administration, the concentrated sodium
chloride injection must be diluted and thoroughly mixed with a
larger volume of fluid.
When a concentration of 3 or 5% are indicated, the solutions should
be administered into a large vein, at a rate not exceeding 100ml/hr.
Sodium chloride 0.9% injections are often used as diluents for the
infusion of drug additives, and 0.9% solutions of sodium chloride are
widely used for sterile irrigation and dilution purposes.
Posology and Method of Administration
Adults, children and the elderly: The concentration and dosage of
sodium chloride solutions for intravenous use is determined by
several factors including the age, weight and clinical condition of the
patient. The usual sodium chloride requirements for adults can be
satisfied by infusion of the equivalent of 1L of sodium chloride
0.9% daily.
Concentrated sodium chloride injection should be sufficiently diluted
to give an isotonic solution.
Adults, Children and the Elderly:
The concentration and dosage of sodium chloride solutions for
injection into a vein (intravenous) is determined by several factors
including the age, weight and clinical condition of the patient.
The usual sodium and chloride requirements for adults can be
satisfied by infusion of the equivalent of 1L of sodium chloride 0.9%
daily.
Contra-indications
Disease states with an already expanded extracellular fluid volume
and those with the inability to excrete sodium rapidly due to kidney
dysfunction. Sodium chloride is contraindicated in cir rhosis of the
liver, congestive heart failure, nephrotic syndrome, acute renal
failure, ischaemic heart disease, hypertension, including preeclampsia and patients on sodium-retaining drugs e.g
corticosteroids, non-steroidal anti-inflammatory drugs or
carbenoxolone.
Special Warnings and Precautions for Use
Caution hypertonic solution, dilute before use.
Restrict intake in impaired renal function, cardiac failure,
hypertension, peripheral and pulmonary oedema, and toxaemia of
pregnancy. Care should be taken when administering sodium
chloride intravenously to very young children and the elderly.
Interactions with other Medicaments and other forms of
Interaction
Streptomycin sulphate is incompatible with sodium chloride.
Pregnancy and Lactation
Use of sodium chloride in pregnancy and lactation is usually safe,
after suitable dilution. Considerable caution must be exercised if
used in pre eclampsia.
Effects on Ability to Drive and Use Machines
Not applicable.
Undesirable Effects
Excessive amounts of Sodium may produce Hypernatraemia i.e. an
abnormally high sodium concentration in the blood, causing
dehydration of the brain which causes somnolence and confusion
progressing to convulsions, respiratory failure, coma and death.
Other symptoms may include nausea, vomiting, diarrhoea,
abdominal cramps, thirst, reduced salivation and lachrymation,
sweating, fever, tachycardia, hypertension, hypotension and also
possible loss of bicarbonate with an acidifying effect on the body,
renal failure, peripheral and pulmonary oedema, headache, dizziness,
restlessness, irritability, weakness, muscular twitching and rigidity.

5. How to store Sterile Sodium Chloride
Concentrate
Keep out of the reach and sight of children.
You should not be given Sterile Sodium Chloride Concentrate after
the expiry date which is printed on the carton and vial label. The
doctor or nurse will check that the expiry date on the label has not
passed before giving the injection to you. The expiry date refers to
the last day of that month.
There are no special storage instructions for this medicine.

6. Further Information
What Sterile Sodium Chloride Concentrate contains
The active substance is sodium chloride 15g/50ml (approximately
5.13mmol/ml of sodium ions and 5.13mmol/ml or chloride ions).
The other ingredient is water for injections.
What Sterile Sodium Chloride Concentrate looks like and
contents of the pack
Sterile Sodium Chloride Concentrate is a clear, colourless solution
supplied in a 50ml clear glass vial with a rubber stopper and
aluminium overseal.
Marketing Authorisation Holder
Aurum Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
RM3 8UG
UK
Manufacturer
Burton Hospital NHS Trust, Belvedere Road, Burton on Trent,
DE13 0RB, United Kingdom.
If you would like any more information, or you would like the leaflet
in a different format, please contact Medical Information at the
above address.
Product licence number:
PL 12064/0021
Leaflet approved: xx/xxxx
Date of revision: December 2007

Also, excessive amounts of sodium may produce without
hypernatraemia an increase in the total sodium and water content of
the body associated with the expansion of the extra cellular fluid
compartment (oedema) which may effect the cerebral, pulmonary or
peripheral systems. Infants may appear not to be severely
dehydrated but coma and convulsions may persist due to vascular
injury. They may show respiratory distress with tachypnoea and
flaring nostrils.
Intra-amniotic injection of hypertonic solution of sodium chloride
can lead to serious adverse affects including disseminated
intravascular coagulation, renal necrosis, cervical and uterine lesions,
haemor rhage, pulmonary embolism, pneumonia and death.
Pseudohyponatremia can occur where spuriously low concentrations
of sodium are found in association with high concentration of lipids
and proteins present in the plasma. This may occur in patients with
diabetes mellitus resulting in false readings for plasma sodium
concentration.
Overdose
Overdose can result from excessive intravenous administration or
accidental ingestion of contents. In the event of recent acute
ingestion of sodium chloride, induction of emesis or gastric lavage
should be carried out along with general symptomatic and
supportive treatment. Dialysis may be necessary if there is significant
renal impairment the patient is moribund, or if the serum sodium
concentration is greater than 200mmol/L. Serum electrolyte levels
need to be monitored and any imbalance corrected.
Pharmacological Properties
The body contains about 4 mol of sodium of which about one third is
found in the skeleton and approximately half is present in
extracellular fluid. The body can adapt to a wide range of intakes by
adjustment of renal excretion through physical and hormonal
factors.
Pharmacokinetic Properties
Sodium chloride is well absorbed from the gastrointestinal tract.
Sodium is predominately excreted by the kidney, but there is
extensive renal reabsorption. Small amounts of sodium are lost in the
faeces and sweat.
Preclinical Safety Data
No further data is available additional to that included in previous
sections of this Technical Leaflet.
Pharmaceutical Particulars
List of Excipients
Water for Injections.
Incompatibilities
The compatibility of sodium chloride with potential diluents should
be confirmed before use. The addition of sodium chloride to
mannitol 20 to 25% may cause precipitation of the mannitol.
Shelf Life
24 months. The contents of the vial should be used immediately after
first opening.
Special Precautions for Storage
Not Applicable
Nature and Contents of Container
50ml TYPE 1 CLEAR GLASS VIAL with A HALOBUTYL ELASTOMER
RUBBER STOPPER and ALUMINIUM OVERSEAL
Instruction for Use/Handling
Discard any unused solution immediately after first use. Solutions
containing visible solid particles should not be used. Don’t use the
product if the packaging is damaged.

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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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