Sodium chloride 30% concentrate for solution for infusion 10ml ampoules

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Sodium chloride
Available from:
Torbay Pharmaceuticals
ATC code:
B05XA03
INN (International Name):
Sodium chloride
Dosage:
300mg/1ml
Pharmaceutical form:
Solution for infusion
Administration route:
Intravenous
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF:
Authorization number:
PL 13079/0007

Read the complete document

Patient Information Leaflet

Sodium Chloride 30% w/v Concentrate for Solution for Infusion

Please read this leaflet carefully before you start using this medicine.

Keep this leaflet in a safe place, you may wish to read it again.

If you have any questions or are not sure about anything, ask your

doctor or pharmacist.

If any side effect 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 Sodium Chloride Concentrate for Solution for Infusion is and what

it is used for

2.

Before you are given Sodium Chloride Concentrate for Solution for Infusion

3.

How Sodium Chloride Concentrate for Solution for Infusion is used

4.

Possible Side Effects

5.

How to store Sodium Chloride Concentrate for Solution for Infusion

6.

Further Information

1. What Sodium Chloride Concentrate for Solution for Infusion is and what it is

used for

This medicine is a concentrated electrolyte solution for infusion into a large vein. When

diluted and mixed thoroughly with another fluid it is used for rehydration.

2. Before you are given Sodium Chloride Concentrate for Solution for Infusion

This medicine should NOT BE USED if you:

Have suffered with heart disease

Have suffered with high blood pressure

Have suffered with diabetes mellitus

Check with your doctor if you are concerned about any of the above.

This medicine should be used with care:

If you are suffering from congestive heart failure

If you have problems with your kidneys

If you have suffered from pulmonary oedema (fluid on the lungs)

If you have suffered from pre-eclampsia (high blood pressure associated with pregnancy)

If you have suffered from peripheral oedema (swelling of hands and feet)

If you have high blood pressure, swelling and protein in the urine during the last 3 months

of pregnancy (toxaemia of pregnancy)

In children

In the elderly

Check with your doctor if you are concerned about any of the above.

Before giving this medicine, the doctor will check if you are taking any other medication,

particularly Streptomycin.

3. How Sodium Chloride Concentrate for Solution for Infusion is used

The doctor will decide what dose of this medicine you should be given. Check the label

carefully. If you are not sure, ask your doctor, nurse or pharmacist.

This medicine is a concentrated solution and must be diluted before administration by

infusion into a large vein at a rate not exceeding 100mL/hr. Doses will be adjusted by the

doctor, but the usual Sodium Chloride requirements for an adult can be satisfied by infusion

of the equivalent of 1 litre of Sodium Chloride 0.9% w/v daily.

If a dose of this medicine is not given at the correct time – the dose should be given as

soon as remembered. The next dose should be given at the usual time. A double dose

should not be given.

If more of this medicine is given than should be – tell your doctor as soon as possible. If

you are a medical practitioner administering this medicine please refer to the Summary of

Characteristics.

4. Possible side effects

As with all medicines, there may be some side effects with this medicine.

The most common side effects are:

Nausea or vomiting

Diarrhoea

Stomach cramps

Dry mouth or stuffy nose

Sweating and high temperature (fever)

Low blood pressure when standing. This may make you feel dizzy or faint

Kidney failure

Fluid on the lungs

Headache

Rapid heart beat

Feeling weak

Restlessness or irritability

Very rare side effects are:

Muscular twitching

Convulsions

Respiratory arrest

Coma

Tell your doctor, nurse or pharmacist immediately if you think you have any of these

or other problems.

Reporting Side Effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any

possible side effects not listed in this leaflet. You can also report side effects directly via the

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can

help provide more information on the safety of this medicine

5. How to store Sodium Chloride Concentrate for Solution for Infusion

This medicine has an expiry date printed on the ampoule, vial and carton. Before use the

doctor or nurse will check that the medicine has not passed this date and the medicine does

not show signs of deterioration. The expiry date refers to the last day of the month.

Store this medicine below 25°C.

Store this medicine in a safe place where children cannot see or reach it.

6. Further information

What this medicine contains:

The active ingredient is Sodium Chloride.

It also contains the inactive ingredient Water for Injections.

What this medicine looks like and contents of pack:

This medicine is a clear and colourless solution. This medicine is available in a 10mL

ampoule containing 3g of Sodium Chloride; a 50mL vial containing 15g Sodium Chloride and

a 100mL vial containing 30g Sodium Chloride. The medicine is packed into cartons

containing 10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may be available at the

same time.

Marketing Authorisation Holder: Torbay and South Devon NHS Foundation Trust,

Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon, TQ4 7FG

Sites of Manufacture:

Torbay and South Devon NHS Foundation Trust

Torbay Pharmaceuticals

Wilkins Drive

Paignton

Devon

TQ4 7FG

This leaflet was last revised in: 02/2017

PL 13079/0007

PIL/7/5

Additional information for Healthcare Professionals

(as stated on the Summary of Product Characteristics)

Therapeutic Indications

The product is used for rehydration only when diluted. Before administration, the

concetrate must be diluted and thoroughly mixed with a larger volume of fluid.

Posology and Method of Administration

When concentrations of 3 and 5% w/v are indicated, the solution should be administered

into a large vein, at a rate not exceeding 100mL per hour.

Adults, Children and the elderly

Concentration and sodium chloride dosage for intravenous use are determined by several

factors, including 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 1 litre of

sodium chloride 0.9% w/v daily.

Sodium Chloride 30% w/v Concentrate for Solution for Infusion should be diluted sufficiently

to obtain an isotonic (0.9% w/v) solution. An isotonic solution can be prepared by diluting

30mL Sodium Chloride 30% w/v Concentrate for Solution for Infusion to 1 litre with a

non-electrolyte solution or water for injections.

Sodium Chloride 0.9% w/v injections are often used as diluents for the infusion of drug

additives, and 0.9% w/v solutions of sodium chloride are widely used for sterile irrigation and

dilution purposes.

Incompatibilities

Streptomycin sulfate is stated to be incompatible with sodium chloride. The addition of

sodium chloride to mannitol 20 - 25% may cause precipitation of the mannitol.

As with all parenteral concentrate solutions, incompatibility of diluting fluids with the

concentrate should be assessed before addition. In the absence of compatibility studies, this

concentrate must not be mixed with other medicinal products.

Patient Information Leaflet

Sodium Chloride 30% w/v Concentrate for Solution for Infusion

Please read this leaflet carefully before you start using this medicine.

Keep this leaflet in a safe place, you may wish to read it again.

If you have any questions or are not sure about anything, ask your

doctor or pharmacist.

If any side effect 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 Sodium Chloride Concentrate for Solution for Infusion is and what

it is used for

2.

Before you are given Sodium Chloride Concentrate for Solution for Infusion

3.

How Sodium Chloride Concentrate for Solution for Infusion is used

4.

Possible Side Effects

5.

How to store Sodium Chloride Concentrate for Solution for Infusion

6.

Further Information

1. What Sodium Chloride Concentrate for Solution for Infusion is and what it is

used for

This medicine is a concentrated electrolyte solution for infusion into a large vein. When

diluted and mixed thoroughly with another fluid it is used for rehydration.

2. Before you are given Sodium Chloride Concentrate for Solution for Infusion

This medicine should NOT BE USED if you:

Have suffered with heart disease

Have suffered with high blood pressure

Have suffered with diabetes mellitus

Check with your doctor if you are concerned about any of the above.

This medicine should be used with care:

If you are suffering from congestive heart failure

If you have problems with your kidneys

If you have suffered from pulmonary oedema (fluid on the lungs)

If you have suffered from pre-eclampsia (high blood pressure associated with pregnancy)

If you have suffered from peripheral oedema (swelling of hands and feet)

If you have high blood pressure, swelling and protein in the urine during the last 3 months

of pregnancy (toxaemia of pregnancy)

In children

In the elderly

Check with your doctor if you are concerned about any of the above.

Before giving this medicine, the doctor will check if you are taking any other medication,

particularly Streptomycin.

3. How Sodium Chloride Concentrate for Solution for Infusion is used

The doctor will decide what dose of this medicine you should be given. Check the label

carefully. If you are not sure, ask your doctor, nurse or pharmacist.

This medicine is a concentrated solution and must be diluted before administration by

infusion into a large vein at a rate not exceeding 100mL/hr. Doses will be adjusted by the

doctor, but the usual Sodium Chloride requirements for an adult can be satisfied by infusion

of the equivalent of 1 litre of Sodium Chloride 0.9% w/v daily.

If a dose of this medicine is not given at the correct time – the dose should be given as

soon as remembered. The next dose should be given at the usual time. A double dose

should not be given.

If more of this medicine is given than should be – tell your doctor as soon as possible. If

you are a medical practitioner administering this medicine please refer to the Summary of

Characteristics.

4. Possible side effects

As with all medicines, there may be some side effects with this medicine.

The most common side effects are:

Nausea or vomiting

Diarrhoea

Stomach cramps

Dry mouth or stuffy nose

Sweating and high temperature (fever)

Low blood pressure when standing. This may make you feel dizzy or faint

Kidney failure

Fluid on the lungs

Headache

Rapid heart beat

Feeling weak

Restlessness or irritability

Very rare side effects are:

Muscular twitching

Convulsions

Respiratory arrest

Coma

Tell your doctor, nurse or pharmacist immediately if you think you have any of these

or other problems.

Reporting Side Effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any

possible side effects not listed in this leaflet. You can also report side effects directly via the

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can

help provide more information on the safety of this medicine

5. How to store Sodium Chloride Concentrate for Solution for Infusion

This medicine has an expiry date printed on the ampoule, vial and carton. Before use the

doctor or nurse will check that the medicine has not passed this date and the medicine does

not show signs of deterioration. The expiry date refers to the last day of the month.

Store this medicine below 25°C.

Store this medicine in a safe place where children cannot see or reach it.

6. Further information

What this medicine contains:

The active ingredient is Sodium Chloride.

It also contains the inactive ingredient Water for Injections.

What this medicine looks like and contents of pack:

This medicine is a clear and colourless solution. This medicine is available in a 10mL

ampoule containing 3g of Sodium Chloride; a 50mL vial containing 15g Sodium Chloride and

a 100mL vial containing 30g Sodium Chloride. The medicine is packed into cartons

containing 10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may be available at the

same time.

Marketing Authorisation Holder: Torbay and South Devon NHS Foundation Trust,

Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon, TQ4 7FG

Sites of Manufacture:

Torbay and South Devon NHS Foundation Trust

Torbay Pharmaceuticals

Wilkins Drive

Paignton

Devon

TQ4 7FG

This leaflet was last revised in: 02/2017

PL 13079/0007

PIL/7/5

Additional information for Healthcare Professionals

(as stated on the Summary of Product Characteristics)

Therapeutic Indications

The product is used for rehydration only when diluted. Before administration, the

concetrate must be diluted and thoroughly mixed with a larger volume of fluid.

Posology and Method of Administration

When concentrations of 3 and 5% w/v are indicated, the solution should be administered

into a large vein, at a rate not exceeding 100mL per hour.

Adults, Children and the elderly

Concentration and sodium chloride dosage for intravenous use are determined by several

factors, including 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 1 litre of

sodium chloride 0.9% w/v daily.

Sodium Chloride 30% w/v Concentrate for Solution for Infusion should be diluted sufficiently

to obtain an isotonic (0.9% w/v) solution. An isotonic solution can be prepared by diluting

30mL Sodium Chloride 30% w/v Concentrate for Solution for Infusion to 1 litre with a

non-electrolyte solution or water for injections.

Sodium Chloride 0.9% w/v injections are often used as diluents for the infusion of drug

additives, and 0.9% w/v solutions of sodium chloride are widely used for sterile irrigation and

dilution purposes.

Incompatibilities

Streptomycin sulfate is stated to be incompatible with sodium chloride. The addition of

sodium chloride to mannitol 20 - 25% may cause precipitation of the mannitol.

As with all parenteral concentrate solutions, incompatibility of diluting fluids with the

concentrate should be assessed before addition. In the absence of compatibility studies, this

concentrate must not be mixed with other medicinal products.

Read the complete document

Object 1

Sodium Chloride 30%w/v Concentrate for

Solution for Infusion

Summary of Product Characteristics Updated 21-Sep-2017 | Torbay & South Devon NHS Foundation

Trust

1. Name of the medicinal product

Sodium Chloride 30% w/v Concentrate for Solution for Infusion

2. Qualitative and quantitative composition

Sodium chloride 300mg per mL (5mmol per mL)

The product is available as:

Sodium chloride 3g/10mL ampoules

Sodium chloride 15g/50mL vials.

Sodium chloride 30g/100mL vials.

For excipients, see 6.1.

3. Pharmaceutical form

Concentrate for solution for infusion. The product is a sterile, clear, colourless solution.

4. Clinical particulars

4.1 Therapeutic indications

The product is used for rehydration only when diluted. Before administration, the concentrate must be

diluted and thoroughly mixed with a larger volume of fluid.

4.2 Posology and method of administration

When concentrations of 3 and 5% w/v are indicated, the solution should be administered into a large vein,

at a rate not exceeding 100mL per hour.

Adults, Children and the elderly

Concentration and sodium chloride dosage for intravenous use are determined by several factors,

including 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 1 litre of sodium chloride 0.9% w/v daily.

Sodium Chloride 30% w/v Concentrate for Solution for Infusion should be diluted sufficiently to obtain

an isotonic (0.9% w/v) solution. An isotonic solution can be prepared by diluting 30 mL Sodium Chloride

30% w/v Concentrate for Solution for Infusion to 1 litre with a non-electrolyte solution or water for

injections.

Sodium Chloride 0.9% w/v injections are often used as diluents for the infusion of drug additives, and

0.9% w/v solutions of sodium chloride are widely used for sterile irrigation and dilution purposes.

4.3 Contraindications

Caution: Sodium Chloride 30% w/v Concentrate for Solution for Infusion is a hypertonic solution, and

should be diluted before use.

4.4 Special warnings and precautions for use

Sodium chloride should be administered with caution to patients with congestive heart failure, peripheral

or pulmonary oedema, impaired renal function or pre-eclampsia. Care should also be taken when

administering sodium chloride intravenously to very young or elderly patients. Excessive administration

may result in hypokalaemia and should be avoided.

Pseudohyponatraemia, a condition where spuriously low concentrations of sodium are found, occurs

when a high concentration of solid matter (such as lipids and protein) are present in the plasma. This

condition has been reported in patients with diabetes mellitus. False reading for plasma concentrations

may be obtained as sodium is present only in the aqueous phase of plasma. Correct values are obtained by

referring the concentration to plasma water, in order to avoid unnecessary, and possibly dangerous,

treatment with sodium chloride.

Only use the solution if it is particle free.

4.5 Interaction with other medicinal products and other forms of interaction

See section 6.2. for streptomycin incompatibility.

4.6 Pregnancy and lactation

It is safe to use in pregnancy and lactation after risk assessment.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

The following general adverse effects may occur due to excess sodium chloride in the body: nausea,

vomiting, diarrhoea, abdominal cramps, thirst, reduced salivation and lachrymation, sweating, fever,

hypotension, tachycardia, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache,

dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and

death. Excess chloride in the body may cause a loss of bicarbonate with an acidifying effect.

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 solutions of sodium chloride can lead to serious adverse effects

such as disseminated intravascular coagulation, renal necrosis, cervical and uterine lesions, haemorrhage,

pulmonary embolism, pneumonia and death.

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 the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.

4.9 Overdose

Excessive administration of sodium chloride causes hypernatraemia, the most serious effect of which is

dehydration of internal organs, especially the brain, which may lead to thrombosis and haemorrhage.

Normal serum-sodium concentrations should be carefully restored at a rate not exceeding 10-15mmol per

day by administration of hypotonic saline solutions intravenously.

Dialysis may be necessary if there is a significant renal impairment, the patient is moribund, or if the

serum-sodium concentration is greater than 200mmol per litre. Serum electrolyte levels need to be

monitored and any imbalance corrected.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group (ATC code): Electrolyte solutions B05X A03

Sodium is the principal cation in the extracellular fluid and is the main osmotic component in the control

of blood volume.

5.2 Pharmacokinetic properties

The body contains 40 - 60mmol of sodium per kg body weight, approximately 40% of which is found in

the skeleton. The normal concentration range for extracellular fluid is 135 - 154mmol per litre. The

intracellular sodium concentration is about 5 - 10mmol per litre.

There are between 0.1 - 1.0% chloride irons in the body, contained in extracellular fluid surrounding the

nerve cell and in gastric juices. 0.6% is found in the urine.

5.3 Preclinical safety data

There are no additional data of significance to the prescriber.

6. Pharmaceutical particulars

6.1 List of excipients

Water for Injections.

6.2 Incompatibilities

Streptomycin sulfate is stated to be incompatible with sodium chloride.

The addition of sodium chloride to mannitol 20 - 25% may cause precipitation of the mannitol.

As with all parenteral concentrate solutions, incompatibility of diluting fluids with the concentrate should

be assessed before addition. In the absence of compatibility studies, this concentrate must not be mixed

with other medicinal products.

6.3 Shelf life

3 years

Discard any unused solution immediately after first use.

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

Store below 25°C.

6.5 Nature and contents of container

Colourless type 1 glass ampoules containing 10mL and colourless type 1 glass vials containing 50mL and

100mL of solution. Vials are closed with bromobutyl rubber stoppers and sealed with aluminium tamper-

proof flip-top seals. The product is packed into cartons containing 10 ampoules, 1 vial or 10 vials. Both

pack sizes of vials may not be available at the same time.

6.6 Special precautions for disposal and other handling

Sodium Chloride 30% w/v Concentrate for Solution for Infusion is a concentrate.

Once opened the product should be used immediately and any unused drug discarded.

This product must be diluted before administration (see section 4.2.).

7. Marketing authorisation holder

Torbay and South Devon NHS Foundation Trust,

Torbay Pharmaceuticals,

Wilkins Drive,

Paignton,

Devon, TQ4 7FG

8. Marketing authorisation number(s)

PL 13079/0007

9. Date of first authorisation/renewal of the authorisation

22 /10/2004 / 21/10/2009

10. Date of revision of the text

08/2017

SPC/7/5

Company Contact Details

Torbay & South Devon NHS Foundation Trust

Address

Wilkins Drive, Paignton, TQ4 7FG

Telephone

+44 (0)1803 660000

Medical Information Direct Line

+44 (0)7824 889143

Customer Care direct line

+44 (0)1803 664707

Stock Availability

+44 (0)1803 664707

http://www.torbaypharmaceuticals.nhs.uk

+44 (0)1803 664354

Medical Information e-mail

[email

protected]

Medical Information Fax

+44 (0)1803 664 354

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