Document: leaflet MAH GENERIC_PL 12064-0052 change

• leaflet MAH GENERIC_PL 01883-0023
• leaflet MAH GENERIC_PL 12064-0052

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leaflet: information for the user    D0243

Sodium Bicarbonate Injection BP 8.4% w/v

Sodium Bicarbonate 8.4% w/v

In this leaflet:

1.    What Sodium Bicarbonate Injection is and what it is used for

2.    Before you are given Sodium Bicarbonate Injection

3.    How Sodium Bicarbonate Injection is given

4.    Possible side effects

5.    How to store Sodium Bicarbonate Injection

6.    Further information

1.    What Sodium Bicarbonate Injection is and what it is used for

Sodium Bicarbonate is one of a group of medicines known as alkalinising agents. It is used to correct the acid-alkaline balance in the body.

This medicine is used to control blood acidity following a heart attack.

2.    Before you are given Sodium Bicarbonate Injection

You should not be given Sodium Bicarbonate Injection if:

•    you are allergic (hypersensitive) to Sodium Bicarbonate or any of the other ingredients of this medicine, listed in section 6 of this leaflet

•    your breathing is faster or deeper than usual (hyperventilation), or slower or more shallow than usual (hypoventilation)

•    you have any blood abnormalities such as high levels of sodium, low levels of calcium, potassium or chloride, or your blood is less acidic than usual (your doctor will need to check this)

•    you are having stomach pains or pain whilst passing urine

•    you are dehydrated

•    you have high blood pressure

•    you have problems with your kidneys

•    you have heart problems

•    you are suffering from eclampsia (a serious complication of pregnancy)

•    you are suffering from swelling caused by excess water retention (oedema)

f any of the above apply to you or your child please tell your doctor or nurse before you are given Sodium Bicarbonate Injection.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have ecently taken any other medicines, including medicines obtained without a prescription, including:

•    corticosteroids or corticotropin (medicines used to reduce swelling or to treat hormone problems)

•    medicines used to treat infections (tetracyclines) such as doxycycline

•    quinidine (a medicine used to treat heart problems)

•    medicines used to treat certain mental disorders and drowsiness

•    ephedrine and pseudoephedrine (medicines used to treat colds and asthma)

•    potassium supplements

•    medicines used to treat water retention and problems with passing urine such as ethacrynic acid, bumetanide or frusemide

•    thiazides (a type of medicine used to treat high blood pressure)

•    lithium (a medicine used to treat a type of depression)

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, or think you may be pregnant or if you are breast-feeding, before being given Sodium Bicarbonate Injection.

Driving and using machines

There are no known effects of having Sodium Bicarbonate Injection on driving or using machines.

Contin ued overleal

3.    How Sodium Bicarbonate Injection is given

Your doctor will give you Sodium Bicarbonate Injection by slow njection into the vein (intravenous injection).

Adults, the elderly and children over 12 years

The usual dose is 1ml per kilogram of bodyweight followed by 0.5ml per kg given every 10 minutes.

Children under 12 years

The usual dose is 1ml per kilogram of bodyweight. In premature babies and newborns the solution should be diluted 1:1 with 5% dextrose solution.

If you think you have been given too much Sodium Bicarbonate Injection

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 if you have any concerns.

4.    Possible side effects

Like all medicines, Sodium Bicarbonate Injection can cause side effects, although not everybody gets them.

Possible side effects include: lower blood acidity than usual lower levels of potassium in the blood than usual very sensitive skin involuntary jerky movements

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.

5.    How to store Sodium Bicarbonate Injection

Keep all medicines out of the reach and sight of children.

This Sodium Bicarbonate Injection should not be used after the expiry date which is printed on the carton and syringe label. The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you. The expiry date refers to the last day of that month.

Do not use if the packaging has been damaged.

Store below 25°C. Store in the original container.

6.    Further Information

What Sodium Bicarbonate Injection contains

The active substance is Sodium Bicarbonate BP 8.4%w/v The other ingredients are nitrogen and water for injections.

What Sodium Bicarbonate Injection looks like and contents of the pack

Sodium Bicarbonate Injection is a clear, colourless solution supplied in a prefilled syringe containing 10ml of the solution.

Marketing Authorisation Holder:

Aurum Pharmaceuticals Ltd

Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, England

Manufacturer:

Federa SC

71 Avenue Jean Jaures Laan, B-1030 Brussels, Belgium

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address

Product licence number: PL 12064/0052 Date of revision: January 2013

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom

Aurum

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TECHNICAL LEAFLET    D00251

Sodium Bicarbonate Injection BP 8.4% w/v

Trade Name of the Medicinal Product

Sodium Bicarbonate 8.4% w/v Injection

Qualitative and Quantitative Composition

Sodium Bicarbonate 8.4% w/v

Pharmaceutical Form

Solution for Injection

CLINICAL PARTICULARS Therapeutic Indications

For the correction of metabolic acidosis associated with cardiac arrest after other resuscitative measures, such as cardiac compression, ventilation, adrenaline and anti arrhythmic agents have been used.

Posology and Method of Administration

For intravenous administration only.

Adults and children over 12 years

The usual dose is Immol/kg (1ml/kg 8.4% solution). Followed by 0.5mmol/kg (0.5ml/kg 8.4% solution) given at 10 minute intervals.

Children under 12 years

The usual dose is Immol/kg (1ml/kg 8.4% solution) by slow iv injection

n premature infants and neonates, a 4.2% solution should be used or the 8.4% solution should be diluted 1:1 with 5% dextrose.

Elderly

As for adults

Contra-indications

Sodium Bicarbonate intravenous infusion is contra-indicated in cases of respiratory and metabolic alkalosis, hypoventilation, aypernatraemia, urinary calculi, potassium and chloride depletion, aypocalcaemia and in situations where supply of sodium is contra-ndicated such as cardiac insufficiency, oedema, hypertension, eclampsia, renal impairment.

Special Warnings and Precautions for Use

Whenever sodium bicarbonate is used intravenously, arterial blood gas analysis, in particular arterial/venous blood pH and carbon dioxide levels, should be performed before and during the course of treatment to minimise the possibility of overdosage and resultant alkalosis. Accidental extravascular injection of hypertonic solutions may cause vascular irritation or sloughing. The use of scalp veins should be avoided. Whenever respiratory acidosis is concomitant with metabolic acidosis, both pulmonary ventilation and perfusion must be adequately supported to get rid of excess CO₂.

Interactions with other Medicaments and other forms of Interaction

Caution should be used when administering sodium ions to patients eceiving corticosteroids and corticotrophin. Urinary alkalisation will ncrease the renal clearance of tetracyclines, especially doxycycline, but it will increase the half life and duration of action of basic drugs such as quinidine, amphetamines, ephedrine and pseudoephedrine. Hypochloraemic alkalosis may occur if sodium bicarbonate is used in conjunction with potassium depleting diuretics such as bumetanide, ethacrynic acid, frusemide and thiazides. Concurrent use in patients taking potassium supplements may reduce serum potassium concentration by promoting an intracellular ion shift. Lithium excretion increased with reduced plasma lithium concentration.

Pregnancy and Lactation

Safe use in pregnancy has not been established. The use of any drug n pregnant or lactating women requires that the expected benefit be carefully weighed against the possible risk to mother and child.

Effects on Ability to Drive and Use Machines

Not applicable; this preparation is intended for use only in emergencies.

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Undesirable Effects

Alkalosis and/or hypokalaemia may ensue as a result of prolonged use or over-correction of the bicarbonate deficit. Hyperirritability or tetany may occur caused by rapid shifts of free ionised calcium or due to serum protein alterations arising from pH changes.

Overdose

Symptoms; metabolic alkalosis accompanied by compensatory hyperventilation, paradoxical acidosis of the cerebrospinal fluid, severe hypokalaemia, hyperirritability and tetany. Treatment; discontinue the administration of sodium bicarbonate, rebreathe expired air or, if more severe administer calcium gluconate especially if tetany is present. In severe alkalosis, an infusion of 2.14% ammonium chloride is recommended, except in patients with pre-existing hepatic disease. If hypokalaemia is present administer potassium chloride.

PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties

Sodium Bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses clinical manifestations of metabolic acidosis.

Pharmacokinetic Properties

Sodium Bicarbonate is eliminated principally in the urine and effectively alkalises it.

Preclinical Safety Data

Not applicable since sodium bicarbonate has been used in clinical practice for many years and its effects are well known.

PHARMACEUTICAL PARTICULARS List of Excipients

Water for Injections Nitrogen

Incompatibilities

Sodium Bicarbonate Injection must not be administered simultaneously with solutions containing Calcium, Magnesium or Phosphate.

Shelf Life

2 years

Special Precautions for Storage

Do not store above 25^oC. Store in the original container.

Nature and Contents of Container

Type 1 clear glass prefilled syringes 10ml stopper rubber PH 50/701C with tip cap rubber W1883, containing 8.4%w/v Sodium Bicarbonate BP in Water for Injections

Instruction for Use/Handling

No needle is provided with this syringe. Discard any unused solution at the end of the session in the appropriate manner. Don't use the product if the packaging is damaged.

ADMINISTRATIVE DATA Marketing Authorisation Holder

Aurum Pharmaceuticals Ltd

Bampton Road

Harold Hill

Romford

Essex

RM3 8UG

Marketing Authorisation Number

PL 12064/0052

Date of revision: January 2013

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom

Au RUM