8.4% w/v Sodium Bicarbonate Intravenous Infusion BP

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Sodium bicarbonate
Available from:
B. Braun Medical Limited
ATC code:
B05XA; B05XA02
INN (International Name):
Sodium bicarbonate
Dosage:
8.4 percent weight/volume
Pharmaceutical form:
Solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Electrolyte solutions; sodium bicarbonate
Authorization status:
Marketed
Authorization number:
PA0179/006/001
Authorization date:
1983-04-01

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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.

What is in this leaflet:

1. What 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP is and

what it is used for

2. What you need to know before you receive 8.4% w/v Sodium Bicar-

bonate Intravenous Infusion BP

3. How to use 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP

4. Possible side effects

5. How to store 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP

6. Contents of the pack and other information

1. WHAT 8.4 % W/V SODIUM BICARBONATE INTRA-

VENOUS INFUSION BP IS AND WHAT IT IS USED FOR

This medicine contains sodium bicarbonate (bicarbonate of soda), a sub-

stance that is able to neutralise acidic substances.

8.4% w/v Sodium Bicarbonate Intravenous Infusion BP is used:

to neutralise excess acidic (= sour) substances in the blood

to render the urine more basic (or alkaline) in the case of poisoning with

acidic substances, e.g. phenobarbital or acetylsalicylic acid, in order to

accelerate their excretion

to render the urine more basic (or alkaline) in order to make some drug

substances, e.g. methotrexate, sulfadiazine, more soluble to improve

their excretion in urine to render the urine more basic (or alkaline) in

order to prevent blocking of the kidneys by haemoglobin fragments in

the case of a massive breakdown of red blood cells (haemolysis).

2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE

8.4 % W/V SODIUM BICARBONATE INTRAVENOUS

INFUSION BP

You should not receive 8.4% w/v Sodium Bicarbonate Intra-

venous Infusion BP

if you are allergic to sodium bicarbonate or any of the other ingredients

of this medicine (listed in section 6)

if your blood is already too alkaline

if your breath is slow or shallow or both

if your blood sodium level is abnormally high

if your blood potassium level is abnormally low

if you lose too much chloride

Warnings and precautions

Talk to your doctor before using 8.4% w/v Sodium Bicarbonate Intra-

venous Infusion BP

Your doctor will take special care

if your blood is too acidic because of breathing problems or lung prob-

lems

if your blood calcium level is abnormally low

if your blood has in total an abnormally high concentration of salts

(hyperosmolarity)

if you have any disease or condition where your sodium intake should

be low, e.g. heart failure, fluid retention associated with swelling, high

blood pressure, eclampsia (a condition associated with tissue swelling

and convulsions during pregnancy) or kidney failure

If breathing problems or lung problems are part of the reason why your

blood is too acidic, care will be taken to help you breathe properly to get

rid of the excess CO2 that is produced after administration of this medi-

cine.

Administration of this medicine may lead to sodium and fluid overload.

Care will be taken to control your blood electrolyte levels, in particular

potassium. Your fluid and acid-base balance will also be monitored.

If necessary you will receive potassium and calcium supplements before

you receive this medicine.

It will be made sure that the cannula or small tube is correctly placed in

a vein in order to avoid severe complications.

The effects of sodium bicarbonate in some conditions leading to too much

acidic substances in your blood, namely diabetic ketoacidosis, cardiac

arrest or lactic acidosis, have not been investigated completely. If you suf-

fer from these conditions, special care will be taken.

Children

Special care will be taken in newborn infants, infants and toddlers, since

a too rapid infusion of sodium bicarbonate solutions may lead to too much

sodium in the blood, a decrease in the pressure of the brain fluid and (in

preterm newborn infants) bleeding within the skull.

Other medicines and 8.4% w/v Sodium Bicarbonate Intra-

venous Infusion BP

Tell your doctor if you are taking, have recently taken or might take any

other medicines.

Sodium bicarbonate may interact with other medicines, in particular

corticosteroids, e.g. hydrocortisone, prednisone

male sex hormones (androgens)

medicines increasing the urine flow (diuretics) in particular those that

promote potassium excretion.

Sodium bicarbonate promotes the excretion of acidic drug substances, e.g.

acetylsalicylic acid, which may lead to a shortening or weakening of their

effects. It may also delay the excretion of alkaline drug substances, which

may make their effects longer lasting or stronger.

Pregnancy and breast-feeding

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 taking this

medicine.

PACKAGE LEAFLET: INFORMATION FOR THE USER

B. Braun Medical Limited · Dublin 12, Ireland

8.4% w/v Sodium Bicarbonate Intravenous Infusion BP

Sodium Bicarbonate

B|BRAUN

Schwarz

210x297 mm

201/12262692/0416

Lätus: 3808

Irland

Font size 9

Projekt34_Layout 1 25.04.16 15:53 Seite 1

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Pregnancy

If you are pregnant, you will receive this medicine only if your doctor con-

siders it absolutely necessary for your recovery. Your doctor will exercise

caution when administering this medicine to you if you suffer from tox-

aemia of pregnancy, because the high sodium content of this medicine

might be dangerous for you.

Breast-feeding

If you are breast-feeding, you will receive this medicine only if your doc-

tor thinks that the benefits clearly outweigh the risks.

Driving and using machines

This medicine has no influence on the ability to drive and use machines.

3. HOW TO USE 8.4 % W/V SODIUM BICARBONATE

INTRAVENOUS INFUSION BP

This medicine will be given to you by a doctor or a nurse. You will be given

this medicine by a drip via a small tube or cannula placed in a large vein.

Your doctor will calculate the right dose of this medicine for you. He/she

will also decide for how long the infusion should be given. This will depend

on your clinical condition.

For urine alkalinisation your dose is adjusted according to the desired

degree of alkalinity and administration will be accompanied by careful

monitoring of the acid-base balance, the water balance and the blood salt

concentrations.

If you received more 8.4% w/v Sodium Bicarbonate Intra-

venous Infusion BP than you should

Overdose may render your blood too alkaline or lead to an abnormally high

blood sodium level or abnormally high salt levels in your blood. It may also

lead to fluid excess. Too rapid infusion may be associated with an

increased risk of brain damage resulting from an increased carbon dioxide

load, especially when you have breathing problems.

Treatment

Your doctor will decide on further treatment and medication that you may

need.

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.

The possible side effects are listed according to their frequency.

Not known (frequency cannot be estimated from the available data):

Abnormally high blood sodium level, abnormally high blood salt levels.

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 HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1

6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie. By reporting

side effects you can help provide more information on the safety of this

medicine.

5. HOW TO STORE 8.4 % W/V SODIUM BICARBONATE

INTRAVENOUS INFUSION BP

Keep this medicine out of the sight and reach of children.

To avoid formation of crystals, do not refrigerate or freeze. Do not store

above 25 °C.

Do not use this medicine after the expiry date which is stated on the bot-

tle and the outer carton. The expiry date refers to the last day of that

month.

This medicine is an almost saturated solution and should therefore not be

stored below normal room temperature. Crystals which may possibly have

developed during storage can be dissolved by simply warming the bottle.

Once opened this product should be used immediately.

Do not use this medicine if you notice

cloudiness of the solution

particles in the solution

discolouration of the solution

leaking of the bottle.

Containers are for single use only. After use discard bottle and any unused

content.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP

contains

The active substance is Sodium Hydrogen Carbonate (Sodium bicarbon-

ate).

100 ml of the solution contains 8.4 g of Sodium Hydrogen Carbonate

(Sodium bicarbonate).

The other ingredients are

disodium edetate and water for injections.

What 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP

looks like and contents of the pack

8.4% w/v Sodium Bicarbonate Intravenous Infusion BP is a solution for

infusion (administration as a vein drip).

It is a clear, colourless, sterile solution of sodium bicarbonate in water.

Theoretical osmolarity

2000 mOsm/l

7.0-8.5

It comes in colourless glass bottles sealed with rubber stoppers con-

taining 100 ml supplied in packs of 20 x 100 ml

Marketing Authorisation Holder and Manufacturer

PA Holder

B. Braun Medical Ltd., 3 Naas Road Industrial Park,

Dublin 12, Ireland

PA Number

PA 179/6/1

Manufacturer

B. Braun Melsungen AG, Carl-Braun-Straße 1,

34212 Melsungen, Germany.

This leaflet was last approved in 04/2016.

The following information is intended for healthcare profes-

sionals only:

Discontinue if adverse reaction occurs.

No other medication or substance should be added unless compatibility

is known.

For use only with a giving set containing an integral airway.

B. Braun Medical Ltd.,

3 Naas Road Industrial Park,

Dublin 12, Ireland

B|BRAUN

Schwarz

210x297 mm

201/12262692/0416

Lätus: 3808

Irland

Font size 9

Projekt34_Layout 1 25.04.16 15:53 Seite 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

8.4% w/v Sodium Bicarbonate Intravenous Infusion BP

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

100 ml of solution contains:

Active ingredient:

Sodium Hydrogen Carbonate (Sodium Bicarbonate)

8.4 g

Electrolyte concentrations:

mmol/100 ml

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Solution for infusion (Infusion)

A clear, colourless, sterile aqueous solution.

Theoretical osmolarity:

2000 mOsm/l

7.0-8.5

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Correction of metabolic acidosis.

Urine alkalinisation:

as part of the management strategy for enhanced elimination in the case of intoxication with weak organic

acids, e.g. phenobarbital or acetylsalicylic acid (depending on the clinical condition, time course of

intoxication and type of poison other options to enhance elimination (e.g. dialysis, hemoperfusion, single-

dose or repeated-dose activated charcoal) might be considered as well);

in order to improve the solubility of drug substances that are poorly soluble in neutral or acid medium, e.g.

methotrexate, sulfadiazine;

in the case of haemolysis.

4.2 Posology and method of administration

Posology

Correction of metabolic acidosis

Correction of metabolic acidosis should not be effected too rapidly. It is advisable to start administering only half of

the calculated dose and adjust further doses according to the actual results of blood gas analysis.

The dose depends on the degree of the disorder of the acid-base status.

According to the blood gas values the amount to be administered is calculated applying the following formula:

mmol sodium bicarbonate = base deficit × kg body weight × 0.2**

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(The factor 0.2 corresponds to the proportion of the extracellular fluid in relation to total body weight.).

Example:

If in a patient of 70 kg bodyweight the base deficit is 5 mmol/l, then

5 x 70 x 0.23 = 70mmol of sodium bicarbonate (

70 ml of 8.4 % w/v Sodium Bicarbonate Intravenous Infusion BP)

are to be given.

Maximum daily dose:

According to the correction requirements.

Maximum infusion rate:

Up to 1.5 mmol of sodium bicarbonate per kg body weight per hour.

Paediatric population

The dosage has to be adjusted individually. The first dose can be up to 1 mmol/kg body weight, administered by slow

intravenous infusion.

In infants (including newborn infants) and toddlers, the daily dose should not exceed 5 mmol per kg body weight per

day, administered by slow intravenous infusion. 4.2% w/v (or less concentrated) sodium bicarbonate solutions should

be preferred (see also section 4.4).

Urine alkalinisation

For urine alkalinisation the dose is adjusted according to the desired pH of the urine and administration should be

accompanied by monitoring of the acid-base balance, the water balance and the electrolyte balance. Care should be

taken not to exceed the maximum infusion rate stated above. In haemodynamically stable adults and children urine

alkalinisation may be achieved with a bolus of 1-2 mmol sodium bicarbonate per kg body weight, followed by an

infusion of 132 mmol sodium bicarbonate in 1 litre of glucose 5% in water, with a flow rate of 1.5-2 times the

maintenance fluid rate. Urine pH should not exceed 8.5.

Method and route of administration

Intravenous use. For central venous infusion only.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Respiratory or metabolic alkalosis

Hypoventilation

Hypernatraemia

Hypokalaemia

Excessive chloride loss

4.4 Special warnings and precautions for use

General

Sodium Bicarbonate should not be administered in the following situations unless it has been established that its

expected benefits clearly outweigh potential risks:

- respiratory acidosis

- hypocalcaemia

- increased serum osmolarity,

- further in all situations where sodium intake must be restricted like cardiac insufficiency, oedema, hypertension,

eclampsia, severe kidney insufficiency.

When respiratory acidosis is concomitant with metabolic acidosis, both pulmonary ventilation and perfusion must be

adequately supported to ensure adequate elimination of excess CO

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Administration of Sodium Bicarbonate may lead to sodium and fluid overload.

Accidental paravenous administration may lead to tissue necrosis.

Patient monitoring should include regular checks of the acid-base balance, the serum electrolyte concentrations and

the water balance.

Correction of the acid-base status is always associated with shifts of the electrolyte balance. In particular, the

potassium balance is affected. Alkalinisation or correction of acidosis promote the potassium influx into cells and may

therefore lead to hypokalaemia.

Hypokalaemia or hypocalcaemia should be corrected before beginning of the alkalinising therapy.

The effects of bicarbonate on organ function, complication rates and survival in diabetic ketoacidosis, cardiac arrest

and lactic acidosis have not been investigated sufficiently. Caution is advised when using sodium bicarbonate in these

conditions.

Paediatric population

Newborn infants, infants and toddlers: Rapid infusion of hypertonic sodium bicarbonate solutions may produce

hypernatraemia, a decrease in cerebrospinal fluid pressure and (in preterm infants) possible intracranial haemorrhage.

Do not administer > 5 mmol per kg body weight per day (see also section 4.2).

4.5 Interaction with other medicinal products and other forms of interaction

Urine alkalinisation by sodium bicarbonate increases the elimination rates of acidic drug substances, e.g.

acetylsalicylic acid, and decreases the elimination rates of basic drug substances.

Sodium bicarbonate may interact with gluco- and mineralocorticoids, androgens and diuretics increasing the

potassium excretion.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of sodium bicarbonate in pregnant women. Animal studies are

insufficient with respect to reproductive toxicity (see section 5.3.). Sodium bicarbonate should not be used during

pregnancy unless the clinical condition of the woman requires treatment with sodium bicarbonate. Bicarbonate readily

crosses the placental barrier.

Caution should be exercised in toxaemia of pregnancy due to the high sodium level of the medicinal product (see

section 4.4).

Breast-feeding

It is unknown whether sodium bicarbonate/metabolites are excreted in human milk. During breast-feeding the solution

should only be given if the benefits clearly outweigh the risks.

Fertility

No data available.

4.7 Effects on ability to drive and use machines

Sodium Bicarbonate has no or negligible influence on the ability to drive and use machines.

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4.8 Undesirable effects

Undesirable effects are listed according to their frequencies as follows:

Very common (

1/10)

Common (

1/100 to < 1/10)

Uncommon (

1/1,000 to < 1/100)

Rare (

1/10,000 to < 1/1,000)

Very rare (< 1/10,000)

Not known (frequency cannot be estimated from the available data)

Metabolism and nutrition disorders

Not known:

Hypernatraemia, serum hyperosmolarity

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

4.9.1. Symptoms

Overdose may lead to alkalosis, hypernatraemia, serum hyperosmolarity or hyperhydration. When an acidosis is

corrected too rapidly, especially in cases of concomitant ventilatory disorders, the increased liberation of carbon

dioxide may transiently aggravate cerebral acidosis.

4.9.2. Emergency treatment, antidotes

Therapy of alkalosis, depending on its severity: Infusion of physiological saline, correction of potassium; in marked

alkalosis infusion of arginine hydrochloride or hydrochloric acid. In general the patient should be treated

symptomatically and electrolytes and acid-base balance should be monitored.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: IV solutions, solutions affecting the electrolyte balance, electrolytes

ATC-Code: B05B B01

Mechanism of action

The pharmacological properties of sodium bicarbonate result from its physiological role in the HCO

buffer

system.

Pharmacodynamic effects

Exogenously administered sodium bicarbonate rapidly absorbs hydrogen ions from the extracellular space and thus

leads to a rise of the pH in the organism.

Secondary pharmacodynamic effects

By this buffering process carbon dioxide is produced which is subsequently eliminated via the lungs. Therefore lung

function should be unimpaired. Otherwise a marked rise of the pCO

will cause an aggravation of intracellular

acidosis.

The raise of the blood pH also affects the electrolyte balance. The cellular potassium uptake is increased so

hypokalaemia may be provoked or an existing hypokalaemia may be aggravated. The binding of calcium to plasma

proteins is increased so hypocalcaemia may be provoked or an existing hypocalcaemia may be aggravated.

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5.2 Pharmacokinetic properties

Distribution

Bicarbonate readily passes across the placental barrier but it passes only slowly across the blood-brain barrier.

Elimination

In the kidneys, bicarbonate is filtered in the glomeruli and the major proportion of it is re-absorbed in the tubules.

When plasma bicarbonate concentrations rise to above 24 mmol/l, bicarbonate is excreted by the kidneys. Renal

bicarbonate reabsorption is reduced under therapy with diuretics of the thiazide group or those acting on the loop of

Henle's.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated

dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium edetate

Water for injections

6.2 Incompatibilities

Due to their alkaline pH, sodium bicarbonate solutions are incompatible with most medicaments. In particular, they

must not be administered simultaneously with solutions containing calcium, magnesium or phosphate because of the

possibility of precipitation.

6.3 Shelf life

Unopened: 2 years.

After first opening:

Not applicable, see section 6.6.

After dilution:

Not applicable, see section 6

6.4 Special precautions for storage

Do not store above 25

To avoid formation of crystals, do not refrigerate or freeze.

6.5 Nature and contents of container

Infusion bottle of colourless glass (type I according to Ph. Eur.) sealed with an EPDM or bromobutyl rubber stopper.

Contents: 100 ml.

supplied in packs of

20 × 100 ml

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6.6 Special precautions for disposal and other handling

No special requirements for disposal.

Single-dose container. Discard container and any unused content after use.

Only to be used if solution is clear, colourless, free from visible particles and the bottle or its closure are undamaged.

This medicinal product is an almost saturated solution, and should therefore not be stored below normal room

temperature. Crystals which may possibly have developed during storage can be dissolved by simply warming the

bottle. As an additional safety measure against crystals that might be inadvertently infused with the solution, it is

recommended to use an infusion set fitted with an integral fluid filter.

The solution should be administered immediately after connecting the container to the giving set.

7 MARKETING AUTHORISATION HOLDER

B. Braun Medical Ltd.

3 Naas Road Industrial Park

Dublin 12

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0179/006/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1

April 1983

Date of last renewal: 1

April 2008

10 DATE OF REVISION OF THE TEXT

August 2017

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