SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Sodium Bicarbonate 4.2% w/v solution for infusion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1000 ml of solution contain

Sodium bicarbonate    42.0 g

Electrolyte concentrations:

Na+    500    mmol/l

HCO3^-    500    mmol/l

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Solution for infusion A clear, colourless aqueous solution

Theoretical osmolarity    1000 mOsm/l

pH    7.0 - 8.5

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

-    Severe metabolic acidosis;

-    Lactate acidosis

-    Rapid urine alkalisation (e.g. for “sulphonamide nephrosis”, and barbiturate intoxication);

-    Temporary therapy in cases of imminent hyperkalaemia.

4.2. Posology and Method of Administration

A blind buffer therapy is to be performed only in life threatening situations; the quantity of

4.2 % w/v Sodium Bicarbonate Intravenous Infusion BP to be infused is determined by the

blood gas values and is calculated according to the following formula:

# ml of 0.5 M (4.2 % w/v) sodium bicarbonate solution = base deficit X kg BW X 0.3 X 2

(The factor 0.3 corresponds to the proportion of the extracellular fluid in relation to total body fluid).

Correction of metabolic acidosis should not be effected too rapidly. It is advisable to start administering only half of the calculated dose and make a continuation of therapy conditional on further blood gas analysis.

Drop rate:

Up to 40 drops/min=120 ml/h Method of administration Intravenous use only.

4.3. Contra-indications

-    Respiratory and metabolic alkalosis,

-    hypoventilation,

-    hypernatraemia,

-    hypokalaemia,

-    hypocalcaemia,

-    increased serum osmolarity,

-    situations where sodium is contraindicated, such as cardiac insufficiency, oedema,

hypertension, eclampsia, renal impairment.

4.4. Special Warnings and Special Precautions for Use

Administration of sodium bicarbonate intravenous infusion may lead to sodium and fluid overload.

Sodium Bicarbonate Intravenous Infusion must be administered strictly intravenously since paravenous administration may lead to tissue necrosis.

If supply of sodium is contraindicated but renal function unimpaired, alkalisation should preferably be performed with THAM solution.

Precautions:

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. Alkalisation or correction of acidosis promote the potassium influx into cells and may therefore lead to hypokalaemia.

Potassium or calcium deficiencies should be corrected before beginning of the alkalinising therapy.

4.5. Interaction with Other Medicinal Products and Other Forms of Interaction

Sodium bicarbonate may interact with lithium, increasing the lithium excretion.

Urine alkalisation by sodium bicarbonate accelerates the elimination of acid drug substances, e.g. acetylsalicylic acid, and delays the elimination of basic drug substances.

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

4.6. Pregnancy and Lactation

Bicarbonate readily crosses the placental barrier.

No adverse effects are anticipated if sodium bicarbonate infusion is given during pregnancy or when lactating. However, administration should be avoided in eclampsia.

4.7. Effects on Ability to Drive and Use Machines

Not applicable, solution is for intravenous infusion.

4.8. Undesirable Effects

None anticipated.

Overdose

Symptoms

Overdose may lead to alkalosis, hypernatraemia, and serum hyperosmolarity. When an acidosis is corrected too rapidly, esp. in the presence respiratory disorders, the increased liberation of carbon dioxide may transiently aggravate cerebral acidosis.

Emergency treatment, antidotes

Therapy of alkalosis, depending on its severity: Infusion of physiological saline, substitution of potassium; in marked alkalosis infusion of arginine hydrochloride or hydrochloric acid.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Sodium Bicarbonate Intravenous Infusion is the subject of a monograph in the British Pharmacopoeia and is an established therapeutic agent.

No pharmacodynamic data are presented

5.2.    Pharmacokinetic Properties

Sodium Bicarbonate Intravenous Infusion is the subject of a monograph in the British Pharmacopoeia and is an established therapeutic agent.

No pharmacokinetic data are presented

5.3.    Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to those already stated in other sections of the SPC.

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 medicinal products. 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.

6.4. Special Precautions for Storage

Do not store above 25 °C.

6.5 Nature and contents of container

Bottles of colourless glass type I (Ph. Eur.), sealed with rubber stoppers,

contents: 100 ml, 250 ml, 500 ml

supplied in packs of

1 x 100 ml, 10 x 100 ml, 20 x 100 ml

1 x 250 ml, 10 x 250 ml

1 x 500 ml, 10 x 500 ml

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements for disposal.

Containers are for single use only. Discard container and any unused content after use.

Only to be used if the solution is clear and colourless and if the bottle and its closure are undamaged.

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

7. MARKETING AUTHORISATION HOLDER

B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen Germany

Postal address B. Braun Melsungen AG 34209 Melsungen Germany

Tel. +49-5661-71-0 Fax: +49-5661-71-45 67

8    MARKETING AUTHORISATION NUMBER(S)

PL 03551/0068

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

01 October 2001

10 DATE OF REVISION OF THE TEXT

14/03/2013