SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

5 % w/v Glucose Intravenous Infusion BP

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains 50 mg glucose (as glucose monohydrate, 55 mg) 1000 ml contain 50.0 g glucose (as glucose monohydrate, 55.0 g)

For excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Solution for infusion Clear, colourless aqueous solution Energy:

Theoretical osmolarity: pH:

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Vehicle solution for compatible electrolyte concentrates and medicinal products.

4.2    Posology and method of administration

Posology

A volume that yields the desired concentration of the medicinal product for which 5 % w/v Glucose Intravenous Infusion is to be used as vehicle solution should be chosen, having regard to the maximum dose stated below.

Of note, provision of the entire daily fluid supply with this solution alone is contraindicated. See sections 4.3 and 4.4.

Adults

Maximum daily intake

Up to 40 ml per kg body weight per day, corresponding to 2 g of glucose per kg body weight per day.

Maximum infusion rate

The maximum infusion rate is 5 ml per kg body weight per hour, corresponding to 0.25 g (250 mg) of glucose per kg body weight per hour.

Paediatric population

Dosing of this solution should be as restrictive as possible and must be accompanied by adequate electrolyte substitution. See also sections 4.3 and 4.4.

The maximum daily dose, in g of glucose per kg body weight and in ml of solution per kg body weight per day, is for:

Pre-term neonates: Term neonates : 1 - 2 year: 3rd - 5th year: 6th - 10th year: 11th - 14th year:

18 g per kg body 180 ml per kg body weight weight 15 g per kg body 150 ml per kg body weight weight 15 g per kg body 150 ml per kg body weight weight 12 g per kg body 120 ml per kg body weight weight 10 g per kg body 100 ml per kg body weight weight 8 g per kg body 80 ml per kg body weight weight

When administering this solution, the total daily fluid intake must be taken into account. The recommended daily parenteral fluid intake for children is as follows:

1st day of life:	60 - 120 ml per kg body weight per day
2nd day of life:	80 - 120 ml per kg body weight per day
3rd day of life:	100 - 130 ml per kg body weight per day
4th day of life:	120 - 150 ml per kg body weight per day
5 th day of life:	140 - 160 ml per kg body weight per day
6th day of life:	140 - 180 ml per kg body weight per day
1st month, prior to establishment of stable growth:	140 - 170 ml per kg body weight per day
1st month, after establishment of stable growth:	140 - 160 ml per kg body weight per day
2nd - 12th month of life:	120 - 150 ml per kg body weight per day

2nd year:	80 - 120 ml per kg body weight per day
3rd - 5th year:	80 - 100 ml per kg body weight per day
6th - 12th year:	60 - 80 ml per kg body weight per day
13 th - 18th year:	50 - 70 ml per kg body weight per day

Method of administration Intravenous use.

The possibility of peripheral venous infusion depends on the osmolarity of the prepared mixture.

4.3 Contraindications

-    Hyperglycaemia, not responding to insulin doses of up to 6 units insulin/hour

-    Metabolic acidosis

If it should be necessary to administer large volumes, further contra-indications can arise on account of the fluid load:

-    Hyperhydration

-    Acute cardiac failure

-    Pulmonary oedema

This solution must not be used alone for fluid supply/rehydration because it does not contain electrolytes. See section 4.4.

4.4 Special warnings and precautions for use

Special warnings

Electrolyte free carbohydrate solutions must not be used for fluid substitution, especially rehydration therapy, without adequate electrolyte administration, because this could lead to markedly decreased serum electrolyte values, notably severe hyponatraemia and hypokalaemia, with potentially detrimental effects on the patient, e.g. brain damage or heart affections. Especially children, elderly patients and patients in poor general condition are at risk.

In states of electrolyte deficiencies like hyponatraemia or hypokalaemia the solution must not be used without adequate electrolyte substitution.

In patients with disturbed glucose metabolism, as present e.g. in postoperative or posttraumatic conditions or in patients with diabetes mellitus, 5 % w/v Glucose Intravenous Infusion must be administered with caution, i.e. with frequent monitoring (see below), and dosage must be adapted as required.

States of hyperglycaemia should be adequately monitored and treated with insulin. The application of insulin causes additional shifts of potassium into the cells and may therefore cause or increase hypokalaemia.

This fluid should also be administered with great caution to patients with renal insufficiency.

Administration of glucose solutions is not recommended after acute ischaemic strokes as hyperglycaemia was reported to worsen ischaemic brain damage and impair recovery. In prehospital management of acute ischemic stroke, glucose-containing solutions should be avoided unless hypoglycaemia is present or strongly suspected.

Glucose infusions should not be administered through the same infusion equipment, simultaneously with, before, or after administration of blood, because of the possibility of pseudo-agglutination.

Precautions for use

Monitoring should include blood glucose, serum electrolytes, fluid and acid-base balance.

Especially, adequate sodium and - in relation to glucose metabolism - potassium supply should be ensured.

Please note: The safety information of the additive provided by the respective manufacturer has to be taken into account.

4.5    Interaction with other medicinal products and other forms of interaction

Interactions with medicinal products with an influence on glucose metabolism should be considered. Prescribers should refer to the information provided with the product concerned.

4.6    Fertility, pregnancy and lactation

Pregnancy

There are no or limited data (less than 300 pregnancy outcomes) from the use of glucose monohydrate in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

5 % w/v Glucose Intravenous Infusion can be used during pregnancy, if indicated as vehicle solution.

Careful monitoring of blood glucose is necessary.

Breast-feeding

Glucose/metabolites are excreted in human milk, but at therapeutic doses of Glucose B. Braun 50 mg/ml no effects on the breast-fed newborns/infants are anticipated.

5 % w/v Glucose Intravenous Infusion can be used during breast-feeding as indicated.

4.7    Effects on ability to drive and use machines

5 % w/v Glucose Intravenous Infusion has no influence on the ability to drive and use machines. The safety information of the additive provided by the respective manufacturer has to be taken into account.

4.8    Undesirable effects

None to be expected if the solution is used according to instructions.

Undesirable effects associated with overdosing or use outside the indication stated (section 4.1), see sections 4.4 and 4.9.

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

Symptoms

Symptoms of glucose overdose

Hyperglycaemia, glucosuria, hyperosmolarity of the serum, up to hyperglycaemic-hyperosmolar coma, and dehydration.

Symptoms of fluid overdose

Fluid overdose may result in hyperhydration with increased skin tension, venous congestion, oedema - possibly also lung or brain oedema - , dilution of serum electrolytes, electrolyte imbalances, notably hyponatraemia and hypokalaemia (see section 4.4), and acid-base imbalances.

Clinical symptoms of water intoxication my occur like nausea, vomiting, spasms.

Further symptoms of overdose may arise depending on the nature of the additive.

Treatment

Depending on type and severity of the disorders:

Immediate stop of infusion, administration of electrolytes, diuretics, or insulin.

For correction of hyponatraemia the following formula can be used:

mmol of Na+ required = (target Na+ level¹¹ -actualNa+ level) x TBW^²⁾

(1)    should not be lower than 130 mmol/l

(2)    TBW: Total body water, calculated as a fraction of body weight: 0.6 in children, 0.6 and 0.5 in non-elderly men and women, respectively, and 0.5 and 0.45 in elderly men and women, respectively

During treatment, serum electrolytes should be monitored.

For treatment of symptoms resulting from overdose of an additive the instructions given by the manufacturer of the respective additive must be followed.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions

ATC code: V07AB Pharmacodynamic effect

Low concentration glucose solutions are suitable diluents for drugs because glucose, as a natural substrate of the cells in the organism, is ubiquitously metabolized. Under physiological conditions glucose is the most important energy-supplying carbohydrate with a caloric value of approx. 17 kJ/g or 4 kcal/g.

Glucose utilisation disturbances (glucose intolerance) can occur under conditions of pathological metabolism. These mainly include diabetes mellitus and states of metabolic stress (e.g. intra-, and postoperatively, severe disease, injury), hormonally mediated depression of glucose tolerance, which can even lead to hyperglycaemia without exogenous supply of the substrate. Hyperglycaemia can - depending on its severity - lead to osmotically mediated renal fluid losses with consecutive hypertonic dehydration, to hyperosmotic disorders up to and including hyperosmotic coma.

Metabolism of glucose and electrolytes are closely related to each other. Potassium, magnesium and phosphate requirements may increase and may therefore have to be monitored and supplemented according to individual needs. Especially cardiac and neurological functions may be impaired without supplementation.

5.2 Pharmacokinetic properties

Absorption

Bioavailability

Since the solution is administered intravenously, its bioavailability is 100 %. Distribution

On infusion glucose is first distributed in the intravascular space and then is taken up into the intracellular space. In adults, the concentration of glucose in the blood is 60 -100 mg/ml, or 3.3 - 5.6 mmol/l (fasting).

Biotransformation

In glycolysis, glucose is metabolized to pyruvate. Under aerobic conditions pyruvate is completely oxidised to carbon dioxide and water. In case of hypoxia pyruvate is converted to lactate. Lactate can be partially re-introduced into the glucose metabolism (CORI cycle).

The final products of the complete oxidation of glucose are eliminated via the lungs (carbon dioxide) and the kidneys (water).

Practically no glucose is excreted renally by healthy persons. In pathological metabolic conditions associated with hyperglycaemia (e.g. diabetes mellitus, postaggression metabolism), glucose is also excreted via the kidneys (glucosuria) when (at blood glucose levels higher than 160 - 180 mg/ml or 8.8 - 9.9 mmol/l) the maximum tubular resorption capacity is exceeded.

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

Water for injections

6.2    Incompatibilities

Because 5 % w/v Glucose Intravenous Infusion has an acid pH, incompatibilities can occur on mixing with other medicinal products.

Erythrocyte concentrates must not be suspended in 5 % w/v Glucose Intravenous Infusion because of the risk of pseudo-agglutination. See also section 4.4.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

- unopened:

3 years

-    after first opening the container:

Containers once opened must be used immediately. See section 6.6.

-    after admixture of additives:

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.

6.4 Special precautions for storage

Do not store above 25°C.For storage conditions after admixture of additives see section 6.3.

6.5 Nature and contents of container

• Bottles of colourless low-density polyethylene (LDPE), contents: 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml available in packs of:

20 x	50 ml, 20 x 100 ml
10 x	250 ml,
10 x	500 ml
10 x	1000 ml

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

The medicinal product is supplied in containers for single use only.

After first use discard container and remaining contents. Do not re-connect partially used containers.

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

Administration should commence immediately after connecting the container to the giving set or infusion equipment.

Before admixing of an additive or preparing a nutrient mixture, physical and chemical compatibility must be confirmed.

Observe the directions given by the manufacturer of the respective additive or drug to be diluted.

When admixing additives observe usual precautions of asepsis strictly.

7    MARKETING AUTHORISATION HOLDER

B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen, Germany

Postal address:

34209 Melsungen, Germany

Tel.: +49/5661/71-0 Telefax: +49/5661/71-4567

8    MARKETING AUTHORISATION NUMBER(S)

PL 03551/0059

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1 August 2001 Date of latest renewal: 8 August 2003

10    DATE OF REVISION OF THE TEXT

07/10/2014