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Glucose B.P (Dextrose Monohydrate)

Document: spc-doc_PL 42671-0008 change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Glucose BP (Dextrose Monohydrate).

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Dextrose Monohydrate (ie Glucose) BP 100 % w/w.

3    PHARMACEUTICAL FORM

Powder.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Taken orally for use in glycogen storage disease, sucrose/isomaltose intolerance, renal failure, liver cirrhosis and in the glucose tolerance test.

4.2    Posology and method of administration

To be taken orally.

Adults (including the elderly) and Children over 12 years

Up to 1 80g daily in divided doses.

Children 1 to 12 years - 90 g daily in divided doses.

For use in Glucose tolerance test: Dose - 50g orally for each test.

4.3    Contraindications

Should not be used in patients with glucose-galactose malabsorption syndrome.

4.4    Special warnings and precautions for use

Glucose tolerance may be impaired in patients with renal failure and in the early posttraumatic state or in those with severe sepsis.

4.5    Interaction with other medicinal products and other forms of interaction

Interacts with cyanocobalamin, kanamycin sulphate, novobiocin sodium or warfarin sodium.

4.6    Fertility, Pregnancy and lactation

Suitable for use in pregnancy and lactation.

4.7    Effects on ability to drive and use machines

None.

4.8    Undesirable effects

None stated.

4.9    Overdose

None stated.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

None stated.

5.2    Pharmacokinetic properties

None stated.

5.3    Preclinical safety data

None stated.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

None.

6.2    Incompatibilities

None stated.

6.3    Shelf life

3 Years.

6.4    Special precautions for storage

None stated.

6.5    Nature and contents of container

Cardboard box or plastic containers and lids 500g.

6.6    Special precautions for disposal and other handling

None stated.

7    MARKETING AUTHORISATION HOLDER

Cox Pharmaceutical Ltd 788-790 Finchley Road,

London NW11 7TJ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 42671/0008

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14th October 1998/ 14th January 1999.

10 DATE OF REVISION OF THE TEXT

28/06/2016