Summary of Product Characteristics (SmPC) - Glucose B.P (Dextrose Monohydrate)
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 post-traumatic 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