Glucobel 40 g/100 ml solution for infusion for horses, cattle, sheep, goats, pigs, dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glucose monohydrate

Available from:

Bela-Pharm GmbH & Co. KG

ATC code:

QB05BA03

INN (International Name):

Glucose monohydrate

Pharmaceutical form:

Solution for infusion

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

carbohydrates

Authorization date:

2022-11-25

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Glucobel 40 g/100 ml solution for infusion for horses, cattle, sheep,
goats, pigs, dogs and cats (AT,
DE, IE, NL, RO, PT)
Glucobel vet. 40 g/100 ml solution for infusion for horses, cattle,
sheep, goats, pigs, dogs and cats (FI,
SE)
Belabel vet.
40 g/100 ml solution for infusion for horses, cattle, sheep, goats,
pigs, dogs and cats (DK, NO)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml contains:
ACTIVE SUBSTANCE:
Glucose monohydrate
44.0 g
(equivalent to 40.0 g glucose, anhydrous)
EXCIPIENTS:
Solution for infusion.
Clear, colourless to slightly yellowish solution, free from visible
particles.
Theoretical osmolarity
2220 mOsm/l
pH value
3.5 – 6.5
Caloric value
6698 kJ/l (1600 kcal/l)
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Horses, cattle, sheep, goats, pigs, dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For infusion therapy in horse, cattle, sheep, goat, pig, dog and cat:
- to partially or completely cover the carbohydrate requirements,
- for acute hypoglycaemia,
For infusion therapy in cattle, sheep and goat:
- in metabolic syndromes with concomitant hypoglycaemia (ketosis).
3.3
CONTRAINDICATIONS
Do not use in cases of:
Hyperglycaemia, hyperhydration, peripheral oedema, anuria, acidosis,
electrolyte deficiency,
hypotonic dehydration, intracranial or intraspinal bleeding, untreated
diabetes mellitus, Addison's
disease (hypoadrenocorticism).
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _
Water for injections
2
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Blood and urinary glucose levels, electrolyte and water balance should
be monitored regularly.
At high doses, potassium and phosphate should be substituted as
required.
Due to its osmotic effect, hypertonic carbohydrate solutions increase
the intravasal volume. Especially
in case of cardiovascular diseases this could lead to hypertonia,
hyperhydration and oedema and even
cause hyperosmolaric coma. Thus in an