Calcibel 240/60/60 mg/ml solution for infusion for horses, cattle, sheep, goats and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium gluconate; Magnesium chloride hexahydrate; Boric acid

Available from:

Bela-Pharm GmbH & Co. KG

ATC code:

QA12AX

INN (International Name):

Calcium gluconate; Magnesium chloride hexahydrate; Boric acid

Dosage:

240/60/60 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

LR: Licensed Retailer as defined in national legislation

Therapeutic group:

Cattle, Goats, Horses, Pigs, Sheep

Therapeutic area:

Calcium, combinations with vitamin D and/or other drugs

Therapeutic indications:

Vitamins and minerals

Authorization status:

Authorised

Authorization date:

2016-04-22

Summary of Product characteristics

Health Products Regulatory Authority
30 April 2021
CRN009W0D
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Calcibel 240/60/60 mg/ml solution for infusion for horses, cattle,
sheep, goats and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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1 ml contains:
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ACTIVE SUBSTANCE:
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Calcium gluconate
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240 mg
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(equivalent to 21.5 mg calcium)
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Magnesium chloride hexahydrate
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60 mg
(equivalent to 7.2 mg magnesium)
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Boric acid
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60 mg
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EXCIPIENT(S):
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless to slightly yellowish solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horse, cattle, sheep, goat, pig.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of acute hypocalcaemia.
4.3 CONTRAINDICATIONS
Do not use in cases of:
- hypercalcaemia and hypermagnesaemia,
- idiopathic hypocalcaemia in foals,
- calcinosis in cattle and small ruminants,
- septicaemia in the course of acute mastitis in cattle,
- chronic renal insufficiency or cases of circulatory or cardiac
disorders.
Do not use following application of high doses of vitamin D3
preparations.
Do not use concomitantly or immediately following application of
inorganic phosphorous solutions.
Do not use in cases of known hypersensitivity to the active
substances.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In case of acute hypomagnesaemia, the administration of a solution
with a higher concentration of magnesium may be
necessary.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
During infusion, the product must be administered slowly and at body
temperature.
Health Products Regulatory Authority
30 April 2021
CRN009W0D
Page 2 of 5
During infusion, cardiac rate and rhythm and circulation must be
monitored. If any sign of overdose (disturbances of the
cardiac rhythm decrease in blood pressure, restlessness) appears, the
infusion should be stopped immediately.
Special precautions