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 MONOHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, BORIC ACID

Available from:

Bela-Pharm GmbH & Co. KG

ATC code:

QA12AX

INN (International Name):

CALCIUM GLUCONATE MONOHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, BORIC ACID

Dosage:

Unknown

Pharmaceutical form:

Solution for Infusion

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Bovine, Caprine, Equine - Food, Ovine, Porcine

Therapeutic area:

Calcium, combinations with other drugs

Therapeutic indications:

Vitamins & Minerals

Authorization status:

Authorised

Authorization date:

2016-04-22

Summary of Product characteristics

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
1 ml contains:
ACTIVE SUBSTANCE:
Calcium gluconate
240 mg
(equivalent to 21.5 mg calcium)
Magnesium chloride hexahydrate
60 mg
(equivalent to 7.2 mg magnesium)
Boric acid
60 mg
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
Acute hypocalcaemic conditions.
4.3 CONTRAINDICATIONS
- hypercalcaemia and hypermagnesaemia,
- idiopathic hypocalcaemia in foals,
- calcinosis in cattle and small ruminants,
- septicaemic processes in the course of acute mastitis in cattle,
- application after high doses of vitamin D
3
preparations,
- chronic renal insufficiency,
- concomitant or immediately following application of inorganic phosphorous solutions.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 15/06/2016_
_CRN 7024103_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
During intravenous infusion, the product must be administered slowly and at body temperature.
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 immedi