Calcibel 240/60/60 mg/ml Solution for Infusion for Horses, Cattle, Sheep, Goats and Pigs

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Boric Acid, Calcium Gluconate Monohydrate, Magnesium Chloride Hexahydrate

MAH:

Bela-Pharm GmbH & Co. KG

ATC_code:

QA12AX

INN:

Boric Acid, Calcium Gluconate Monohydrate, Magnesium Chloride Hexahydrate

pharmaceutical_form:

Solution for infusion

prescription_type:

POM-V - Prescription Only Medicine – Veterinarian

therapeutic_group:

Cattle, Goats, Horses, Pigs, Sheep

therapeutic_area:

Mineral

authorization_status:

Authorized

authorization_date:

2016-04-25

SPC

Revised: June 2021
AN: 00634/2020
Page 1 of 6
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
Each 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
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.
Revised: June 2021
AN: 00634/2020
Page 2 of 6
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.
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 to be taken by the person administering the
veterinary medicinal
p