Calcibel Forte, 380/60/50 mg/ml Solution for Infusion for Horses, Cattle, Sheep, Goats and Pigs

País: Reino Unido

Idioma: inglés

Fuente: VMD (Veterinary Medicines Directorate)

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05-11-2021

Ingredientes activos:

Boric Acid, Calcium Gluconate Monohydrate, Magnesium Chloride Hexahydrate

Disponible desde:

Bela-Pharm GmbH & Co. KG

Código ATC:

QA12AX

Designación común internacional (DCI):

Boric Acid, Calcium Gluconate Monohydrate, Magnesium Chloride Hexahydrate

formulario farmacéutico:

Solution for injection

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Cattle, Goats, Horses, Pigs, Sheep

Área terapéutica:

Mineral

Estado de Autorización:

Authorized

Fecha de autorización:

2021-11-02

Ficha técnica

                                Issued: November 2021
AN: 00927/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Calcibel Forte, 380/60/50 mg/ml solution for infusion for horses,
cattle, sheep, goats
and pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Calcium gluconate for injection
380 mg
(equivalent to 34.0 mg calcium)
Magnesium chloride hexahydrate
60 mg
(equivalent to 7.2 mg magnesium)
Boric acid
50 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, slightly, yellow-brownish solution, free from visible particles
Strongly hypertonic solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses, cattle, sheep, goats, pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Acute hypocalcaemic conditions.
4.3
CONTRAINDICATIONS
Do not use in cases of hypercalcaemia and hypermagnesemia.
Do not use in cases of idiopathic hypocalcaemia in foals.
Do not use in cases of calcinosis in cattle and small ruminants.
Do not use following administration of high doses of vitamin D3.
Do not use in cases of chronic kidney insufficiency or in cases of
circulatory or cardiac
disorders.
Do not use in cattle suffering septicaemic processes in the course of
acute mastitis in
cattle.
Do not administer inorganic phosphate solutions simultaneously or
shortly after the
infusion.
Do not use in case of known hypersensitivity to the active substances.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
Issued: November 2021
AN: 00927/2020
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The medicinal product must be administered only slowly intravenously.
The solution should be warmed to body temperature before
administration.
During infusion, heart rate, rhythm and circulation must be monitored.
In case of symptoms of overdosing (cardiac arrhythmia, fall in blood
pressure,
agitation), the infusion should be stopped immediately.
Special precautions to be taken by the person administering the
veterin
                                
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