Calcitat 25, solution for infusion and injection in cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium gluconate monohydrate; Calcium borogluconate; Calcium hydroxide; Magnesium chloride hexahydrate

Available from:

aniMedica GmbH

ATC code:

QA12AA

INN (International Name):

Calcium gluconate monohydrate; Calcium borogluconate; Calcium hydroxide; Magnesium chloride hexahydrate

Dosage:

1.55, 21.45, 0.66, 3.25 grams/100 millilitres

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

LR: Licensed Retailer as defined in national legislation

Therapeutic group:

Cattle

Therapeutic area:

Calcium

Therapeutic indications:

Vitamins and minerals

Authorization status:

Authorised

Authorization date:

1999-10-01

Summary of Product characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Calcitat 25, solution for infusion and injection in cattle.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 ml of solution contains:
ACTIVE SUBSTANCES
Calcium Gluconate Monohydrate 1.55 g
Calcium Borogluconate 21.45 g
Calcium Hydroxide 0.66 g
Magnesium Chloride Hexahydrate 3.25 g
EXCIPIENTS
Methyl Parahydroxybenzoate (E219) 0.10 g
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for infusion and injection.
A clear colourless solution.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Bovine.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Paresis resulting from hypocalcaemia before, during and after
parturition or during lactation. Downer
cow syndrome.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances.
Do not use in animals suffering from hypercalcaemia,
hyperparathyroidism, acidosis, severe kidney
damage.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Caution must be exercised when this product is used intravenously. As
intravenous administration of
this product could cause death, this route should only be used by a
veterinary surgeon.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Intravenous - administer slowly and at body temperature. Monitor
cardiac performance during
administration.
Subcutaneous - divide large volumes into several injection sites.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Rapid intravenous infusion may result in transient cardiac distress.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
The product may safely be used during pregnancy and lactation and most
clinical indications occur at
this time.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The use of admixtures should be avoided because of possible
incompatibility with other substances in
solution.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Administe