Calciject PMD Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Boric acid ; Calcium gluconate; Dextrose Monohydrate; Magnesium hypophosphite hexahydrate

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QA12AA20

INN (International Name):

Boric acid ; Calcium gluconate; Dextrose Monohydrate; Magnesium hypophosphite hexahydrate

Dosage:

166, 34, 200, 50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic area:

calcium (different salts in combination)

Authorization status:

Authorised

Authorization date:

1991-10-01

Summary of Product characteristics

Health Products Regulatory Authority
30 January 2019
CRN008TJD
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Calciject PMD Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains:
​
​
Active Substance
​
​
Calcium Gluconate
​166 mg
​
Boric Acid
​34 mg
​
Dextrose Monohydrate
​200 mg
​
Magnesium Hypophosphite
(as hexahydrate)
​50 mg
​
Excipients
​
​
Chlorocresol (as preservative)
​1 mg
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear pale yellow sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calciject PMD is indicated in the treatment of hypocalcaemia
complicated by a
deficiency of magnesium with accompanying hypoglycaemia.
4.3 CONTRAINDICATIONS
None.
Health Products Regulatory Authority
30 January 2019
CRN008TJD
Page 2 of 4
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The solution should be warmed to body temperature before
administration.
Intravenous injections should be given slowly and stopped at the first
signs of
adverse reaction. Rapid intravenous injection may result in cardiac
arrhythmias and,
in severely toxaemic animals, collapse and death.
As intravenous administration of this product could cause death, this
route should
only be used by a veterinary surgeon.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT TO
ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Calciject PMD can be safely administered to pregnant and lactating
animals.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Administer by subcutaneous or slow intravenous injection
Sheep: 50 - 80 ml
4.10 OVERDOSE (SYMPTOMS, EMERGENCY PRO