Downlands Calcium Borogluconate 20% w/v PMD Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Boric Acid, Calcium, Glucose, Magnesium

Available from:

Norbrook Laboratories Limited

ATC code:

amendedS

INN (International Name):

Boric Acid, Calcium, Glucose, Magnesium

Authorization status:

Expired

Summary of Product characteristics

                                Revised: June 2010
ATCVet code amended
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Downlands Calcium Borogluconate 20% w/v PMD Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Contains Calcium Gluconate 16.6% w/v, Magnesium Hypophosphite
Hexahydrate 5.0% w/v, and Glucose Monohydrate 22.0% w/v
EACH 400 ML CONTAINS:
5.92 g calcium (provided by calcium gluconate and calcium
borogluconate) and
1.84 g magnesium (provided by magnesium hypophosphite hexahydrate)
80 g glucose provided by glucose monohydrate.
Also contains 3.40% w/v boric acid.
EXCIPIENTS:
Chlorocresol 0.1% w/v
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
A clear pale yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of hypocalcaemia complicated by deficiency of
magnesium
with accompanying hypoglycaemia. In the treatment of pregnancy
toxaemia and
other metabolic imbalances in periparturient sheep
4.3
CONTRAINDICATIONS
Not to be administered by intravenous or intramuscular routes
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warning.
Revised: June 2010
ATCVet code amended
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
The solution should be warmed to body temperature before
administration.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection.
If accidental self-injection occurs, seek medical advice.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Can be safely administered to pregnant and lactating animals
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
The solution should be warmed to body temperature before
administra
                                
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