Downlands Calcium Borogluconate 40% w/v CM Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Boric Acid, Calcium, Magnesium

Available from:

Norbrook Laboratories Limited

ATC code:

QA12AX

INN (International Name):

Boric Acid, Calcium, Magnesium

Pharmaceutical form:

Solution for injection

Prescription type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Cattle

Therapeutic area:

Mineral

Authorization status:

Authorized

Authorization date:

1999-07-05

Summary of Product characteristics

Revised: July 2018
AN: 02259/2017
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Downlands Calcium Borogluconate 40% w/v CM Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
_Each ml contains:_
400 mg Calcium Borogluconate and 50 mg Magnesium Hypophosphite
Hexahydrate.
EACH 400 ML CONTAINS:
11.9 g calcium (provided by calcium gluconate and calcium
borogluconate) and 1.85 g
magnesium hypophosphite hexahydrate)
Also contains 6.84% w/v boric acid.
EXCIPIENTS:
For the 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
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of hypocalcaemia in cattle where increased blood magnesium
levels are
required.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Revised: July 2018
AN: 02259/2017
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.
Intravenous injections should be given slowly in order to
avoid possible
neuromuscular dysfunction and cardiac insufficiency. Normal aseptic
precautions
should be observed. Sites of subcutaneous
administration should be messaged
gently.
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)
Occasional temporary swelling may occur at sites of subcutaneous
administration.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Safe for use during pregnancy and lactation.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None
4.9
AMOUNT(S) TO BE ADMINISTERED AND ADMINISTR