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:

Contains Calcium Borogluconate 33.33% w/v and Magnesium Hypophosphite Hexahydrate 5% w/v

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 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

Cattle

Downlands Calcium Borogluconate 40% CM is indicated in the treatment of hypocalcaemia in cattle where increased blood magnesium levels are required.

4.3 Contraindications

None

4.4 Special Warnings for each target species

None

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

Downlands Calcium Borogluconate 40% CM is safe for use during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None

4.9 Amounts to be administered and administration route

Administer by subcutaneous or slow intravenous injection

Cattle : 200 - 400 ml

Not applicable.

Meat – Zero days

Milk – Zero hours

5. pharmacological properties

Pharmacotherapeutic group: Mineral supplements, Calcium, Calcium, combinations with other drugs

ATC Vet Code: QA12AX

5.1 Pharmacodynamic properties

Calcium Borogluconate and Magnesium Hypophosphite are soluble salts of calcium and magnesium respectively used extensively in fluid infusions in correction of metabolic disturbances. On parenteral administration they rapidly increase plasma concentrations of calcium, magnesium and phosphorus. This is effective in the treatment of hypocalcaemia with associated magnesium and phosphorus deficiencies.

6. Pharmaceutical particulars

6.1 List of excipients

Sodium Bicarbonate 10% or Boric Acid 5% (for pH adjustment)

Water for Injections

None known

Shelf life of the veterinary medicinal product as packaged for sale:

Glass bottles 2 years.

Polypropylene vials 18 months

Do not store above 25^oC. Protect from light.

This product does not contain an antimicrobial preservative. Any solution remaining in the vial following withdrawal of the required dose should be discarded.

Downlands Calcium Borogluconate 40% CM is marketed in either 400 ml Amber Type III glass vials sealed using black rubber wads and aluminium screw caps, or 400ml polypropylene containers sealed with bromobutyl bungs and aluminium caps.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down

BT35 6JP

8. MARKETING AUTHORISATION NUMBER(S)

Vm 02000/4214

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 5^th July 1999

10. DATE OF REVISION OF THE TEXT

June 2010