SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Calciject 40 CM Solution For Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance:

Contains Calcium Borogluconate 40% w/v Magnesium Hypophosphite Hexahydrate 5% w/v

Each 400ml contains :

11.9g calcium (provided by calcium gluconate and calcium borogluconate)

1.85g magnesium (provided by magnesium hypophosphite). 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

4.2 Indications for use, specifying the target species

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 massaged 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: may cause irritation at site of injection.

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 Amounts to be administered and administration route

Administer by subcutaneous or slow intravenous injection

Cattle:200 to 400 ml

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Not applicable.

4.11 Withdrawal period

Cattle

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% Water for Injections

6.2 Incompatibilities

None known

6.3 Shelf life

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

Glass bottles: 2 years

Polypropylene vials: 18 months

6.4 Special precautions for storage

Do not store above 25oC. Protect from light.

The product does not contain an antimicrobial preservative. The product is intended for single use only. Any product remaining in the bottle after withdrawal of the required dose should be discarded.

6.5 Nature and composition of immediate packaging

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.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

Camlough Road

NEWRY

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm 02000/4125

9. DATE OF FIRST AUTHORISATION

5^th July 1994

10. DATE OF REVISION OF THE TEXT

July 2010