Medine.co.uk

Downland Low Volume Calcium Solution For Injection

Revised: September 2010

AN: 00348/2010


SUMMARY OF PRODUCT CHARACTERISTICS


1. Name of the veterinary medicinal product


Downland Low Volume Calcium Solution for Injection


2. Qualitative and quantitative composition


Active Substance(s)


Each 100 ml contains 4.2g calcium (provided by calcium gluconate, calcium borogluconate and calcium hydroxide) and 0.78g magnesium (provided by magnesium chloride hexahydrate). Also contains 7.34% w/v boric acid.


For a full list of excipients, see section 6.1


3. Pharmaceutical form


Solution for Injection.

A clear, colourless to 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 complicated by a deficiency of magnesium.


4.3 Contraindications


None


4.4 Special Warnings for each target species


In cases of acute hypomagnesaemia the administration, by appropriate routes, of a solution with a higher concentration of magnesium may be necessary.


4.5 Special precautions for use


Special precautions for use in animals



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


Solutions for intravenous injection should be warmed to body temperature and infused slowly.



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)



Rapid intravenous injection may result in cardiac arrythmias and in severely toxaemic cows, collapse and death.



4.7 Use during pregnancy, lactation or lay

Provided the above precautions are observed the product should be safe for use during pregnancy and lactation.



4.8 Interaction with other medicinal products and other forms of interaction



None recorded.



4.9 Amounts to be administered and administration route



Slow intravenous injection


Subcutaneous injection.

Massage the site gently after administration.


Dosage: Cattle - 100 - 200 ml


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



Rapid intravenous injection may result in cardiac arrythmias or heart block. Therefore intravenous injections should be given slowly and stopped on the first signs of adverse reaction.



Withdrawal period



Cattle - Meat: Zero Days

Milk: Zero Hours



5. pharmacological properties



Pharmacotherapeutic group: Metabolic & Fluid Preparation


ATC Vet Code: QA12AA20



Pharmacodynamic properties


Calcium borogluconate, calcium hydroxide and magnesium chloride hexahydrate are soluble salts of calcium and magnesium respectively, used extensively in fluid metabolite preparations. On parenteral administration they rapidly increase plasma concentrations of calcium and magnesium. This is effective in the treatment of hypocalcaemia with associated hypomagnesaemia.


5.2 Pharmacokinetic properties

After injection of Downland Low Volume Calcium, plasma levels of calcium and magnesium were recorded at 2.51 +0.039 mmol/L and 0.889 +0.041 mmol/L respectively which are within the normal ranges for plasma calcium and magnesium.


Mean Cmax values for calcium of 4.2 +0.08 mmol/L were obtained following administration of Calicject LV. The corresponding mean AUC values for calcium were 61.38 +0.59 mmol/L.hr


6. Pharmaceutical particulars


6.1 List of excipients


Phosphoric Acid, Concentrated.

Sodium Hydroxide

Water for Injections



Incompatibilities


None known


Shelf life


Shelf life of the veterinary medicinal product as packaged for sale: 2 years.


Special precautions for storage


Do not store above 25ÂșC.

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.


Nature and composition of immediate packaging


Carton containing 8 x 100 ml clear colourless glass Type II vial with rubber bromobutyl bung with aluminium overseal.


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

Newry

Co. Down, BT35 6JP

Northern Ireland


8. MARKETING AUTHORISATION NUMBER


Vm: 02000/4291


9. DATE OF RENEWAL OF AUTHORISATION


3 August 2010


10. DATE OF REVISION OF THE TEXT


September 2010


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