Medine.co.uk

Rumbul Rumen Bullet 15 G Continuous Release Intraruminal Device, Sheep/Calves

Revised: October 2011

AN: 01098/2011


SUMMARY OF PRODUCT CHARACTERISTICS


1.

NAME OF THE VETERINARY MEDICINAL PRODUCT




Rumbul Rumen Bullet 15g continuous release intraruminal device, Sheep/calves



2.

QUALITATIVE AND QUANTITATIVE COMPOSITION




Each bullet has a mass of 37g, comprising 17.44g (Mg-Al-Cu) alloy and 19.61g iron shot (ratio 47:53)




Active Ingredient:




Magnesium (in Mg-Al-Cu alloy) 15g/bolus




For full list of excipients, see section 6.1



3.

PHARMACEUTICAL FORM




Continuous release intraruminal device


Solid preparation of moulded magnesium alloy in bolus form.



4.

CLINICAL PARTICULARS



4.1

Target species




Sheep

Calves



4.2

Indications for use, specifying the target species




As an aid in the prevention of hypomagnesaemia in sheep of at least 30kg bodyweight during the high risk period associated with the grazing of early spring grass after lambing.


As an aid in the prevention of hypomagnesaemia in suckling calves, of at least 50kg bodyweight, where the diet is predominantly milk.



4.3

Contra-indications




Not to be used in sheep weighing less than 30kg


Not to be used in calves weighing less than 50kg





4.4

Special warnings for each target species




Rumbul Bullets may occasionally be regurgitated. This may happen very shortly after being administered if they have not been completely swallowed. The bullet may more readily reach the reticulum or base of the rumen if it is not given immediately after hay of silage has been given. Animals should be observed carefully for a few minutes after administration. Towards the end of their useful life (when the bullets become shorter and of considerably reduced diameter) there is a small chance that regurgitation may occur. If it is noticed that an individual animal has regurgitated a bullet, treatment should be repeated.



4.5

Special precautions for use,




i. Special precautions for use in animals


See 4.9 below for special precautions during administration.




ii. Special precautions to be taken by the person




There are no special precautions to be taken by person administering Rumbul sheep bullets



4.6

Adverse reactions (frequency and seriousness)




None known



4.7

Use during pregnancy and lactation




There are no restrictions on the use of the product during pregnancy and lactation.



4.8

Interaction with other medicinal products and other forms of interaction




None known



4.9

Amounts to be administered and administration route




Sheep

One Rumbul Sheep Bullet should be given to each sheep 2 days before the expected period of risk, e.g. after lambing or transfer to new grazing. If necessary dosing should be repeated after 3 weeks.




Calves

Two Rumbul sheep bullets should be given to each animal. One treatment should prevent a serious reduction in blood magnesium concentration for at least 3 weeks, thereafter a repeat dose should be given if the calf is still receiving a predominantly milk diet.




Administration orally by using the specially designed bulleting gun.


Load the gun by inserting the bullet into the open end, ensuring that the bullet is pressed into the metal cup and held firmly by the rubber head.



The gun should then be passed carefully and gently into the animal’s mouth until the rubber head is in the region of the back of the tongue. Severe pressure on the tongue should be avoided. Depression of the plunger will effect delivery of the bullet onto the rear part of the tongue thereby initiating a swallowing action. The gun should then be carefully withdrawn, taking care during removal to maintain its central position in the mouth.


For calves only: A second bullet should then be administered following the same procedure. Observe each animal for a short time after dosing to ensure both bullets have been swallowed.

And not regurgitated.


Note 1. It is desirable when administering the bullet that the head and neck are extended in a straight line in front of the animal. Once the bullet has been introduced on to the back of the tongue by means of the gun, its further progress will depend upon the reflex swallowing action of the animal. Any restraint, which interferes with this action is likely to reduce the chances of effecting a proper administration.


Note 2. The curvature of the gun is designed to facilitate the placing of the bullet on the back of the tongue. It is essential that the gun is maintained in an upright plane in the mid line of the mouth throughout the operation.


Further Information

In areas where there is no known copper deficiency, no additional supplement of copper should be given to sheep, which have been administered Rumbul Bullets, for the active life of the bullets (3 weeks).


4.10

Overdose (Symptons, emergency procedures, antidotes) if necessary




In the unlikely event of an accidental overdose, no special treatment is required



4.11

Withdrawal Periods




Meat – Zero days

Milk – Zero hours



5.

PHARMACOLOGICAL PROPERTIES



5.1

Pharmacodynamic properties




Rumbul Rumen Bullets for Sheep are a sustained release product, supplying magnesium to supplement that available in the diet. The magnesium is released from the Bullets by electrolytic action, when in contact with reticulo-rumen liquor, and is currently supplied continuously at a mean rate in the order of 0.5g/Bullet/day, throughout an active life of the Bullet of approximately 3 weeks. No permanent residues remain in the reticulo-rumen

5.2

Pharmacokinetic properties




Following oral administration, ionic magnesium is released into the reticulo-rumen. The mechanism of action of the product is identical to dietary magnesium. Once absorbed, magnesium is stored in the body intracellularly in soft tissues and in bone. Magnesium absorbed in excess of body requirements is excreted in the urine.


Magnesium is an essential cofactor of many enzymes and for the normal physiology of neuromuscular function.



6.

PHARMACEUTICAL PARTICULARS



6.1

List of excipients




Aluminium

Copper

Iron Shot



6.2

Incompatibilities




None known.



6.3

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




10 years



6.4

Special precautions for storage




Store in the original package

Keep the package tightly sealed

Store in a dry place



6.5

Nature and composition of immediate packaging




Rumbul Rumen Bullets – Sheep are moulded metal boluses packed in 10’s in a 400 gauge polyethylene sleeve sealed at both ends. Two 10-bullet sleeves are packed in a cardboard box (105 x 85 x 55mm), together with the pack leaflet.



6.6

Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate




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




Agrimin Limited

Arlanda Way

Humberside Airport

Kirmington

North Lincolnshire

DN39 6YH



8.

MARKETING AUTHORISATION NUMBER



Vm 04261/4004



9.

DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION



Date: 5th August 1993/5th August 2003.



10.

DATE OF REVISION OF TEXT




Date: October 2011



11.

ANY OTHER INFORMATION REQUIRED BY THE SECRETARY OF STATE




None


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