Introduction

Company name: Veterinary Immunogenics Ltd

Address: Carleton Hill

Penrith

Cumbria

CA11 8TZ

Telephone: 01768 863881

Fax: 01768 891389

Email: tombarr@veterinaryimmunogenics.com

Website: www.veterinaryimmunogenics.com

Presentation

HYPERMUNE is frozen equine plasma for intravenous transfusion, containing not less than 24 grams of equine IgG and not less than 50 grams of equine total protein, in a 1 litre PVC with DEHP human plasma bag and is for single use only. It contains the excipient Acid Citrate Dextrose-A to ensure citrate content 10-20mmols/l.

Uses

For foals with Failure of Passive Transfer. To raise the level of circulating IgG in neonatal foals aged 24 hours to 6 days which have been shown to have low levels (less than 4g/l). The raised level has been demonstrated approximately 24 hours after administration but the duration of the effect is not known.

Dosage and administration

Hypermune may be administered to foals from 24 hours to 6 days of age where it has been shown after testing that they have low levels of serum IgG (less than 4 g/l). The dose required is one litre for a 50 kg foal (and pro rata, i.e. 20 ml per kg). The required dose is administered via a catheter placed in the jugular vein using a blood giving set equipped with a mesh filter. The product should be administered slowly, particularly at the start, and administration should take 15 – 20 minutes. Throughout the administration, the foal should be monitored for signs of adverse reactions. A blood sample should be collected from the foal approximately 24 hours later and re-tested for the level of serum IgG. If this is still low, a further dose may be administered. This should be given within 24 – 48 hours of the first administration and be given in the same manner as the first (intravenously, via a blood giving set, over 15 - 20 minutes).

The foal may be mildly sedated if necessary the skin anaesthetised over the aseptically prepared jugular vein site and a 16G x 2' catheter used.

Contra-indications, warnings, etc

Withdrawal periods

Zero days.

There are no absolute contra indications.

It should be noted that ACD-A is an excipient and that excess citrate may cause a reaction in the recipient foal. This may be seen as muscle fasciculations, weakness and cardiac abnormalities

Transfusion Reactions are very rare; signs include tachycardia, hyperventilating and trembling.

Anaphylaxis is very rare, but can occur with products of this nature. Signs include tachycardia, hyperventilating and trembling, or other signs such as colic, pyrexia, cardiac arrhythmias, urticaria and collapse.

Volume Overload is a very rare but possible hazard of plasma transfusion especially if the administration is carried out too quickly. Signs include respiratory distress, hyperventilation, staggering and collapse when in standing restraint. Additionally, if the foal is in lateral recumbency froth may be seen at the nostril.

If tachycardia, hyperventilating or trembling occurs, slow the transfusion down or stop altogether. If signs abate within five minutes, as they should, then continue transfusing. If they recur again, stop entirely. If severe, or other signs occur such as colic, pyrexia, cardiac arrhythmias, urticaria and collapse, stop transfusion and if necessary administer epinephrine (0.01mg/kg), corticosteroids and intravenous saline. These emergency drugs should always be on hand. Flunixin meglumine at 0.25mg/kg may be used prophylactically to reduce the incidence of side effects.

Do not mix other products with HYPERMUNE, and use straight from the bag.

Do not administer more than 2 doses to any one animal.

It is recommended that no other immunological product be administered within 14 days following administration of Hypermune apart from tetanus antitoxin which may be administered simultaneously but not intravenously. As with colostrum derived passive immunity, the passive immunity transferred by Hypermune may interfere with response to vaccine. It is recommended that this is considered when starting a vaccine programme with due adherence to the vaccine manufacturer's instructions.

Pharmaceutical precautions

STORAGE: Frozen at –25ºC ± 5oC. HYPERMUNE should be handled carefully when being unpacked and stored in the freezer. The bubble-wrap should not be removed as it protects the brittle frozen plastic which is susceptible to damage from careless handling such as being dropped or knocked in the freezer. When thawed it should be stored in a refrigerator and used within 24 hours. Do not use after the expiry date stated on the label.

Keep out of the sight and reach of children.

Thawing should not take place in a microwave oven. The litre bag of plasma should be immersed only in warm water at not more than 40ºC. A water bath such as a sink full of domestic warm water is ideal. As the plasma thaws and the water cools, more warm water may be added as required but hot water (not greater than hand hot) must be avoided as it will damage the proteins. The entire litre of plasma should be brought slowly to body temperature before use to ensure all the cryoprecipitate is dissolved. Under optimum conditions this whole process may take 2-2½ hours. Occasionally small amounts of fibrin may still be seen floating in the plasma. It is not significant but must be filtered out by the filter in the blood administration set.

Inspect for leakage and if apparent on thawing the entire contents must be discarded.

Unused product and empty pack should be discarded and disposed of as clinical waste.