PlasmaLife Frozen fresh equine plasma for horses Active ingredients Quantity IgG ≥ 24 < 40 g/L Total proteins ≥ 50 < 90 g/L Excipients ACD-A citrates (expressed as citrate ion) < 4.73 g/L INDICATIONS Equine plasma is used to increase IgG in hypogammaglobulinemic foals (IgG < 8 g/L) for failed transfer of colostral immunity during the period between birth and 6 days of age. CONTRAINDICATIONS Do not use in case of intolerance to the immunoglobulins or excipients contained. Do not use in species other than the intended use species. Do not use in pregnant or lactating mares. Do not use in horses of ages other than the authorized ones. Do not use a route of administration other than the intravenous route. ADVERSE REACTIONS The risk of adverse drug reactions is extremely low. Immunological reactions of an anaphylactic type may arise following administration of equine plasma due to the presence of red blood cells or protein aggregates. The clinical signs of the anaphylactic reaction are characterized by tachycardia, tachypnea, hives, hyperthermia, cardiac arrhythmia, muscle tremors, colic, and collapse. The cardiac and respiratory parameters of the receiver must above all be carefully monitored when starting the administration of the plasma. A slow infusion at the start of the administration allows the receiving foal to show the first signs of reaction at an early stage so as to allow prompt intervention to counteract the reaction itself. If this happens, reduce the velocity of administration for 5-10 minutes or stop it completely. It is advisable to have available epinephrine (0.01 mg/kg), corticosteroids (prednisolone from 0.25 to 1 mg/kg slow IV), flunixin meglumine (1.1 mg/kg IV) and intravenous saline solutions, which must be used by the veterinarian administering the plasma in the case that anaphylactic shock occurs. However, since both the IgG and other proteins present in the plasma do not degrade and do not coagulate if the product is stored according to the described procedure, the risk of an anaphylactic reaction is notably reduced. Furthermore, the use of special infusion sets for the transfusion with filters to retain any corpuscular particles present in the plasma almost completely eliminates this risk. An excess of citrates can cause muscle fasciculations, weakness and cardiac abnormalities. However, the equine plasma contains a negligible amount of these in relation to the plasmatic mass of the receiving subject and studies conducted on the product’s safety in foals from 24 hours to 3 months old have not shown problems in this regard. If serious adverse reactions or other reactions not mentioned in this information leaflet occur, please inform the veterinarian. INTENDED USE SPECIES Horses. DOSAGE, ROUTE AND METHOD OF ADMINISTRATION The recommended dose of plasma is 20 ml per kilogram of live weight. One liter can be administered to a foal (45 – 50 kg) in a period of at least 20 minutes. It is recommended to begin the administration slowly (for the first 50-100 ml) and to carefully monitor the receiver. The complications, though rare, are well-characterized by symptoms such as tachypnea, tachycardia, tremors and colic. If this happens, reduce the velocity of administration further for 5-10 minutes or stop it completely. The foal must then be subjected to a test for the evaluation of serum IgG. If the IgG level has remained below 8 g/L after the first administration, it is advisable to administer a second bag of plasma. The latter must not be administered before 6 hours have passed after the first infusion. The administration occurs through infusion into the jugular vein of the foal into which a 14G x 2” catheter has previously been inserted, in an aseptic manner, following shaving and local anesthesia at the injection site. The entire bag of plasma is then administered to the foal within at least 20 minutes using a special infusion set with a filter to trap any protein aggregates. ADVICE ON CORRECT ADMINISTRATION The transient increase of the antibody titer that is found in the bloodstream after the administration of PlasmaLife can give rise to false positives in the serological tests. The effectiveness of the product depends on the immune status and on the possible presence of disease in the receiver. The administration of the medicinal product must only be performed by the veterinarian. WITHDRAWAL PERIOD Zero days. SPECIAL PRECAUTIONS FOR STORAGE Keep out of reach of children. Store in the original packaging, unopened, at a temperature of -20°C ± 5°C.
Do not use after the expiry date stated on the label. The product must be used within 6 hours of thawing. After opening the product must immediately be completely used and not stored. SPECIAL WARNINGS The transient increase of the antibody titer that is found in the bloodstream after the administration of PlasmaLife can give rise to false positives in the serological tests. The effectiveness of the product depends on the immune status and on the possible presence of disease in the receiver. The administration of the medicinal product must only be performed by the veterinarian. Special precautions for use in animals It is recommended to begin the administration slowly (for the first 50-100 ml) and carefully monitor the receiver. The complications, though rare, are well-characterized by symptoms such as tachypnea, tachycardia, tremors and colic. If this happens, reduce the velocity of administration further for 5-10 minutes or stop it completely. If the signs stop within 5 minutes you can continue the transfusion; if instead they occur again, you must definitively stop it. Be careful not to cause an overload of the blood volume (infusion rate < 50 ml/min for a 50-kg foal). Use the product only if it has been stored correctly, frozen at temperatures of -20 ± 5° C within the expiration date printed on the package. Thaw the product in a water bath at a temperature not greater than 37°C to limit flocculation and the formation of aggregates of plasma proteins. Administer the drug intravenously within 6 hours of thawing using a special infusion set with a filter to trap any protein aggregates. Special precautions that must be taken by the person that administers the product to the animals In case of accidental spillage onto the skin, the drug is not harmful and can be removed with soap and water. In case of accidental self-administration, self-injection or ingestion, contact a doctor immediately, showing him the information leaflet or the label. Use during pregnancy and lactation The drug is not intended for use in adult horses. The safety of the veterinary medicinal product on fertility has not been established. Interaction with other veterinary medicinal products and other forms of interaction Equine plasma has no interactions with numerous categories of drugs such as antimicrobials (e.g. penicillin, gentamicin, oxytetracycline), non-steroidal anti-inflammatory drugs (e.g. flunixin meglumine), and corticosteroids (e.g. dexamethasone). There is currently no evidence in the literature of interactions with other drugs administered concurrently to the foal. However, since further studies have not yet been carried out in relation to interactions of the plasma with other drugs, we recommend extreme caution in the concomitant administration of any drug with the plasma. In any case, since the risk of contamination or alteration of the plasma proteins exists, it is contraindicated to combine other veterinary drugs with the equine plasma. Overdose (symptoms, emergency procedures, antidotes) if necessary The consecutive administration of 2 or more liters of plasma or too fast of a transfusion of the plasma itself can cause an overload of the blood volume with consequences on the foal’s cardiopulmonary system characterized by alterations in the heart rate and breathing rate: in case these symptoms occur, immediately interrupt the administration, allowing the foal to compensate for the increase in blood volume. Following the remission of the symptoms, the administration may be restarted with a slower rate of infusion. The administration of up to 4 liters of plasma in an appropriate period of time without side effects is however reported. An excess of citrates (ACD) can cause muscle fasciculations, weakness and cardiac abnormalities. If these symptoms occur, immediately interrupt the administration. However, the equine plasma contains a negligible amount of these in relation to the plasmatic mass of the receiving subject and studies conducts on the safety of the product in foals from 24 hours to 3 months old have not shown problems in this regard. SPECIAL PRECAUTIONS TO TAKE FOR THE DISPOSAL OF THE UNUSED PRODUCT OR ANY WASTE All veterinary medicinal products that have not been used, are visibly damaged, or that have packaging that is not intact and the empty bags following transfusion must be disposed of in accordance with the local legislation and placed into appropriate collection and disposal systems for unused or expired medicinal products. NAME AND ADDRESS OF THE HOLDER OF THE AUTHORIZATION FOR MARKETING Soc. IL CEPPO S.a.s. Via di Monteresi, 3 - 53035 Monteriggioni (SI) Italy DATE OF THE LAST REVISION OF THE INFORMATION LEAFLET January 2013
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