PlasmaLife® – Product properties
PlasmaLife ® is the only registered hyperimmune horse plasma entirely produced in Italy with permission and registration of the Italian Health Ministry (AIC No. 104 114 018).
PlasmaLife ® will supply foals with hypogammaglobulinemia (IgG <8 g / l) caused by the failure of (partial or complete) passive transfert of IgG with immediate support for the immune system even after the first 24 hours of life, when oral therapies do not guarantee further survival and the plasma remains the only choice of successful therapy.
Life plasma is obtained from donors who have increased levels of gamma globulin concentrations in the blood compared with normal horses. So each bag of plasmalife contains a minimum quantity of 24 g / l of IgG and 50 g / l of total proteins, but average values are normally much higher.
Life plasma is collected in special transfusion bags of 950 ml and correctly stored so that the plasma can be used immediately after thawing for the transfusion.
WHY CHOOSE PLASMALIFE®?
- It has been approved by the Italian Ministry of Health
- It is manufactured in a licensed pharmaceutical factory and is certified in accordance with the guidelines for quality assurance in production processes and production environment of medicines and drugs (GMP – Good Manufacturing Practice)
- It is obtained from healthy, universal and hyper immune donor horses
- The donor horses are tested before each donation for 16 infectious diseases
- It is sterile
- It is endotoxin-free
- It guarantees a minimum level of IgG> = 24 g / protein> = 50 g / l
- It can be stored in a standard freezer at -20 ± 5 ° C
- It is collected in a bag of Transfusion Medicine
- It is the only way to provide larger amounts of IgG for the foal after the first 24 hours of life
Storage and thawing
Plasmalife contains no preservatives and is not pasteurized. It is frozen and stored immediately after collection at a temperature of -20 ± 5 ° C. Then it must be stored, at the temperatures kept in a normal freezer.
The frozen bags should be handled carefully to avoid damages.
The thawing of plasmalife should be made by immersion in a water bath with a maximum of 37 ° C water temperature.
The temperature of the water during the thawing process must be checked by a thermometer, and if water cools down too much, it can be heated by adding more warm water, avoiding direct contact with the transfusion bag. It is recommended removing the bag from the bath during the addition of hot water, and when the water has been restored up to the desired temperature of 37 ° C, immerse the bag again.
This process can be repeated until the plasma is unfreezed completely. Usually, the liquefied thawed plasma is appearing transparent, but the presence of some rare fibrin cloths do not change the plasma’s quality.
These aggregates are delayed by the specified filter in the set that is absolutely necessary for secure transfusion. Do not use a microwave to unfreeze the plasma, since they alter the product’s properties.
PlasmaLife® – Administration
Plasma may only be given intravenously to foals using venous catheters and the transfusion set with special filters.
The normal dose is 20 ml / kg of foal body weight; a liter of plasma can be completely infused to a 50-kg foal in a time of 20 minutes (infusion rate <50 ml / min) without problems.
It is recommended that the first 50-100 ml are transfused slowly to monitoring clinical parameters of the foal accurately to evidence early symptoms of anaphylactic reactions such as tachycardia, tachypnea, and muscle tremors. In the rare occurring cases, the administration should be slowed or even stopped if necessary.
The administration of the plasmalife must be carried out under supervision and responsibility of veterinarian.
PlasmaLife® – Legislation
Horse plasma: ANIMAL DRUGS
On 6 April 2006, Italy adopted the European Directive 2004/28/EC of the European Parliament and the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products and implemented by the publication of Decree Law No. 193 (Article 1) “veterinary medicines are defined as:
– Any substance or combination of substances which are presented as having properties for treating or preventing disease in animals;
– Any substance or combination of substances used in or on the animal body or an animal can be administered to either restore the physiological functions by exerting a pharmacological, immunological or metabolic action, correcting or modifying, or making a medical diagnosis “
To this aim, active ingredients are considered any matter irrespective of its origin, namely:
– Human origins, like the blood and its derivatives
– Animal origin, such as micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products
– … … … .. ”
Horse plasma is therefore a veterinary medicine and is depending to all the regulations and controls shall be subject to veterinary medicine.
“No medicinal product under this Regulation or the European Directive 2004/28/EC may circulate without permission of Health Ministry”(Legislative Decree n.193 April 6, 2006, Article 5).
PlasmaLife® received the approval for the sale of horse plasma by the Health Ministry with the number 104114018 dated 12 January 2011 (with publication in the Official Gazette of the Italian Republic dated 02/09/2011).
“For the manufacture of veterinary medicines is needed a permission from the Ministry of Health” (D. Lgs n.193 April 6, 2006, Art.46)
“The holder of a permission for the manufacture of veterinary medicines is responsible for: … … … … …. adherence to the principles and guidelines of good manufacturing practice (or rules of Good Manufacturing Practice, GMP) for Medicines … … … … “ (Legislative Decree n.193 April 6, 2006, art. 52)
The company “Il Ceppo” has received the “approval for the production” and the certification of compliance with the rules of Good Manufacturing Pratice ,GMP by the Ministry of Health.
PlasmaLife® – Pharmacovigilance
Pharmacovigilance is called the control mechanism by which veterinarians, pharmacists, health authorities, pharmaceutical companies and not least the Ministry of Health are working with the aim to assess, with continuous and systematic monitoring of the safety of a finished product for animals to discover its adverse effects, and to understand to take any appropriate action to reduce any possible risk.
Who has reason to believe that the use of a veterinary drug has suspects side-effects, must report back to the regional center of pharmacovigilance … ……and to the Ministry of Health which will bring out without new or with even higher cost to the state budget, all the necessary measures avoiding other risks.” (Legislative Decree n.193 April 6, 2006, art.91)
It is therefore a moral and institutional obligation to report adverse reactions and side effects of administration of veterinary medicinal products to the competent authorities.
For more information on Pharmacovigilance, we urge you to read the reporting of suspected side effects, to visit the Ministry of Health at www.salute.gov.it