Blood Products

Critical care

All around the world, acutely ill and injured people seek care every day.  Frontline providers manage children and adults with medical, surgical and obstetric emergencies, including injuries and infections, heart attacks and strokes, asthma and acute complications of pregnancy.  Prioritising an integrated approach to early recognition and resuscitation reduces the impact of all of these conditions.

Human Albumin

Therapeutic indications:
restoration and maintenance of circulatory blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate in such physiopathological conditions as liver cirrhosis, trauma, cardio-circulatory insufficiency, or severe burns.

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-summary-product-characteristics-human-albumin-solution-revision-3_en.pd

Human Prothrombin Complex

Therapeutic indications:
Treatment of bleeding and peri-operative prophylaxis of hemorrhagic accidents due to an acquired deficiency in clotting factors of the prothrombin complex, such as deficiency induced by anti-vitamin K treatment, or in case of overdose in anti-vitamin KK vitamins, when urgent deficit correction is required.

https://www.ema.europa.eu/en/documents/scientific-guideline/core-spc-human-prothrombin-complex-products-cpmp/bpwg/3735/02_en.pdf

Hemophilia

Hemophilia is usually an inherited bleeding disorder in which the blood does not clot properly. This can lead to spontaneous bleeding as well as bleeding following injuries or surgery. Blood contains many proteins called clotting factors that can help to stop bleeding. People with hemophilia have low levels of either factor VIII (8) or factor IX (9). The severity of hemophilia that a person has is determined by the amount of factor in the blood. The lower the amount of the factor, the more likely it is that bleeding will occur which can lead to serious health problems.

Human plasma derived Anti-hemophilic Factor VIII / Factor IX

The preparations produced from human blood plasma contain the original natural factor in concentrated form indicated for patients with hemophilia type A or B

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-summary-product-characteristics-human-plasma-derived-recombinant-coagulation-factor_en.pdf

Recombinant Anti-hemophilic Factor VIII – Factor IX

Genetically engineered Anti-hemophilic Factor VIII / IX are proteins artificially generated in cultured animal cells, indicated for patients with hemophilia A or B

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-spc-human-plasma-derived-recombinant-coagulation-factor-ix-products_en.pdf

Immunology

Immunology is the study of the immune system. The immune system protects us from infection through various lines of defence. If the immune system encounters a pathogen, for instance, a bacterium, virus, or parasite, it mounts a so-called immune response. This innate immunity includes the external barriers of our body — the first line of defense against pathogens — such as the skin and mucous membranes of the throat and gut. The adaptive immune system is activated when the innate system fails to clear pathogens from the body. It consists of a variety of cells and molecules, among which lymphocytes and antibodies are the key elements.

As we are exposed to diseases or get vaccinated, we build up a library of antibodies to different pathogens. This is sometimes referred to as immunological memory because our immune system remembers previous enemies.

Passive immunity is “borrowed” from another source, but it does not last indefinitely. For instance, a baby receives antibodies from the mother through the placenta before birth and in breast milk following birth.

If the immune system is not functioning as it should, it can result in Immunodeficiency disorderst hat impair its ability to mount an appropriate defence..  these are almost always associated with severe infections that persist, recur and/or lead to complications, making these disorders severely debilitating and even fatal. It is also now becoming clear that immune responses contribute to the development of many common disorders not traditionally viewed as immunologic, including metabolic, cardiovascular, and neurodegenerative conditions.

There are two types of immunodeficiency disorders:

Primary and secondary immunodeficiencies:

  • Primary immunodeficiencies are typically present from birth, are generally hereditary and are relatively rare.
  • Secondary immunodeficiencies generally develop later in life and may result following an infection, as is the case with AIDS following HIV infection.

Autoimmune diseases

Autoimmune diseases occur when the immune system attacks the body it is meant toprotect. People suffering from autoimmune diseases have a defect that makes them unable to distinguish ‘self’ from ‘non-self’ or ‘foreign’ molecules.

Both passive immunization and immunedeficiencies disorders can be treated trhough concentrates of antibodies (Immunoglobulins) manufactured by fractionating human blood plasma. Immunogloulins are mainly of two types:

1) Normal Immunoglobulin are preparations for intravenous use containing high concentrations of generic antibodies to treat primary and secondary immunodeficiencies, and some neurologic diseases

Therapeutic indications:
Replacement therapy in:
• Primary immunodeficiency syndromes (PID)
• Secondary immunodeficiencies (SID)
Immunomodulation in:
• Primary immune thrombocytopenia (ITP)
• Guillain Barré syndrome
• Kawasaki disease
• Chronic inflammatory demyelinating poliradiculoneuropathy (CIDP)
• Multifocal motor neuropathy (MMN)

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-human-normal-immunoglobulin-intravenous-administration-ivig-rev-6_en.pdf

2) Hyperimmune/Specific immunoglobulins are preparations that contain a high concentration of antibodies to treat particular viruses or bacteria.

Human anti D immunoglobulin for intramuscular use:
Therapeutic indications:
Prevention of Rh(D) immunisation in Rh(D) negative childbearing age women

Antenatal prophylaxis

  • Planned antenatal prophylaxis
  • Antenatal prophylaxis following complications of pregnancy including:
  • Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole, intrauterine fetal death (IUFD), transplacental haemorrhage (TPH) resulting from ante-partum haemorrhage (APH), amniocentesis, chorionic biopsy, obstetric manipulative procedures e.g. external version, invasive interventions, cordocentesis, blunt abdominal trauma or fetal therapeutic intervention.

Postnatal prophylaxis

  • Delivery of a Rh(D) positive (D, Dweak, Dpartial) baby
  • Treatment of Rh(D) negative childbearing age women after incompatible transfusions of Rh(D) positive blood or other products containing red blood cells e.g. platelet concentrate.

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-human-anti-d-immunoglobulin-intramuscular-use_en.pdf

Human anti hepatite B immunoglobulins for intamuscular or intravenous use from human origin.
Therapeutic indications:
– Prevention of hepatitis B virus recurrence after liver transplantation for hepatitis B virus induced liver failure. The concomitant use of adequate virostatic agents should be considered, if appropriate, as a standard in hepatitis B re-infection prophylaxis.

-Immunoprophylaxis of hepatitis B

  • In case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown).
  • In haemodialysed patients, until vaccination has become effective.
  • In the newborn of a hepatitis B virus carrier-mother.

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-spc-human-plasma-derived-hepatitis-b-immunoglobulin-intravenous-use-cpmp/bpwg/4027/02_en.pdf

Human anti tetanus immunoglobulins for intramuscular use from human or animal origin.
Therapeutic indications:

  • Post-exposure prophylaxis
    Immediate prophylaxis after tetanus prone injuries in patients not adequately vaccinated, in patients whose immunisation status is not known with certainty and in patients with severe deficiency in antibody production.
  • Therapy of clinically manifest tetanus
    Active tetanus vaccination should always be administered in conjunction with tetanus immunoglobulin unless there are contraindications or confirmation of adequate vaccination.

https://www.ema.europa.eu/en/documents/scientific-guideline/core-spc-human-tetanus-immunoglobulin-intramuscular-use-cpmp/bpwg/3730/02_en.pdf

Other specific human immunoglobulins.
Human anti citomegalovirus, anti rabies, anti varicella zoster.

Discover also our Serums and Vaccines products.