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    • Please send requests for the Summary of Product Characteristics to the following e-mail address:
    info@nobipharm.pl
    or by phone:
    22 633 98 02

    Medicinal products – Biotest Pharma GmbH

    As part of its operations, Biotest develops and markets immunoglobulins, blood coagulation factors, and albumins obtained from human blood plasma, which are used in the treatment of immune system and hematopoietic disorders. Biotest’s plasma-derived products are used to treat life-threatening conditions such as severe infections, immune system disorders, and blood clotting disorders (hemophilia). The most important starting material used in drug production is human plasma, which is processed into effective, highly purified medicinal products at one of the most modern production facilities. Biotest processes plasma sourced exclusively from officially licensed and regularly monitored blood donation centers in Germany, Belgium, Austria, and the USA. Before processing begins, donor plasma undergoes virological screening for antibodies against HIV-1 and -2, hepatitis C, and HbsAg. Plasma that tests positive is discarded and does not undergo further processing. Repeated testing of donor plasma, together with a multi-step procedure aimed at eliminating or inactivating viruses, includes, among other steps, nanofiltration (20nm), which ensures the highest degree of protection against the transmission of viruses pathogenic to humans. Biotest’s products meet the highest standards and are sold in countries with the most stringent registration requirements in the world. The quality and safety of Biotest’s products are trusted by patients, hospital staff, medical clinics, laboratories, and companies in more than 70 countries.

    Immunoglobulins

    Pentaglobin

    An IgG preparation enriched with IgM class antibodies. The product holds a marketing authorization in Poland.

    Varitect CP*

    Human immunoglobulin containing antibodies against the varicella zoster virus (chickenpox and shingles)

    *medicinal product available in Poland exclusively under the procedure set out in Article 4(8) of the Act of 6 September 2001 – Pharmaceutical Law.

    Megalotect CP

    Human immunoglobulin containing antibodies against cytomegalovirus. The product holds a marketing authorization in Poland.

    Zutectra

    Human immunoglobulin against hepatitis B virus, for subcutaneous administration. The product holds a marketing authorization in Poland.

    Hepatect CP

    Human immunoglobulin containing antibodies against hepatitis B virus. The product holds a marketing authorization in Poland.

    Intratect 50g/l, Intratect 100g/l

    Human normal immunoglobulin (IVIg). The product holds a marketing authorization in Poland.

    Haemophilia

    Haemoctin SDH 250, 500 and 1000 - Blood coagulation factor VIII. The product holds a marketing authorization in Poland.

    Albumins

    Albiomin 20% - A natural human albumin preparation with well-established benefits. The product holds a marketing authorization in Poland.