Therapeutic Indication:

Heparin Sodium ROVI 5,000 IU/ml is indicated for the prevention of thromboembolic disorders and as part of the treatment for venous or arterial thromboembolic disorders (including the early treatment of heart attacks as well as unstable angina pectoris). It is also indicated as an anticoagulant during treatment or operation with an extracorporeal circulation (e.g. heart/lung machine, haemodialysis).

• Composition: 25,000 IU Heparin Sodium and 50 mg Benzyl Alcohol in 5 ml solution.
• Pharmaceutical Form: Solution for injection.
• Method of Administration: Intravenous or subcutaneous.
• How Supplied: 5 ml vial in packs of 100 vials.
• Manufacturer: Laboratorios Farmacéuticos ROVI, Spain.

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Therapeutic Indication:

Konakion® MM Paediatric is indicated for prophylaxis and treatment of vitamin K Deficiency Bleeding in the newborn. Vitamin K prophylaxis in neonates is recommended.

• Composition: Phytomenadione 2 mg/0.2 ml.
• Pharmaceutical Form: Solution for injection.
• Method of Administration: Intravenous or oral.
• How Supplied: Pack of 5 ampoules of 0.2 ml.
• Manufacturer: Cheplapharm GmbH, Germany.

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Therapeutic Indication:

Konakion® MM is indicated for the treatment of haemorrhage or risk of haemorrhage as a result of severe hypoprothrombinaemia of various etiologies (as antidote to anticoagulant of the Coumarin/Warfarin type). Phytomenadione is the first line therapy for reversal of anticoagulant, especially warfarin or coumarin type according to several major clinical practice guidelines. In many countries (including developing countries).

• Composition: Phytomenadione 10 mg /1 ml.
• Pharmaceutical Form: Solution for injection.
• Method of Administration: Intravenous or oral.
• How Supplied: Pack of 5 ampoules of 1 ml.
• Manufacturer: Cheplapharm GmbH, Germany.

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Therapeutic Indication:

Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment starts.

The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis.

• Composition: Human Hepatitis B Immunoglobulin 500 IU/ml
• Pharmaceutical Form: Solution for Infusion.
• Method of Administration: Intravenous.
• How Supplied: Pack of 5x 1ml Prefilled Syringes.
• Manufacturer: Biotest AG, Germany.

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Therapeutic Indication:

• Prophylaxis against hepatitis B in adults and children over 2 years of age who have not been vaccinated against hepatitis B (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis B by accidental contact with Hepatitis B virus containing material (needle-stick injuries, mucosal contact). When the administration of an intramuscular hepatitis B immunoglobulin is not possible. The immunoglobulin should be administered in association with hepatitis B vaccine.
• Prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis B virus.
• Immunoprophylaxis of hepatitis B in the newborns of a hepatitis B virus carrier mothers.

• Composition: Human Hyper-immunoglobulin 50 IU/ml.
• Pharmaceutical Form: Solution for Infusion.
• Method of Administration: Intravenous.
• How Supplied: 75 IU and 150 IU vials.
• Manufacturer: IBSA Institute Biochimique SA, Switzerland.

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Therapeutic Indication:

• Pentaglobin® is the first and only IgM preparation for treating patients with severe bacterial infections in combination with antibiotic therapy, especially in sepsis caused by gram-positive or gram-negative bacteria and their toxins.
• Immunoglobulin replacement therapy for immunosuppressed patients and those with severe secondary antibody deficiency syndrome (immunocompromised patients and those with a suppressed immune system).

• Composition: 50 mg/1 ml, ≥ 95% immunoglobulin (IgM 6 mg, IgA 6 mg, IgG 38 mg).
• Pharmaceutical Form: Solution for Injection or Infusion.
• Method of Administration: Intravenous.
• How Supplied: 10 ml vial.
• Manufacturer: Biotest AG, Germany.

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Therapeutic Indication:

Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendation.

• Composition: Human Albumin 200 g/L.
• Pharmaceutical Form: Solution for Infusion.
• Method of Administration: Intravenous.
• How Supplied: 50 ml or 100 ml vials.
• Manufacturer: Biotest AG, Germany.

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Therapeutic Indication:

Replacement therapy in adults, and children and adolescents (0-18 years) in:

• Primary immunodeficiency syndromes with impaired antibody production.
• Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, inwhom prophylactic antibiotics have failed.
• Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients whohave failed to respond to pneumococcal immunisation.
• Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT).
• Congenital AIDS with recurrent bacterial infections.

Immunomodulation in adults, and children and adolescents (0-18 years) in:

• Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
• Guillain Barré syndrome.
• Kawasaki disease.

• Composition: Immunoglobulin Normal Human 100 mg/1 ml.
• Pharmaceutical Form: Solution for infusion.
• Method of Administration: Intravenous.
• How Supplied: 50 g/l (5%) or 100 g/l (10%) in 1g, 5g and 10g vials.
• Manufacturer: Biotest AG, Germany.

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Therapeutic Indication:

Treatment and prophylaxis of bleeding in patients with haemophilia A (Congenital Factor VIII Deficiency) and in patient with acquired factor VIII deficiency. Although Haemoctin SDH contains defined quantities of von Willebrand factor (vWF), it is not approved for the treatment of von Willebrand’s disease.

• Composition: Human Plasma Coagulation Factor VIII.
• Pharmaceutical Form: Powder and Solvent for Solution for Injection.
• Method of Administration: Intravenous.
• How Supplied: 250 IU (50 IU / ml), 500 IU (50 IU / ml) and 1000 IU (100 IU / ml) vials.
• Manufacturer: Biotest AG, Germany.

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