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Cytomegalovirus immunoglobulin human parenteral


Infusions of cytomegalovirus immunoglobulin human.

Drugs List

  • CYTOTECT CP BIOTEST 1000unit/10ml solution for infusion vial
  • CYTOTECT CP BIOTEST 5000unit/50ml solution for infusion vial
  • immunoglobulin human cytomegalovirus 1000unit/10ml solution for infusion vial
  • immunoglobulin human cytomegalovirus 5000unit/50ml solution for infusion vial
  • Therapeutic Indications


    Prevention of CMV disease in patients receiving immunosuppressive therapy


    Administration should be initiated on the day of transplantation. In the case of bone marrow transplantation, prophylaxis up to 10 days prior to transplantation can be expected, particularly in cytomegalovirus sero-positive patients. A total of 6 single doses at 2 to 3 week intervals should be given.


    Single dose: 1ml/kg bodyweight.


    Single dose: 1ml/kg bodyweight.

    Additional Dosage Information

    In the case of adverse reaction, the rate of administration must be reduced or the infusion stopped. If well tolerated the rate of administration may be gradually increased to a maximum of 0.8ml/kg bodyweight per hour for the remainder of the infusion.


    For intravenous infusion at an initial rate of 0.08ml/kg bodyweight per hour for 10 minutes.


    Immunoglobulin A deficiency with IgA antibodies

    Precautions and Warnings

    Predisposition to thromboembolic disease
    Untreated infection or underlying chronic inflammation
    Diabetes mellitus
    Renal impairment

    Live virus vaccine should not be given for 3 months after treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Derived from human blood - transmission of infectious agents possible
    Do not mix with other drugs or substances
    If adverse reactions occur, reduce rate or temporarily stop infusion
    Monitor throughout infusion and for 1 hour post first infusion
    Record name and batch number of administered product
    Monitor renal function before treatment and regularly during treatment
    Ensure adequate hydration prior to infusion
    Monitor patient closely for haemolysis
    Monitor serum creatine periodically
    Monitor urine output
    Discontinue if signs of pulmonary distress
    Management of cases of shock should follow current medical standards
    May affect results of some laboratory tests
    Discontinue if Aseptic Meningitis Syndrome occurs
    Discontinue if renal function deteriorates
    Measles vaccine may not be effective for up to 1 year after treatment

    Patients naive to human immunoglobulin, patients switched from an intravenous human immunoglobulin product or when there has been a long interval since the previous infusion, should be monitored at the hospital during the first infusion and for the first hour after the infusion in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration.

    In patients at risk of thromboembolic adverse reactions or acute renal failure, intravenous human immunoglobulin products should be administered at the minimum rate of infusion and dose practicable.

    Risk factors for acute renal failure should identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or age over 65 years.

    Patients showing signs of aseptic meningitis syndrome (AMS) should receive a thorough neurological examination, including cerebrospinal fluid (CSF) analysis to rule out other causes of meningitis.

    Pregnancy and Lactation


    Use cytomegalovirus immunoglobulin human with caution during pregnancy.

    The manufacturer advises caution if cytomegalovirus immunoglobulin human is used during pregnancy. At the time of writing there is limited published information regarding the use of cytomegalovirus immunoglobulin human during pregnancy. Intravenous human immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester. Potential risks are unknown.


    Use cytomegalovirus immunoglobulin human with caution during breastfeeding.

    The manufacturer advises caution if cytomegalovirus immunoglobulin human is used when breastfeeding. Whilst available data indicates immunoglobulins are present in human breast milk, the quantity is not considered to be sufficient to cause adverse effects in the breastfed infant. Effects on exposed infants are unknown.

    Side Effects

    Acute renal failure
    Allergic reaction
    Anaphylactic reaction
    Anaphylactic shock
    Anaphylactoid reaction
    Aseptic meningitis
    Back pain
    Decrease in blood pressure
    Deep vein thrombosis (DVT)
    Fixed drug eruption
    Haemolytic anaemia
    Haemolytic transfusion reaction
    Hypersensitivity reactions
    Lupus erythematosus
    Myocardial infarction
    Pulmonary embolism
    Serum creatinine increased
    Thromboembolic complications
    Transfusion related acute lung injury (TRALI)

    Effects on Laboratory Tests

    Administration of immunoglobulin may cause the transient rise of various antibodies in the patient's blood. This may result in misleading positive results in serological testing for red cell antibodies, for example the direct antiglobulin test (Coombs' test).

    Further Information

    Last Full Review Date: April 2020

    Reference Sources

    Summary of Product Characteristics: Cytotect CP Biotest 100 U/ml solution for infusion. Biotest Pharma GmbH. Revised January 2020.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.