Menveo Special Precautions

vaccine, meningococcal




Zuellig Pharma
Full Prescribing Info
Special Precautions
Before the injection of any vaccine, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions including thorough medical history and current health status.
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following administration of the vaccine.
Anxiety‐related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see Adverse Reactions). It is important that procedures are in place to avoid injury from fainting.
Menveo should under no circumstances be administered intravascularly.
Menveo will not protect against infections caused by any other serogroups of N. meningitidis not present in the vaccine.
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see Pharmacology: Pharmacodynamics under Actions).
Studies with Menveo have shown a waning of serum bactericidal antibody titers against serogroup A when using human complement in the assay (hSBA) (see Pharmacology: Pharmacodynamics under Actions). The clinical relevance of the waning of hSBA serogroup A antibody titers is unknown. If an individual is expected to be at particular risk of exposure to Men A and received a dose of Menveo more than approximately one year previously, consideration may be given to administering a booster dose.
There are no data on the applicability of the vaccine for post-exposure prophylaxis.
In immunocompromised individuals, vaccination may not result in an appropriate protective antibody response. While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people. Individuals with complement deficiencies and individuals with functional or anatomical asplenia may not mount an immune response to meningococcal group A, C, W135 and Y conjugate vaccines.
Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group A, C, W-135 and Y, even if they develop antibodies following vaccination with Menveo.
Menveo has not been evaluated in persons with thrombocytopenia, bleeding disorders or that are receiving anticoagulant therapy, because of the risk of haematoma. The risk- benefit ratio for persons at risk of haematoma following intramuscular injection must be evaluated by health care professionals.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Dizziness has been very rarely reported following vaccination. This may temporarily affect the ability to drive or use machines.
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