unoglobulins suggests that no harmful effects on fertility are to be expected.
4.7 Effects on ability to drive and use machines
The ability to drive and operate machines may be impaired by some adverse reactions associated with KIOVIG. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
4.8 Undesirable effects
Summary of the safety profile
Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions have been observed with human normal immunoglobulin. Reversible haemolytic reactions have been observed in patients, especially those with blood groups A, B, and AB. Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment (see also Section 4.4).
Increase in serum creatinine level and/or acute renal failure have been observed.
Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thromboses.
Tabulated list of adverse reactions
The tables presented below are according to the MedDRA system organ classification (SOC and Preferred Term Level). Table 1 shows the adverse reactions from clinical trials and Table 2 shows the post-marketing ARs.
Frequencies have been eva luated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1
Frequency of Adverse Reactions (ADRs) in clinical studies with KIOVIG
MedDRA
System Organ Class (SOC)
Adverse reaction
Frequency
Infections and infestations
Bronchitis, nasopharyngitis
Common
Chronic sinusitis, fungal infection, infection, kidney infection, sinusitis, upper respiratory tract infection, urinary tract infection, bacterial urinary trct infection, meningitis aseptic
Uncommon
Blood and lymphatic system disorders
Anaemia, lymphadenopathy
Common
Immune system disorders
Hypersensitivity, anaphylactic reaction
Uncommon
Endocrine disorders
Thyroid disorder
Uncommon
Metabolism and nutrition disorders
Decreased appetite
Common
Psychiatric disorders
Insomnia, anxiety
Common
Irritability
Uncommon
Nervous system disorders
Headache
Very common
Dizziness, migraine, paresthesia, hypoesthesia
Common
Amnesia, dysarthria, dysgeusia, balance disorder, tremor
Uncommon
Eye disorders
Conjunctivitis
Common
Eye pain, eye swelling
Uncommon
Ear and labyrinth disorders
Vertigo, fluid in middle ear
Uncommon
Cardiac disorders
Tachycardia
Common
Vascular disorders
Hypertension
Very common
Flushing
Common
Peripheral coldness, phlebitis
Uncommon
Respiratory, thoracic and mediastinal disorders
Cough, rhinorrhoea, asthma, nasal congestion, oropharyngeal pain, dyspnea
Common
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