Adverse reactions : תופעות לוואי

ADVERSE REACTIONS
Adverse Reactions from Clinical Trials
The adverse reactions presented in this section have been identified based on clinical trial experience with HEMOFIL M in patients previously treated with other Factor VIII concentrates or blood products (N = 74), and previously untreated patients (PUPs; N = 50).


Clinical Trial Adverse Reactions
System Organ Class (SOC)                     Preferred MedDRA Term                                  Number of Cases (Frequency
Percentage)
BLOOD AND LYMPHATIC                                    Factor VIII inhibition                               3 (5.7%)     a 

SYSTEM DISORDERS
NERVOUS SYSTEM                                                Dizziness                                       1 (0.8%) DISORDERS                                                     Headache                                        1 (0.8%) Dysgeusia                                       1 (0.8%)
GENERAL     DISORDERS                                          Pyrexia                                        1 (0.8%) AND
ADMINISTRATION SITE                                 Infusion site inflammation                                2 (1.6%) CONDITIONS
 a
In a study that included 43 evaluable PUPs and 10 minimally treated patients (MTPs), i.e., patients with a single exposure to other Factor VIII concentrates or blood products, 3 of the total of 53 patients (5.7%) developed an inhibitor while on study.


HEMOFIL M was administered to 11 patients previously untreated with Antihemophilic Factor (Human). They have shown no signs of hepatitis or HIV infection following three to nine months of evaluation.
A study of 25 patients treated with HEMOFIL M and monitored for three to six months has demonstrated no evidence of antibody response to mouse protein. More than 1,000 infusions of HEMOFIL M have been administered during the clinical trials. Reported events included a single episode each of chest tightness, fuzziness and dizziness, and one patient reported an unusual taste after each infusion.

Post-marketing Adverse Reactions
In addition to clinical trials, the following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term.

Immune System Disorders : anaphylactic reaction, hypersensitivity
Eye Disorders: visual impairment, ocular hyperemia
Cardiac Disorders: cyanosis, bradycardia, tachycardia
Vascular Disorders: hypotension, flushing
Respiratory, Thoracic, and Mediastinal Disorders: bronchospasm, dyspnea, cough, hyperventilation
Gastrointestinal Disorders: diarrhea, vomiting, nausea, abdominal pain Skin and Subcutaneous Tissue Disorders: urticaria, rash, pruritus, hyperhidrosis Musculoskeletal and Connective Tissue Disorders : musculoskeletal pain General Disorders And Administration Site Conditions : facial edema, edema, chills, fatigue, chest pain, irritability