Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 5

HOS-150433 · Präparat HOS-100320

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-150434 · Präparat HOS-100320

No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): factor VIII (HOS-089600)

Wechselwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-150436 · Präparat HOS-100320

No interaction studies have been performed.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-150437 · Präparat HOS-100320

Summary of the safety profile

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-150438 · Präparat HOS-100320

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-150439 · Präparat HOS-100320

Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ALTUVOCT (see section 5.1). If such inhibitors occur, the condition may manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-150440 · Präparat HOS-100320

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-150441 · Präparat HOS-100320

Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies of adverse reactions are based on Phase 3 clinical studies in 277 previously treated patients (PTPs) with severe haemophilia A, of which 161 (58.2%) were adults (18 years of age and older), 37 (13.4%) were adolescents (12 to < 18 years of age), and 79 (28.5%) were children under the age of 12 years.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-150442 · Präparat HOS-100320

Adverse drug reactions (ADRs) (summarized in Table 2) were reported in 111 (40.1%) of the 277 subjects treated in clinical studies with routine prophylaxis or on-demand therapy or reported in post- marketing setting.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-150443 · Präparat HOS-100320

Frequencies have been evaluated 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 the available data).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-150444 · Präparat HOS-100320

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7–8

HOS-150445 · Präparat HOS-100320

7 Table 2: Adverse reactions reported for ALTUVOCT

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-150446 · Präparat HOS-100320

MedDRA system organ class Adverse reactions Frequency category 1 Blood and lymphatic system disorders Factor VIII inhibition Very common (PUPs)2 Uncommon (PTPs)3 Immune system disorders Hypersensitivity, Not known anaphylactic reactions1 Nervous system disorders Headache4 Very common Gastrointestinal disorders Vomiting Common Skin and subcutaneous tissue disorders Eczema Common Rash5 Common Urticaria6 Common Musculoskeletal and connective tissue disorders Arthralgia Very common Pain in extremity Common Back pain Common General disorders and administration site Pyrexia Common conditions Injection site reaction7 Uncommon 1 Reported in post-marketing setting. 2 PUPs = Previously-Untreated Patients. Frequency is based on studies with other Factor VIII products which included PUPs with severe haemophilia A. 3 PTPs = Previously-Treated Patients. Frequency is based on studies with all Factor VIII products which included PTPs with severe haemophilia A. 4 Headache, including migraine. 5 Rash, including rash maculo papular. 6 Urticaria, including urticaria papular. 7 Injection site reaction, including injection site haematoma and injection site dermatitis.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-150447 · Präparat HOS-100320

Paediatric population

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-150448 · Präparat HOS-100320

No age-specific differences in adverse reactions were observed between paediatric and adult patients.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-150449 · Präparat HOS-100320

Reporting of suspected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Altuvoct

ALTUVOCT 250 IU powder and solvent for solution for injection ALTUVOCT 500 IU powder and solvent for solution for injection ALTUVOCT 750 IU powder and solvent for solution for injection ALTUVOCT 1 000 IU powder and solvent for solution for injection ALTUVOCT 2 000 IU powder and solvent for solution for injection ALTUVOCT 3 000 IU powder and solvent for solution for injection ALTUVOCT 4 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-150450 · Präparat HOS-100320

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.