החמרה לעלון

:‫תאריך‬

03.12.2013 Neupogen® Vials 30 MU/ML Neupogen® Pre-filled Syringe 30 MU/0.5 ML Neupogen® Pre-filled Syringe 48 MU/0.5 ML

:‫שם התכשיר באנגלית‬

058-31-27318-00 117-22-29875-00 117-21-29876-00

:‫מספרי רישום‬

!‫טופס זה מיועד לפרוט ההחמרות בלבד‬

‫ההחמרות המבוקשות‬ ‫טקסט חדש‬

Capillary leak syndrome has been reported after granulocyte colonystimulating factor administration, and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8). Vascular disorders, including venoocclusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by transplantation. In normal donors, dyspnoea has been reported commonly and other pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltrates, and hypoxia) have been reported uncommonly.

‫טקסט נוכחי‬

In normal donors, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltrates, dyspnoea and hypoxia) have been reported very rarely in post marketing experience. Haematuria was common and proteinuria Haematuria and proteinuria occurred in a small number of patients. occurred in a small number of patients. In PBPC mobilisation in normal donors the most commonly reported undesirable effect was musculoskeletal pain. Leukocytosis was observed in donors and thrombocytopenia following

‫פרק בעלון‬ 4.4

Special warnings and precautions for use

4.4

Special warnings and precautions for use

4.4

Special warnings and precautions for use

4.4

Special warnings and precautions for use 4.8

Undesirable effects

‫ההחמרות המבוקשות‬ ‫טקסט חדש‬

‫טקסט נוכחי‬

‫פרק בעלון‬

filgrastim and leukapheresis was also observed in donors. Splenomegaly and splenic rupture were also reported. Some cases of splenic rupture were fatal. In SCN patients the most frequent undesirable effects attributable to Neupogen were bone pain, general musculoskeletal pain and splenomegaly. Myelodysplastic syndromes (MDS) or leukaemia have developed in patients with congenital neutropaenia treated with Neupogen. Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥ 1/1000 to < 1/100) in cancer patients undergoing chemotherapy and healthy donors undergoing peripheral blood progenitor cell mobilization following administration of granulocyte colonystimulating factors. In cancer patients: MedDRA system organ class

Commo n (≥ 1/100 to < 1/10)

Blood and lymphati c system disorder s

Nervous system disorder s

4.8

Undesirable effects

Uncommo n (≥ 1/1000 to < 1/100)

Rare (≥ 1/10, 000 to < 1/100 0)

Very rare (< 1/10,0 00)

Drug hypersen sitivitya

Blood uric acid increased Blood lactate dehydrog enase increased Decrease d appetitea Headache a

Graft versus Host Diseaseb Pseudogou ta

4.8

System organ class

Frequency

Undesirable effect

Metabolism and nutrition disorders

Very common

Blood alkaline phosphatase increased Blood lactate dehydrogena se increased Blood uric acid increased

Common

Anorexia

Nervous system disorders

Common

Headache

Vascular disorders

Rare

Angiopathy

Respiratory, thoracic and mediastinal disorders

Common

Cough Pharyngolary ngeal pain

Very rare

Lung infiltration

Very common

Nausea Vomiting

Common

Constipation Diarrhoea

Very common

Gammaglutamyl transferase increased

Sickle cell crisisa

Immune system disorder s Metaboli sm and nutrition disorder s

Undesirable effects

In cancer patients: Adverse reactions

Very common (≥ 1/10)

4.8

Gastrointesti nal disorders

Hepatobiliary disorders

Undesirable effects

‫ההחמרות המבוקשות‬ ‫טקסט חדש‬ Vascular Disorder s

Hypoten sion

Venoocclusive diseased Fluid volume disturbance s Capillary leak syndromea

Respirat ory, thoracic and mediasti nal disorder s

Orophary ngeal paina

Haemopt ysise

Acute respiratory distress syndromea

Cougha

Respiratory failurea

Dyspnoea

Pulmonary oedemaa Interstitial lung diseasea Lung infiltrationa Pulmonary haemorrha ge

Gastroin testinal disorder s

Diarrhoea a

Vomitinga Constipati ona Nauseaa

Hepatobi liary disorder s

Gammaglutamyl transferas e increased Blood alkaline phosphat ase increased

Skin and subcuta neous tissue disorder s Musculo skeletal and connecti ve tissue disorder s Renal and urinary disorder s

Rasha

Sweets syndrome

Alopeciaa Cutaneous vasculitisa Musculos keletal painc

Exacerbati on of rheumatoid arthritis

Dysuria

Urine abnormality

‫טקסט נוכחי‬

‫פרק בעלון‬

Skin and subcutaneou s tissue disorders

Common

Alopecia Rash

Musculoskele tal and connective tissue disorders

Common

Musculoskel etal pain

Renal and urinary disorders

Very rare

Urine abnormality

General disorders and administratio n site conditions

Common

Fatigue Asthenia Mucosal inflammation Chest pain

Uncommon

Pain

‫ההחמרות המבוקשות‬ ‫טקסט חדש‬ General disorder s and administ ration site conditio ns

Astheniaa Fatigue

a

Chest paina

‫טקסט נוכחי‬ Paina

Mucosal inflammati ona

PBPC mobilisation in normal donors:

PBPC mobilisation in normal donors: MedDRA system organ class

Blood and lymphatic system disorders

Adverse reactions Very common (≥ 1/10)

Thrombocy topenia

Commo n (≥ 1/100 to