‫הודעה על החמרה ( מידע בטיחות) בעלון לרופא‬
)05.2013 ‫(מעודכן‬
21/07/2013 :‫תאריך‬
Removab concentrate for solution for infusion – 146 57 33255 :‫שם תכשיר באנגלית ומספר הרישום‬
Neopharm Scientific Ltd. :‫שם בעל הרישום‬
! ‫טופס זה מיועד לפרוט ההחמרות בלבד‬
‫ההחמרות המבוקשות‬
‫טקסט חדש‬
‫טקסט נוכחי‬
Women of childbearing potential
Removab is not recommended in women of childbearing potential not
using contraception.
Women of childbearing potential
Removab is not recommended in women of childbearing
potential not using contraception.
Pregnancy
There are no or limited amount of data from the use of catumaxomab
in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity
(see section 5.3).
Removab is not recommended during pregnancy and in women of
childbearing potential not using contraception.
Pregnancy
There are no or limited amount of data from the use of
catumaxomab in pregnant women.
Animal studies are insufficient with respect to reproductive
toxicity (see section 5.3).
Removab is not recommended during pregnancy.
‫פרק בעלון‬
4.6 Fertility,
pregnancy
and
lactation
b) Tabulated list of adverse reactions
The adverse reactions listed below are derived from an integrated
safety analysis including 1112 clinical studies. 517728 patients
received Removab in intraperitoneally, 293 patients as 6 hour - and
224435 patients as 3 hour infusions.
b) Tabulated list of adverse reactions
The adverse reactions listed below are derived from an integrated
safety analysis including 11 clinical studies. 517 patients
received Removab in intraperitoneally, 293 patients as 6 hour and 224 patients as 3 hour infusions.
Infections and infestations:
Common: Infection, urinary tract infection
Blood and lymphatic system disorders
Common: Anaemia*, lymphopenia, leukocytosis, neutrophilia,
thrombocytosis.
Uncommon: Thrombocytopenia*, coagulopathy*.
Immune system disorders
Common: Cytokine release syndrome*, hypersensitivity*.
Metabolism and nutrition disorders
Common: Decreased appetite* / anorexia, dehydration*,
hypokalaemia, hypoalbuminaemia, hyponatraemia*, hypocalcaemia*,
hypoproteinaemia, hyperglycaemia, hypoalbuminaemia.
Vascular disorders
Common: Hypotension*, hypertension*, flushing, hot flush.
Respiratory, thoracic and mediastinal disorders
Common: Dyspnoea*, pleural effusion*, hypoxia*, cough.
Uncommon: Pulmonary embolism*, hypoxia*.
Gastrointestinal disorders
Common: Constipation*, dyspepsia, abdominal distension,
Infections and infestations:
Common: Infection, urinary tract infection
Blood and lymphatic system disorders
Common: Anaemia, lymphopenia, leukocytosis, neutrophilia,
thrombocytosis.
Uncommon: Thrombocytopenia*
Immune system disorders
Common: Cytokine release syndrome*, hypersensitivity.
Metabolism and nutrition disorders
Common: Decreased appetite* / anorexia, dehydration*,
hypokalaemia, hyponatraemia, hypocalcaemia,
hypoproteinaemia, hyperglycaemia, hypoalbuminaemia.
Vascular disorders
Common: Hypotension*, hypertension*, flushing, hot flush.
Respiratory, thoracic and mediastinal disorders
Common: Dyspnoea*, pleural effusion*, hypoxia*, cough.
Uncommon: Pulmonary embolism*
Gastrointestinal disorders
Common: Constipation*, abdominal distension, dyspepsia,
4.8
Undesirable
effects
dyspepsia,sub-ileus*, flatulence, ileus*, sub-ileus*, gastric disorder,
ileus*, gastroesophageal reflux disease, dry mouth.
Skin and subcutaneous tissue disorders
Common: Rash*, erythaema*, pruritus, hyperhidrosis, dermatitis
allergic*.pruritus
Uncommon: Skin reaction*, dermatitis allergic*.
Renal and urinary disorders
Common: Proteinuria, haematuria, leukocyturia
General disorders and administration site conditions
Very Common: Pyrexia*, fatigue*, chills*, pain.
Common: Pain, asthenia*, Systemic inflammatory response
syndrome*, asthenia, oedema incl. oedema peripheral,*, general
physical health deterioration*, chest pain, influenza-like illness,
malaise,*, catheter site erythema.
Uncommon: Extravasation*, application site inflammation*, general
physical health deterioration*.
flatulence, ileus*, sub-ileus*, gastric disorder, gastroesophageal
reflux disease.
Skin and subcutaneous tissue disorders
Common: Rash*, erythaema*, pruritus, hyperhidrosis, dermatitis
allergic*.
Uncommon: Skin reaction*.
Renal and urinary disorders
Common: Proteinuria, haematuria, leukocyturia.
General disorders and administration site conditions
Very Common: Pyrexia*, fatigue*, chills*, pain.
Common: Systemic inflammatory response syndrome*, asthenia,
oedema incl. oedema peripheral, chest pain, influenza-like
illness, malaise, catheter site erythema.
Uncommon: Extravasation*, application site inflammation*,
general physical health deterioration*.
Cytokine release related symptoms with higher intensities:
In 4.45.1% of patients pyrexia reached an intensity of CTCAE grade 3
as it was the case with cytokine release syndrome (1.20%), chills
(1.0.8%), nausea (3.74%), vomiting (5.64.4%), dyspnoea (1.46%) and
hypo-/hypertension (2.1.9% / 1.2% / 0.8%). In one patient (0.2%)
dsyspnoea1%) dyspnoea and in 3 patients (0.64%) hypotension was
reported in CTCAE grade 4 intensity.
Symptoms of pain and pyrexia can be ameliorated or avoided by premedication (see sections 4.2 and 4.4).
Cytokine release related symptoms with higher intensities:
In 4.4% of patients pyrexia reached an intensity of CTCAE grade
3 as it was the case with cytokine release syndrome (1.2%), chills
(1.0%), nausea (3.7%), vomiting (5.6%), dyspnoea (1.4%) and
hypo-/hypertension (1.9% / 1.2%). In one patient (0.2%)
dsyspnoea) and in 3 patients (0.6%) hypotension was reported in
CTCAE grade 4 intensity.
Symptoms of pain and pyrexia can be ameliorated or avoided by
pre-medication (see sections 4.2 and 4.4).
Systemic Inflammatory Response Syndrome (SIRS):
In 4.63.8 % of the patients symptoms of SIRS were observed within
24 hours after Removab infusion. In three patients (0. 64 %) an
Systemic Inflammatory Response Syndrome (SIRS):
In 4.6% of the patients symptoms of SIRS were observed within
24 hours after Removab infusion. In three patients (0. 6 %) an
intensity of CTCAE grade 4 was observed. These reactions resolved
under symptomatic treatment.
intensity of CTCAE grade 4 was observed. These reactions
resolved under symptomatic treatment.
Abdominal pain:
In 48.443.7 % of patients abdominal pain was reported as an adverse
reaction reaching grade 3 in 9.98.2 % of patients, but it resolved under
symptomatic treatment.
Abdominal pain:
In 48.4. % of patients abdominal pain was reported as an adverse
reaction reaching grade 3 in 9.9 % of patients, but it resolved
under symptomatic treatment.
Hepatic enzymes:
Transient increase in hepatic enzymes was commonly observed after
the administration of Removab.
In general, the changes in laboratory parameters were not clinically
relevant and mostly returned to
baseline after end of treatment,
Only in case of clinically relevant or persisting increase further
diagnostics or therapy should be
considered.