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טפדינה 15 מ"ג TEPADINA 15 MG (THIOTEPA)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-ורידי : I.V
צורת מינון:
אבקה להכנת תמיסה מרוכזת לעירוי : POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8 Undesirable effects Summary of the safety profile The safety of thiotepa has been examined through a review of adverse events reported in published data from clinical trials. In these studies, a total of 6,588 adult patients and 902 paediatric patients received thiotepa for conditioning treatment prior to haematopoietic progenitor cell transplantation. Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process. These include infection and Graft-versus host disease (GvHD) which, although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT. The most frequently adverse reactions reported in the different conditioning treatments including thiotepa are: infections, cytopenia, acute GvHD and chronic GvHD, gastrointestinal disorders, haemorrhagic cystitis, mucosal inflammation. Leukoencephalopathy Cases of leukoencephalopathy have been observed following treatment with thiotepa in adult and paediatric patients with multiple previous chemotherapies, including methotrexate and radiotherapy. Some cases had a fatal outcome. Tabulated list of adverse reactions Adults The adverse reactions considered at least possibly related to conditioning treatment including thiotepa, reported in adult patients as more than an isolated case, are listed below by system organ class and by frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: 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). System organ Not Known Very common Common Uncommon class Infections and Infection Toxic shock infestations susceptibility syndrome increased Sepsis Neoplasms Treatment related benign, second malignancy malignant and unspecified (incl cysts and polyps) Blood and Leukopenia lymphatic Thrombocytopenia system Febrile disorders neutropenia Anaemia Pancytopenia Granulocytopenia Immune system Acute graft versus Hypersensitivity disorders host disease Chronic graft versus host disease Endocrine Hypopituitarism disorders Metabolism and Anorexia nutrition Decreased appetite disorders Hyperglycaemia Psychiatric Confusional state Anxiety Delirium disorders Mental status Nervousness changes Hallucination Agitation Nervous system Dizziness Intracranial Leukoencephalopathy disorders Headache aneurysm Vision blurred Extrapyramidal Encephalopathy disorder Convulsion Cognitive disorder Paraesthesia Cerebral haemorrhage Eye disorders Conjunctivitis Cataract Ear and Hearing impaired labyrinth Ototoxicity disorders Tinnitus Cardiac Arrhythmia Tachycardia Cardiomyopathy disorders Cardiac failure Myocarditis Vascular Lymphoedema Haemorrhage disorders Hypertension Embolism Respiratory, Idiopathic Pulmonary oedema Hypoxia thoracic and pneumonia Cough mediastinal syndrome Pneumonitis disorders Epistaxis Gastrointestinal Nausea Constipation Gastrointestinal disorders Stomatitis Gastrointestinal ulcer Oesophagitis perforation Vomiting Ileus Diarrhoea Dyspepsia Abdominal pain Enteritis Colitis Hepatobiliary Venoocclusive disorders liver disease Hepatomegaly Jaundice Skin and Rash Erythema Pigmentation Severe toxic skin subcutaneous Pruritus disorder reactions including tissue disorders Alopecia Erythrodermic cases of Stevens- psoriasis Johnson syndrome and toxic epidermal necrolysis Musculoskeletal Back pain and connective Myalgia tissue disorders Arthralgia Renal and Cystitis Dysuria urinary haemorrhagic Oliguria disorders Renal failure Cystitis Haematuria Reproductive Azoospermia Menopausal system and Amenorrhoea symptoms breast disorders Vaginal Infertility female haemorrhage Infertility male General Pyrexia Multi-organ failure disorders and Asthenia Pain administration Chills site conditions Generalised oedema Injection site inflammation Injection site pain Mucosal inflammation Investigation Weight increased Blood creatinine Blood bilirubin increased increased Blood urea Transaminases increased increased Gamma- Blood amylase glutamyltransferase increased increased Blood alkaline phosphatase increased Aspartate aminotransferase increased Paediatric population The adverse reactions considered at least possibly related to conditioning treatment including thiotepa, reported in paediatric patients as more than an isolated case, are listed below by system organ class and by frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: 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). System organ class Very common Common Not known Infections and infestations Infection Thrombocytopenic susceptibility purpura increased Sepsis Neoplasms benign, malignant and Treatment related unspecified (incl cysts and polyps) second malignancy Blood and lymphatic system Thrombocytopenia disorders Febrile neutropenia Anaemia Pancytopenia Granulocytopenia Immune system disorders Acute graft versus host disease Chronic graft versus host disease Endocrine disorders Hypopituitarism Hypogonadism Hypothyroidism Metabolism and nutrition disorders Anorexia Hyperglycaemia Psychiatric disorders Mental status Mental disorder changes due to a general medical condition Nervous system disorders Headache Ataxia Leukoencephalopathy Encephalopathy Convulsion Cerebral haemorrhage Memory impairment Paresis Ear and labyrinth disorders Hearing impaired Cardiac disorders Cardiac arrest Cardiovascular insufficiency Cardiac failure Vascular disorders Haemorrhage Hypertension Respiratory, thoracic and Pneumonitis Idiopathic Pulmonary arterial mediastinal disorders pneumonia hypertension syndrome Pulmunary haemorrage Pulmonary oedema Epistaxis Hypoxia Respiratory arrest Gastrointestinal disorders Nausea Enteritis Stomatitis Intestinal Vomiting obstruction Diarrhoea Abdominal pain Hepatobiliary disorders Venoocclusive Liver failure liver disease Skin and subcutaneous tissue Rash Severe toxic skin disorders Erythema reactions including Desquamation cases of Stevens- Pigmentation Johnson syndrome disorder and toxic epidermal necrolysis Musculoskeletal and connective Growth tissue disorders retardation Renal and urinary disorders Bladder disorders Renal failure Cystitis haemorrhagic General disorders and Pyrexia administration site conditions Mucosal inflammation Pain Multi-organ failure Investigation Blood bilirubin Blood urea increased increased Transaminases Blood electrolytes increased abnormal Blood creatinine Prothrombin time increased ratio increased Aspartate aminotransferase increased Alanine aminotransferase increased Reporting of suspected adverse reactions 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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il
שימוש לפי פנקס קופ''ח כללית 1994
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