Quest for the right Drug
טפדינה 100 מ"ג TEPADINA 100 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 malignant and malignancy unspecified (incl cysts and polyps) Blood and Leukopenia lymphatic Thrombocytope system nia disorders Febrile neutropenia Anaemia Pancytopenia Granulocytopeni a Immune Acute graft Hypersensitivity system versus host disorders disease Chronic graft versus host disease Endocrine Hypopituitarism disorders Metabolism Anorexia and nutrition Decreased disorders appetite Hyperglycaemia Psychiatric Confusional Anxiety Delirium disorders state Nervousness Mental status Hallucination changes Agitation Nervous Dizziness Intracranial Leukoencephalopat system Headache aneurysm hy disorders Vision blurred Extrapyramidal Encephalopathy disorder Convulsion Cognitive Paraesthesia disorder Cerebral haemorrhage Eye disorders Conjunctivitis Cataract Ear and Hearing labyrinth impaired disorders Ototoxicity Tinnitus Cardiac Arrhythmia Tachycardia Cardiomyopat disorders Cardiac failure hy Myocarditis Vascular Lymphoedema Haemorrhage disorders Hypertension Embolism Respiratory, Idiopathic Pulmonary Hypoxia thoracic and pneumonia oedema mediastinal syndrome Cough disorders Epistaxis Pneumonitis Gastrointestin Nausea Constipation Gastrointestin al disorders Stomatitis Gastrointestinal al 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 Alopecia Erythrodermic cases of Stevens- disorders psoriasis Johnson syndrome and toxic epidermal necrolysis Musculoskelet Back pain al and Myalgia connective Arthralgia tissue disorders Renal and Cystitis Dysuria urinary haemorrhagic Oliguria disorders Renal failure Cystitis Haematuria Reproductive Azoospermia Menopausal system and Amenorrhoea symptoms breast Vaginal Infertility female disorders haemorrhage Infertility male General Pyrexia Multi-organ disorders and Asthenia failure administration Chills Pain site conditions Generalised oedema Injection site inflammation Injection site pain Mucosal inflammation Investigation Weight Blood creatinine increased increased Blood bilirubin Blood urea increased increased Transaminases Gamma- increased glutamyltransfera Blood amylase se 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, Treatment related malignant and unspecified second (incl cysts and polyps) malignancy Blood and lymphatic Thrombocytopenia system Febrile disorders 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 Anorexia disorders 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 Hearing impaired disorders 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 Rash Severe toxic skin tissue disorders Erythema reactions including Desquamation cases of Stevens- Pigmentation Johnson syndrome disorder and toxic epidermal necrolysis Musculoskeletal and Growth connective tissue retardation disorders Renal and urinary Bladder disorders Renal failure disorders Cystitis haemorrhagic General disorders and Pyrexia administration site Mucosal conditions 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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