Drug information for INCRELEX

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; SUBCUTANEOUS 40MG/4ML (10MG/ML) Prescription  (Reference Drug) MECASERMIN RECOMBINANT myotrophin TERCICA 21839
2011-02-24 Label

2011-02-18 Letter

2005-10-12 Review

2005-09-08 Letter

2005-08-31 Label

Drug Adverse Effects information for INCRELEX

Role code Indications Reaction # Reports
PS BODY HEIGHT BELOW NORMAL DISTURBANCE IN ATTENTION 1
PS BODY HEIGHT BELOW NORMAL DIZZINESS 1
PS BODY HEIGHT BELOW NORMAL FATIGUE 1
PS BODY HEIGHT BELOW NORMAL GAIT DISTURBANCE 1
PS BODY HEIGHT BELOW NORMAL HEADACHE 2
PS BODY HEIGHT BELOW NORMAL HYPOGLYCAEMIA 1
PS BODY HEIGHT BELOW NORMAL INTRACRANIAL PRESSURE INCREASED 1
PS BODY HEIGHT BELOW NORMAL NEPHROLITHIASIS 1
PS BODY HEIGHT BELOW NORMAL POST PROCEDURAL HAEMORRHAGE 1
PS BODY HEIGHT BELOW NORMAL POST PROCEDURAL INFECTION 1
PS BODY HEIGHT BELOW NORMAL TONSILLECTOMY 1
PS CONVULSION ALOPECIA 4
PS CONVULSION CONDITION AGGRAVATED 3
PS CONVULSION CONVULSION 4
PS DIABETES MELLITUS CONVULSION 1
PS FAILURE TO THRIVE CONDITION AGGRAVATED 2
PS FAILURE TO THRIVE CONVULSION 2
PS FAILURE TO THRIVE DRUG DOSE OMISSION 1
PS FAILURE TO THRIVE NAUSEA 2
PS FAILURE TO THRIVE OFF LABEL USE 2
PS FAILURE TO THRIVE VOMITING 2
PS FOETAL GROWTH RESTRICTION ABDOMINAL DISTENSION 2
PS FOETAL GROWTH RESTRICTION ACTIVATED PARTIAL THROMBOPLASTIN TIME SHORTENED 1
PS FOETAL GROWTH RESTRICTION ANAEMIA 5
PS FOETAL GROWTH RESTRICTION ASCITES 2
PS FOETAL GROWTH RESTRICTION ASTHMA 2
PS FOETAL GROWTH RESTRICTION BLOOD THYROID STIMULATING HORMONE DECREASED 2
PS FOETAL GROWTH RESTRICTION BRONCHITIS 4
PS FOETAL GROWTH RESTRICTION CEREBRAL ATROPHY 3
PS FOETAL GROWTH RESTRICTION CEREBROVASCULAR DISORDER 1
PS FOETAL GROWTH RESTRICTION COLLATERAL CIRCULATION 1
PS FOETAL GROWTH RESTRICTION CULTURE URINE POSITIVE 4
PS FOETAL GROWTH RESTRICTION CYTOLYTIC HEPATITIS 2
PS FOETAL GROWTH RESTRICTION DIARRHOEA 3
PS FOETAL GROWTH RESTRICTION DRUG ADMINISTRATION ERROR 1
PS FOETAL GROWTH RESTRICTION EAR INFECTION 5
PS FOETAL GROWTH RESTRICTION EPSTEIN-BARR VIRUS INFECTION 2
PS FOETAL GROWTH RESTRICTION EPSTEIN-BARR VIRUS TEST POSITIVE 2
PS FOETAL GROWTH RESTRICTION ESCHERICHIA INFECTION 1
PS FOETAL GROWTH RESTRICTION ESCHERICHIA TEST POSITIVE 4
PS FOETAL GROWTH RESTRICTION FEBRILE CONVULSION 5
PS FOETAL GROWTH RESTRICTION GASTROENTERITIS 5
PS FOETAL GROWTH RESTRICTION GENERAL PHYSICAL HEALTH DETERIORATION 3
PS FOETAL GROWTH RESTRICTION HEPATIC CIRRHOSIS 5
PS FOETAL GROWTH RESTRICTION HEPATOMEGALY 2
PS FOETAL GROWTH RESTRICTION HYPERTHERMIA 1
PS FOETAL GROWTH RESTRICTION INFLAMMATION 4
PS FOETAL GROWTH RESTRICTION INTERSTITIAL LUNG DISEASE 1
PS FOETAL GROWTH RESTRICTION LUNG DISORDER 4
PS FOETAL GROWTH RESTRICTION MALNUTRITION 3
PS FOETAL GROWTH RESTRICTION NASOPHARYNGITIS 5
PS FOETAL GROWTH RESTRICTION PORTAL HYPERTENSION 3
PS FOETAL GROWTH RESTRICTION PROTHROMBIN TIME PROLONGED 1
PS FOETAL GROWTH RESTRICTION PYREXIA 1
PS FOETAL GROWTH RESTRICTION RENAL DISORDER 1
PS FOETAL GROWTH RESTRICTION SPLENIC VARICES 2
PS FOETAL GROWTH RESTRICTION SPLENOMEGALY 3
PS FOETAL GROWTH RESTRICTION TOXOPLASMOSIS 5
PS FOETAL GROWTH RESTRICTION VOMITING 3
PS FOETAL GROWTH RESTRICTION WEIGHT DECREASED 3
PS GROWTH HORMONE DEFICIENCY ALOPECIA 4
PS GROWTH HORMONE DEFICIENCY BETA HAEMOLYTIC STREPTOCOCCAL INFECTION 1
PS GROWTH HORMONE DEFICIENCY CONDITION AGGRAVATED 3
PS GROWTH HORMONE DEFICIENCY CONVULSION 4
PS GROWTH HORMONE DEFICIENCY GRAND MAL CONVULSION 1
PS GROWTH HORMONE DEFICIENCY HEADACHE 1
PS GROWTH HORMONE DEFICIENCY HYPOGLYCAEMIA 1
PS GROWTH HORMONE DEFICIENCY INTRACRANIAL PRESSURE INCREASED 1
PS GROWTH HORMONE DEFICIENCY PNEUMONIA 1
PS GROWTH HORMONE DEFICIENCY PNEUMONIA STREPTOCOCCAL 1
PS GROWTH HORMONE DEFICIENCY RHINORRHOEA 1
PS GROWTH HORMONE DEFICIENCY THYROID NEOPLASM 1
PS GROWTH HORMONE DEFICIENCY VOMITING 1
PS GROWTH RETARDATION ADVERSE EVENT 1
PS GROWTH RETARDATION AGGRESSION 1
PS GROWTH RETARDATION ANAEMIA 1
PS GROWTH RETARDATION DRUG DOSE OMISSION 1
PS GROWTH RETARDATION LEUKOPENIA 1
PS GROWTH RETARDATION THROMBOCYTOPENIA 1
PS GROWTH RETARDATION VAGINAL ABSCESS 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED ABDOMINAL DISTENSION 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED ABDOMINAL PAIN 3
PS INSULIN-LIKE GROWTH FACTOR DECREASED ADENOIDAL HYPERTROPHY 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED ADENOTONSILLECTOMY 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED ASTHENIA 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED BACTERIAL TEST POSITIVE 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED BENIGN INTRACRANIAL HYPERTENSION 4
PS INSULIN-LIKE GROWTH FACTOR DECREASED BETA HAEMOLYTIC STREPTOCOCCAL INFECTION 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED BODY MASS INDEX INCREASED 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED CHROMATURIA 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED CONSTIPATION 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED CONVULSION 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED CRYING 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED CSF WHITE BLOOD CELL COUNT POSITIVE 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED DEHYDRATION 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED DYSPNOEA 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED EMOTIONAL DISORDER 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED EXOSTOSIS 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED EYELID OEDEMA 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED HAEMATOCRIT DECREASED 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED HAEMATURIA 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED HAEMOGLOBIN DECREASED 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED HEADACHE 4
PS INSULIN-LIKE GROWTH FACTOR DECREASED HETEROPHORIA 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED HYPERSENSITIVITY 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED HYPOGLYCAEMIA 3
PS INSULIN-LIKE GROWTH FACTOR DECREASED IGA NEPHROPATHY 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED INJECTION SITE INDURATION 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED INJECTION SITE PRURITUS 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED INSOMNIA 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED LIP SWELLING 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED MENTAL DISORDER 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED MIGRAINE 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED MUSCULOSKELETAL PAIN 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED NASAL OEDEMA 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED NAUSEA 2
PS INSULIN-LIKE GROWTH FACTOR DECREASED OPTIC NEURITIS 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED PAIN IN EXTREMITY 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED PAPILLOEDEMA 4
PS INSULIN-LIKE GROWTH FACTOR DECREASED PARAESTHESIA 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED PORTAL SHUNT 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED POST PROCEDURAL COMPLICATION 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED PROTEIN URINE PRESENT 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED PYREXIA 2
PS INSULIN-LIKE GROWTH FACTOR DECREASED REFRACTION DISORDER 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED SLEEP APNOEA SYNDROME 2
PS INSULIN-LIKE GROWTH FACTOR DECREASED SNORING 2
PS INSULIN-LIKE GROWTH FACTOR DECREASED TONSILLAR HYPERTROPHY 2
PS INSULIN-LIKE GROWTH FACTOR DECREASED TREATMENT NONCOMPLIANCE 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED UNRESPONSIVE TO STIMULI 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED VIRAL INFECTION 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED VISUAL IMPAIRMENT 1
PS INSULIN-LIKE GROWTH FACTOR DECREASED VOMITING 3
PS INSULIN-LIKE GROWTH FACTOR DECREASED WHITE BLOOD CELL COUNT DECREASED 1
PS PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY CONVULSION 1
PS PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY DRUG DOSE OMISSION 1
PS PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY HYPERTROPHY 1
PS PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY MENTAL DISORDER 1
PS PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY OBESITY 1
PS PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY PYELONEPHRITIS 1
PS PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY SOFT TISSUE DISORDER 1
PS PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY WEIGHT INCREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION ALOPECIA 3
PS PRODUCT USED FOR UNKNOWN INDICATION BODY MASS INDEX INCREASED 2
PS PRODUCT USED FOR UNKNOWN INDICATION CONDITION AGGRAVATED 3
PS PRODUCT USED FOR UNKNOWN INDICATION CONVULSION 3
PS PRODUCT USED FOR UNKNOWN INDICATION GAIT DISTURBANCE 1
PS PRODUCT USED FOR UNKNOWN INDICATION OSTEONECROSIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION UPPER LIMB FRACTURE 1
PS PRODUCT USED FOR UNKNOWN INDICATION WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
PS RETT'S DISORDER EPILEPSY 1
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