Drug information for SOMATULINE DEPOT

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; SUBCUTANEOUS EQ 120MG BASE Prescription  (Reference Drug) LANREOTIDE ACETATE lanreotide IPSEN PHARMS 22074
2011-03-08 Letter

2011-03-07 Label

2007-11-06 Review

2007-09-04 Label

2007-09-04 Letter
INJECTABLE; SUBCUTANEOUS EQ 60MG BASE Prescription  (Reference Drug) LANREOTIDE ACETATE lanreotide IPSEN PHARMS   "
INJECTABLE; SUBCUTANEOUS EQ 90MG BASE Prescription  (Reference Drug) LANREOTIDE ACETATE lanreotide IPSEN PHARMS   "

Drug Adverse Effects information for SOMATULINE DEPOT

Role code Indications Reaction # Reports
PS ACROMEGALY ABASIA 3
PS ACROMEGALY ABDOMINAL DISTENSION 1
PS ACROMEGALY ABDOMINAL PAIN 1
PS ACROMEGALY ANAL INFLAMMATION 1
PS ACROMEGALY ASTHENIA 2
PS ACROMEGALY BALANCE DISORDER 3
PS ACROMEGALY BLOOD GLUCOSE DECREASED 2
PS ACROMEGALY BLOOD PRESSURE DECREASED 1
PS ACROMEGALY CHOLECYSTECTOMY 1
PS ACROMEGALY CONDITION AGGRAVATED 1
PS ACROMEGALY DEFAECATION URGENCY 1
PS ACROMEGALY DEPRESSED LEVEL OF CONSCIOUSNESS 1
PS ACROMEGALY DIARRHOEA 1
PS ACROMEGALY DIZZINESS 1
PS ACROMEGALY ENDOMETRIAL HYPERPLASIA 1
PS ACROMEGALY FLATULENCE 2
PS ACROMEGALY FLUSHING 1
PS ACROMEGALY GENERAL PHYSICAL HEALTH DETERIORATION 2
PS ACROMEGALY HEADACHE 1
PS ACROMEGALY HEPATIC ENZYME INCREASED 1
PS ACROMEGALY HYPERTHYROIDISM 1
PS ACROMEGALY HYPOGLYCAEMIA 1
PS ACROMEGALY HYPONATRAEMIA 1
PS ACROMEGALY HYPOPHAGIA 1
PS ACROMEGALY INCREASED APPETITE 1
PS ACROMEGALY INFLUENZA 1
PS ACROMEGALY INFLUENZA LIKE ILLNESS 1
PS ACROMEGALY INJECTION SITE ABSCESS 1
PS ACROMEGALY INJECTION SITE EXTRAVASATION 1
PS ACROMEGALY INJECTION SITE PAIN 1
PS ACROMEGALY INJECTION SITE PRURITUS 1
PS ACROMEGALY INSULIN-LIKE GROWTH FACTOR INCREASED 1
PS ACROMEGALY INTRAVENTRICULAR HAEMORRHAGE 1
PS ACROMEGALY MALNUTRITION 1
PS ACROMEGALY MASS 1
PS ACROMEGALY MUSCLE SPASMS 1
PS ACROMEGALY NASOPHARYNGITIS 1
PS ACROMEGALY NEOPLASM RECURRENCE 1
PS ACROMEGALY NERVOUS SYSTEM NEOPLASM SURGERY 1
PS ACROMEGALY PALPITATIONS 1
PS ACROMEGALY PERICARDITIS 1
PS ACROMEGALY PITUITARY TUMOUR RECURRENT 1
PS ACROMEGALY PITUITARY TUMOUR REMOVAL 2
PS ACROMEGALY SINUS BRADYCARDIA 1
PS ACROMEGALY TACHYCARDIA 1
PS ACROMEGALY VISION BLURRED 1
PS ACROMEGALY VOMITING 1
PS DIARRHOEA DEHYDRATION 2
PS DIARRHOEA HYPOTENSION 2
PS DIARRHOEA MALAISE 1
PS HEPATIC CYST OFF LABEL USE 1
PS HEPATIC CYST URINARY TRACT INFECTION 1
PS HEPATIC NEOPLASM MALIGNANT RESECTABLE DEHYDRATION 2
PS HEPATIC NEOPLASM MALIGNANT RESECTABLE HYPOTENSION 2
PS HEPATIC NEOPLASM MALIGNANT RESECTABLE MALAISE 1
PS NAUSEA GENERAL PHYSICAL HEALTH DETERIORATION 1
PS NEUROENDOCRINE TUMOUR GRANULOMA 1
PS NEUROENDOCRINE TUMOUR HAEMATOCRIT DECREASED 1
PS NEUROENDOCRINE TUMOUR HAEMOGLOBIN DECREASED 1
PS NEUROENDOCRINE TUMOUR URINARY BLADDER HAEMORRHAGE 1
PS PRODUCT USED FOR UNKNOWN INDICATION BILIARY FISTULA 1
PS PRODUCT USED FOR UNKNOWN INDICATION DEATH 2
PS PRODUCT USED FOR UNKNOWN INDICATION NEUTROPENIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION NODULE 1
SS ACROMEGALY BLOOD SODIUM DECREASED 14
SS ACROMEGALY CONSTIPATION 1
SS ACROMEGALY DEHYDRATION 14
SS ACROMEGALY DIARRHOEA 1
SS ACROMEGALY HEART RATE DECREASED 1
SS ACROMEGALY INJECTION SITE HAEMORRHAGE 14
SS ACROMEGALY MOBILITY DECREASED 1
SS ACROMEGALY MUSCLE SPASMS 14
SS ACROMEGALY PRURITUS 6
SS ACROMEGALY WEIGHT DECREASED 14
SS MINERAL SUPPLEMENTATION CONSTIPATION 1
SS MINERAL SUPPLEMENTATION DIARRHOEA 1
SS MINERAL SUPPLEMENTATION HEART RATE DECREASED 1
SS MINERAL SUPPLEMENTATION MOBILITY DECREASED 1
SS PRODUCT USED FOR UNKNOWN INDICATION CONSTIPATION 1
SS PRODUCT USED FOR UNKNOWN INDICATION DIARRHOEA 1
SS PRODUCT USED FOR UNKNOWN INDICATION HEART RATE DECREASED 1
SS PRODUCT USED FOR UNKNOWN INDICATION MOBILITY DECREASED 1
SS PROSTATE CANCER CONSTIPATION 1
SS PROSTATE CANCER DIARRHOEA 1
SS PROSTATE CANCER HEART RATE DECREASED 1
SS PROSTATE CANCER MOBILITY DECREASED 1
C NEUROENDOCRINE TUMOUR CHRONIC OBSTRUCTIVE PULMONARY DISEASE 2
C NEUROENDOCRINE TUMOUR RESPIRATORY FAILURE 2
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