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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