Lietojuma piemēri
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10 piemēri teikumus
- In the corresponding 2 year study in mice 2 mg kg day less than systemic exposure following a human dose of 0.5 mg day based on plasma AUC , there was an increased incidence of adrenal cortical adenoma and carcinoma, interstitial cell tumors of the testis, benign and malignant ovarian tumors and benign uterine glandular polyps.
- In two year carcinogenicity studies conducted in rats 1 mg kg day 7 times systemic exposure following a human dose of 0.5 mg day based on plasma AUC an increased incidence of renal tubular adenoma and carcinoma in males and granulosa cell tumours of the ovary in females was noted.
- In a 2 year study in mice, incidences of hepatocellular adenoma in males and hepatocellular carcinomas in females were increased at the maximum dose used, and the maximum dose used was 250 fold higher than the highest human dose on a mg kg body weight basis.
- Two studies involving subjects with sporadic adenomatous polyps were conducted with celecoxib i. e., the APC trial adenoma Prevention with Celecoxib and the PreSAP trial Prevention of Spontaneous adenomatous Polyps .
- A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the 6 cycle rat study while no tumours or pre neoplastic changes were evident in dog studies.
- 31 Carcinogenicity studies conducted in mouse and rat showed increased incidences of lymphomas male and female mouse , hepatocellular adenoma and carcinoma male mouse and granulocytic leukaemia female mouse .
- 47 Carcinogenicity studies conducted in mouse and rat showed increased incidences of lymphomas male and female mouse , hepatocellular adenoma and carcinoma male mouse and granulocytic leukaemia female mouse .
- Carcinogenicity studies conducted in mouse and rat showed increased incidences of lymphomas male and female mouse , hepatocellular adenoma and carcinoma male mouse and granulocytic leukaemia female mouse .
- In mice, increased incidences of combined bronchiolar alveolar adenoma and or carcinoma were observed at systemic exposures, 144 213 times the expected plasma exposure in humans at 1 mg day.
- The following effects were reported in mice and or rats in the carcinogenicity studies conducted granulocytic leukaemia, lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.