Apidra (insulin glulisine) - Sanofi Canada

More documents

Recommendations

Info

Table 12: Insulin glulisine – Incidence of female SD-rats with mammary tumors in a 12-month toxicity study (30 rats per group) Total Tumor Bearers: Benign and Malignant Insulin glulisine Human regular insulin Controls 2 x 2.5 2 x 5.0 2 x 20 2 x 50 2 x 5.0 2 x 20 2 x 50 U/kg U/kg U/kg U/kg IU/kg IU/kg IU/kg 0 6* 3 6* 3 3 6* 4 *Significant increase in the one sided Fisher Exact Test (p
Table 14: Reproductive & Developmental Toxicity: Effects on Embryofetal Development Species/ Route Dosage/Duration No. of Animals/ Findings Strain Group Sprague Subcutaneous Insulin glulisine once Groups of 6 • There was treatment-related mortality and Dawley daily as a solution in mated females clinical signs due to hypoglycemia at all rats placebo solution at dose levels tested. the dose levels of 0, 15, 50, 150 or 500 • Food consumption was slightly higher at the dose level of 150 U/kg. U/kg body weight from day 6 - 17 of pregnancy • • No compound-related findings were observed at necropsy. The animals found dead exhibited only empty implantation sites or conceptuses in the uterus. • Fetal weight and crown/rump lengths were slightly decreased at 150 U/kg. No abnormalities were detected at caesarean section of the other animals. • Based on the results of this study, the dose of 10 U insulin glulisine/kg body weight per day is considered to be a suitable high dose for the main study. Sprague Subcutaneous Dose levels of 0, 1, Groups of 20-25 • Administration of both insulin glulisine and Dawley 3.15 or 10 U /kg mated female HR1799 caused clinical signs and mortality rats body weight of at the daily dose of 10 U/kg body weight. insulin glulisine or • Slightly increased incidences of minor rib HR1799 at the dose anomalies were seen at this maternally levels of 1 or 10 U toxic dose level in the fetuses from the /kg body weight, HR1799 group. once daily as a solution in placebo from day 6-17 of pregnancy • Neither maternal nor embryo-fetal toxicity were observed after administration of insulin glulisine at the daily dose of 3.15 U/kg body weight and after administration of HR1799 at the daily dose of 1 U/kg body weight. Sprague Subcutaneous Insulin glulisine once Groups of 10 • Treatment-related mortality due to Dawley daily as a solution in mated females hypoglycemia was seen in the 10.0 U/Kg rats placebo solution at group. the dose levels of • No abnormalities were observed by 1.0, 3.15 or 10.0 U/kg body weight from day 6 - 12 of pregnancy • caesarean section. Rats displayed a systemic exposure to substantial concentrations of insulin glulisine over 1h and an overproportional increase of Cmax with escalating dose. • Highest plasma concentration of insulin glulisine were detected 15 minutes after administration of the test compound (first collection) in all groups and were 10.6, 46.7 and 159 ng/ml in the low, intermediate and high dose group, respectively. Page 35 of 61
Page 1 and 2: PRODUCT MONOGRAPH APIDRA ® insulin
Page 3 and 4: PRODUCT MONOGRAPH APIDRA ® insulin
Page 5 and 6: PHARMACOLOGY). APIDRA given by subc
Page 7 and 8: Hyperglycemia: The use of too low i
Page 9 and 10: and reduced insulin metabolism, sim
Page 11 and 12: Occupational Hazards The patient’
Page 13 and 14: Table 2 - Number (percentage) of pe
Page 15 and 16: Table 4 - Common (≥1%) Adverse Dr
Page 17 and 18: Table 5- Established or Potential D
Page 19 and 20: APIDRA should be administered by su
Page 21 and 22: ACTION AND CLINICAL PHARMACOLOGY Ph
Page 23 and 24: Table 7. Pharmacokinetic and Pharma
Page 25 and 26: gender did not show differences in
Page 27 and 28: Opened APIDRA SoloSTAR should not b
Page 29 and 30: glargine followed by randomization.
Page 31 and 32: treatment regimens. No differences
Page 33: TOXICOLOGY Single and Repeated Dose
Page 37 and 38: Table 15: Reproductive & Developmen
Page 39 and 40: PART III: CONSUMER INFORMATION APID
Page 41 and 42: INTERACTIONS WITH THIS MEDICATION O
Page 43 and 44: 12. Make sure the tip of the needle
Page 45 and 46: Hyperglycemia Hyperglycemia (too mu
Page 47 and 48: MORE INFORMATION Your physician, ph
Page 49 and 50: APIDRA should be given within 15 mi
Page 51 and 52: Do not take a double dose to make u
Page 53 and 54: history of diabetes, or in patients
Page 55 and 56: MORE INFORMATION Your physician, ph
Page 57 and 58: efore or within 20 minutes after st
Page 59 and 60: Preparing the Dose 1. To avoid medi
Page 61: • redness, itching, swelling, or

Apidra (insulin glulisine) - Sanofi Canada

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?