Apidra (insulin glulisine) - Sanofi Canada

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Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ........................................................... 4 SUMMARY PRODUCT INFORMATION ......................................................................... 4 DESCRIPTION..................................................................................................................... 4 INDICATIONS AND CLINICAL USE ............................................................................... 5 CONTRAINDICATIONS .................................................................................................... 5 WARNINGS AND PRECAUTIONS ................................................................................... 5 ADVERSE REACTIONS ................................................................................................... 12 DRUG INTERACTIONS ................................................................................................... 17 DOSAGE AND ADMINISTRATION ............................................................................... 19 OVERDOSAGE ................................................................................................................. 21 ACTION AND CLINICAL PHARMACOLOGY ............................................................. 22 STORAGE AND STABILITY ........................................................................................... 27 SPECIAL HANDLING INSTRUCTIONS ........................................................................ 28 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................. 28 PART II: SCIENTIFIC INFORMATION ................................................................................. 29 PHARMACEUTICAL INFORMATION ........................................................................... 29 CLINICAL TRIALS ........................................................................................................... 29 TOXICOLOGY .................................................................................................................. 34 REFERENCES ................................................................................................................... 39 PART III: CONSUMER INFORMATION................................................................................ 40 PART III: CONSUMER INFORMATION................................................................................ 49 PART III: CONSUMER INFORMATION................................................................................ 57 Page 2 of 61
PRODUCT MONOGRAPH APIDRA ® insulin glulisine (rDNA origin) Antidiabetic Agent Short-acting Recombinant Human Insulin Analogue PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Subcutaneous Solution for injection DESCRIPTION 100 U/mL Clinically Relevant Nonmedicinal Ingredients m-cresol, trometamol, sodium chloride, polysorbate 20, water for injection, hydrochloric acid and sodium hydroxide (for pH adjustment) For a complete listing see Dosage Forms, Composition and Packaging section. APIDRA ® (insulin glulisine [rDNA origin]) is a recombinant human insulin analogue that is a rapid-acting, parenteral blood glucose-lowering agent. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin ∗ in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid (see PHARMACEUTICAL INFORMATION). ∗ In some studies regular human insulin refers to short acting insulin marketed internationally. Page 3 of 61
Page 1: 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 and 34: TOXICOLOGY Single and Repeated Dose
Page 35 and 36: Table 14: Reproductive & Developmen
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
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Apidra (insulin glulisine) - Sanofi Canada

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