Téléchargeur: Oliver
Pays: Czech Republic
Temps de chargement: Aug 10, 2018
Prix: Gratuit
Évaluation: Basé sur 1 utilisateurs

S'il vous plaît, vérifiez que vous n'êtes pas un robot pour charger le reste des pages

tÉlÉcharger apidra package insert pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
APIDRA safely and effectively. See full prescribing information for
APIDRA.
APIDRA (insulin glulisine [rDNA origin] injection) solution for injection
Initial U.S. Approval: 2004
----------------------------RECENT MAJOR CHANGES-------------------------Indications and Usage (1)
10/2008
----------------------------INDICATIONS AND USAGE--------------------------APIDRA is a rapid acting human insulin analog indicated to improve
glycemic control in adults and children with diabetes mellitus. (1)
----------------------DOSAGE AND ADMINISTRATION----------------------The dosage of APIDRA must be individualized (2.1)
Subcutaneous
Injection
Continuous
Subcutaneous
Infusion Pump
Intravenous
Infusion
Administer within 15 minutes before a meal or within 20
minutes after starting a meal. Use in a regimen with an
intermediate or long-acting insulin. (2.1, 2.2)
APIDRA must not be mixed or diluted when used in an
external insulin infusion pump. (2.3)
Infuse intravenously (0.05 Units/mL to 1 Units/mL APIDRA
in 0.9% sodium chloride using polyvinyl chloride infusion
bags) only under strict medical supervision with close
monitoring of blood glucose and potassium. (2.4)
-----------------------WARNINGS AND PRECAUTIONS-----------------------• Dose adjustment and monitoring: Closely monitor blood glucose in all
patients treated with insulin. Change insulin regimens cautiously and only
under medical supervision.(5.1)
• Hypoglycemia: Most common adverse reaction of insulin therapy and may
be life-threatening (5.2)
• Allergic reactions: Severe, life-threatening, generalized allergy, including
anaphylaxis, can occur with any insulin, including APIDRA (5.3)
• Hypokalemia: All insulins, including APIDRA can cause hypokalemia,
which if untreated, may result in respiratory paralysis, ventricular
arrhythmia, and death (5.4)
• Renal or hepatic impairment: Like all insulins, may require a reduction in
the APIDRA dose (5.5)
• Mixing: APIDRA for subcutaneous injection should not be mixed with insulins
other than NPH insulin. Do not mix APIDRA with any insulin for intravenous
administration or for use in a continuous infusion pump (5.6)
• Pump use: Change the APIDRA in the pump reservoir every 48 hours (5.7)
• Intravenous use: Frequently monitor for hypoglycemia and hypokalemia. (5.8)
------------------------------ADVERSE REACTIONS------------------------------Adverse reactions commonly associated with APIDRA include hypoglycemia,
allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.
(6.1)
To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis
at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
---------------------DOSAGE FORMS AND STRENGTHS---------------------APIDRA 100 units/mL (U-100) is available as: (3)
• 10 mL vials
• 3 mL cartridge system for use in OptiClik ® (Insulin Delivery Device)
------------------------------DRUG INTERACTIONS------------------------------• Certain drugs affect glucose metabolism and may necessitate insulin dose
adjustment (7)
• The signs of hypoglycemia may be reduced or absent in patients taking
anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and
reserpine). (7)
-------------------------------CONTRAINDICATIONS-----------------------------• Do not use during episodes of hypoglycemia (4)
• Do not use in patients with hypersensitivity to APIDRA or any of its
excipients (4)
-----------------------USE IN SPECIFIC POPULATIONS-----------------------• APIDRA has not been studied in children under 4 years of age (8.4)
See 17 for PATIENT COUNSELING INFORMATION
Revised: October 2008
_______________________________________________________________________________________________________________________________________
8.3 Nursing mothers
8.4 Pediatric use
8.5 Geriatric use
WARNING
10 OVERDOSAGE
1 INDICATIONS AND USAGE
11 DESCRIPTION
2 DOSAGE AND ADMINISTRATION
2.1 Dosage considerations
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of action
2.2 Subcutaneous administration
12.2 Pharmacodynamics
2.3 Continuous subcutaneous infusion (insulin pump)
12.3 Pharmacokinetics
2.4 Intravenous administration
12.4 Clinical pharmacology in specific populations
3 DOSAGE FORMS AND STRENGTHS
13 NONCLINICAL TOXICOLOGY
4 CONTRAINDICATIONS
13.1 Carcinogenesis, mutagenesis, impairment of fertility
5 WARNINGS AND PRECAUTIONS
5.1 Dose adjustment and monitoring
14 CLINICAL STUDIES
14.1 Type 1 Diabetes-Adults
5.2 Hypoglycemia
14.2 Type 2 Diabetes-Adults
5.3 Hypersensitivity and allergic reactions
14.3 Type 1 Diabetes-Adults: Pre-and post-meal administration
5.4 Hypokalemia
14.4 Type 1 Diabetes-Pediatric patients
5.5 Renal or hepatic impairment
14.5 Type 1 Diabetes-Adults: Continuous subcutaneous insulin infusion
5.6 Mixing of insulins
5.7 Subcutaneous insulin infusion pumps
16 HOW SUPPLIED/STORAGE AND HANDLING