LANTUS PRESCRIBING INFORMATION PDF DOWNLOAD

and in adults with type 2 diabetes mellitus. See Safety Info. which may affect their blood glucose. Click here for Full Prescribing Information for Lantus. starting dose for your patients with type 2 diabetes. See Safety Info. are rounded down to the nearest whole unit. (From LantusĀ® Prescribing Information.) . See Safety Info. or innovator, product; Currently, there are no FDA- approved AB/AP-rated follow-on biologic insulins1 More info on follow-on biologics +.

Author: Bragal Kajilkree
Country: Nigeria
Language: English (Spanish)
Genre: Health and Food
Published (Last): 22 August 2007
Pages: 498
PDF File Size: 9.30 Mb
ePub File Size: 13.20 Mb
ISBN: 784-6-72237-381-1
Downloads: 72488
Price: Free* [*Free Regsitration Required]
Uploader: Dit

Put the needle through lantus prescribing information rubber top of the vial and push the plunger to inject the air into the vial. This dosage reduction will lower the likelihood of hypoglycemia [see Warnings and Precautions 5. Check the insulin to make sure it is clear and colorless. Hypoglycemia is often called an “insulin reaction” or “low blood sugar”.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Injecting too much or too little insulin dose may lantus prescribing information to unwanted blood sugar changes see the package leaflet for your insulin. Patients and caregivers must be educated to lantus prescribing information and manage hypoglycemia.

Similar effects on HbA1c Table 9 and the incidence of hypoglycemia were observed in both treatment groups [See Adverse Reactions 6. Monitor blood glucose in all patients treated with insulin. Each SoloStar contains in total units of insulin.

Lantus prescribing information will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. If the solution is cloudy, slightly colored, or has lantus prescribing information in it, do not use the Cartridge System. The concentration of insulin glargine is units per milliliter mLor U A person with hypoglycemia who is unable to take foods or liquids with sugar by mouth, or is unconscious needs medical help fast and will need treatment with a glucagon injection or glucose given intravenously IV.

Patients should be informed that the ability to concentrate and react may be impaired as a result of hypoglycemia. The number in the dose window will lantus prescribing information to “0” as you inject.

Informatiln episodes of hypoglycemia can usually be treated with oral carbohydrates. Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. After subcutaneous injection of 0. You feel resistance during dose-setting and the Dosage Knob will not turn further forward to the right: Your insulin needs may change because of illness, stress, other medicines, or changes in diet or prescrubing level.

TOP Related Articles  NOVEL BAHARON KE SANG SANG FREE PDF DOWNLOAD

In a combined fertility and prenatal and postnatal study in lantus prescribing information and female rats at subcutaneous doses up to 0. This can happen when too pdescribing insulin lantus prescribing information injected. You can reduce the chance of getting an injection site reaction if you change rotate the injection site each time.

If you use other than U insulin syringe, you may get the wrong dose of insulin causing serious problems for you, such as a blood sugar level that is too low or too high.

In lantus prescribing information studies in adult patients, there was a lantus prescribing information incidence of treatment-emergent injection site pain in LANTUS-treated patients 2. The results for the primary endpoint are shown lantus prescribing information Table 13 for both the per-protocol and Prescirbing populations, and indicate similarity of Lantus to NPH in the progression of diabetic retinopathy as assessed by this outcome. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. Rotate insulin injection or infusion ingormation within the same region to reduce the risk lantus prescribing information lipodystrophy.

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

Insulin glargine was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells Ames- and HGPRT-test and in tests for detection of chromosomal aberrations cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters. You should always make sure that:.

Dosing | BASAGLAR (insulin glargine injection)

Metabolism and Elimination A metabolism study in humans indicates that insulin glargine is prescriblng metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of human insulin, M1 21 A -Gly-insulin and M2 21 A -Gly-des B -Thr-insulin. Innformation needles should be placed in sharps containers such as red biohazard containershard plastic containers such as detergent bottlesor metal containers such as an empty coffee can.

TOP Related Articles  BASIC MARINE ENGINEERING BY J.K.DHAR DOWNLOAD

Retinopathy graders were blinded to treatment group assignment. If not, repeat the Safety Test. Gently tap the Cartridge System until the air rises to the top of the Cartridge System tip. This is especially important if you use more than lantus prescribing information type of insulin. Regular, NPH, analogslantus prescribing information beef, pork, beef-pork, human perscribing method of manufacture informatiob Lantus prescribing information versus animal-source insulin may need a change in the dose.

The average age was The relevance of these observations in dogs to lantus prescribing information is unknown. Open In-Use SoloStar disposable insulin device: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including LANTUS.

Accessdata Error

Patients with pre-specified post-baseline eye procedures pan-retinal photocoagulation for proliferative or severe nonproliferative diabetic retinopathy, lantus prescribing information photocoagulation for new vessels, and vitrectomy for diabetic retinopathy were also considered as 3-step progressors regardless of actual change in ETDRS score from baseline.

This profile allows once-daily dosing as a basal insulin. The patient’s ability to concentrate and react may be impaired as a result of lantus prescribing information. If you have hypoglycemia often or it is hard for you to know if you have the symptoms of hypoglycemia, talk to your healthcare provider.

Do not administer subcutaneously via an insulin pump or intravenously because severe hypoglycemia can occur 5. Therefore, tell your healthcare provider if you lantus prescribing information planning to have a baby, are pregnant, or nursing a baby.

The opened in-use SoloStar device must be discarded 28 days after being opened.

FDA Internet Application Site (Accessdata) Error

Peripheral Edema Some patients taking LANTUS have lantus prescribing information sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Lipodystrophy Administration lantus prescribing information insulin subcutaneously, including LANTUS, has resulted in lipoatrophy depression pdescribing the skin or lipohypertrophy enlargement or thickening of tissue in some patients [see Dosage and Administration 2.

Do not make any dose changes unless your healthcare provider tells you to.