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Instructions for patients

Patients should be informed that changes to insulin regimens must be made cautiously and only under medical supervision.

Patients should be informed about the potential side effects of insulin therapy, including lipodystrophy (and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and hypoglycemia. Patients should be informed that the ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia should be advised to use caution when driving or operating machinery.

Accidental mix-ups between Lantus (Insulin Glargine) injections and other insulins, particularly short-acting insulins, have been reported. To avoid medication errors between Lantus insulin injections and other insulins, patients should be instructed to always check the insulin label before each injection.

Lantus (Insulin Glargine) injections 100 IU / ml must only be used if the solution is clear and colorless with no particles visible. Patients must be advised that Insulin Glargine (Lantus) injections must NOT be diluted or mixed with any other insulin or solution.

Patients should be advised not to share disposable or reusable insulin devices or needles with other patients, because doing so carries a risk for transmission of blood-borne pathogens.

Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals.

Patients with diabetes should be advised to inform their health care professional if they are pregnant or are contemplating pregnancy.

Refer patients to the Lantus injections "Patient Information" for additional information.

Manufactured and distributed by Sanofi-Aventis pharmaceutical company and its divisions.

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