SEMGLEE Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Mylan Specialty L.P.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Limitations of Use: SEMGLEE is not recommended ...

2. Dosage and Administration

2.1 Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions (5.4)]. Visually inspect SEMGLEE vials and prefilled pens for particulate ...

3. Dosage Forms and Strengths

Injection: 100 units per mL (U-100) a clear, colorless, solution available as: 10 mL multiple-dose vial 3 mL single-patient-use prefilled pen

4. Contraindications

SEMGLEE is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions (5.3)]. in patients with hypersensitivity to insulin glargine or one of its excipients [see Warnings ...

5. Warnings and Precautions

5.1 Never Share a SEMGLEE Prefilled Pen, Syringe or Needle Between Patients SEMGLEE prefilled pens must never be shared between patients, even if the needle is changed. Patients using SEMGLEE vials must ...

6. Adverse Reactions

The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions (5.3)] Medication Errors [see Warnings and Precautions (5.4)] Hypersensitivity and ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another ...

6.2. Immunogenicity

As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay ...

6.3. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of another insulin glargine product. Because these reactions are reported voluntarily from a population of uncertain size, it ...

7. Drug Interactions

Table 8 includes clinically significant drug interactions with SEMGLEE. Table 8. Clinically Significant Drug Interactions with SEMGLEE: Drugs that May Increase the Risk of Hypoglycemia Drugs: ...

8. Use in Specific Populations

8.8 Obesity In clinical trials, subgroup analyses based on BMI did not show differences in safety and efficacy between SEMGLEE and another insulin glargine product.

8.1. Pregnancy

Risk Summary Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see Data). There are ...

8.2. Lactation

Risk Summary There are either no or only limited data on the presence of insulin glargine in human milk, the effects on breastfed infant, or the effects on milk production. Endogenous insulin is present ...

8.4. Pediatric Use

The safety and effectiveness of SEMGLEE to improve glycemic control in pediatric patients with type 1 diabetes mellitus have been established in pediatric patients. The use of SEMGLEE for this indication ...

8.5. Geriatric Use

In clinical studies of patients with type 1 and type 2 diabetes who were treated with another insulin glargine product, 15% of patients were ≥65 years of age and 2% were ≥75 years of age. The only difference ...

8.6. Renal Impairment

The effect of renal impairment on the pharmacokinetics of SEMGLEE has not been studied. Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. ...

8.7. Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of SEMGLEE has not been studied. Frequent glucose monitoring and dose adjustment may be necessary for SEMGLEE in patients with hepatic impairment ...

10. Overdosage

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)]. Mild episodes of hypoglycemia can usually be treated with oral glucose. Adjustments ...

11. Description

SEMGLEE contains insulin glargine as a sterile solution for subcutaneous use. Insulin glargine is a recombinant human long-acting insulin analog [see Clinical Pharmacology (12)]. SEMGLEE is produced ...

12.1. Mechanism of Action

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal ...

12.2. Pharmacodynamics

The pharmacodynamic profile for SEMGLEE was determined after subcutaneous administration of a single 0.5 U/kg dose in a euglycemic clamp study conducted in 116 type 1 diabetes patients. The median time ...

12.3. Pharmacokinetics

Absorption After subcutaneous injection of a single 0.5 U/kg dose of SEMGLEE in a euglycemic clamp study conducted in 116 type 1 diabetes patients, the M1 active metabolite plasma concentration profile ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In mice and rats, standard two-year carcinogenicity studies with another insulin glargine product were performed at doses up to 0.455 mg/kg, which was for the rat approximately 65 times the recommended ...

14. Clinical Studies

14.1 Overview of Clinical Studies Following are the results of studies conducted with SEMGLEE and with another insulin glargine product in adult and pediatric patients with type 1 diabetes mellitus and ...

16.1. How Supplied

SEMGLEE (insulin glargine injection) is supplied as a clear, colorless, solution 100 units/mL (U-100) available as: SEMGLEE Total Volume Concentration Total Units Available in Presentation Dose Increment ...

16.2. Storage and Handling

Dispense in the original sealed carton with the enclosed Instructions for Use. Do not store SEMGLEE in the freezer and do not allow to freeze. Discard SEMGLEE if it has been frozen. Protect SEMGLEE from ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Never Share a SEMGLEE Prefilled Pen or Syringe Between Patients Advise patients that they must ...