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GENOTROPIN®Index Section (somatropin)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Pediatric Patients

1.2 Adult Patients

2 DOSAGE AND ADMINISTRATION

2.1 Dosing of Pediatric Patients

2.2 Dosing of Adult Patients

2.3 Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Acute Critical Illness

5.2 Prader-Willi Syndrome in Children

5.3 Neoplasms

5.4 Impaired Glucose Tolerance and Diabetes Mellitus

5.5 Intracranial Hypertension

5.6 Severe Hypersensitivity

5.7 Fluid Retention

5.8 Hypoadrenalism

5.9 Hypothyroidism

5.10 Slipped Capital Femoral Epiphyses in Pediatric Patients

5.11 Progression of Preexisting Scoliosis in Pediatric Patients

5.12 Otitis Media and Cardiovascular Disorders in Turner Syndrome

5.13 Lipoatrophy

5.14 Laboratory Tests

5.15 Pancreatitis

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

7 DRUG INTERACTIONS

7.1 11 β-Hydroxysteroid Dehydrogenase Type 1

7.2 Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocortioid Treatment

7.3 Cytochrome P450-Metabolized Drugs

7.4 Oral Estrogen

7.5 Insulin and/or Oral/Injectable Hypoglycemic Agents

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Adult Growth Hormone Deficiency (GHD)

14.2 Prader-Willi Syndrome (PWS)

14.3 SGA

14.4 Turner Syndrome

14.5 Idiopathic Short Stature

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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