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5.1 Thromboembolic Events (VWD Patients) 5.2 Monitoring for Intravascular Hemolysis 5.3 Monitoring VWF:RCo and FVIII Levels 5.4 Transmission of Infectious Agents 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Labor and Delivery
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labeling.cslbehring.comFULL PRESCRIBING INFORMATION Helixate® FS Antihemophilic Factor (Recombinant) Formulated with Sucrose 1TIONS AND USAGE INDICA Helixate® FS is a recombinant antihemophilic factor indicated for: • On-demand treatment and control of bleeding episodes in adults and children with
(2.3) • PI: Administer at regular intervals from daily up ...
labeling.cslbehring.com14.1 Primary Immunodeficiency (PI) 14.2 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. HIGHLIGHTS OF PRESCRIBING INFORMATION
(2.3) HIZENTRA •Infusion sites – Up to 8 ... - CSL Behring
labeling.cslbehring.como Ensure that patients have received Immune Globulin Intravenous (Human) (IGIV) treatment at regular intervals for at least 3 months. o Obtain the patient’ s serum IgG trough level to guide subsequent dose adjustments (see below, under Dose Adjustment).
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labeling.cslbehring.com12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3Pharmacokinetics 13 NONCLINICAL T OXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING PATIENT COUNSELING INFORMATION
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den8dhaj6zs0e.cloudfront.net5.4 Venous Thromboembolic Events 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Use with Anticancer Agents 7.2 Effect of Other Drugs on Lynparza 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.5 Geriatric Use 8.6 Renal Impairment
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www.pi.amgen.com• To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration (2.3)]. • Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and …