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1%) are pruritus, elevated serum amylase, hemodilution (resulting in dilution of blood components, e.g., coagulation factors and other plasma proteins, and in a decrease in hematocrit). (6) Anaphylactoid/hypersensitivity reactions can occur. To report SUSPECTED ADVERSE REACTIONS, contact Hospira Inc. at 1-800-441-4100 or electronically at [email protected] or FDA at 1-800-FDA-1088 or electronically at www.fda.gov/medwatch. DRUG INTERACTIONS- No interactions with other drugs or nutritional products are known. (7) The safety and compatibility of additives have not been established. USE IN SPECIFIC POPULATIONS- ? Pediatric patients: Dosage should be adjusted to individual patient needs. (2.2, 8.4) ? Renal impaired or geriatric patients: Dose adjustment needed dependent on patient?s status. (8.5, 8.6) See

17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Issued: 07/2014 FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION 2.1 Adult Dose 2.2 Pediatric Dose 2.3 Directions for Use of Voluven?

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS 5.1 Anaphylactoid Reactions 5.2 Renal Dysfunction 5.3 Coagulopathy 5.4 Fluid Equilibrium 5.5 Monitoring: Laboratory Tests 5.6 Interference with Laboratory Tests

6 ADVERSE REACTIONS 6.1 Overall Adverse Reaction Profile

2 6.2 Adverse Reactions in Clinical Trials 6.3 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment

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 13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage

17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed FULL PRESCRIBING INFORMATION WARNING: MORTALITY RENAL REPLACEMENT THERAPY ? In critically ill adult patients, including patients with sepsis, use of hydroxyethyl starch (HES) products, including Voluven? , increases risk of o Mortality o Renal replacement therapy ? Do not use HES products, including Voluven? , in critically ill adult patients, including patients with sepsis.

1 INDICATIONS AND USAGE Voluven? (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma.

2 DOSAGE AND ADMINISTRATION Voluven? is administered by intravenous infusion only. The daily dose and rate of infusion depend on the patient'

s blood loss, on the maintenance or restoration of hemodynamics and on the hemodilution (dilution effect). Voluven? can be administered repetitively over several days. [see Warnings and Precautions (5)] The initial

10 to

20 mL should be infused slowly, keeping the patient under close observation due to possible anaphylactoid reactions. [see General Warnings and Precautions (5.1)]

3 2.1 Adult Dose Up to

50 mL of Voluven? per kg of body weight per day (equivalent to

3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to

3500 mL of Voluven? for a

70 kg patient. 2.2 Pediatric Dose The dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status. In