VITRASE hyaluronidase ovine injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYALURONIDASE, OVINE (UNII: 64R4OHP8T0) (HYALURONIDASE, OVINE - UNII:64R4OHP8T0)

Available from:

Bausch & Lomb Incorporated

INN (International Name):

HYALURONIDASE, OVINE

Composition:

HYALURONIDASE, OVINE 200 [USP'U] in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

VITRASE- HYALURONIDASE, OVINE INJECTION, SOLUTION
BAUSCH & LOMB INCORPORATED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VITRASE (HYALURONIDASE INJECTION) OVINE,
200 USP UNITS/ML SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR VITRASE .
VITRASE (HYALURONIDASE INJECTION) OVINE, 200 USP UNITS/ML
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
• Dosage and Administration (2) – 03/2012
• Contraindications (4) – 03/2012
INDICATIONS AND USAGE
• VITRASE is indicated as an adjuvant in subcutaneous fluid
administration for achieving hydration (1.1)
• to increase the dispersion and absorption of the other injected
drugs (1.2)
• in subcutaneous urography for improving resorption of radiopaque
agents. (1.3)
DOSAGE AND ADMINISTRATION
Draw the desired amount of VITRASE into the syringe to obtain target
hyaluronidase activity (USP Units) according to
table. (2)
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DOSAGE FORMS AND STRENGTHS
Ovine hyaluronidase: 200 USP units/mL single use vials. (3)
CONTRAINDICATIONS
Hypersensitivity (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
ALLERGIC AND ANAPHYLACTIC-LIKE REACTIONS HAVE BEEN REPORTED, RARELY.
(6).TO REPORT SUSPECTED ADVERSE
REACTIONS, CONTACT BAUSCH & LOMB AT 1-800-323-0000, OR FDA AT
1-800-FDA-1088 OR
WWW.FDA.G O V/MEDWATCH
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
Pediatric Use: The dosage of subcutaneous fluids administered is
dependent upon the age, weight and clinical condition of
the patient. For premature infants or during the neonatal period, the
daily dosage should not exceed 25 mL/kg of body
weight, and the rate of administration should not be greater than 2 mL
per minute. Special care must be taken in pediatric
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Subcutaneous Fluid Administration: Inject 200 Units of VITRASE prior
to clysis. It will facilitate absorption of 1,000
mL or more of solution. The dosage of subcutaneous fluids administered
is dependent upon the age, weight, and
clinical condition of the pati