"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
Subcutaneous Fluid Administration
VITRASE (hyaluronidase injection) is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
Dispersion and Absorption of Injected Drugs
VITRASE is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
VITRASE (hyaluronidase injection) should be administered as discussed below, since its effects relative to absorption and dispersion of other drugs are not produced when it is administered intravenously.
Draw the desired amount of VITRASE into the syringe to obtain the target Hyaluronidase Activity (USP Units) according to the table below.
Amount of VITRASE Solution Withdrawn Per Target Hyaluronidase
|Target Hyaluronidase Activity (USP Units)||Volume Withdraw from Vial (mL)|
|50 Units||0.25 mL|
|75 Units||0.38 mL|
|150 Units||0.75 mL|
|200 Units||1.0 mL|
After admixture with drug, store at 15-25°C (59-77°F) and use within 6 hours.
Subcutaneous Fluid Administration (Hypodermoclysis)
Insert needle with aseptic precautions. With tip lying free and movable between skin and muscle, begin clysis; fluid should start in readily without pain or lump. Then inject VITRASE (hyaluronidase injection) into rubber tubing close to needle.
An alternate method is to inject VITRASE under skin prior to clysis. 200 Units will facilitate absorption of 1,000 mL or more of solution. As with all parenteral fluid therapy, observeeffect closely, with same precautions for restoring fluid and electrolyte balance as in intravenous injections. The dose, the rate of injection, and the type of solution (saline, glucose, Ringer's etc.) must be adjusted carefully to the individual patient. When solutions devoid of inorganic electrolytes are given by hypodermoclysis, hypovolemia may occur. This may be prevented by using solutions containing adequate amounts of inorganic electrolytes and/or controlling the volume and speed of administration.
VITRASE may be added to small volumes of solution (up to 200 mL), such as small clysis for infants or solutions of drugs for subcutaneous injection. For infants and children less than 3 years old, the volume of a single clysis should be limited to 200 mL; and in premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight; the rate of administration should not be greater than 2 mL per minute. For older patients, the rate and volume of administration should not exceed those employed for intravenous infusion.
Absorption and Dispersion of Injected Drugs
Absorption and dispersion of other injected drugs may be enhanced by adding 50 - 300 Units, most typically 150 Units of VITRASE hyaluronidase to the injection solution.
The subcutaneous route of administration of urographic contrast media is indicated when intravenous administration cannot be successfully accomplished, particularly in infants and small children. With the patient prone, 75 Units of VITRASE (hyaluronidase injection) is injected subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.
Dosage Forms and Strengths
Ovine hyaluronidase 200 USP Units/mL single use vials
VITRASE (hyaluronidase injection) Ovine is supplied sterile as 200 USP Units/mL of ovine hyaluronidase non-preserved in a single-use 2 mL glass vial with a rubber stopper and aluminum seal.
- NDC 67425-002-10
- Protect from light.
- Store unopened vial in refrigerator at 2-8°C (35-46°F).
- Do not freeze.
Distributed by: ISTA Pharmaceuticals, Inc., Irvine, CA 92618. Manufactured by: Alliance Medical Products, Inc., CA 92618. Revised: 03/2012
Last reviewed on RxList: 5/3/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Vitrase Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.