Vitrase - Hyaluronidase, Ovine injection, Solution
(Hyaluronidase, Ovine)Vitrase - Hyaluronidase, Ovine injection, Solution Prescribing Information
VITRASE is an endoglycosidase indicated as an adjuvant:
- in subcutaneous fluid administration for achieving hydration. ()
1.1 Subcutaneous Fluid Administration (Hypodermoclysis)VITRASE®(hyaluronidase injection) is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
- for increasing the dispersion and absorption of other injected drugs. ()
1.2 Dispersion and Absorption of Injected DrugsVITRASE is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.
- for improving resorption of radiopaque agents, in subcutaneous urography. ()
1.3 Subcutaneous UrographyVITRASE is indicated as an adjuvant in subcutaneous urography for improving resorption of radiopaque agents.
- Draw the desired amount of VITRASE into the syringe to obtain target hyaluronidase activity (USP Units) according to table. ()
2.1 Important Administration InstructionsParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
VITRASE 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.
Table 1. Amount of VITRASE SolutionWithdrawn Per TargetHyaluronidase ActivityTarget HyaluronidaseActivity (USP Units)VolumeWithdrawnfrom Vial (mL)50 Units
0.25 mL
75 Units
0.38 mL
150 Units
0.75 mL
200 Units
1.00 mL
After admixture with drug, store at 15°C to 25°C (59°F to 77°F) and use within 6 hours. Consult the Prescribing Information of other drugs for additional storage information.
- Before adding VITRASE to a solution containing another drug check appropriate references regarding physical/chemical incompatibilities. ()
7 DRUG INTERACTIONSIt is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding VITRASE to a solution containing another drug.
- Furosemide, benzodiazepines and phenytoin are incompatible with hyaluronidase.
- Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.
- Local anesthetics: Hyaluronidase hastens onset and shortens duration of effect, increases incidence of systemic reactions.
- Large doses of salicylates, cortisone, adrenocorticotropic hormone (ACTH), estrogens or antihistamines: Concomitant use may require larger amounts of hyaluronidase for equivalent dispersing effect.
7.1 IncompatibilitiesFurosemide, benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase.
7.2 Drug-Specific PrecautionsHyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.
When considering the administration of any other drug with hyaluronidase, it is recommended that appropriate references first be consulted to determine the usual precautions for the use of the other drug.
7.3 Local Anesthetic AgentWhen hyaluronidase is added to a local anesthetic agent, it hastens the onset of analgesia and tends to reduce the swelling caused by local infiltration, but the wider spread of the local anesthetic solution increases its absorption; this shortens its duration of action and tends to increase the incidences of systemic reaction.
7.4 Salicylates, Cortisone, ACTH, Estrogens, AntihistaminesPatients receiving large doses of salicylates, cortisone, adrenocorticotropic hormone (ACTH), estrogens, or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect, since these drugs apparently render tissues partly resistant to the action of hyaluronidase.
- 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 depends upon the age, weight, clinical condition of the patient, and laboratory determinations. Rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. (,
2.2 Dosage for Subcutaneous Fluid Administration (Hypodermoclysis)Insert needle with aseptic precautions. With tip free and movable between skin and muscle, begin clysis; fluid should start in readily without pain or lump. Then inject VITRASE 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, observe effect 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.
)8.4 Pediatric UseThe safety and effectiveness of VITRASE have been established in pediatric patients. Use of VITRASE in these patients is supported by evidence from adequate and well-controlled studies. Clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with VITRASE.
The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. The potential for chemical or physical incompatibilities should be kept in mind
[ see Drug Interactions (7)].The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. 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.
During subcutaneous fluid administration, special care must be taken in pediatric patients to avoid overhydration by controlling the rate and total volume of the infusion
[see Dosage and Administration (2.2)]. - Increasing absorption and dispersion of injected drugs: Add 50–300 Units (most typically 150 Units) of VITRASE to the injection solution. ()
2.3 Dosage for Absorption and Dispersion of Injected DrugsAbsorption and dispersion of other injected drugs may be enhanced by adding 50 Units to 300 Units, most typically 150 Units of VITRASE to the injection solution.
- Subcutaneous urography: With the patient prone, inject 75 Units of VITRASE subcutaneously over each scapula, followed by injection of the contrast medium at the same sites. ()
2.4 Dosage for Subcutaneous UrographyThe 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 are injected subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.
Injection: 200 USP Units/mL as a clear, colorless solution in a single-dose vial.
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 patients to avoid overhydration by controlling the rate and total volume of the infusion (
Insert needle with aseptic precautions. With tip free and movable between skin and muscle, begin clysis; fluid should start in readily without pain or lump. Then inject VITRASE 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, observe effect 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.
The safety and effectiveness of VITRASE have been established in pediatric patients. Use of VITRASE in these patients is supported by evidence from adequate and well-controlled studies. Clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with VITRASE.
The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. The potential for chemical or physical incompatibilities should be kept in mind
The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. 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.
During subcutaneous fluid administration, special care must be taken in pediatric patients to avoid overhydration by controlling the rate and total volume of the infusion
VITRASE is contraindicated in patients with known hypersensitivity to hyaluronidase or any other ingredient in the formulation.
Discontinue VITRASE if sensitization occurs.
- Spread of Localized Infection ()
5.1 Spread of Localized InfectionHyaluronidase should not be injected into or around infected or acutely inflamed area because of the danger of spreading to a localized infection. Hyaluronidase should not be used to reduce the swelling of bites or stings.
- Ocular Cornea Damage ()
5.2 Ocular Cornea DamageVITRASE should not be applied directly to the cornea.
- Enzyme Inactivation with Intravenous Administration ()
5.3 Enzyme Inactivation with Intravenous AdministrationVITRASE should not be used for intravenous injections because the enzyme is rapidly inactivated.