Биогиал

Uses

Биогиал recombinant is a tissue permeability modifier used as an adjuvant-

• In subcutaneous fluid administration for achieving hydration
• To increase the dispersion and absorption of other injected drugs
• In subcutaneous urography for improving resorption of radiopaque agents

Биогиал is also used to associated treatment for these conditions: Parenteral rehydration therapy, Parenteral drug administration, Subcutaneous urography

How Биогиал works

Биогиал cleaves hyaluronic acid at the glucosaminidic bond between C1 of glucosamine and C4 of glucuronic acid. Hyaluronic acid is a key component of the extracellular matrix. Injection of hyaluronidase with other fluids, drugs, or radiopaque agents improves the ability of these other compounds to permeate the extracellular space more easily.

Dosage

Биогиал dosage

Inject 150 units Биогиал recombinant prior to subcutaneous fluid administration. 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 patient as well as laboratory determinations. The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion

Increasing dispersion and absorption of injected drugs: Add 50-300 units (most typically 150 U) Биогиал recombinant to the injection solution.

Subcutaneous Urography: Inject 75 units Биогиал recombinant subcutaneously over each scapula, followed by injection of the contrast medium at the same sites

Side Effects

The following adverse reactions have been identified during post-approval use of hyaluronidase products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most frequently reported adverse reactions have been mild local injection site reactions such as erythema and pain. Биогиал has been reported to enhance the adverse reactions associated with co-administered drug products. Edema has been reported most frequently in association with subcutaneous fluid administration. Allergic reactions (urticaria or angioedema) have been reported in less than 0.1% of patients receiving hyaluronidase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.

Toxicity

Data regarding overdose of hyaluronidase is not readily available. In the even of an overdose, treat patients with symptomatic and supportive measures.

Precaution

Spread of Localized Infection: Биогиал should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection. Биогиал should not be used to reduce the swelling of bites or stings.

Ocular Damage: Биогиал should not be applied directly to the cornea. It is not for topical use.

Enzyme Inactivation with Intravenous Administration: Биогиал recombinant should not be administered intravenously. Its effects relative to dispersion and absorption of other drugs are not produced when it is administered intravenously because the enzyme is rapidly inactivated.

Interaction

It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding Биогиал recombinant to a solution containing another drug.

Food Interaction

Биогиал Drug Interaction

Minor: aspirin, aspirin, hydrocortisone, hydrocortisoneUnknown: epinephrine, epinephrine, multivitamin, multivitamin, sulfamethoxazole / trimethoprim, sulfamethoxazole / trimethoprim, methadone, methadone, morphine, morphine, acetaminophen, acetaminophen, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol

Volume of Distribution

Data regarding the volume of distribution of hyaluronidase are not readily available.

Elimination Route

Data regarding the absorption of hyaluronidase are not readily available.

Half Life

Биогиал has a half life of two minutes, but a duration of action of 24-48 hours due to its high potency.

Clearance

Data regarding the clearance of hyaluronidase are not readily available.

Elimination Route

After nonspecific proteolysis, the amino acids from protein drugs are reused for protein synthesis or further broken down and eliminated by the kidneys.

Pregnancy & Breastfeeding use

Pregnancy Category C. It is also not known whether Биогиал recombinant can cause fetal harm when administered to a pregnant woman. Биогиал recombinant should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether hyaluronidase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when hyaluronidase is administered to a nursing woman

Contraindication

Биогиал recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in Биогиал recombinant. A preliminary skin test for hypersensitivity to Биогиал recombinant can be performed. The skin test is made by an intradermal injection of approximately 0.02 mL (3 Units) of a 150 Unit/mL solution. A positive reaction consists of a wheal with pseudopods appearing within 5 minutes and persisting for 20 to 30 minutes and accompanied by localized itching. Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction. Discontinue Биогиал recombinant if sensitization occurs.

Special Warning

Pediatric Use: Clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with Биогиал recombinant.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

Storage Condition

Store unopened in a refrigerator at 2° to 8°C. DO NOT FREEZE.

Innovators Monograph

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