MUDr. Dana Maňasková

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Hyaluronidáza - Hylase apod.

Hylase Dessau®

Redukce kosmetických výplní z k. hyaluronové

  • Hyaluronidase enzyme which dissolves BDDE bonded hyaluronan-gel (so-called hyaluronic acid-based gel for cosmetic injections)
    • Into a non-viscous (watery) liquid.
  • The dissolved hyaluronic acid can then be transported away out from the skin by the lymphatic system.
    • Can be pushed aside with your fingertips, returning however to its original position
    • Hylase works immediately but the elimination process takes a while.
    • Swellings or protrusions from injections performed years earlier can be treated.
  • Video jak rozpustí hyaluronovou kyselinu www.youtube.com/watch?v=VPkG7zFcTvw
    • Crosslinky - gelovitá struktura - určuje perzistenci v tkáních - zmizí enzymatickým účinkem
  • Dermální výplň dnes nejčastěji k. hyaluronová - pokud se to nepovede - lze injikovat enzym
    • Video Reversing dermal fillers

SPC v Češtině


Hylase složení dle země

  • Ingredient matches for Hylase

Hyaluronic Acid sodium

  • Derivative of Hyaluronic Acid
  • Ingredient of Hylase in the following countries:
    • United States

Hyaluronidase

  • Reported as an ingredient of Hylase in the following countries:
    • Czech Republic
    • Oman
www.drugs.com/international/

Hylase Wound - topický gel

www.drugs.com/cdi/hylase-wound.html

Složení

  • Contains sodium hyaluronate !!! (substrát nikoliv enzym !!!)
    • Salt of hyaluronic acid
      • Efficacy in maintaining tissue hydration

Indikace

  • To promote healing of skin ulcers and wounds
  • Treatment of leg ulcers, pressure ulcers, diabetic ulcers, and exuding wounds prone to bleeding.

KI

  • Allergy to hyaluronic acid , hyaluronate sodium cream, gel, and spray

Aplikace gelu

  • Do not take Hylase Wound (hyaluronate sodium cream, gel, and spray) by mouth
  • Use on your skin only
  • Wash your hands before and after use.
  • Clean affected part before use. Make sure to dry well.
  • Put a thin layer on the affected skin.
  • Cover the wound with a clean dressing.

WARNING/CAUTION:

Allergic reaction - velmi vzácné

    • Rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever;
    • Wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness;
    • Or swelling of the mouth, face, lips, tongue, or throat.

Irritation

  • Where Hylase Wound (hyaluronate sodium cream, gel, and spray) is used

Hylase (hyaluronidase injection)

DOSAGE FORMS AND STRENGTHS

  • Injection: 150 USP Units/mL single dose vials.

Indikace

Adjuvant to increase the absorption and dispersion of other injected drugs.

  • Adding 50 to 300 Units
  • Most typically 150 Units of Hylase , to the injection solution

Subcutaneous urography for improving resorption of radiopaque agents

  • Indicated when intravenous administration cannot be successfully accomplished
    • In infants and small children
  • 75 Units of Hylase is injected subcutaneously over each scapula
    • Followed by injection of the contrast medium at the same sites

Hypodermoclysis

  • Hylase as an adjuvant in subcutaneous fluid administration for achieving hydration
  • 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 Hylase into rubber tubing close to needle.
  • An alternate method
    • Inject Hylase under skin prior to clysis.
    • 150 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.
  • Hylase may be added to small volumes of solution (up to 200 mL),
    • As small clysis for infants
    • Solutions of drugs for subcutaneous injection.
  • For infants and children less than 3 years old
    • Volume of a single clysis should be limited to 200 mL;
  • In premature infants or during the neonatal period,
    • 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,
    • Rate and volume of administration should not exceed those employed for intravenous infusion.

Other administrations

  • May be administered for
    • Infiltration use,
    • Interstitial use,
    • Intramuscular use,
    • Intraocular use,
    • Retrobulbar use,
    • Soft tissue use
    • Subcutaneous use

Prevence pooperačních adhezí v břiše

  • Good effects were seen also by contrykal (aprotinin) and hylase (hyaluronidase).
  • By the combination of dextran 70 30% with contrykal the spread of adhesions was very low
    • But the effect was not significant better than with dextran 70 10% alone.
www.semanticscholar.org/topic/hylase/1913269

Intra-cervical Hylase

  • Did not dilate the cervix but successfully softened it within 5 minutes to make metallic dilatation simple.
  • The hygroscopic Isogel tents achieved dilatation of 10 mm or more in 73% of the patients in 12 hours.
www.semanticscholar.org/topic/hylase/1913269

Extravazální únik chemoterapeutika

  • Hyaluronidase was used in the case of one myeloma patient who received a large dose of hyaluronidase locally to resolve extravasation of a highly toxic melphalan-containing drug
www.sciencedirect.com/topics/medicine-and-dentistry/hyaluronidase

Zvýšení účinku chemoterapie

  • Hyaluronidase in combination with chemotherapy may be helpful only in specific tumor entities, however, in a wide dose range
www.sciencedirect.com/topics/medicine-and-dentistry/hyaluronidase


Important Administration Instructions

  • Do not administer Hylase intravenously
    • Rapidly inactivated with intravenous administration.
  • Visually inspect parenteral drug products for
    • Particulate matter
    • Discoloration
  • Always use aseptic precautions.
  • Consult physical or chemical incompatibilities before adding Hylase to a solution containing another drug.

CONTRAINDICATIONS

Hypersensitivity

  • Hypersensitivity to Hylase or any other ingredient in the formulation
  • Preliminary skin test for hypersensitivity to Hylase can be performed
    • 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 five minutes
      • Persisting for 20 to 30 minutes
      • Accompanied by localized itching
    • Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction.
  • Discontinue Hylase if sensitization occurs.

WARNINGS AND PRECAUTIONS

  • Spread of Localized Injection
    • Should not be injected into or around an infected or acutely inflamed area
      • Danger of spreading a localized infection.
    • Hylase should not be used to reduce the swelling of bites or stings !!
      • Prof. Konopík to používal jen v kombinaci s antibiotiky !!!

Ocular Damage

  • Hylase should not be applied directly to the cornea.

ADVERSE REACTIONS

  • Local injection site reactions
  • Enhance the adverse events associated with co-administered drug products
  • Edema has been reported most frequently in association with hypodermoclysis.
  • Allergic reactions (urticaria, angioedema) have been reported in less than 0.1% of patients
  • Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
  • Most frequently reported adverse reactions have been local injections site reactions

DRUG INTERACTIONS

  • Consult physical or chemical incompatibilities before adding Hylase to a solution containing another drug.

Incompatible with Hylase

  • Furosemide,
  • Benzodiazepines
  • Phenytoin
  • Dopamine
  • Alpha agonist drugs

Anestetika

  • Hastens the onset effect
  • Shortens duration of effect
  • Increases incidence of systemic reactions

Snížení efektu Hylasy

  • Large doses of:
    • Salicylated
    • Cortisone
    • ACTH
    • Estrogens
    • Antihistamines
  • May require larger amounts of hydaluronidase for equivalent dispensing effect
    • Drugs apparently render tissues partly resistant to the action of Hylase.

Pregnancy

  • No adequate and well controlled animal studies have been conducted with Hylase to determine reproductive effects.
  • Hylase should be used during pregnancy only if clearly needed.

Labor and Delivery

  • Hylase during labor was reported to cause no complications:
    • No increase in blood loss or differences in cervical trauma were observed.
  • It is not known whether Hylase has an effect on the later growth, development, and functional maturation of the infant.

Nursing Mothers

  • Not known whether Hylase is excreted in human milk.
  • Because many drugs are excreted in human milk, caution should be exercised when Hylase is administered to a nursing woman.

Pediatric Use

  • May be added to small volumes of solution, such as small clysis for infants or solutions of drugs for subcutaneous injection. The potential for chemical or physical incompatibilities should be kept in mind [see Dosage and Administration (2)].

OVERDOSAGE

  • Local edema or urticaria, erythema, chills,
  • Nausea, vomiting, dizziness, tachycardia, and hypotension.
  • Enzyme should be discontinued and supportive measures initiated immediately.

DESCRIPTION

  • Hylase (hyaluronidase injection) is a preparation of purified bovine testicular Hylase, a protein enzyme
  • Exact chemical structure of this enzyme is unknown.
  • Is supplied as sterile, colorless, odorless, ready for use solution
  • Each vial contains 150 USP units of Hylase per mL calcium chloride (0.4 mg),
    • Edetate disodium (1 mg),
    • Sodium chloride (8.5 mg),
    • Monobasic sodium phosphate buffer,
    • Sodium hydroxide to adjust the pH,
    • Sterile water.
  • Hylase has an approximate pH of 6.9 and an osmolality of 275 to 305 mOsm.

Mechanism of Action

  • Modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid
    • Polysaccharide found in the intercellular ground substance of
      • Connective tissue,
      • Umbilical cord
      • Vitreous humor
  • Hyaluronic acid is also present in the capsules of type A and C hemolytic streptococci
  • Hylase hydrolyzes hyaluronic acid
    • By splitting the glucosaminidic bond between C1 of the glucosamine moiety and C4 of glucuronic acid
    • Temporarily decreases the viscosity of the cellular cement
    • Promotes diffusion of injected fluids or of localized transudates or exudates
  • Hylase cleaves
    • Glycosidic bonds of hyaluronic acid to a variable degree
    • Some other acid mucopolysaccharides of the connective tissue
  • The activity is measured in vitro
    • By monitoring the decrease in the amount of an insoluble serum albumin-hyaluronic acid complex
      • The enzyme cleaves the hyaluronic acid component.

Pharmacokinetics

  • Blood of a number of mammalian species brings about the inactivation of Hylase
  • Studies have demonstrated that Hylase is antigenic
  • Repeated injections of relatively large amounts of this enzyme may result in the formation of neutralizing anti-bodies.
  • The reconstitution of the dermal barrier removed by intradermal injection of Hylase (20, 2, 0.2, 0.02, and 0.002 Units/mL) to adult humans
    • At 24 hours the restoration of the barrier is incomplete
    • Inversely related to the dosage of enzyme
    • at 48 hours the barrier is completely restored in all treated areas
  • Influence of Hylase in bone repair support the conclusion that this enzyme alone does not deter bone healing when given at the usual clinical dosage.

NONCLINICAL TOXICOLOGY

  • Long-term animal studies have not been performed to assess the carcinogenic or mutagenic potential of Hylase.
  • Hylase is found in most tissues of the body.
  • Long-term animal studies have not been performed to assess whether Hylase impaired fertility;
  • testicular degeneration may occur with the production of organ-specific antibodies against this enzyme following repeated injections
  • Human studies on the effect of intravaginal Hylase in sterility due to oligospermia indicated that Hylase may have aided conception.

Storage

  • In a refrigerator at 2° to 8°C
  • DO NOT FREEZE.
www.sdrugs.com/?c=drug&s=hylase#1%20indications%20and%20usage

Kvalita

  • 19.07.2017, 18:08 SÚKL stahuje Hylase Dessau
    • Tři šarže léčivého přípravku Hylase Dessau 150 I.U, inj. plv. sol. 10 (Riemser Pharma)
    • Z důvodu závady v jakosti – tvorba částic v roztoku po rozpuštění.
https://www.apatykar.info/kratke-zpravy-13093/

Hyaluronidase (Hylase Dessau®) a otoky očních víček

  • Lower eyelid edema
    • Common post-interventional complication of cosmetic procedures
      • Injection of hyaluronic acid fillers for tear-trough augmentation
  • Retrospective analysis with 20 patients with lower eyelid edema
    • 14 presented with edema following hyaluronic acid injection
    • ?6 were treated due to idiopathic edema (malar edema or malar mounds)
    • Local infiltration of approximately 0.2 ml to 0.5 ml of hyaluronidase (Hylase Dessau® 20 IU to 75 IU) per eyelid
      • Photographs were taken prior to and seven days after infiltration.
      • Hyaluronidase was found to reduce effectively and rapidly or resolve eyelid edema after a single injection.
      • No relevant adverse effects were observed.
      • May also dissolve injected hyaluronic acid fillers - may therefore negatively affect tear-trough augmentations
        • Treatment for edema due to tear-trough augmentation were permanent
        • Malar edema and malar mounds reoccurred within two to three weeks
    • www.ncbi.nlm.nih.gov/pmc/articles/PMC4063423/

Hyaluronidáza výskyt

  • Testes nejvšší koncentrace - spermie se tak dostávají do vejce
    • Izolována z ovcí aj. dobytka pro medic. účinky
  • Hmyz s lokálním anestetikem
    • Pro lepší sání krve

Hyaluronidáza vlastnosti

    • Hyaluronic acid-metabolizing enzyme
  • Loosen the extracellular matrix
  • Improving the diffusion of local anesthetics
  • Endoglycosidase
  • Specific hyaluronidases have alternative substrates to hyaluronan (HA) or do not exhibit any enzymatic activity
  • High-molecular weight HA polymers
    • Elicit signaling effects
    • Opposite those of the hyaluronidase-digested HA oligomers
  • Combined overexpression of HA synthesizing enzymes with hyaluronidases that confers tumorigenic potential

Výborné pokračování o významu hyaluronidázy ve vztahu k nádorům


O úroveň výše

Poslední aktualizace: 25. 11. 2019 12:31:46
© Dana Maňasková, metabalance.cz
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