Application Information

This drug has been submitted to the FDA under the reference 006343/002.

Names and composition

"WYDASE" is the commercial name of a drug composed of HYALURONIDASE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
006343/002 WYDASE HYALURONIDASE INJECTABLE/INJECTION 150 UNITS per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
006343/005 WYDASE HYALURONIDASE INJECTABLE/INJECTION 1,500 UNITS per VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
006343/006 WYDASE HYALURONIDASE INJECTABLE/INJECTION 150 UNITS per VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
006343/002 WYDASE HYALURONIDASE INJECTABLE/INJECTION 150 UNITS per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
006343/005 WYDASE HYALURONIDASE INJECTABLE/INJECTION 1,500 UNITS per VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
006343/006 WYDASE HYALURONIDASE INJECTABLE/INJECTION 150 UNITS per VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021640/001 VITRASE HYALURONIDASE INJECTABLE/INJECTION 6,200 UNITS per VIAL
021640/002 VITRASE HYALURONIDASE INJECTABLE/INJECTION 200 UNITS per VIAL
021665/001 AMPHADASE HYALURONIDASE INJECTABLE/INJECTION 150 UNITS per ML
021716/001 HYDASE HYALURONIDASE INJECTABLE/INJECTION 150 UNITS per ML

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Answered questions

Hi,Can anyone tell me about possible treatment options of oral submucous fibrosis...?
Specially interferon gamma and steroids..... I hve read an artical saying interferon gamma can reverse it..... Asked by Elvia Magel 1 year ago.

Drug Name Dexamethasone (Decadron) -- For various inflammatory diseases. Decreases inflammation by suppressing migration of polymorphonuclear leukocytes and reducing capillary permeability. Adult Dose 4 mg IV/IM (suggested in studies) Pediatric Dose Dose in children should be based on severity of disease and response rather than adherence to dose indicated by age, body weight, or BSA Contraindications Documented hypersensitivity; active bacterial or fungal infection Interactions Effects decrease with coadministration of barbiturates, phenytoin, and rifampin; decreases effect of salicylates and vaccines used for immunization Pregnancy C - Safety for use during pregnancy has not been established. Precautions Increases risk of multiple complications, including severe infections; monitor adrenal insufficiency when tapering drug; abrupt discontinuation of glucocorticoids may cause adrenal crisis; hyperglycemia, edema, osteonecrosis, myopathy, peptic ulcer disease, hypokalemia, osteoporosis, euphoria, psychosis, myasthenia gravis, growth suppression, and infections are possible complications; caution with individuals exposed to viral illnesses, such as chickenpox or measles Drug Name Triamcinolone acetonide (Aristocort, Kenaject) -- Suppresses immune system by reducing activity and volume of lymphatic system. Treats inflammatory mucosal lesions that are responsive to steroids. Decreases inflammation by suppressing the migration of polymorphonuclear leukocytes and by reversing capillary permeability. Adult Dose Oral inflammatory or ulcerative lesions (dental paste): Apply thin film bid/tid pc and hs 40-80 mg IM (studies have used 10 mg/mL diluted in 1 mL of lidocaine 2% to avoid tissue irritation and facilitate proper distribution of drug) Pediatric Dose Not established Contraindications Documented hypersensitivity; fungal, viral, and mycobacterial mucosal infections Interactions Coadministration with barbiturates, phenytoin, and rifampin decreases effects; effects of vaccine and toxoid may be reduced Pregnancy C - Safety for use during pregnancy has not been established. Precautions Multiple complications (eg, severe infections, hyperglycemia, edema, osteonecrosis, myopathy, peptic ulcer disease, hypokalemia, osteoporosis, euphoria, psychosis, myasthenia gravis, growth suppression) may occur; abrupt discontinuation may cause adrenal crisis Drug Name Betamethasone valerate (Diprosone) -- For inflammatory reactions responsive to steroids. Decreases inflammation by suppressing migration of polymorphonuclear leukocytes and by reversing capillary permeability. Affects production of lymphokines and has inhibitory effect on Langerhans cells. Adult Dose Suggested dose: 0.05% topically q6h for 3 wk Pediatric Dose Not established Contraindications Documented hypersensitivity; paronychia; cellulitis; impetigo; angular cheilitis; erythrasma; erysipelas; rosacea; perioral dermatitis; acne Interactions None reported Pregnancy C - Safety for use during pregnancy has not been established. Precautions Do not use in skin with decreased circulation; can cause atrophy of groin, face, and axillae; may cause striae distensae and rosacealike eruption; may increase skin fragility; rarely may suppress HPA axis; if infection develops and is not responsive to antibiotic treatment, discontinue until infection is under control; do not use monotherapy to treat widespread plaque psoriasis Drug Category: Extravasation antidotes -- Can enhance the diffusion of locally irritating or toxic drugs in the management of intravenous extravasation.Drug Name Hyaluronidase (Wydase Injection) -- Stimulates hydrolysis of hyaluronic acid, one of the chief ingredients of tissue cement, which offers resistance to diffusion of liquids through tissues. Used to aid in absorption and dispersion of injected drugs. Adult Dose 150 U added to vehicle solution and administered SC/ID Pediatric Dose Administer as in adults Contraindications Documented hypersensitivity Interactions Salicylates, cortisone, corticotropin, estrogens, and antihistamines may decrease effects Pregnancy C - Safety for use during pregnancy has not been established. Precautions Avoid injecting into inflamed or cancerous areas; perform intradermal skin test for sensitivity before initiating infusion; discontinue if sensitivity or extravasation occur Drug Category: Interferons -- Are naturally produced proteins with antiviral, antitumor and immunomodulatory actions. Alpha-, beta-, and gamma-interferons may be given topically, systemically, or intralesionally.Drug Name Interferon gamma (Actimmune) -- Believed to act via ability to counteract cell surface expression of proinflammatory or proadhesion molecules on immune cells, among other effects. More studies needed to fully understand mechanisms of action. Adult Dose BSA >0.5 m2: 50 mcg/m2 SC 3 times/wk BSA <0.5 m2: 1.5 mcg/kg/dose SC 3 times/wk Pediatric Dose Not established Contraindications Documented hypersensitivity; Escherichia coli derivatives or components Interactions Live vaccines; rotavirus vaccine Pregnancy C - Safety for use during pregnancy has not been established. Precautions Caution in preexisting cardiac disease, seizure disorder, or compromised CNS function; myelosuppression Answered by Janita Norbury 1 year ago.


Hi,Can anyone tell me about possible treatment options of oral submucous fibrosis...?
Specially interferon gamma and steroids..... I hve read an artical saying interferon gamma can reverse it..... Asked by Delmer Roscigno 1 year ago.

Drug Name Dexamethasone (Decadron) -- For various inflammatory diseases. Decreases inflammation by suppressing migration of polymorphonuclear leukocytes and reducing capillary permeability. Adult Dose 4 mg IV/IM (suggested in studies) Pediatric Dose Dose in children should be based on severity of disease and response rather than adherence to dose indicated by age, body weight, or BSA Contraindications Documented hypersensitivity; active bacterial or fungal infection Interactions Effects decrease with coadministration of barbiturates, phenytoin, and rifampin; decreases effect of salicylates and vaccines used for immunization Pregnancy C - Safety for use during pregnancy has not been established. Precautions Increases risk of multiple complications, including severe infections; monitor adrenal insufficiency when tapering drug; abrupt discontinuation of glucocorticoids may cause adrenal crisis; hyperglycemia, edema, osteonecrosis, myopathy, peptic ulcer disease, hypokalemia, osteoporosis, euphoria, psychosis, myasthenia gravis, growth suppression, and infections are possible complications; caution with individuals exposed to viral illnesses, such as chickenpox or measles Drug Name Triamcinolone acetonide (Aristocort, Kenaject) -- Suppresses immune system by reducing activity and volume of lymphatic system. Treats inflammatory mucosal lesions that are responsive to steroids. Decreases inflammation by suppressing the migration of polymorphonuclear leukocytes and by reversing capillary permeability. Adult Dose Oral inflammatory or ulcerative lesions (dental paste): Apply thin film bid/tid pc and hs 40-80 mg IM (studies have used 10 mg/mL diluted in 1 mL of lidocaine 2% to avoid tissue irritation and facilitate proper distribution of drug) Pediatric Dose Not established Contraindications Documented hypersensitivity; fungal, viral, and mycobacterial mucosal infections Interactions Coadministration with barbiturates, phenytoin, and rifampin decreases effects; effects of vaccine and toxoid may be reduced Pregnancy C - Safety for use during pregnancy has not been established. Precautions Multiple complications (eg, severe infections, hyperglycemia, edema, osteonecrosis, myopathy, peptic ulcer disease, hypokalemia, osteoporosis, euphoria, psychosis, myasthenia gravis, growth suppression) may occur; abrupt discontinuation may cause adrenal crisis Drug Name Betamethasone valerate (Diprosone) -- For inflammatory reactions responsive to steroids. Decreases inflammation by suppressing migration of polymorphonuclear leukocytes and by reversing capillary permeability. Affects production of lymphokines and has inhibitory effect on Langerhans cells. Adult Dose Suggested dose: 0.05% topically q6h for 3 wk Pediatric Dose Not established Contraindications Documented hypersensitivity; paronychia; cellulitis; impetigo; angular cheilitis; erythrasma; erysipelas; rosacea; perioral dermatitis; acne Interactions None reported Pregnancy C - Safety for use during pregnancy has not been established. Precautions Do not use in skin with decreased circulation; can cause atrophy of groin, face, and axillae; may cause striae distensae and rosacealike eruption; may increase skin fragility; rarely may suppress HPA axis; if infection develops and is not responsive to antibiotic treatment, discontinue until infection is under control; do not use monotherapy to treat widespread plaque psoriasis Drug Category: Extravasation antidotes -- Can enhance the diffusion of locally irritating or toxic drugs in the management of intravenous extravasation.Drug Name Hyaluronidase (Wydase Injection) -- Stimulates hydrolysis of hyaluronic acid, one of the chief ingredients of tissue cement, which offers resistance to diffusion of liquids through tissues. Used to aid in absorption and dispersion of injected drugs. Adult Dose 150 U added to vehicle solution and administered SC/ID Pediatric Dose Administer as in adults Contraindications Documented hypersensitivity Interactions Salicylates, cortisone, corticotropin, estrogens, and antihistamines may decrease effects Pregnancy C - Safety for use during pregnancy has not been established. Precautions Avoid injecting into inflamed or cancerous areas; perform intradermal skin test for sensitivity before initiating infusion; discontinue if sensitivity or extravasation occur Drug Category: Interferons -- Are naturally produced proteins with antiviral, antitumor and immunomodulatory actions. Alpha-, beta-, and gamma-interferons may be given topically, systemically, or intralesionally.Drug Name Interferon gamma (Actimmune) -- Believed to act via ability to counteract cell surface expression of proinflammatory or proadhesion molecules on immune cells, among other effects. More studies needed to fully understand mechanisms of action. Adult Dose BSA >0.5 m2: 50 mcg/m2 SC 3 times/wk BSA <0.5 m2: 1.5 mcg/kg/dose SC 3 times/wk Pediatric Dose Not established Contraindications Documented hypersensitivity; Escherichia coli derivatives or components Interactions Live vaccines; rotavirus vaccine Pregnancy C - Safety for use during pregnancy has not been established. Precautions Caution in preexisting cardiac disease, seizure disorder, or compromised CNS function; myelosuppression Answered by Merissa Uselman 1 year ago.


Hi,Can anyone tell me about possible treatment options of oral submucous fibrosis...?
Specially interferon gamma and steroids..... I hve read an artical saying interferon gamma can reverse it..... Asked by Markus Hinkson 1 year ago.

Drug Name Dexamethasone (Decadron) -- For various inflammatory diseases. Decreases inflammation by suppressing migration of polymorphonuclear leukocytes and reducing capillary permeability. Adult Dose 4 mg IV/IM (suggested in studies) Pediatric Dose Dose in children should be based on severity of disease and response rather than adherence to dose indicated by age, body weight, or BSA Contraindications Documented hypersensitivity; active bacterial or fungal infection Interactions Effects decrease with coadministration of barbiturates, phenytoin, and rifampin; decreases effect of salicylates and vaccines used for immunization Pregnancy C - Safety for use during pregnancy has not been established. Precautions Increases risk of multiple complications, including severe infections; monitor adrenal insufficiency when tapering drug; abrupt discontinuation of glucocorticoids may cause adrenal crisis; hyperglycemia, edema, osteonecrosis, myopathy, peptic ulcer disease, hypokalemia, osteoporosis, euphoria, psychosis, myasthenia gravis, growth suppression, and infections are possible complications; caution with individuals exposed to viral illnesses, such as chickenpox or measles Drug Name Triamcinolone acetonide (Aristocort, Kenaject) -- Suppresses immune system by reducing activity and volume of lymphatic system. Treats inflammatory mucosal lesions that are responsive to steroids. Decreases inflammation by suppressing the migration of polymorphonuclear leukocytes and by reversing capillary permeability. Adult Dose Oral inflammatory or ulcerative lesions (dental paste): Apply thin film bid/tid pc and hs 40-80 mg IM (studies have used 10 mg/mL diluted in 1 mL of lidocaine 2% to avoid tissue irritation and facilitate proper distribution of drug) Pediatric Dose Not established Contraindications Documented hypersensitivity; fungal, viral, and mycobacterial mucosal infections Interactions Coadministration with barbiturates, phenytoin, and rifampin decreases effects; effects of vaccine and toxoid may be reduced Pregnancy C - Safety for use during pregnancy has not been established. Precautions Multiple complications (eg, severe infections, hyperglycemia, edema, osteonecrosis, myopathy, peptic ulcer disease, hypokalemia, osteoporosis, euphoria, psychosis, myasthenia gravis, growth suppression) may occur; abrupt discontinuation may cause adrenal crisis Drug Name Betamethasone valerate (Diprosone) -- For inflammatory reactions responsive to steroids. Decreases inflammation by suppressing migration of polymorphonuclear leukocytes and by reversing capillary permeability. Affects production of lymphokines and has inhibitory effect on Langerhans cells. Adult Dose Suggested dose: 0.05% topically q6h for 3 wk Pediatric Dose Not established Contraindications Documented hypersensitivity; paronychia; cellulitis; impetigo; angular cheilitis; erythrasma; erysipelas; rosacea; perioral dermatitis; acne Interactions None reported Pregnancy C - Safety for use during pregnancy has not been established. Precautions Do not use in skin with decreased circulation; can cause atrophy of groin, face, and axillae; may cause striae distensae and rosacealike eruption; may increase skin fragility; rarely may suppress HPA axis; if infection develops and is not responsive to antibiotic treatment, discontinue until infection is under control; do not use monotherapy to treat widespread plaque psoriasis Drug Category: Extravasation antidotes -- Can enhance the diffusion of locally irritating or toxic drugs in the management of intravenous extravasation.Drug Name Hyaluronidase (Wydase Injection) -- Stimulates hydrolysis of hyaluronic acid, one of the chief ingredients of tissue cement, which offers resistance to diffusion of liquids through tissues. Used to aid in absorption and dispersion of injected drugs. Adult Dose 150 U added to vehicle solution and administered SC/ID Pediatric Dose Administer as in adults Contraindications Documented hypersensitivity Interactions Salicylates, cortisone, corticotropin, estrogens, and antihistamines may decrease effects Pregnancy C - Safety for use during pregnancy has not been established. Precautions Avoid injecting into inflamed or cancerous areas; perform intradermal skin test for sensitivity before initiating infusion; discontinue if sensitivity or extravasation occur Drug Category: Interferons -- Are naturally produced proteins with antiviral, antitumor and immunomodulatory actions. Alpha-, beta-, and gamma-interferons may be given topically, systemically, or intralesionally.Drug Name Interferon gamma (Actimmune) -- Believed to act via ability to counteract cell surface expression of proinflammatory or proadhesion molecules on immune cells, among other effects. More studies needed to fully understand mechanisms of action. Adult Dose BSA >0.5 m2: 50 mcg/m2 SC 3 times/wk BSA <0.5 m2: 1.5 mcg/kg/dose SC 3 times/wk Pediatric Dose Not established Contraindications Documented hypersensitivity; Escherichia coli derivatives or components Interactions Live vaccines; rotavirus vaccine Pregnancy C - Safety for use during pregnancy has not been established. Precautions Caution in preexisting cardiac disease, seizure disorder, or compromised CNS function; myelosuppression Answered by Juana Witfield 1 year ago.


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