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  4. Collagenase Santyl

Collagenase Santyl


Smith & Nephew, Inc
Human Prescription Drug
NDC 50484-010
Collagenase Santyl is a human prescription drug labeled by 'Smith & Nephew, Inc'. National Drug Code (NDC) number for Collagenase Santyl is 50484-010. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Collagenase Santyl drug includes Collagenase Clostridium Histolyticum - 250 [arb'U]/g . The currest status of Collagenase Santyl drug is Active.

Drug Information:

Drug NDC: 50484-010
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Collagenase Santyl
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Collagenase Santyl
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Smith & Nephew, Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Ointment
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:COLLAGENASE CLOSTRIDIUM HISTOLYTICUM - 250 [arb'U]/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: BLA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 18 Oct, 2006
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 14 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: BLA101995
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:SMITH & NEPHEW, INC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:309509
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0350484010300
UPC stands for Universal Product Code.
UNII:9X7O8V25IT
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Collagen-specific Enzyme [EPC]
Collagenases [Chemical/Ingredient]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
50484-010-301 TUBE in 1 CARTON (50484-010-30) / 30 g in 1 TUBE18 Oct, 2006N/ANo
50484-010-901 TUBE in 1 CARTON (50484-010-90) / 90 g in 1 TUBE10 Mar, 2014N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.
Other medicines with the same generic name

Collagenase Santyl


Ointment
SMITH & NEPHEW, INC
NDC: 50484-010

Product Elements:

Collagenase santyl collagenase santyl collagenase clostridium histolyticum collagenase clostridium histolyticum petrolatum white to off white

Indications and Usage:

Indications and usage collagenase santyl ◊ ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21

Dosage and Administration:

Dosage and administration collagenase santyl ◊ ointment should be applied once daily (or more frequently if the dressing becomes soiled, as from incontinence). when clinically indicated, crosshatching thick eschar with a #10 blade allows collagenase santyl ◊ ointment more surface contact with necrotic debris. it is also desirable to remove, with forceps and scissors, as much loosened detritus as can be done readily. use collagenase santyl ◊ ointment in the following manner: 1 - prior to application the wound should be cleansed of debris and digested material by gently rubbing with a gauze pad saturated with normal saline solution, or with the desired cleansing agent compatible with collagenase santyl ◊ ointment (see precautions ), followed by a normal saline solution rinse. 2 - whenever infection is present, it is desirable to use an appropriate topical antibiotic powder. the antibiotic should be applied to the wound prior to the application of collagenase santyl â
—Š ointment. should the infection not respond, therapy with collagenase santyl ◊ ointment should be discontinued until remission of the infection. 3 - collagenase santyl ◊ ointment may be applied directly to the wound or to a sterile gauze pad which is then applied to the wound and properly secured. 4 - use of collagenase santyl ◊ ointment should be terminated when debridement of necrotic tissue is complete and granulation tissue is well established.

Contraindications:

Contraindications collagenase santyl ◊ ointment is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.

Adverse Reactions:

Adverse reactions no allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. however, one case of systemic manifestations of hypersensitivity to collagenase in a patient treated for more than one year with a combination of collagenase and cortisone has been reported.

Overdosage:

Overdosage no systemic or local reaction attributed to overdose has been observed in clinical investigations and clinical use. if deemed necessary the enzyme may be inactivated by washing the area with povidone iodine.

Description:

Description collagenase santyl ◊ ointment is a sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum usp. the enzyme collagenase is derived from the fermentation by clostridium histolyticum . it possesses the unique ability to digest collagen in necrotic tissue.

Clinical Pharmacology:

Clinical pharmacology since collagen accounts for 75% of the dry weight of skin tissue, the ability of collagenase to digest collagen in the physiological ph and temperature range makes it particularly effective in the removal of detritus. 1 collagenase thus contributes towards the formation of granulation tissue and subsequent epithelization of dermal ulcers and severely burned areas. 2, 3, 4, 5, 6 collagen in healthy tissue or in newly formed granulation tissue is not attacked. 2, 3, 4, 5, 6, 7, 8 there is no information available on collagenase absorption through skin or its concentration in body fluids associated with therapeutic and/or toxic effects, degree of binding to plasma proteins, degree of uptake by a particular organ or in the fetus, and passage across the blood brain barrier.

How Supplied:

How supplied collagenase santyl ◊ ointment contains 250 units of collagenase enzyme per gram of white petrolatum usp. do not store above 25°c (77°f). sterility guaranteed until tube is opened. collagenase santyl ◊ ointment is available in the following sizes: 30 g tube ndc 50484-010-30 90 g tube ndc 50484-010-90 references 1 – mandl, i., adv enzymol. 23:163, 1961. 2 – boxer, a.m., gottesman, n., bernstein, h., & mandl, i., geriatrics. 24:75, 1969. 3 – mazurek, i., med. welt. 22:150, 1971. 4 – zimmermann, we., in “collagenase,” mandl, i., ed., gordon & breach, science publishers, new york, 1971, p. 131, p. 185. 5 – vetra, h., & whittaker, d., geriatrics. 30:53, 1975. 6 – rao, d.b., sane, p.g., & georgiev, e.l., j. am. geriatrics soc. 23:22, 1975. 7 – vrabec, r., moserova, j., konickova, z., behounkova, e., & blaha, j., j. hyg. epidemiol. microbiol. immunol. 18:496, 1974. 8 – lippmann, h.i., arch. phys.
med. rehabil. 54:588, 1973. 9 – german, f. m., in “collagenase,” mandl, i., ed., gordon & breach, science publishers, new york, 1971, p. 165. 10 – haimovici, h. & strauch, b., in “collagenase,” mandl, i., ed., gordon & breach, science publishers, new york, 1971, p. 177. 11 – lee, l.k., & ambrus, j.l., geriatrics. 30:91, 1975. 12 – locke, r.k., & heifitz, n.m., j. am. pod. assoc. 65:242, 1975. 13 – varma, a.o., bugatch, e., & german, f.m., surg. gynecol. obstet. 136:281, 1973. 14 – barrett, d., jr., & klibanski, a., am. j. nurs. 73:849, 1973. 15 – bardfeld, l.a., j. pod. ed. 1:41, 1970. 16 – blum, g., schweiz, rundschau med praxis. 62:820, 1973. abstr. in dermatology digest, feb. 1974, p. 36. 17 – zaruba, f., lettl, a., brozkova, l., skrdlantova, h., & krs, v., j. hyg. epidemiol. microbiol. immunol. 18:499, 1974. 18 – altman, m.i., goldstein, l., & horwitz, s., j. am. pod. assoc. 68:11, 1978. 19 – rehn, v.j., med. klin. 58:799, 1963. 20 – krauss, h., koslowski, l., & zimmermann, w. e., langenbecks arch. klin. chir. 303:23, 1963. 21 – gruenagel, h.h., med. klin. 58:442, 1963. manufactured by: smith & nephew, inc fort worth, texas 76109 us gov’t license #2004 marketed by: smith & nephew ◊ 1-800-441-8227 smith & nephew, inc., fort worth, texas 76109 © 2016 smith & nephew, inc. santyl is a registered trademark of smith & nephew, inc. 140749-0316

Package Label Principal Display Panel:

Package label.principal display panel 2228603f-figure-01

Tube label.principal display panel 2228603f-figure-02


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