SANTYL OINTMENT

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

COLLAGENASE

Dostępny od:

SMITH & NEPHEW INC

Kod ATC:

D03BA02

INN (International Nazwa):

COLLAGENASE

Dawkowanie:

250UNIT

Forma farmaceutyczna:

OINTMENT

Skład:

COLLAGENASE 250UNIT

Droga podania:

TOPICAL

Sztuk w opakowaniu:

15G/30G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0112254001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2014-12-11

Charakterystyka produktu

PRODUCT MONOGRAPH
SANTYL OINTMENT
(Collagenase)
Topical Enzymatic Debriding Agent
Smith & Nephew Inc.
Date of Authorization:
Mississauga, Ontario
December 7, 2023
L5N 6H8
Control number: 278543
NAME OF DRUG
SANTYL OINTMENT
(Collagenase)
THERAPEUTIC CLASSIFICATION
Topical enzymatic debriding agent
STRUCTURAL FORMULA AND CHEMISTRY
Collagenase is a large protein molecule of biologic origin, being
derived from the
fermentation of Clostridium histolyticum. The enzyme may be obtained
in two forms,
one a protein of 105,000 molecular weight, collagenase A and a
molecule of 57,000
molecular weight, collagenase B. SANTYL contains a mixture of these
two forms in an
indeterminable ratio.
Both collagenase A and collagenase B require free sulfhydryl
groups for formation of enzyme substrate complex. Collagenase also
requires enzyme
bound zinc for activity. The optimal pH range for enzymatic activity
is 7 to 8. Like all
enzymes having sulfhydryl groups at the active site, inactivation with
heavy metals,
such as mercury, silver, cobalt, magnesium, and manganese can occur.
The specific
substrate for collagenase is collagen. However, minimal amounts of
other amidase and
esterase activity may be found in the collagenase enzyme preparation.
DESCRIPTION
Each gram of SANTYL Ointment contains 250 units of collagenase enzyme
per gram of
white petrolatum U.S.P. The potency assay of collagenase is based on
the digestion of
undenatured collagen (from bovine Achilles tendon) at pH 7.2 and 37°C
for 24 hours. The
number of peptides cleaved are measured by reaction with ninhydrin.
Peptides released
by a trypsin digestion control are subtracted. One net collagenase
unit will solubilize
ninhydrin reactive material equivalent to 4 micromoles of leucine.
ACTION
Collagenase digests collagen in the physiologic pH and temperature
range.
Since
collagen accounts for 75% of the dry weight of skin tissue,
collagenase is useful in the
removal of detritus from the craters of dermal ulcers or skin burns.
Rapid debridement
contributes toward the formation of