TESTIM 1% GEL

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

TESTOSTERONE

Beschikbaar vanaf:

PALADIN LABS INC.

ATC-code:

G03BA03

INN (Algemene Internationale Benaming):

TESTOSTERONE

Dosering:

1%

farmaceutische vorm:

GEL

Samenstelling:

TESTOSTERONE 1%

Toedieningsweg:

TRANSDERMAL

Eenheden in pakket:

30X5G

Prescription-type:

Schedule G (CDSA IV)

Therapeutisch gebied:

ANDROGENS

Product samenvatting:

Active ingredient group (AIG) number: 0106405004; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2017-02-03

Productkenmerken

- 1 -
Testim 1% Product Monograph
PRODUCT MONOGRAPH
C
TESTIM
®
1%
(testosterone gel)
Androgens
Paladin Labs Inc.
100 Alexis Nihon Blvd., Suite 600
St. Laurent, Quebec
H4M 2P2
DATE OF REVISION:
February 3, 2017
CONTROL NO: 201331
- 2 -
Testim 1% Product Monograph
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
3
SUMMARY PRODUCT INFORMATION
3
INDICATIONS AND CLINICAL USE
3
CONTRAINDICATIONS
3
WARNINGS AND PRECAUTIONS
4
ADVERSE REACTIONS
9
DRUG INTERACTIONS
15
DOSAGE AND ADMINISTRATION
16
OVERDOSAGE
17
ACTION AND CLINICAL PHARMACOLOGY
17
STORAGE AND STABILITY
20
SPECIAL HANDLING INSTRUCTIONS
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
21
PART II: SCIENTIFIC INFORMATION
22
PHARMACEUTICAL INFORMATION
22
CLINICAL TRIALS
22
MICROBIOLOGY
27
TOXICOLOGY
27
REFERENCES
30
PART III: CONSUMER INFORMATION
32
- 3 -
Testim 1% Product Monograph
C
TESTIM
®
1%
(testosterone gel)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
INDICATIONS AND CLINICAL USE
Testim
®
1% (testosterone gel) is indicated for testosterone replacement
therapy in adult
males for
conditions associated with a deficiency or absence of endogenous
testosterone.
Testim
®
1% (testosterone gel) should not be used to treat non-specific
symptoms
suggestive of
hypogonadism
if
testosterone
deficiency
has
not
been
demonstrated
and
if
other
etiologies
responsible for the symptoms have not been excluded. Testosterone
deficiency should be clearly
demonstrated by clinical features and confirmed by two separate
validated biochemical assays
(morning testosterone) before initiating therapy
with any testosterone replacement, including
Testim
®
1% treatment.
GERIATRICS (> 65 YEARS OF AGE):
There are limited controlled clinical study data supporting the use of
Testim
®
1% in the
geriatric
population (see
WARNINGS AND PRECAUTIONS
and
CLINICAL
TRIALS
).
PEDIATRICS (_< _18 YEARS OF AGE):
Testim
®
1% is not indicated for use in children < 18 years of age since safety
and efficacy have not
been established in this patient population (see
WARNINGS AND