Androderm

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Testosterone 1.41%{relative} (12.2mg/system);  

Dostupné z:

Teva Pharma (New Zealand) Limited

INN (Medzinárodný Name):

Testosterone 1.41% w/v (12.2mg/system)

Dávkovanie:

12.2 mg

Forma lieku:

Transdermal patch

Zloženie:

Active: Testosterone 1.41%{relative} (12.2mg/system)   Excipient: Ethanol Glycerol Glyceryl mono-oleate Carbomer copolymer (Type B) Methyl laurate Purified water Sodium hydroxide

Počet v balení:

Sachet, laminate, 30 patches

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

Productos Quimicos Naturales SA de CV

Terapeutické indikácie:

Androderm® is indicated for testosterone replacement therapy for confirmed testosterone deficiency in males.

Prehľad produktov:

Package - Contents - Shelf Life: Sachet, laminate, - 30 patches - 24 months from date of manufacture stored at or below 25°C - Sachet, laminate, - 60 patches - 24 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

1995-08-17

Príbalový leták

Androderm NZ CMI – Version 4.0
CONSUMER MEDICINE INFORMATION
ANDRODERM
®
TESTOSTERONE
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about Androderm
®
. It does not contain all
the available information. It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
possible risks of you
using Androderm
®
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE TALK TO YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT ANDRODERM
®
IS USED FOR
Androderm
®
is used to replace testosterone in males when the body is unable to
produce
enough of its own. Testosterone is a hormone that is necessary for the
normal development
and maintenance of male reproductive tissues and other characteristic
male traits.
Androderm
®
is a testosterone transdermal delivery patch. This means that when the
patch is
applied to the skin, the testosterone passes from the patch, through
the skin and into the
bloodstream.
The testosterone in Androderm
®
is identical to the naturally occurring testosterone present in
the body.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
This medicine is not expected to affect your ability to drive a car or
operate machinery.
There is not enough information to recommend the use of this medicine
for children below the
age of 15 years.
BEFORE YOU USE ANDRODERM
®
_WHEN YOU MUST NOT USE IT_
DO NOT USE ANDRODERM
®
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing testosterone
•
any of the ingredients listed at the end of this leaflet.
Androderm NZ CMI – Version 4.0
Symptoms of an allergic reaction may include shortness of breath,
wheezing or difficulty
breathing; swelling of the face, lips, tongue or other pa

Súhrn charakteristických

Teva Pharma New Zealand
Version 9.0
Page 1 of 9
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
ANDRODERM® (testosterone) 12.2mg Transdermal Patch.
ANDRODERM® (testosterone) 24.3mg Transdermal Patch.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Testosterone is a white crystalline powder, or colourless or
yellowish-white crystals, practically
insoluble in water, freely soluble in alcohol and in methylene
chloride, practically insoluble in fatty
oils.
Androderm® provides continuous delivery of testosterone for 24 hours
following application to
intact, non-scrotal skin (e.g. back, abdomen, thighs, upper arms).
Two Strengths of Androderm® Transdermal Patches are available which
deliver _in vivo_ 2.5 mg or 5
mg of testosterone per day across skin of average permeability.
The Androderm® 2.5 mg/day Transdermal Patch has a 7.5 cm
2
active surface area and contains 12.2
mg testosterone USP. The Androderm® 5 mg/day Transdermal Patch has a
15 cm
2
active surface
area and contains 24.3 mg testosterone USP.
Excipients with known effect: ethanol
For the full list of excipients, see SECTION 6.1.
3 PHARMACEUTICAL FORM
Androderm® is a transdermal drug delivery system consisting of a
self-adhesive patch surrounding a
central drug reservoir of testosterone dissolved in an alcohol-based
gel.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Androderm® is indicated for testosterone replacement therapy for
confirmed testosterone
deficiency in males.
4.2
DOSE AND METHOD OF ADMINISTRATION
The usual dose is one Androderm® 5 mg/day transdermal patch (or two
2.5 mg/day patches)
applied nightly (approximately 10.00pm) and worn for 24 hours,
providing approximately 5 mg
testosterone per day.
The dose can be adjusted up to 7.5 mg/day (i.e., one 5 mg/day and one
2.5 mg/day patch or three
2.5 mg/day patches) nightly or down to 2.5 mg/day (i.e., one 2.5
mg/day patch) nightly depending
on the serum testosterone measured in the morning after the
application. Measurement of serum
testosterone should be repeated taking care to ensure proper patch
adhe