ANDROFEME 1 testosterone 1% w/v (10 mg/mL) cream tube

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

testosterone, Quantity: 10 mg/mL

Disponibil de la:

Lawley Pharmaceuticals Pty Ltd

Forma farmaceutică:

Cream

Compoziție:

Excipient Ingredients: Almond oil; butylated hydroxytoluene; carbomer 940; cetomacrogol 1000; cetostearyl alcohol; citric acid; dl-alpha-tocopheryl acetate; trolamine; purified water; phenoxyethanol; propyl hydroxybenzoate; ethyl hydroxybenzoate; isobutyl hydroxybenzoate; butyl hydroxybenzoate; methyl hydroxybenzoate

Calea de administrare:

Topical

Unități în pachet:

50 mL

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

ANDROFEME 1 is indicated for the treatment of hypoactive sexual desire dysfunction (HSDD) in postmenopausal women. Therapeutic intervention with ANDROFEME 1 should only be initiated in women following failure of appropriate education and correction of modifiable biopsychosocial factors (which may include neuroendocrine imbalance, physical ill health or disease, interpersonal difficulties, psychological distress or specific cultural or religious beliefs), according to the International Society for the Study of Women?s Sexual Health (ISSWSH) process of care (see Figure 1).

Rezumat produs:

Visual Identification: White soft cream with faint odour of emulsifying wax with a fine dispersion of testosterone particles; Container Type: Tube; Container Material: Other plastic laminate/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2020-11-23

Prospect

ANDROFEME
®
1
- January 2021
1
ANDROFEME® 1
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ANDROFEME 1?
ANDROFEME 1 contains the active ingredient testosterone. ANDROFEME 1
is used to treat postmenopausal women with
hypoactive sexual desire dysfunction. For more information, see
Section 1. Why am I using ANDROFEME 1? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ANDROFEME 1?
Do not use if you have ever had an allergic reaction to testosterone,
tree nuts (almond oil) or any of the ingredients listed at the
end of the CMI. Do not use if you have or have had any of the
following:
•
breast cancer or any other cancer which your doctor has described as
being caused or stimulated by androgen
•
kidney disease known as nephrotic syndrome
•
blockage of a blood vessel by a blood clot (thromboembolism)
•
high calcium levels in the blood (hypercalcaemia)
Do not use if you: still menstruate; are pregnant or breastfeeding;
are a child.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use ANDROFEME 1? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ANDROFEME 1 and affect how it works.
A list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE ANDROFEME 1?
•
The usual starting dose is 0.5 mL (5 mg) of cream by measured
applicator per day.
•
Detailed instructions on how to safely use the applicator syringe and
cream can be found in Section 4. How do I use
ANDROFEME 1? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ANDROFEME 1?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ANDROFEME 1. Keep all
appointments to monitor your progress.
•
Contact your doctor

Caracteristicilor produsului

AndroFeme1-pi-aust--November-2020
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION – ANDROFEME
® 1
(TESTOSTERONE) 1% W/V CREAM
1
NAME OF THE MEDICINE
Testosterone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ANDROFEME 1 contains 1% w/v testosterone (10 mg testosterone per 1
mL).
Contains tree nut products (almond oil) and hydroxybenzoates.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Cream.
ANDROFEME 1 is a white, opaque, oil-in-water cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ANDROFEME 1 is indicated for the treatment of hypoactive sexual desire
dysfunction
(HSDD) in postmenopausal women.
Therapeutic intervention with ANDROFEME 1 should only be initiated in
women following
failure of appropriate education and correction of modifiable
biopsychosocial factors (which
may include neuroendocrine imbalance, physical ill health or disease,
interpersonal
difficulties, psychological distress or specific cultural or religious
beliefs), according to the
International Society for the Study of Women’s Sexual Health
(ISSWSH) process of care
(see Figure 1).
AndroFeme1-pi-aust--November-2020
Page 2 of 16
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended starting dose is 5 mg testosterone (0.5 mL) applied
once daily, at
approximately the same time each day, to either the upper outer thigh
or buttock.
If no improvement in symptoms is seen within 3 months and if the
testosterone concentration
is within the premenopausal reference range a dose increase up to 10
mg testosterone
(1.0 mL) daily can be used with follow up clinical and biochemical
monitoring. This dose
should only rarely be exceeded. (See Monitoring)
Clinical trials have shown that there is a four to eight-week time lag
between starting
testosterone treatment and an improvement in sexual motivation. If
there is no improvement
in symptoms after 6 months of continuous therapy, treatment should be
discontinued and
alternative options be considered.
METHOD OF ADMINISTRATION
The patient should be directed to