ANDROGEL 50 MG

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

TESTOSTERONE

Verfügbar ab:

CTS LTD

ATC-Code:

G03BA03

Darreichungsform:

GEL

Zusammensetzung:

TESTOSTERONE 0.05 MG/SACHET

Verabreichungsweg:

TRANSDERMAL

Verschreibungstyp:

Required

Hergestellt von:

BESINS-INTERNATIONAL LABORATORIES, FRANCE

Therapiegruppe:

TESTOSTERONE

Therapiebereich:

TESTOSTERONE

Anwendungsgebiete:

Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Berechtigungsdatum:

2023-08-31

Gebrauchsinformation

لوحكلا ةبسن
ّ
نلأ ،ة
ّ
يلسانتلا ءاضعلأا ةقطنم ىلع نهدلا زوجي
لا
.ا
ً
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يعضوم ا
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ج
ّ
يهت ب
ّ
بست دق رضحتسملا يف ةعفترملا رضحتسملا
ّ
فجي ى
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تح رانلل ض
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رعتلا وأ ةراچيس لاعشإ زوجي لا
.ا
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مامت
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.طقف
ّ
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ةعباتملاو صوحفلا
ءدبلا لبق ةلماش ة
ّ
ي
ّ
بط صوحف ءارجلإ كهيجوتب بيبطلا موقيس
ءارجلإ ا
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ضيأ كهيجوت
ّ
متيس جلاعلا ةرتف للاخ .ءاودلا لامعتساب
نيت
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رم وأ
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لقلأا ىلع ةنسلا يف ةدحاو ة
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رم( ة
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يرود ة
ّ
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ّ
بط صوحف
ةئفلا وأ
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نسلا يف ةم
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.)رطخلا ةرئاد يف ةدوجوملا ة
ّ
ينا
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رهظت دقف مزلالا نم ربكأ ة
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أطخ ءاودلا علبب دلو ماق اذإ وأ ةطرفم
ةعرج تلوانت اذإ
رضحأو ىفشتسملا يف ئراوطلا ةفرغ ىلإ وأ
بيبطلا ىلإ ا
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.ءاودلا ة
ّ
وبع كعم
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ّ
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مك نهدب مقت لاف ،بولطملا تقولا يف لجلا
نهد تيسن اذإ
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يدايتعلاا تقولا يف ة
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يدايتعلاا ة
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بجي نم دكأتو قصل
ُ
ملا عجار !ةمتعلا يف ةيودلأا لوانت زوجي
لا ة
ّ
ي
ّ
بطلا تارا
ّ
ظنلا عض .ءاودلا اهيف لوانتت ةرم �

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT:
ANDROGEL, 50 mg, gel in unit-dose sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Testosterone 0.05 g per 5 g sachet
Excipients with known effect: Ethanol.
For the full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM: Gel
Transparent or slightly opalescent, colorless gel in sachet.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Testosterone replacement therapy for male hypogonadism when
testosterone deficiency has been
confirmed by clinical features and biochemical tests. (see 4.4 Special
warnings and special
precautions for use)
4.2 POSOLOGY AND ADMINISTRATION ROUTE
Posology
_Adults and elderly men _
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone)
applied once daily, at about the
same time, preferably in the morning. The daily dose should be
adjusted by the doctor depending on
the clinical or laboratory response in individual patients, not
exceeding 10 g of gel per day. The
adjustment of posology should be achieved by 2.5 g of gel steps.
Steady state plasma testosterone concentrations are reached
approximately on the 2
nd
day of
treatment by this medicine . In order to adjust the testosterone dose,
serum testosterone
concentrations must be measured in the morning before application from
the 3
rd
day on after starting
treatment (one week seems reasonable). The dose may be reduced if the
plasma testosterone
concentrations are raised above the desired level. If the
concentrations are low, the dosage may be
increased, not exceeding 10 g of gel per day.
_Paediatric population _
This medicine
is not indicated for use in children and has not been evaluated
clinically in males under
18 years of age.
Use in women
This medicine is not indicated for use in women.
Method of administration
Transdermal use.
The application should be administered by the patient himself, onto
clean, dry, healthy skin over
both shoulders, or both arms or abdomen.
After opening the sachet, the total content must be extracted from the
sachet and app