Reandron 1000

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Testosterone undecylate 1000mg;  

Dostopno od:

Bayer New Zealand Limited

INN (mednarodno ime):

Testosterone undecylate 1000 mg

Odmerek:

1000 mg/4mL

Farmacevtska oblika:

Solution for injection

Sestava:

Active: Testosterone undecylate 1000mg   Excipient: Benzyl benzoate Castor oil

Enote v paketu:

Ampoule, glass, 4 mL - type I glass ampoule 1 x 1,000 mg dose, 1 dose unit

Razred:

Prescription

Tip zastaranja:

Prescription

Izdeluje:

Bayer AG

Terapevtske indikacije:

Testosterone replacement in primary and secondary male hypogonadism

Povzetek izdelek:

Package - Contents - Shelf Life: Ampoule, glass, 4 mL - type I glass ampoule 1 x 1,000 mg dose - 1 dose units - 5 years from date of manufacture stored at or below 30°C protect from light - Vial, glass, Amber Type 1 with bromobutyl gray stopper with foil clad ETFE - 1 dose units - 60 months from date of manufacture stored at or below 30°C protect from light

Datum dovoljenje:

2006-08-14

Navodilo za uporabo

REANDRON
®
1000
1
RESTRICTED
REREANDRON® 1000
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 REANDRON?
REANDRON contains the active ingredient
testosterone undecanoate
. REANDRON is used to replace the body’s testosterone
in male hypogonadism a condition where there are low levels of
testosterone in the body.
For more information, see Section 1. Why am I using REANDRON?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE REANDRON?
Do not use if you have ever had an allergic reaction to REANDRON or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS SUCH AS
DIABETES, FLUID RETENTION, BLEEDING DISORDERS, HIGH BLOOD
PRESSURE, PROSTATE TUMOURS, EPILEPSY OR IF YOU TAKE ANY OTHER
MEDICINES
For more information, see Section 2. What should I know before I use
REANDRON?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with REANDRON and affect how it works.
Let your doctor know if you take medicines to thin
the blood, control blood sugar levels, suppress the immune system, for
pain and inflammation or for treatment of sleeping
problems and nervousness.
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 REANDRON?
REANDRON is injected by your healthcare professional every 10-14
weeks.
More instructions can be found in Section 4. How do I use REANDRON?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING REANDRON?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
REANDRON.
•
Keep all of your doctor’s appointments. Your doctor may monitor your
blood pressure, examine
your prostate and conduct other tests from time to time.
LOOKING AFTER
YOUR MEDICINE
•
Store it in a cool dry place away from moisture, heat or sunlight
where the temperature stays below
30°C
For more informati

Lastnosti izdelka

Reandron 1000 DS VX3.0; CCDS10
DATA SHEET
1.
REANDRON
® 1000 (1000 MG/4 ML SOLUTION FOR INJECTION)
Reandron 1000, 1000 mg/ 4 mL solution for injection
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule/vial contains 1000 mg testosterone undecanoate
(equivalent to 631.5 mg
testosterone) in a 4 mL solution for injection (250 mg testosterone
undecanoate/mL).
Each mL solution for injection contains 250 mg testosterone
undecanoate corresponding to
157.9 mg testosterone.
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Reandron 1000 is a clear, colourless to yellowish-brown oily solution
for injection.
Testosterone undecanoate is a white or off-white crystalline
substance.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Testosterone replacement in primary and secondary male hypogonadism.
4.2
DOSE AND METHOD OF ADMINISTRATION
4.2.1
DOSE
Reandron 1000 (1 ampoule/vial equivalent to 1000 mg testosterone
undecanoate) is injected
every 10 to 14 weeks for testosterone replacement, where testosterone
deficiency has been
confirmed by clinical features and biochemical tests. Injections with
this frequency are
capable of maintaining sufficient testosterone levels and do not lead
to accumulation.
4.2.1.1 START OF TREATMENT
Serum testosterone levels should be measured before start of treatment
and during initiation
of treatment. Depending on serum testosterone levels and clinical
symptoms, the first
injection interval may be reduced to a minimum of 6 weeks as compared
to the
recommended range of 10 to 14 weeks for maintenance. With this loading
dose, sufficient
steady-state testosterone levels may be achieved more rapidly.
4.2.1.2 INDIVIDUALISATION OF TREATMENT
The injection interval should remain within the recommended range of
10 to 14 weeks. It is
advisable to measure and monitor testosterone serum levels regularly,
particularly if the
dosage regimen is changed or if there is clinical concern about the
adequacy or
excessiveness of testosterone replacement. Measurements should be
performed at