NEBIDO Solution

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Testosterone undecanoate

Dostupné z:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC kód:

G03BA03

Dávkovanie:

1000.0 mg/4 ml

Forma lieku:

SOLUTION, STERILE

Zloženie:

Testosterone undecanoate 1000.0 mg/4 ml

Spôsob podávania:

INTRAMUSCULAR

Typ predpisu:

Prescription Only

Výrobca:

Bayer AG (Berlin, Müllerstraße)

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2007-05-21

Príbalový leták

NEBIDO
1. NAME OF THE MEDICINAL PRODUCT
Nebido 1000 mg/4ml, solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule / vial contains 1000 mg testosterone undecanoate
(corresponding to 631.5mg testosterone) in a 4-ml solution for
injection (250mg testosterone undecanoate/ml).
For a full list of excipients, see section 6.1, “List of
excipients”.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, yellowish oily solution.
4. CLINICAL PARTICULARS
4.1 INDICATION(S)
Testosterone replacement therapy for male hypogonadism when
testosterone deficiency has been confirmed by clinical features and
biochemical tests (see section 4.4, “Special warnings and
precautions for use”).
4.2 DOSAGE AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION_
Solution for injection
_DOSAGE REGIMEN_
Nebido (1 ampoule / vial corresponding to 1000 mg testosterone
undecanoate) is injected every 10 to 14 weeks. Injections with this
frequency are capable of maintaining sufficient testosterone levels
and do not lead to accumulation.
The injections must be administered very slowly. Nebido is strictly
for intramuscular injection. Care should be taken to inject Nebido
deeply into the gluteal muscle following the usual precautions for
intramuscular administration. Special care must be given to avoid
intravasal injection. The contents of an ampoule or vial are to be
injected intramuscularly immediately after opening. See section 6.6
“Instructions for use/ handling” to avoid injury when opening. *
_Start of treatment_
Serum testosterone levels should be measured before start 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. *
_Maintenance and individualization of treatment_
The injection interval should be within the recommended range of

Súhrn charakteristických

Nebido / 1000 mg/4 ml Solution for injection / CCDS 10_Jan 2022
NEBIDO® 1000MG/4ML
SOLUTION FOR INJECTION
1. NAME OF THE MEDICINAL PRODUCT
Nebido 1000 mg/4ml, solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule / vial contains 1000 mg testosterone undecanoate
(corresponding to 631.5mg
testosterone) in a 4-ml solution for injection (250mg testosterone
undecanoate/ml).
For a full list of excipient(s), see section, “List of
excipients”.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless to yellowish-brown oily solution.
4. CLINICAL PARTICULARS
4.1 INDICATION(S)
Testosterone replacement therapy for male hypogonadism when
testosterone deficiency has been
confirmed by clinical features and biochemical tests (see section 4.4,
“Special warnings and
precautions for use”).
4.2 DOSAGE AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
Solution for injection
_DOSAGE REGIMEN_
Nebido (1 ampoule / vial corresponding to 1000 mg testosterone
undecanoate) is injected every
10 to 14 weeks. Injections with this frequency are capable of
maintaining sufficient testosterone
levels and do not lead to accumulation.
The injections must be administered very slowly. Nebido is strictly
for intramuscular injection.
Care should be taken to inject Nebido deeply into the gluteal muscle
following the usual
precautions for intramuscular administration. Special care must be
given to avoid intravasal
injection. The contents of an ampoule or vial are to be injected
intramuscularly immediately after
opening. See section “Instructions for use/ handling” to avoid
injury when opening.
-
_Start of treatment _
_ _
Serum testosterone levels should be measured before start 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
Nebido / 1