NEBIDO INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Bayer (Pty) Ltd û Isando

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH 4,0 ml SOLUTION CONTAINS TESTOSTERONE UNDECANOATE 1000,0 mg

Authorization status:

Registered

Authorization date:

2005-08-04

Patient Information leaflet

PATIENT INFORMATION LEAFLET – NEBIDO SOLUTION FOR INJECTION
BAYER (PTY) LTD
DATE OF REVISION OF TEXT: 02 AUGUST 2022
CCDS09/042020/SA03/082022
Page
1
of
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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S5
NEBIDO 1000 MG / 4 ML SOLUTION FOR INJECTION
TESTOSTERONE UNDECANOATE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING NEBIDO.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, your
pharmacist, nurse or other health
care provider.
•
NEBIDO has been prescribed for you personally and you should not share
your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1. What NEBIDO is and what it is used for
2. What you need to know before you use NEBIDO
3. How to use NEBIDO
4. Possible side effects
5. How to store NEBIDO
6. Contents of the pack and other information
1.
WHAT NEBIDO IS AND WHAT IT IS USED FOR
NEBIDO contains testosterone, a male hormone, as the active
ingredient. NEBIDO is injected
into a muscle in
your body. There it can be stored and gradually released over a period
of time.
NEBIDO is used in adult men for testosterone replacement to treat
various health problems
caused by a lack of testosterone (male hypogonadism).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NEBIDO
DO NOT USE NEBIDO:
•
if you are allergic to testosterone undecanoate or any of the other
ingredients of NEBIDO
(see ‘What NEBIDO contains’.).
•
if you have certain types of cancers caused by testosterone or
suspected cancer of the
prostate or of the breast.
•
if you have or had a liver tumour.
•
if you have increased calcium levels in the blood accompanying
malignant tumours.
NEBIDO is not intended for use in women.
PATIENT INFORMATION LEAFLET – NEBIDO SOLUTION FOR INJECTION
BAYER (PTY) LTD
DATE OF REVISION OF TEXT: 02 AUGUST 2022
CCDS09/042020/SA03/082022
Page
2
of
7
WARNING AND PRECAUTIONS
TELL YOUR DOCTOR OR HEALTH CARE PROVIDER BEFORE BEING GIVEN THE
INJECTION:
A healthcare profes

Summary of Product characteristics

PROFESSIONAL INFORMATION – NEBIDO SOLUTION FOR INJECTION
BAYER (PTY) LTD
DATE OF REVISION OF TEXT: 02 AUGUST 2022
CCDS09/042020/SA03/082022
Page
1
of
9
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S5
1.
NAME OF THE MEDICINE
NEBIDO
1000 mg / 4 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule/vial contains 1000 mg testosterone undecanoate in a 4 ml
solution for injection (250 mg
testosterone undecanoate/ml).
Sugar free
For the full excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to yellowish-brown oily solution
4.
CLINICAL PARTICUARS
4.1
THERAPEUTIC INDICATIONS
Testosterone replacement in primary and secondary male hypogonadism.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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.
Start of treatment
Serum testosterone levels should be measured before the start of
treatment. The first injection interval may
be reduced to a minimum of 6 weeks. With this loading dose,
steady-state levels will be reached quickly.
Individualisation of treatment
It is advisable to occasionally measure testosterone serum levels at
the end of an injection interval. Serum
levels below normal range would indicate the need for a shorter
injection interval. In the case of high serum
levels, an extension of the injection interval may be considered. The
injection interval should remain within
the recommended range of 10 to 14 weeks.
PROFESSIONAL INFORMATION – NEBIDO SOLUTION FOR INJECTION
BAYER (PTY) LTD
DATE OF REVISION OF TEXT: 02 AUGUST 2022
CCDS09/042020/SA03/082022
Page
2
of
9
SPECIAL POPULATIONS
_Paediatric population _
NEBIDO is not indicated for use in children and adolescents, and it
has not been clinically evaluated in males
under 18 years of age (see section 4.4).
_Geriatric patients_
Limited data do not suggest the need for a dosa