REANDRON

Main information

  • Trade name:
  • REANDRON 1000 testosterone undecanoate 1000 mg/4 mL injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • REANDRON 1000 testosterone undecanoate 1000 mg/4 mL injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213942
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213942

REANDRON 1000 testosterone undecanoate 1000mg in 4mL oily solution for injection vial

ARTG entry for

Medicine Registered

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072

Australia

ARTG Start Date

7/01/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. REANDRON 1000 testosterone undecanoate 1000 mg/4 mL injection vial

Product Type

Single Medicine Product

Effective date

9/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Testosterone replacement in primary and secondary male hypogonadism.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Coloured 5 Years

Store below 30

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

4 mL

(S4) Prescription Only Medicine

Components

1. REANDRON 1000 testosterone undecanoate 1000 mg/4 mL injection vial

Dosage Form

Injection

Route of Administration

Intramuscular

Visual Identification

Clear, yellowish oily solution.

Active Ingredients

testosterone undecanoate

1000 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:43:49 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

REANDRON

1000 CMI

REANDRON

®

1000

(Ree·ANNE·dron)

testosterone undecanoate

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some

common questions about

Reandron. It does not contain all

the available information.

It does not take the place of

talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has

weighed the risks of you using

Reandron against the benefits

they expect it will have for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine.

You may need to read it again.

WHAT REANDRON IS

USED FOR

Male hypogonadism is the

condition where there are low

levels of testosterone in the

body.

Reandron is used to replace the

body’s natural hormone

testosterone when not enough is

made by the body.

Testosterone is a natural male

hormone, known as an androgen,

which controls normal sexual

development in men.

Testosterone is essential for the

development and maintenance of

the male reproductive organs as

well as other male

characteristics, such as hair

growth, deep voice, sexual drive,

muscle mass and body fat

distribution.

Reandron contains testosterone

undecanoate, as the active

ingredient. Reandron is injected

into a location in your body

(buttock muscle) where it can be

stored and gradually released

over a period of time.

Ask your doctor if you have

any questions about why this

medicine has been prescribed

for you.

Your doctor may have prescribed

it for another reason.

BEFORE YOU ARE

GIVEN REANDRON

When you must not be

given it

Do not use Reandron if you

have or are suspected to have:

prostate cancer

male breast cancer

high blood calcium levels

associated with tumours

past or present liver tumours

Do not use Reandron if you are

a woman.

Do not use Reandron if you

have an allergy to:

testosterone undecanoate

any of the ingredients listed

at the end of this leaflet

Some of the symptoms of an

allergic reaction may include:

shortness of breath, wheezing

or difficulty breathing

swelling of the face, lips,

tongue or other parts of the body

rash, itching or hives on the

skin.

It is not recommended to give

this medicine to a child under

the age of 18 years.

Do not use this medicine after

the expiry date printed on the

carton and vial.

The expiry date is printed on the

carton and on each vial after

“EXP” (e.g. 11 18 refers to

November 2018). The expiry

date refers to the last day of that

month. If it has expired return it

to your pharmacist for disposal.

Do not use this medicine if the

packaging is torn or shows

signs of tampering.

If the packaging is damaged,

return it to your pharmacist for

disposal.

If you are not sure whether

you should start using this

medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have

allergies to any other

medicines, foods, preservatives

or dyes.

Tell your doctor if you have, or

have had, any of the following

medical conditions:

diabetes

a bleeding disorder

thrombophilia (an

abnormality of blood

coagulation that increases

the risk of thrombosis -

blood clots in blood vessels)

REANDRON

1000 CMI

a tendency to retain fluid

(signs may include swollen

feet or ankles)

high blood pressure or if you

are being treated for high

blood pressure as

testosterone may cause a rise

in blood pressure

epilepsy

migraines

sleep apnoea (abnormal

pauses in breathing during

sleep)

If you are suffering from severe

heart, liver or kidney disease,

treatment with Reandron may

cause severe complications in the

form of water retention in your

body and sometimes

accompanied by (congestive)

heart failure. Please inform your

doctor immediately if you notice

any signs of water retention.

Reandron may increase the rate

of progression of prostatic

tumours including benign

prostatic hypertrophy

(enlargement of the prostate

gland) and/or prostate cancer.

Before treatment, your doctor

will conduct tests to ensure that

you do not have prostate cancer.

People using testosterone

replacement over long periods of

time may develop an abnormal

increase in the number of red

blood cells in the blood

(polycythaemia). Your doctor

may organise regular blood

counts to monitor this.

If you have not told your

doctor about any of the above,

tell them before you are given

Reandron.

Athletes should note that the

active substance testosterone

undecanoate may produce a

positive reaction in anti-doping

tests.

Use of androgens for reasons

other than what your doctor

prescribed carries a serious health

risk and is strongly discouraged.

Taking other medicines

Tell your doctor or pharmacist

if you are taking any other

medicines, including any that

you get without a prescription

from your pharmacy,

supermarket or health food

shop.

Some medicines and Reandron

may interfere with each other.

These include:

oral anticoagulants, ‘blood

thinning’ medications to treat

or prevent blood clots

medicines used to control

blood sugar levels in

diabetes

oxyphenbutazone, a

medicine used to treat pain

and inflammation

cyclosporin, a medicine used

to suppress the immune

system

barbiturates, medicines used

to treat nervousness and

sleeping problems

These medicines may be affected

by Reandron or may affect how

well it works. You may need to

use different amounts of your

medicine, or you may need to

take different medicines. Your

doctor will advise you.

Your doctor and pharmacist have

more information on medicines

to be careful with or avoid while

using this medicine.

HOW REANDRON IS

GIVEN

Follow all directions given to

you by your doctor or

pharmacist carefully.

They may differ from the

information contained in this

leaflet.

If you do not understand the

instructions printed on the

pharmacist label, ask your

doctor or pharmacist for help.

How much is given

Reandron (1 ampoule/vial

corresponding to 1000 mg

testosterone undecanoate) will be

injected by your healthcare

professional every 10-14 weeks.

At the start of treatment your

doctor will measure your blood

testosterone levels. Depending

on the results, the second

injection may be given before 10

weeks. This is so that the

necessary testosterone levels can

be reached more quickly.

How it is given

The injection will be

administered very slowly into

your buttock muscle by your

doctor.

If you are given too much

(overdose)

As Reandron is given to you

under the supervision of your

doctor, it is very unlikely that you

will receive too much. However

if you experience any side effects

after being given it, tell your

doctor immediately. Side effects

such as irritability, nervousness,

weight gain, or prolonged or

frequent erections may indicate

the need for dosage adjustment.

Immediately telephone the

Poisons Information Centre on

13 11 26 for advice, or go to

Accident and Emergency at the

nearest hospital, if you think

that you or anyone else may

have been given too much

REANDRON

1000 CMI

Reandron. Do this even if there

are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

WHILE YOU ARE

RECEIVING

REANDRON

Things you must do

If you are about to be started

on any new medicine, remind

your doctor and pharmacist

that you are using Reandron.

Tell any other doctors,

dentists, and pharmacists who

treat you that you are using

this medicine.

Keep all of your doctor’s

appointments.

Reandron helps control the

symptoms of your condition, but

does not cure it. Therefore, your

doctor must administer Reandron

every 10 – 14 weeks.

Your doctor may monitor your

blood pressure, examine your

prostate and conduct other tests

from time to time, particularly if

you are elderly. This is to make

sure the medicine is working and

to check for unwanted side

effects.

SIDE EFFECTS

Tell your doctor or pharmacist

as soon as possible if you do

not feel well while you are

using Reandron.

All medicines can have side

effects. Sometimes they are

serious, most of the time they are

not. You may need medical

attention if you get some of the

side effects.

Do not be alarmed by the list of

possible side effects.

You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

High doses of Reandron may

affect sperm cell development

(spermatogenesis), which

reduces the size of the testes.

This is reversible once treatment

is stopped.

Tell you doctor if you notice any

of the following and they worry

you:

weight gain

acne

enlarged prostate

hot flushes

injection site reactions such

as pain or discomfort,

itching, bruising, redness or

irritation

These are the most common side

effects of Reandron.

Tell your doctor as soon as

possible if you notice any of the

following:

depression, irritability or

aggression

The above list includes serious

side effects that may require

urgent medical attention.

Tell your doctor immediately, or

go to the Accident and Emergency

department at your nearest

hospital if you notice any of the

following:

weakness, tiredness, headache,

light-headedness

signs of allergy such as rash,

swelling of the face, lips,

mouth, throat or other parts

of the body, shortness of

breath, wheezing or trouble

breathing

coughing, increased

sweating, chest pain, feeling

faint

yellowing of the skin and

eyes, also called jaundice

unwanted frequent or

prolonged and painful

erections

severe stomach pain or

tenderness which do not

disappear within a short time

The above list includes very

serious side effects. You may

need urgent medical attention or

hospitalisation.

Tell your doctor or pharmacist

if you notice anything that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

AFTER RECEIVING

REANDRON

Storage

Keep it where children cannot

reach it.

A locked cupboard at least one-

and-a half metres above the

ground is a good place to store

medicines.

Store Reandron in a cool dry

place where the temperature

stays below 30

C.

Do not store it or any other

medicine in the bathroom, near

a sink, or on a window-sill.

Do not leave it in the car.

Heat and dampness can destroy

some medicines.

Disposal

If your doctor tells you to stop

using this medicine or the

expiry date has passed, ask

your pharmacist what to do

with any medicine that is left

over.

REANDRON

1000 CMI

Return any unused medicine to

your pharmacist.

PRODUCT

DESCRIPTION

What it looks like

Reandron is a clear, yellowish

oily solution contained in a 5 mL

glass ampoule or 6 mL glass vial.

Ingredients

Active ingredient:

Reandron 1000 – 1000 mg

testosterone undecanoate per

ampoule/vial

Inactive ingredients:

benzyl benzoate

castor oil

Supplier

Bayer Australia Ltd

ABN 22 000 138 714

875 Pacific Highway

Pymble NSW 2073

Bayer New Zealand Limited

3 Argus Place, Hillcrest,

North Shore

Auckland 0627

Australian Registration

Number

Reandron 1000 (ampoule) –

AUST R 106946

Reandron 1000 (vial) – AUST R

213942

Date of preparation

July 2017

See TGA website

(www.ebs.tga.gov.au

) for latest

Australian Consumer Medicine

Information.

See MEDSAFE website

(www.medsafe.govt.nz

) for latest

New Zealand Consumer

Medicine Information.

® Registered trademark of the

Bayer Group, Germany

© Bayer Australia Ltd

All rights reserved

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