How

to

succ

essf

ully

adm

inis

ter

Neb

ido ®

Info

rmat

ion

for

hea

lth

care

pro

fess

ion

als

This

leafl

et p

rovi

des

info

rmat

ion

on

cer

tain

asp

ects

of N

ebid

o® a

dmin

istr

atio

n in

ord

er t

o

wid

en y

our

know

ledg

e on

eve

nts

that

mig

ht o

ccu

r du

rin

g or

aft

er t

he

Neb

ido®

inje

ctio

n

Bay

er P

harm

a A

GM

ülle

rstr

aße

178

1335

3 B

erlin

Ger

man

y

ww

w.b

ayer

.com

Chec

k fo

r co

ntra

indi

cati

ons

and

spec

ial w

arn

ings

acc

ordi

ng

to t

he

Prod

uct

In

form

atio

n/H

ealt

hca

re P

rofe

ssio

nal

Info

rmat

ion

Befo

re a

dmin

iste

rin

g th

e in

ject

ion

, ch

eck

the

pati

ent

for

any

cont

rain

dica

tion

s: a

ndr

ogen

-dep

ende

nt

carc

inom

a of

th

e pr

osta

te o

r of

th

e m

ale

mam

mar

y gl

and;

pas

t or

pre

sent

live

r tu

mou

rs; h

yper

sen

siti

vity

to

th

e ac

tive

su

bsta

nce

or

to a

ny

of t

he

exci

pien

ts. N

ebid

o® is

not

indi

cate

d fo

r u

se in

wom

en.

Neb

ido®

– t

he

lon

g-ac

tin

g te

stos

tero

ne

Neb

ido®

– p

repa

rin

g th

e in

ject

ion

Neb

ido®

(tes

tost

eron

e u

nde

can

oate

, TU

) is

a lo

ng-

acti

ng

test

oste

ron

e pr

epar

atio

n fo

r th

e tr

eatm

ent

of m

ale

hyp

ogon

adis

m c

onfi

rmed

by

clin

ical

sym

ptom

s an

d bi

och

emic

al t

ests

. Th

e in

tram

usc

ula

r in

ject

ion

form

s a

depo

t fr

om w

hic

h T

U is

gra

dual

ly re

leas

ed. A

s a

resu

lt, t

esto

ster

one

leve

ls o

f th

e pa

tien

t w

ill n

orm

alis

e an

d re

mai

n w

ith

in t

he

nor

mal

ran

ge fo

r 10

–14

wee

ks.

Do

not

refr

iger

ate

Han

dlin

g of

th

e vi

al

Glo

ves

shou

ld b

e w

orn

wh

ile re

mov

ing

the

plas

tic

cap

on t

he

vial

.

Ster

ilize

th

e ru

bber

mem

bran

eU

se a

n a

lcoh

ol w

ipe

to s

teri

lize

the

rubb

er

mem

bran

e w

hic

h is

now

exp

osed

bef

ore

w

ith

draw

ing

the

med

icat

ion

.

0203

X

Use

a 5

ml s

yrin

gePr

epar

atio

n o

f pa

tien

t

Nee

dle

size

s•

To w

ith

draw

th

e so

luti

on fr

om t

he

vial

, use

an

18G

(1.3

mm

) nee

dle

• Se

lect

th

e ap

prop

riat

e n

eedl

e si

ze a

ccor

din

g to

th

e pa

tien

t’s fa

t an

d m

usc

le m

ass

of t

he

glu

teal

regi

on

• Ex

pert

s re

com

men

d th

e u

se o

f a 2

0G (0

.9m

m),

21G

1 (0.8

mm

) or

22G

(0.7

mm

) nee

dle

to e

nsu

re a

slo

w

intr

amu

scu

lar

inje

ctio

n a

nd

depo

siti

on o

f Neb

ido®

Lay

the

pati

ent

dow

n in

a c

omfo

rtab

le p

osit

ion

• Th

e de

ep, i

ntra

mu

scu

lar

inje

ctio

n s

hou

ld b

e ad

min

iste

red

wit

h t

he

pati

ent

lyin

g do

wn

• Th

e be

d sh

ould

be

com

plet

ely

flat

an

d th

e pa

tien

t’s h

ands

sh

ould

be

kept

un

der

thei

r h

ead

• Yo

u s

hou

ld a

lso

rem

ind

the

pati

ent

to re

mai

n s

till

duri

ng

the

inje

ctio

n

Rela

x5m

lsy

ringe

0405

The

inje

ctio

n p

roce

ss –

ste

p-by

-ste

p

• A

s w

ith

all

oily

sol

uti

ons,

Neb

ido®

mu

st b

e in

ject

ed s

tric

tly

intr

amu

scu

larl

y an

d ve

ry s

low

ly

• It

is re

com

men

ded

to in

ject

Neb

ido®

ove

r ap

prox

imat

ely

2 m

inu

tes

• A

fter

sel

ecti

ng

the

inje

ctio

n s

ite,

cle

anse

th

e ar

ea w

ith

an

ant

isep

tic

• If

th

ere

is li

ttle

mu

scle

mas

s, y

ou m

ay n

eed

to p

inch

up

2 to

3 e

dges

of t

he

glu

teal

mu

scle

to

prov

ide

mor

e vo

lum

e an

d ti

ssu

e to

inse

rt t

he

nee

dle

• In

sert

th

e n

eedl

e in

to t

he

skin

at

a 90

° an

gle

to e

nsu

re it

is d

eepl

y em

bedd

ed in

th

e m

usc

le

• G

rasp

th

e ba

rrel

of t

he

syri

nge

firm

ly w

ith

on

e h

and.

Usi

ng

the

oth

er h

and,

pu

ll th

e pl

un

ger

back

to

aspi

rate

for

bloo

d

–

If b

lood

app

ears

, do

not

pro

ceed

wit

h t

he

inje

ctio

n. T

ake

the

nee

dle

out

of t

he

pati

ent

imm

edia

tely

an

d re

plac

e it

–

Car

efu

lly re

peat

th

e st

eps

for

inje

ctio

n

• If

no

bloo

d is

asp

irat

ed, h

old

the

nee

dle

posi

tion

to

avoi

d an

y m

ovem

ent

• A

pply

th

e in

ject

ion

ver

y sl

owly

by

depr

essi

ng

the

plu

nge

r ca

refu

lly a

nd

at a

con

stan

t ra

te u

ntil

all

the

med

icat

ion

is d

eliv

ered

(ide

ally

ove

r 2

min

ute

s)

• If

pos

sibl

e, u

se y

our

free

han

d to

man

ual

ly p

robe

or

chec

k fo

r de

pot

form

atio

n

• W

ith

draw

th

e n

eedl

e

Perf

orm

ing

the

inje

ctio

n

The

pref

erre

d si

te fo

r in

tram

usc

ula

r in

ject

ion

is t

he

glu

teu

s m

ediu

s m

usc

le lo

cate

d in

th

e u

pper

ou

ter

quad

rant

of t

he

butt

ock.

Car

e m

ust

be

take

n t

o pr

even

t th

e n

eedl

e fr

om h

itti

ng

the

supe

rior

gl

ute

al a

rter

y an

d sc

iati

c n

erve

. Neb

ido®

sh

ould

not

be

split

into

por

tion

s an

d it

sh

ould

nev

er b

e ad

min

iste

red

into

th

e u

pper

arm

or

the

thig

h.

At a 90

°an

gle

GLUTEUS

MED

IUS

GLU

TEU

SM

AX

IMU

S

SUPE

RIO

RG

LUTE

AL

ART

ERY

INFE

RIO

RG

LUTE

AL

ART

ERY

PIRF

ORM

IS

0607

The

pati

ent

shou

ld b

e ob

serv

ed d

uri

ng

and

imm

edia

tely

aft

er e

ach

inje

ctio

n o

f N

ebid

o® in

ord

er

to a

llow

for

earl

y re

cogn

itio

n o

f po

ssib

le s

ign

s an

d sy

mpt

oms

wh

ich

may

indi

cate

pu

lmon

ary

oily

m

icro

embo

lism

(PO

ME)

.

Reco

mm

ende

d tr

eatm

ent

sch

edu

leRi

sk m

anag

emen

t of

Neb

ido®

-tre

ated

pat

ient

s

Pulm

onar

y oi

ly m

icro

embo

lism

POM

E is

an

inje

ctio

n-b

ased

reac

tion

an

d is

pa

thop

hysi

olog

ical

ly re

late

d to

fat

embo

lism

sy

ndr

ome.

It c

an o

ccu

r fol

low

ing

dire

ct v

ascu

lar o

r ly

mph

ovas

cula

r del

iver

y of

oil-

base

d pr

epar

atio

ns,

w

hic

h th

en re

ach

the

lun

g fr

om v

enou

s ci

rcu

lati

on

and

righ

t h

eart

ou

tpu

t.

Pulm

onar

y m

icro

embo

lism

of o

ily s

olu

tion

s ca

n in

ra

re c

ases

lead

to s

ign

s an

d sy

mpt

oms

such

as:

cou

gh

(or u

rge

to c

ough

), dy

spn

oea,

mal

aise

, hyp

erh

idro

sis,

ch

est

pain

, diz

zin

ess,

par

aest

hes

ia, o

r syn

cope

.

Thes

e re

acti

ons

may

occ

ur d

uri

ng

or im

med

iate

ly

afte

r th

e in

ject

ion

an

d ar

e re

vers

ible

. Tre

atm

ent

is

usu

ally

su

ppor

tive

, e.g

. by

adm

inis

trat

ion

of

supp

lem

enta

l oxy

gen

.

Som

etim

es th

ese

sym

ptom

s m

ay b

e di

fficu

lt to

di

stin

guis

h fr

om a

n a

llerg

ic re

acti

on w

hic

h c

an o

ccu

r w

ith

use

of a

ny in

ject

able

pro

duct

.

Susp

ecte

d an

aphy

lact

ic re

acti

ons

afte

r Neb

ido®

in

ject

ion

hav

e be

en re

port

ed.

Neb

ido®

– t

he

prep

arat

ion

Neb

ido®

is a

n o

ily s

olu

tion

th

at c

onta

ins

1000

mg

TU d

isso

lved

in 4

ml c

asto

r oi

l.

As

wit

h a

ll oi

ly s

olu

tion

s, N

ebid

o® m

ust

be

inje

cted

str

ictl

y in

tram

usc

ula

rly

and

very

slo

wly

.

Intr

amu

scu

lar

inje

ctio

n o

f an

oil-

base

d pr

epar

atio

n re

quir

es s

peci

al c

are

to p

reve

nt

acci

dent

al, d

irec

t de

liver

y of

th

e oi

l-ba

sed

solu

tion

to

the

vasc

ula

r sy

stem

.

Neb

ido®

is in

ject

ed in

inte

rval

s of

10–

14 w

eeks

.

Star

tin

g tr

eatm

ent

Seru

m t

esto

ster

one

leve

ls s

hou

ld b

e m

easu

red

befo

re s

tart

an

d du

rin

g in

itia

tion

of t

reat

men

t. D

epen

din

g on

se

rum

tes

tost

eron

e le

vels

an

d cl

inic

al s

ympt

oms,

th

e fi

rst

inje

ctio

n in

terv

al m

ay b

e re

duce

d to

a m

inim

um

of

6 w

eeks

as

com

pare

d to

th

e re

com

men

ded

ran

ge o

f 10

to 1

4 w

eeks

for

mai

nten

ance

. Wit

h t

his

load

ing

dose

, su

ffici

ent

stea

dy s

tate

tes

tost

eron

e le

vels

may

be

ach

ieve

d m

ore

rapi

dly.

Mai

nten

ance

an

d in

divi

dual

isat

ion

of

trea

tmen

tA

fter

th

is “

load

ing

dose

”, fu

rth

er in

ject

ion

s sh

ould

be

give

n w

ith

in t

he

reco

mm

ende

d ra

nge

of 1

0–14

wee

ks.

Car

efu

l mon

itor

ing

of s

eru

m t

esto

ster

one

leve

ls is

requ

ired

du

rin

g m

aint

enan

ce o

f tre

atm

ent.

It is

adv

isab

le

to m

easu

re t

esto

ster

one

seru

m le

vels

regu

larl

y.

Mea

sure

men

ts s

hou

ld b

e pe

rfor

med

at

the

end

of a

n in

ject

ion

inte

rval

an

d cl

inic

al s

ympt

oms

con

side

red

for

indi

vidu

alis

atio

n o

f th

erap

y w

ith

Neb

ido®

. Th

ese

seru

m le

vels

sh

ould

be

wit

hin

th

e lo

wer

th

ird

of t

he

nor

mal

ra

nge

. Ser

um

leve

ls b

elow

nor

mal

ran

ge w

ould

indi

cate

th

e n

eed

for

a sh

orte

r in

ject

ion

inte

rval

. In

cas

e of

h

igh

ser

um

leve

ls a

n e

xten

sion

of t

he

inje

ctio

n in

terv

al m

ay b

e co

nsi

dere

d.

06

1830

Wee

ks o

f tr

eatm

ent

Mea

sure

men

t of

ser

um

tes

tost

eron

efo

r in

divi

dual

isat

ion

of

ther

apy

Load

ing

dose

12 w

eeks

12 w

eeks

6 w

eeks

0809

1011

Safe

ty m

onit

orin

g du

rin

g te

stos

tero

ne

repl

acem

ent

ther

apy

Peri

odic

ch

eck-

ups

du

rin

g lo

ng-

term

an

drog

en t

her

apy

are

reco

mm

ende

d fo

r pr

osta

te d

isea

se, h

aem

oglo

bin

, h

aem

atoc

rit

and

liver

fun

ctio

n t

ests

.

Pros

tate

saf

ety

Prio

r to

init

iati

on o

f tes

tost

eron

e th

erap

y, a

ll pa

tien

ts m

ust

un

derg

o a

deta

iled

pros

tate

ex

amin

atio

n (d

igit

al re

ctal

exa

min

atio

n a

nd

dete

rmin

atio

n o

f ser

um

PSA

) in

ord

er t

o

excl

ude

ris

k of

pre

-exi

stin

g pr

osta

tic

can

cer.

Aft

er s

tart

ing

test

oste

ron

e th

erap

y, c

aref

ul

and

regu

lar

mon

itor

ing

for

pros

tate

dis

ease

sh

ould

be

perf

orm

ed in

acc

orda

nce

wit

h

reco

mm

ende

d st

anda

rd o

f car

e m

eth

ods

(dig

ital

rect

al e

xam

inat

ion

an

d se

rum

PSA

) at

3–6

mon

ths,

at

12 m

onth

s an

d at

leas

t an

nu

ally

th

erea

fter

(tw

ice

year

ly in

eld

erly

pa

tien

ts a

nd

pati

ents

at

risk

).2

Hae

mat

ocri

t an

d h

aem

oglo

bin

Poly

cyth

aem

ia o

ccas

ion

ally

dev

elop

s du

rin

g te

stos

tero

ne

trea

tmen

t. T

her

efor

e, h

aem

atol

ogic

al a

sses

smen

t is

indi

cate

d be

fore

tre

atm

ent,

aft

er 3

–4 m

onth

s an

d 12

mon

ths

in t

he

firs

t ye

ar a

nd

then

an

nu

ally

th

erea

fter

. D

ose

adju

stm

ents

may

be

nec

essa

ry in

cas

e of

ele

vate

d h

aem

atoc

rit

and/

or h

aem

oglo

bin

.2

Neb

ido®

(Tes

tost

eron

e u

nde

can

oate

) EU

Ess

enti

al In

form

atio

nN

ebid

o 10

00 m

g/4

ml,

solu

tion

for

in

ject

ion

. Re

fer

to S

mPC

(da

te o

f re

visi

on:

Nov

embe

r 20

12)

befo

re p

resc

ribi

ng.

Com

posi

tion

: 4

ml

solu

tion

con

tain

ing

1000

mg

test

oste

ron

e u

nde

can

oate

as

acti

ve i

ngr

edie

nt

and

ben

zyl

ben

zoat

e an

d ca

stor

oil

as e

xcip

ien

ts.

Indi

cati

ons:

Tes

tost

eron

e re

plac

emen

t th

erap

y of

co

nfi

rmed

m

ale

hyp

ogon

adis

m.

Con

trai

ndi

cati

ons:

A

ndr

ogen

-dep

ende

nt

carc

inom

a of

th

e pr

osta

te o

r of

th

e m

ale

mam

mar

y gl

and;

pas

t or

pre

sen

t liv

er

tum

ours

; h

yper

sen

siti

vity

to

the

acti

ve s

ubs

tan

ce o

r to

an

y of

th

e ex

cipi

ents

. Sp

ecia

l war

nin

gs a

nd

prec

auti

ons:

Neb

ido

is n

ot r

ecom

men

ded

for

use

in c

hild

ren

an

d ad

oles

cen

ts. N

ebid

o is

not

indi

cate

d fo

r u

se in

wom

en. P

rior

to

test

oste

ron

e in

itia

tion

, all

pati

ents

mu

st u

nde

rgo

a de

taile

d ex

amin

atio

n in

ord

er t

o ex

clu

de a

ri

sk o

f pre

-exi

stin

g pr

osta

tic

can

cer.

Car

efu

l an

d re

gula

r mon

itor

ing

of t

he

pros

tate

gl

and

and

brea

st m

ust

be

perf

orm

ed.

The

follo

win

g la

bora

tory

par

amet

ers

shou

ld b

e ch

ecke

d pe

riod

ical

ly:

test

oste

ron

e, h

aem

oglo

bin

, h

aem

atoc

rit,

an

d liv

er f

un

ctio

n t

ests

. A

ndr

ogen

s m

ay a

ccel

erat

e th

e pr

ogre

ssio

n o

f su

b-cl

inic

al

pros

tati

c ca

nce

r an

d be

nig

n p

rost

atic

hyp

erpl

asia

. N

ebid

o sh

ould

be

use

d w

ith

ca

uti

on i

n c

ance

r pa

tien

ts a

t ri

sk o

f h

yper

calc

aem

ia.

Regu

lar

mon

itor

ing

of

seru

m c

alci

um

con

cen

trat

ion

s is

rec

omm

ende

d in

th

ese

pati

ents

. Be

nig

n a

nd

mal

ign

ant

liver

tu

mou

rs h

ave

been

rep

orte

d in

pat

ien

ts r

ecei

vin

g te

stos

tero

ne

repl

acem

ent

ther

apy.

In

pat

ien

ts s

uff

erin

g fr

om s

ever

e ca

rdia

c, h

epat

ic o

r re

nal

in

suff

icie

ncy

or

isch

aem

ic h

eart

dis

ease

, tre

atm

ent

wit

h t

esto

ster

one

may

cau

se

seve

re c

ompl

icat

ion

s ch

arac

teri

sed

by o

edem

a w

ith

or

wit

hou

t co

nge

stiv

e ca

rdia

c fa

ilure

. In

su

ch c

ase,

tre

atm

ent

mu

st b

e st

oppe

d im

med

iate

ly. T

he

limit

atio

ns

of

usi

ng

intr

amu

scu

lar i

nje

ctio

ns

in p

atie

nts

wit

h a

cqu

ired

or i

nh

erit

ed b

lood

clo

ttin

g ir

regu

lari

ties

alw

ays

hav

e to

be

obse

rved

. Neb

ido

shou

ld b

e u

sed

wit

h c

auti

on in

pa

tien

ts w

ith

epi

leps

y an

d m

igra

ine,

as

the

con

diti

ons

may

be

aggr

avat

ed. A

thle

tes

shou

ld b

e ad

vise

d th

at N

ebid

o co

nta

ins

an a

ctiv

e su

bsta

nce

wh

ich

may

pro

duce

a

posi

tive

rea

ctio

n i

n a

nti

-dop

ing

test

s. A

ndr

ogen

s ar

e n

ot s

uit

able

for

en

han

cin

g m

usc

ula

r de

velo

pmen

t in

hea

lth

y in

divi

dual

s or

for

incr

easi

ng

phys

ical

abi

lity.

As

wit

h a

ll oi

ly s

olu

tion

s, N

ebid

o m

ust

be

inje

cted

str

ictl

y in

tram

usc

ula

rly

and

very

sl

owly

(ove

r tw

o m

inu

tes)

. Pu

lmon

ary

mic

roem

bolis

m o

f oi

ly s

olu

tion

s ca

n in

rar

e ca

ses

lead

to s

ign

s an

d sy

mpt

oms

such

as

cou

gh, d

yspn

oea,

mal

aise

, hyp

erh

idro

sis,

ch

est p

ain

, diz

zin

ess,

par

aest

hes

ia, o

r syn

cope

. Th

ese

reac

tion

s m

ay o

ccu

r du

rin

g or

im

med

iate

ly a

fter

th

e in

ject

ion

an

d ar

e re

vers

ible

. Tre

atm

ent

is u

sual

ly s

upp

orti

ve,

e.g.

by

ad

min

istr

atio

n

of

supp

lem

enta

l ox

ygen

. U

nde

sira

ble

effe

cts:

M

ost

freq

uen

t u

nde

sira

ble

effe

cts:

acn

e an

d in

ject

ion

sit

e pa

in. S

usp

ecte

d an

aph

ylac

tic

reac

tion

s af

ter

Neb

ido

inje

ctio

n h

ave

been

rep

orte

d. A

ndr

ogen

s m

ay a

ccel

erat

e th

e pr

ogre

ssio

n o

f su

b-cl

inic

al p

rost

atic

can

cer

and

ben

ign

pro

stat

ic h

yper

plas

ia.

Oth

er c

omm

on a

dver

se d

rug

reac

tion

s (A

DRs

): p

olyc

yth

aem

ia, w

eigh

t in

crea

sed,

h

ot f

lush

, pr

osta

te s

peci

fic

anti

gen

in

crea

sed,

pro

stat

e ex

amin

atio

n a

bnor

mal

, be

nig

n p

rost

ate

hyp

erpl

asia

, in

ject

ion

sit

e re

acti

ons

(inje

ctio

n d

isco

mfo

rt, p

ruri

tus,

eryt

hem

a, h

aem

atom

a, i

rrit

atio

n a

nd

reac

tion

). U

nco

mm

on A

DRs

: H

aem

atoc

rit

incr

ease

d, r

ed b

lood

cel

l cou

nt

incr

ease

d, h

aem

oglo

bin

incr

ease

d, h

yper

sen

siti

vity

, in

crea

sed

appe

tite

, gl

ycos

ylat

ed h

aem

oglo

bin

in

crea

sed,

hyp

erch

oles

tero

laem

ia,

bloo

d tr

igly

ceri

des

incr

ease

d, b

lood

ch

oles

tero

l in

crea

sed,

dep

ress

ion

, em

otio

nal

di

sord

er,

inso

mn

ia,

rest

less

nes

s,

aggr

essi

on,

irri

tabi

lity,

h

eada

che,

m

igra

ine,

tr

emor

, car

diov

ascu

lar d

isor

der,

hyp

erte

nsi

on, d

izzi

nes

s, b

ron

chit

is, s

inu

siti

s, c

ough

, dy

spn

oea,

sn

orin

g, d

ysph

onia

, di

arrh

oea,

nau

sea,

liv

er f

un

ctio

n t

est

abn

orm

al,

aspa

rtat

e am

inot

ran

sfer

ase

incr

ease

d, a

lope

cia,

ery

them

a, r

ash

, pr

uri

tus,

dry

sk

in,

arth

ralg

ia,

pain

in

ext

rem

ity,

mu

scle

dis

orde

rs,

mu

scu

losk

elet

al s

tiff

nes

s,

bloo

d cr

eati

ne

phos

phok

inas

e in

crea

sed,

uri

ne

flow

dec

reas

ed, u

rin

ary

rete

nti

on,

uri

nar

y tr

act

diso

rder

, n

octu

ria,

dy

suri

a,

pros

tati

c in

trae

pith

elia

l n

eopl

asia

, pr

osta

te in

dura

tion

, pro

stat

itis

, pro

stat

ic d

isor

der,

libid

o ch

ange

s, t

esti

cula

r pa

in,

brea

st in

dura

tion

, bre

ast

pain

, gyn

aeco

mas

tia,

oes

trad

iol i

ncr

ease

d, t

esto

ster

one

incr

ease

d, f

atig

ue,

ast

hen

ia,

hyp

erh

idro

sis.

Pu

lmon

ary

mic

roem

bolis

m o

f oi

ly

solu

tion

s ca

n in

rar

e ca

ses

lead

to

sign

s an

d sy

mpt

oms

such

as

cou

gh, d

yspn

oea,

m

alai

se,

hyp

erh

idro

sis,

ch

est

pain

, di

zzin

ess,

par

aest

hes

ia,

or s

ynco

pe.

Oth

er

know

n A

DRs

of

test

oste

ron

e-co

nta

inin

g pr

epar

atio

ns:

ner

vou

snes

s, h

osti

lity,

sl

eep

apn

oea,

var

iou

s sk

in r

eact

ion

s in

clu

din

g se

borr

hoe

a, in

crea

sed

freq

uen

cy o

f er

ecti

ons,

rar

e ca

ses

of p

ersi

sten

t, pa

infu

l ere

ctio

ns

(pri

apis

m),

in v

ery

rare

cas

es

jau

ndi

ce. T

her

apy

wit

h h

igh

dos

es o

f te

stos

tero

ne

com

mon

ly r

ever

sibl

y in

terr

upt

s or

red

uce

s sp

erm

atog

enes

is, t

her

eby

redu

cin

g th

e si

ze o

f th

e te

stic

les.

Hig

h-d

osed

or

lon

g-te

rm a

dmin

istr

atio

n o

f tes

tost

eron

e oc

casi

onal

ly in

crea

ses

the

occu

rren

ces

of w

ater

ret

enti

on a

nd

oede

ma.

Pos

olog

y an

d m

eth

od o

f ad

min

istr

atio

n:

Neb

ido

is i

nje

cted

eve

ry 1

0 to

14

wee

ks.

Neb

ido

is s

tric

tly

for

intr

amu

scu

lar

inje

ctio

n

and

mu

st b

e ad

min

iste

red

very

slo

wly

(ov

er t

wo

min

ute

s). C

are

shou

ld b

e ta

ken

to

in

ject

Neb

ido

deep

ly i

nto

th

e gl

ute

al m

usc

le f

ollo

win

g th

e u

sual

pre

cau

tion

s fo

r in

tram

usc

ula

r ad

min

istr

atio

n. S

peci

al c

are

mu

st b

e ta

ken

to

avoi

d in

trav

asal

in

ject

ion

. Th

e fi

rst

inje

ctio

n i

nte

rval

may

be

redu

ced

to a

min

imu

m o

f 6

wee

ks.

Neb

ido

is n

ot i

ndi

cate

d fo

r u

se i

n c

hild

ren

an

d ad

oles

cen

ts a

nd

it h

as n

ot b

een

ev

alu

ated

clin

ical

ly i

n m

ales

un

der

18 y

ears

of

age.

Leg

al C

ateg

ory:

Med

icin

al

prod

uct

su

bjec

t to

med

ical

pre

scri

ptio

n.

Mar

keti

ng

Au

thor

isat

ion

hol

der:

Bay

er

Phar

ma

AG

, 133

53 B

erlin

, Ger

man

y. F

or f

urt

her

det

ails

con

tact

you

r lo

cal

Baye

r Ph

arm

a or

gan

isat

ion

. Ver

sion

: 16

July

201

2.

Refe

renc

es1.

Sar

tori

us

G e

t al

. Asi

an J

And

rol 2

010;

12(2

):22

7–23

3.2.

Wan

g C

et

al. E

ur U

rol 2

009;

55:1

21–1

30.

Dat

e of

pre

para

tion

: Ju

ne

2013

G.G

M.M

H.0

3.20

13.0

198

Esse

ntia

l Pre

scri

bin

g In

form

atio

n

Any

sus

pect

ed a

dver

se d

rug

reac

tions

can

be

repo

rted

to:

Med

icin

es A

utho

rity,

Pos

t-lic

ensi

ng D

irect

orat

e, 2

03, L

evel

3, R

ue D

'Arg

ens,

Gira

GR

136

8, M

ALT

A,

or a

t: ht

tp://

ww

w.m

edic

ines

auth

ority

.gov

.mt/a

drpo

rtal

Tele

phon

e N

umbe

r: +3

56 2

343

9000

O

rA

lfred

Ger

a &

Son

s Lt

d, T

riq il

-Mas

ar, Q

orm

i QR

M 3

217,

MA

LTA

,or

at:

pv@

alfre

dger

a.co

m

Tel

epho

ne N

umbe

r: +3

56 2

1446

205