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IMIPENEM/CILASTATIN 500MG/500MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): CILASTATIN SODIUM / IMIPENEM MONOHYDRATE

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Package leaflet:
Information for the user
Imipenem/Cilastatin 500 mg/500 mg
Powder for Solution for Infusion
imipenem/cilastatin
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
ee t is lea et ou ma need to read it again
ou a e urt er uestions, as our doctor or armacist
is medicine as been rescribed or ou onl
o not ass it on
to ot ers t ma arm t em, e en i t eir signs o illness are t e
same as ours
ou get an side e ects, tal to our doctor or armacist
is
includes an ossible side e ects not listed in t is lea et
What is in this leaflet:
at mi enem ilastatin is and
at it is used or
at ou need to no be ore ou use mi enem ilastatin
o to use mi enem ilastatin
ossible side e ects
o to store mi enem ilastatin
ontents o t e ac and ot er in ormation

1. What Imipenem/Cilastatin is and what it is used for
mi enem ilastatin belongs to a grou o medicines called carba enem
antibiotics t ills a ide range o bacteria germs t at cause in ections
in arious arts o t e bod in adults and c ildren one ear o age and
abo e

Treatment
our doctor as rescribed mi enem ilastatin because ou a e one or
more o t e ollo ing t es o in ection
om licated in ections in t e abdomen
n ection a ecting t e lungs neumonia
n ections t at ou can catc during or a ter t e deli er
om licated urinar tract in ections
om licated s in and so t tissue in ections
mi enem ilastatin ma be used in t e management o atients it lo
ite blood cell counts,
o a e e er t at is sus ected to be due to a
bacterial in ection
mi enem ilastatin ma be used to treat bacterial in ection o t e blood
ic mig t be associated it a t e o in ection mentioned abo e

2. What you need to know before you use Imipenem/Cilastatin
Do not use Imipenem/Cilastatin
i ou are allergic
ot er ingredients o t
i ou are allergic
enicillins, ce alos

ersensiti e to imi enem, cilastatin or an o t e
is medicine listed in section
ersensiti e to ot er antibiotics suc as
orins, or carba enems

Warnings and precautions
al to our doctor be ore using mi enem ilastatin ell our doctor
about an medical condition ou a e or a e ad including
allergies to an medicines including antibiotics sudden li e t reatening
allergic reactions re uire immediate medical treatment
colitis or an ot er gastrointestinal disease
an central ner ous s stem disorders suc as locali ed tremors or
e ile tic sei ures
li er, idne or urinar roblems
ou ma de elo a ositi e test oombs test
ic indicates t e
resence o antibodies t at ma destro red blood cells our doctor
discuss t is it ou

ill

ell our doctor i ou are ta ing medicines called al roic acid or sodium
al roate see Other medicines and Imipenem/Cilastatin belo
Children
mi enem ilastatin is not recommended in c ildren less t an one ear o
age or c ildren it idne roblems

Other medicines and Imipenem/Cilastatin
ell our doctor or armacist i ou are ta ing, a e recentl ta en or
mig t ta e an ot er medicines
ell our doctor i
iral in ections

ou are ta ing ganciclo ir

ic is used to treat some

lso, tell our doctor i ou are ta ing al roic acid or sodium al roate
used to treat e ile s , bi olar disorder, migraine, or sc i o renia or an
blood t inners suc as ar arin
our doctor ill decide
et er ou s ould use mi enem
combination it t ese medicines

ilastatin in

Pregnancy and breast-feeding
ou are regnant or breast eeding, t in ou ma be regnant or are
lanning to a e a bab , as our doctor or armacist or ad ice be ore
ta ing t is medicine
mi enem ilastatin as not been studied in regnant omen
mi enem ilastatin s ould not be used during regnanc unless our
doctor decides t e otential benefit ustifies t e otential ris to t e oetus
mall amounts o t is medicine ma ass into breast mil and it ma
a ect t e bab
ere ore, our doctor ill decide
et er ou s ould use
mi enem ilastatin
ile breast eeding

Driving and using machines
ere are some side e ects associated it t is roduct suc as seeing,
earing, or eeling somet ing t at is not t ere, di iness, slee iness, and
a s inning sensation t at ma a ect some atients abilit to dri e or
o erate mac iner see section
Imipenem/Cilastatin contains 1.6 mmol (or 37.5 mg) sodium per
500 mg dose which should be taken into consideration by patients
on a controlled sodium diet.

3. How to use Imipenem/Cilastatin
mi enem ilastatin ill be re ared and gi en to ou b a doctor or
anot er ealt care ro essional our doctor ill decide o muc
mi enem ilastatin ou need
Adults and adolescents
e usual dose o mi enem ilastatin or adults and adolescents is
mg
mg e er
ours or ,
mg ,
mg e er
or
ours
ou a e idne roblems or eig less t an
g, our doctor ma
lo er our dose
Method of administration
mi enem ilastatin is gi en intra enousl into a ein o er
or a dose o
mg
mg or
minutes or a dose o
mg
mg

minutes

Use in children
e usual dose or c ildren one ear o age or older is
or
mg g dose e er
ours mi enem ilastatin is not recommended
in c ildren under one ear o age and c ildren it idne roblems

If you use more Imipenem/Cilastatin than you should
m toms o o erdose ma include sei ures, con usion, tremors, nausea,
omiting, lo blood ressure and slo
eart rate
ou are concerned
t at ou ma a e been gi en too muc mi enem ilastatin, contact our
doctor or anot er ealt care ro essional immediatel

If you forget to use Imipenem/Cilastatin
ou are concerned t at ou ma a e missed a dose, contact our
doctor or anot er ealt care ro essional immediatel
o not ta e a double dose to ma e u

or a orgotten dose

If you stop using Imipenem/Cilastatin
o not sto using mi enem ilastatin until our doctor tells ou to
ou a e an urt er uestions on t e use o t is medicine, as
doctor or armacist

our

4. Possible side effects
i e all medicines, t is medicine can cause side e ects, alt oug not
e er bod gets t em

Severe allergic reactions
ou a e a se ere allergic reaction, stop using Imipenem/Cilastatin
and see a doctor immediately. ou ma need urgent medical treatment
e signs ma include a sudden onset o

e ollo ing in ormation is intended or ealt care ro essionals onl

Reconstitution of the intravenous solution
o

e roduct is su lied as dr sterile o der in ials containing t e e ui alent
mg o imi enem and
mg o cilastatin

e roduct is bu ered it sodium drogen carbonate, in order to obtain
solutions bet een
and
ere is no significant modification o t e
en t e solutions are re ared and used as indicated
e roduct contains
mg o sodium
mmol
or single use onl

iscard an unused solution

e reconstitution o o der is to be made under ase tic conditions using
t e diluents mentioned belo
e solution is to be ins ected isuall or
articulate matter and discoloration rior to administration
e solution s ould
onl be used i it is clear and ree rom articles
econstituted solution stabilit as been establis ed or
in ection and sterile ater or n ections

sodium c loride

econstituted and diluted solutions s ould be used immediatel

Reconstitution of the 100 ml vial
e sterile o der must be reconstituted as directed belo
t must be s a en
until a clear solution is obtained allo ing
minutes to reconstitute t e
o der
e ariations in colour, rom colourless to ello , do not a ect t e
otenc o t e roduct

H04018

B l ack:

e ere ras , itc ing or i es on t e s in
elling o t e ace, li s, tongue or ot er arts o t e bod
ortness o breat ,
ee ing or trouble breat ing

Other side effects:
Common (may affect up to 1 in 10 people):
ausea, omiting, diarr oea ausea and omiting a ear to occur
more re uentl in atients it lo number o
ite blood cells
elling and redness along a ein
ic is e tremel tender
en
touc ed
• Rash
bnormal li er unction detected b blood tests
ncrease in some
ite blood cells
Uncommon (may affect up to 1 in 100 people):
ocal s in redness
ocal ain and ormation o a firm lum at t e in ection site
in itc iness
i es
e er
lood disorders a ecting t e cell com onents o t e blood and usuall
detected b blood tests s m toms ma be tiredness, aleness o s in,
and rolonged bruising a ter in ur
bnormal idne , li er and blood unction detected b blood tests
remors and uncontrolled t itc ing o muscles
ei ures
s c ic disturbances suc as mood s ings and im aired udgment
eeing, earing or eeling somet ing t at is not t ere allucinations
on usion
i iness, slee iness
o blood ressure
Rare (may affect up to 1 in 1,000 people):
in eeling to ic e idermal necrol sis
e ere s in reactions te ens o nson s ndrome and er t ema
multi orme
e ere s in ras
it loss o s in and air e oliati e dermatitis
ungal in ection candidiasis
taining o t e teet and or tongue
n ammation o t e colon it se ere diarr oea
isturbances in taste
nabilit o t e li er to er orm normal unction
n ammation o t e li er
nabilit o t e idne to er orm normal unction
anges in t e amount o urine, c anges in urine colour
isease o t e brain, tingling sensation ins and needles , localised
tremor
earing loss
Very rare (may affect up to 1 in 10,000 people):
e ere loss o li er unction due to in ammation ulminant e atitis
n ammation o stomac or intestine gastro enteritis
n ammation o intestine it blood diarr oea aemorr agic colitis
ed s ollen tongue, o ergro t o t e normal ro ections on t e
tongue gi ing it a air a earance, eartburn, sore t roat, increase in
t e roduction o sali a
tomac ain
s inning sensation ertigo , eadac e
inging in t e ears tinnitus
ain in se eral oints, ea ness
rregular eartbeat, t e eart beating orce ull or ra idl
est discom ort, di ficult breat ing, abnormall ast and su erficial
breat ing, ain in t e u er s ine
lus ing, bluis discoloration o t e ace and li s, s in te ture c anges,
e cessi e s eating
tc ing o t e ul a in omen
anges in t e amounts o blood cells
orsening o a rare disease associated it muscle ea ness
aggra ation o m ast enia gra is

Reporting of side effects
ou get an side e ects, tal to our doctor or
an ossible side e ects not listed in t is lea et
e ects directl ia
United Kingdom
ello
ard c eme
ebsite
m ra go u

armacist
is includes
ou can also re ort side

ello card

Malta

e orting
ebsite
medicinesaut orit go mt adr ortal

re orting side e ects ou can el
sa et o t is medicine

ro ide more in ormation on t e

5. How to store Imipenem/Cilastatin
ee t is medicine out o t e reac and sig t o c ildren
o not use t is medicine a ter t e e ir date
ic is stated on t e ial
label and carton
e e ir date re ers to t e last da o t at mont
rior to reconstitution, t is medicinal roduct does not re uire an s ecial
storage conditions
re ared solutions s ould be used immediatel
e time inter al bet een
t e beginning o reconstitution and t e end o intra enous in usion s ould
not e ceed t o ours re ared solutions s ould not be ro en
o not t ro a a an medicines ia aste ater or ouse old aste s
our armacist o to t ro a a medicines ou no longer use
ese
measures ill el rotect t e en ironment

6. Contents of the pack and other information
What Imipenem/Cilastatin contains
e acti e substances are imi enem and cilastatin ac ial contains
mg o imi enem mono drate and
mg o cilastatin sodium
corres onding to
mg o imi enem and
mg o cilastatin
e ot er ingredient is sodium drogen carbonate

What Imipenem/Cilastatin looks like and contents of the pack
is medicine is an o
ite to ello is
ite grosco ic o der or
solution or in usion in a glass ial ac s o t e
ml ials contain
ials
er carton ac s o t e
ml ials contain
ial er carton ot all ac
si es ma be mar eted

Marketing Authorisation Holder and Manufacturer
e

ar eting ut orisations or mi enem ilastatin are eld b
os ira
imited, ori on, one ane, urle , aiden ead,
,

e manu acturer res onsible or batc release o t e roduct in t e
is os ira
imited, ori on, one ane, urle , aiden ead,
,
This medicinal product is authorised in the Member States of the
EEA under the following names:
ustria
mi enem ilastatin os ira
mg
mg ul er ur
erstellung einer n usionsl sung
rus
mi enem ilastatin os ira
mg
mg
ec

e ublic mi enem ilastatin os ira
mg
ra u in u n o ro to u
erman
mi enem ilastatin os ira
mg
erstellung einer n usionsl sung
reece
mi enem ilastatin os ira
mg

mg r

e

ro

mg ul er ur
mg

ungar

mi enem ilastatin os ira
mg
mg or oldatos
in i o
tal
mi enem ilastatina os ira
mg
mg ol ere
er solu ione er in usione
at ia
mi enem ilastatin os ira
mg
mg ul eris
in i u
duma agata o anai
it uania
mi enem ilastatin os ira
mg
mg miltelaia
in u iniam tir alui
alta
mi enem ilastatin os ira
mg
mg o der or
olution or n usion
oland
mi enemum ilastatinum os ira,
mg
mg,
ros e do s or d ania ro t oru do in u i
ortugal
mi enem
ilastatina os ira,
mg
mg
ara solu o ara er us o
omania
mi enem ilastatin os ira
mg
mg, ulbere
entru solu ie er u abil
ain
mi enem ilastatina os ira
mg
mg ol o ara
soluci n ara er usi n
nited ingdom mi enem ilastatin
mg
mg o der or olution
or n usion
This leaflet was last revised in 04/2016.

ose
imi enem in mg
500

olume o sol ent to
be added ml

o

100

5

ean a ro imate concentration
roduct mg ml o imi enem

Reconstitution of the 20 ml vial
e contents o t e ial must be sus ended and trans erred to
ml
o an a ro riate solution or in usion suggested rocedure is to add
a ro imatel
ml o a ro riate in usion solution to t e ial
a e ell and
trans er t e resulting sus ension to t e in usion solution container
aution

e sus ension is not or direct in usion

e eat it an additional
ml o in usion solution to ensure com lete
trans er o t e ial contents to t e in usion solution
e resulting mi ture must
be s a en until clear
n unused medicinal roduct or aste material s ould be dis osed o in
accordance it local re uirements

Incompatibility
e roduct is c emicall incom atible it lactate and must not be
reconstituted in solutions t at contain it o e er, it can be administered into
an
tubing, t roug
ic a lactate solution is to be in used
e roduct must not be mi ed or

sicall added to ot er antibiotics

After reconstitution and dilution
econstituted and diluted solutions s ould be used immediatel
e time
inter al bet een t e beginning o reconstitution and t e end o intra enous
in usion s ould not e ceed t o ours
H04018

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