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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

B l ack:

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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