CIPROFLOXACIN 400MG/200ML SOLUTION FOR INFUSION

Active substance: CIPROFLOXACIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
solutions), especially in combination with solutions adjusted to an alkaline
pH (pH of the ciprofloxacin infusion solutions: (4.0 - 4.9).

Ciprofloxacin 100 mg/50 ml,
solution for infusion
Ciprofloxacin 200 mg/100 ml,
solution for infusion
Ciprofloxacin 400 mg/200 ml,
solution for infusion

After intravenous initiation of treatment, the treatment can be continued
orally as well.

Ciprofloxacin (as hydrogen sulphate)

Read all of this leaflet carefully before you start using this medicine.
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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Ciprofloxacin is and what it is used for
Before you use Ciprofloxacin
How to use Ciprofloxacin
Possible side effects
How to store Ciprofloxacin
Further information

1. WHAT CIPROFLOXACIN IS AND WHAT IT IS USED FOR
Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family.
The active substance is ciprofloxacin. Ciprofloxacin works by killing
bacteria that cause infections. It only works with specific strains of bacteria.

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Adults

Before you are given Ciprofloxacin

Ciprofloxacin is used in adults to treat the following bacterial infections:

Tell your doctor if you:

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respiratory tract infections
long lasting or recurring ear or sinus infections
urinary tract infections
infections of the testicles
genital organ infections in women
gastro-intestinal tract infections and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
to treat infections in patients with a very low white blood cell count
(neutropenia)
to prevent infections in patients with a very low white blood cell count
(neutropenia)
anthrax inhalation exposure

If you have a severe infection or one that is caused by more than one type
of bacterium, you may be given additional antibiotic treatment in addition
to Ciprofloxacin.
Children and adolescents
Ciprofloxacin is used in children and adolescents, under specialist medical
supervision, to treat the following bacterial infections:
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lung and bronchial infections in children and adolescents suffering
from cystic fibrosis
complicated urinary tract infections, including infections that have
reached the kidneys (pyelonephritis)
anthrax inhalation exposure

Ciprofloxacin may also be used to treat other specific severe infections in
children and adolescents when your doctor considered this necessary.
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Heart problems
Caution should be taken when using this kind of medicine, if you were born
with or have family history of prolonged QT interval (seen on ECG,
electrical recording of the heart), have salt imbalance in the blood
(especially low level of potassium or magnesium in the blood), have a very
slow heart rhythm (called 'bradycardia'), have a weak heart (heart failure),
have a history of heart attack (myocardial infarction), you are female or
elderly or you are taking other medicines that result in abnormal ECG
changes (see section Taking other medicines).
While under treatment with Ciprofloxacin
Tell your doctor immediately, if any of the following occurs during
treatment with Ciprofloxacin. Your doctor will decide whether treatment
with Ciprofloxacin needs to be stopped.
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BEFORE YOU USE CIPROFLOXACIN

You must NOT be given Ciprofloxacin if you are:
· allergic (hypersensitive) to the active substance, to other quinolone
drugs or to any of the other ingredients of Ciprofloxacin (see section 6)
· taking tizanidine (see Section 2: Taking other medicines)
Take special care with Ciprofloxacin

have ever had kidney problems because your treatment may need
to be adjusted
suffer from epilepsy or other neurological conditions
have a history of tendon problems during previous treatment with
antibiotics such as Ciprofloxacin
have myasthenia gravis (a type of muscle weakness)
have a history of abnormal heart rhythms (arrythmias)

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Severe, sudden allergic reaction (an anaphylactic reaction/shock,
angio-oedema). Even with the first dose, there is a rare chance that
you may experience a severe allergic reaction with the following
symptoms: tightness in the chest, feeling dizzy, feeling sick or faint,
or experience dizziness on standing. If this happens, tell your doctor
immediately since the administration of Ciprofloxacin will have
to be stopped.
Pain and swelling in the joints, and tendinitis may occur
occasionally, particularly if you are elderly and are also being treated
with corticosteroids. At the first sign of any pain or inflammation
Ciprofloxacin will have to be stopped, rest the painful area.
Avoid any unnecessary exercise as this might increase the risk
of a tendon rupture.
If you suffer from epilepsy or other neurological conditions such as
cerebral ischemia or stroke, you may experience side effects
associated with the central nervous system. If this happens, stop
taking Ciprofloxacin and contact your doctor immediately.

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You may experience psychiatric reactions after first administration
of ciprofloxacin. If you suffer from depression or psychosis, your
symptoms may become worse under treatment with Ciprofloxacin.
If this happens, stop taking Ciprofloxacin and contact your doctor
immediately.
You may experience symptoms of neuropathy such as pain, burning,
tingling, numbness and/or weakness. If this happens, stop taking
Ciprofloxacin and contact your doctor immediately.
Diarrhoea may develop while you are on antibiotics, including
Ciprofloxacin, or even several weeks after you have stopped using
them. If it becomes severe or persistent or you notice that your stool
contains blood or mucus tell your doctor immediately. Ciprofloxacin
treatment will have to be stopped immediately, as this can be lifethreatening. Do not take medicines that stop or slow down bowel
movements.
Tell the doctor or laboratory staff that you are taking Ciprofloxacin if you
have to provide a blood or urine sample.
Ciprofloxacin may cause liver damage. If you notice any symptoms
such as loss of appetite, jaundice (yellowing of the skin), dark urine,
itching, or tenderness of the stomach, Ciprofloxacin must be stopped
immediately.
Ciprofloxacin may cause a reduction in the number of white blood cells
and your resistance to infection may be decreased. If you
experience an infection with symptoms such as fever and serious
deterioration of your general condition, or fever with local infection
symptoms such as sore throat/pharynx/mouth or urinary problems you
should see your doctor immediately. A blood test will be taken to check
possible reduction of white blood cells (agranulocytosis). It is important
to inform your doctor about your medicine.
Tell your doctor if you or a member of your family is known to have
a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since
you may experience a risk of anemia with ciprofloxacin.
Your skin becomes more sensitive to sunlight or ultraviolet (UV)
light under treatment with Ciprofloxacin. Avoid exposure to strong
sunlight or artificial UV light such as sunbeds.

Taking other medicines
You must tell your doctor if you are taking other medicines that can alter your
heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g.
quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide,
ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the
group of macrolides), some antipsychotics.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription.

Do not use Ciprofloxacin together with tizanidine, because this may
cause side effects such as low blood pressure and sleepiness
(see Section 2: "You must not be given Ciprofloxacin if you are").
The following medicines are known to interact with Ciprofloxacin
in your body. Using Ciprofloxacin together with these medicines can
influence the therapeutic effect of these medicines. It can also increase
the probability of experiencing side effects.
Tell your doctor if you are taking:
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warfarin or other oral anti-coagulants (to thin the blood)
probenecid (for gout)
methotrexate (for certain types of cancer, psoriasis, rheumatoid
arthritis)
theophylline (for breathing problems)
tizanidine (for muscle spasticity in multiple sclerosis)
clozapine (an antipsychotic)
ropinirole (for Parkinson's disease)
phenytoin (for epilepsy)

Ciprofloxacin may increase the levels of the following medicines
in your blood:
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pentoxifylline (for circulatory disorders)
caffeine

Taking Ciprofloxacin with food and drink
Food and drink does not affect your treatment with Ciprofloxacin.
Pregnancy and breast-feeding
It is preferable to avoid the use of Ciprofloxacin during pregnancy.
Tell your doctor if you are planning to get pregnant.
Do not take Ciprofloxacin during breast feeding because ciprofloxacin is
excreted in breast milk and can be harmful for your child.
Driving and using machines
Ciprofloxacin may make you feel less alert. Some neurological adverse
events can occur. Therefore, make sure you know how you react to
Ciprofloxacin before driving a vehicle or operating machinery.
If in doubt, talk to your doctor.
Important information about some of the ingredients of Ciprofloxacin

If you are on a low-sodium diet, take into account that 100 ml
of Ciprofloxacin contains 15.1 mmol (= 347 mg) sodium.

Uncommon side effects (between 1 and 10 in every 1,000 people are
likely to get these):

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HOW TO USE CIPROFLOXACIN

Your doctor will explain to you exactly how much Ciprofloxacin you will be
given as well as how often and for how long. This will depend on the type of
infection you have and how bad it is.
Tell your doctor if you suffer from kidney problems because your dose may
need to be adjusted.
Treatment usually lasts between 5 and 21 days, but may be longer for
severe infections.
Your doctor will give you each dose by slow infusion through a vein into
your bloodstream. For children, the infusion duration is 60 minutes. In adult
patients, infusion time is 60 minutes for 400 mg Ciprofloxacin and
30 minutes for 200 mg Ciprofloxacin. Administering the infusion slowly
helps prevent immediate side effects occurring.
Remember to drink plenty of fluids while you are taking Ciprofloxacin.

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If you stop your course of Ciprofloxacin
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It is important that you finish the course of treatment even if you
begin to feel better after a few days. If you stop using this medicine too
soon your infection may not be completely cured and the symptoms
of the infection may return or get worse. You might also develop
resistance to the antibiotic.

If you have any more questions about the use of this product, ask your
doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Ciprofloxacin can cause side effects, although not
everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.

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Rare side effects (between 1 and 10 in every 10,000 people are likely to
get these):
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Common side effects (between 1 and 10 in every 100 people are likely
to get these):

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nausea, diarrhoea, vomiting
joint pains in children
local reaction at the injection site, rash
temporary increased amounts of substances in the blood
(transaminases)

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fungal superinfections
a high concentration of eosinophils, a type of white blood cell,
increased or decreased amounts of a blood cloting factor
(thrombocytes)
loss of appetite (anorexia)
hyperactivity, agitation, confusion, disorientation, hallucinations
headache, dizziness, sleeping problems, taste disorders, pins and
needles, unusual sensitivity to stimuli of the senses, seizures (see
Section 2: Take special care with Ciprofloxacin), giddiness
eyesight problems
loss of hearing
rapid heartbeat (tachycardia)
expansion of the blood vessels (vasodilation), low blood pressure
abdominal pain, digestive problems such as stomach upset
(indigestion/heartburn), wind
liver disorders, increased amounts of one substance in the blood
(bilirubin), jaundice (cholestatic icterus)
itching, hives
joint pain in adults
poor kidney function, kidney failure
pains in your muscles and bones, feeling unwell (asthenia), fever, fluid
retention
increase in blood alkaline phosphatase (a certain substance in the
blood)

inflammation of the bowel (colitis) linked to antibiotic use (can be fatal
in rare cases) (see Section 2: Take special care with Ciprofloxacin)
changes to the blood count (leukopenia, leukocytosis, neutropenia,
anaemia), a drop in the number of red and white blood cells and
platelets (pancytopenia), which may be fatal, bonemarrow depression
which may also be fatal (see Section 2: Take special care with
Ciprofloxacin)
allergic reaction, allergic swelling (oedema), rapid swelling of the skin
and mucous membranes (angiooedema), severe allergic reaction
(anaphylactic shock) which can be life-threatening (see Section 2:
Take special care with Ciprofloxacin)
increased blood sugar (hyperglycemia)
anxiety reaction, strange dreams, depression, mental disturbances
(psychotic reactions) (see Section 2: Take special care with Ciprofloxacin)

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decreased skin sensitivity, tremor, migraine, disorder of sense of smell
(olfactory disorders)
tinnitus, impaired hearing
fainting, inflammation of the blood vessel (vasculitis)
shortness of breath including asthmatic symptoms
pancreatitis
hepatitis, death of liver cells (liver necrosis) very rarely leading to lifethreatening liver failure
sensitivity to light (see Section 2: Take special care with Ciprofloxacin),
small, pinpoint bleeding under the skin (petechiae)
muscle pain, inflammation of the joints, increased muscle tone,
cramping, tendon rupture especially of the large tendon at the back of
the ankle (Achilles tendon) (see Section 2: Take special care with
Ciprofloxacin)
blood or crystals in the urine (see Section 2: Take special care with
Ciprofloxacin), urinary tract inflammation
excessive sweating
abnormal levels of a clotting factor (prothromibin) increased levels of
the enzyme amylase

Very rare side effects (less than 1 in every 10,000 people are likely to get
these):
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a special type of reduced red blood cell count (haemolytic anaemia);
a dangerous drop in a type of white blood cells (agranulocytosis)
severe allergic reaction (anaphylactic reaction, anaphylactic shock,
serum sickness) which can be fatal (see Section 2: Take special care
with Ciprofloxacin)
disturbed coordination, unsteady walk (gait disturbance), pressure on
the brain (intracranial pressure)
visual colour distortions
various skin eruptions or rashes (e.g. the potentially fatal StevensJohnson syndrome or toxic epidermal necrolysis)
muscle weakness, tendon inflammation, worsening of the symptoms
of myasthenia gravis (see Section 2: Take special care with
Ciprofloxacin)

Frequency not known (cannot be estimated from the available data)
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troubles associated with the nervous system such as pain, burning,
tingling, numbness and/ or weakness in extremities
Abnormal fast heart rhythm, life-threatening irregular heart rhythm,
alteration of the heart rhythm (called 'prolongation of QT interval', seen
on ECG, electrical activity of the heart)

5. HOW TO STORE CIPROFLOXACIN
Keep out of the reach and sight of children.
Do not use Ciprofloxacin after the expiry date which is stated on the
packaging after “Exp”. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Store the infusion bag in the overpouch until it is used in order to protect
from light.
· Store the infusion bottle in the outer carton until it is used in order
to protect from light.
Medicines should not be disposed via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help protect the environment.
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FURTHER INFORMATION

What Ciprofloxacin contains The active substance is ciprofloxacin (as
hydrogen sulphate)
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The other ingredients are sodium chloride, sulphuric acid, sodium
hydroxide for pH adjustment, water for injections

What Ciprofloxacin looks like and contents of the pack
Ciprofloxacin is a sterile, clear and colourless solution.
Ciprofloxacin is contained in a clear flexible polyolefine bag with aluminium
overpouch (Excel bags and Freeflex bags) or in a polyethylene bottle (KabiPac).
50 ml solution contains 100 mg ciprofloxacin.
100 ml solution contains 200 mg ciprofloxacin.
200 ml solution contains 400 mg ciprofloxacin.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi Limited,
Cestrian Court, Eastgate Way
Manor Park, Runcorn
Cheshire, Wa7 1NT
UK
Manufacturer:
Fresenius Kabi Norge AS
Postboks 430, N-1753 Halden, Norway

Fresenius Kabi Polska Sp. z o.o.
Wytwórnia P³ynów Infuzyjnych
ul. Sienkiewicza 25, 99-300 Kutno, Poland
This medicinal product is authorised in the Member States of the EEA
under following names:
AT: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml
Infusionslösung
BE: Ciprofloxacin Fresenius Kabi 200 mg/100 ml, -400 mg/200 ml
solution pour perfusion/ Infusionslösung/ oplossing voor
intraveneuze infusie
CY: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml
äéÜëõìá ãéá Ýã÷õóç
CZ: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml
infuzní roztok
DE: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, 400 mg/200 ml
Infusionslösung
DK: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvæske, opløsning
EL: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml
äéÜëõìá ãéá Ýã÷õóç
ES: Ciprofloxacin 2 mg/ml solución para perfusión
FI: Ciprofloxacin Fresenius Kabi 2 mg/ml infuusioneste, liuos
HU: Ciprofloxacin 200 mg/100 ml, -400 mg/200 ml oldatos infúzió
IT: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml
soluzione per infusione
NL: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml
oplossing voor intraveneuze infusie
PL: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml
roztwór do infuzji
PT: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml
Solução para perfusão
SE: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvätska, lösning
SK: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml
infúzny intravenózny roztok
UK: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml
solution for infusion
This leaflet was last approved in
06/2011

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Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective
against viral infections.
If your doctor has prescribed antibiotics, you need them precisely for your
current illness.
Despite antibiotics, some bacteria may survive or grow. This phenomenon
is called resistance: some antibiotic treatments become ineffective.
Misuse of antibiotics increases resistance. You may even help bacteria
become resistant and therefore delay your cure or decrease antibiotic
efficacy if you do not respect appropriate:
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dosage
schedules
duration of treatment

Consequently, to preserve the efficacy of this drug:
1.
2.
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4.
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Use antibiotics only when prescribed.
Strictly follow the prescription.
Do not re-use an antibiotic without medical prescription, even if you
want to treat a similar illness.
Never give your antibiotic to another person; maybe it is not adapted to
her/his illness.
After completion of treatment, return all unused drugs to your chemist's
shop to ensure they will be disposed of correctly

The following information is intended for medical or healthcare
professionals only:
Ciprofloxacin should be administered by intravenous infusion.
For children, the infusion duration is 60 minutes. In adult patients, infusion
time is 60 minutes for 400 mg Ciprofloxacin and 30 minutes for 200 mg
Ciprofloxacin. Slow infusion into a large vein will minimise patient
discomfort and reduce the risk of venous irritation. The infusion solution
can be infused either directly or after mixing with other compatible infusion
solutions.
Unless compatibility with other infusion solutions/drugs has been
confirmed, the infusion solution must always be administered separately.
The visual signs of incompatibility are e.g. precipitation, clouding, and
discolouration.
Incompatibility appears with all infusion solutions/drugs that are physically
or chemically unstable at the pH of the solution (e.g. penicillin, heparin

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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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