0.9% SODIUM CHLORIDE INJECTION

Active substance: NO ACTIVES PRESENT

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2011

GB-IE - AW_72211

Sporanox ® I.V. 10 mg/ml
concentrate and solvent for solution for infusion
itraconazole
Read all of this leaflet carefully
before you are given this
medicine:
• Keep this leaflet. You may need to
read it again.
• If you have any further questions, ask
your doctor or nurse.
• 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 nurse.

In this leaflet:
1 What Sporanox I.V. is and what it

is used for

2 Before you are given Sporanox I.V.
3 How you will be given

Sporanox I.V.

4 Possible side effects
5 How Sporanox I.V. is stored
6 Further information

1 What Sporanox I.V. is and what it is used for
Sporanox I.V. is one of a group of
medicines called “antifungals”. These
medicines are used to treat infections
caused by fungi including yeasts.

Sporanox I.V. is used to:

• Treat fungal infections of the internal
organs.

2 Before you are given Sporanox I.V.
You should not be given
Sporanox I.V. if:

• You are allergic (hypersensitive) to any
of the ingredients in Sporanox I.V.
(listed in section 6 further information)
• You are pregnant, think you might be
pregnant or are trying to become
pregnant, (see the section on
Pregnancy)
• Your kidney function is seriously
reduced
• You cannot have sodium chloride by
injection.
• You are taking any of the following
medicines:
- terfenadine, astemizole or mizolastine
(antihistamine for allergies)
- bepridil-used to treat angina
(crushing chest pain)
- nisoldipine (used for high blood
pressure)
- cisapride (used for stomach upsets)
- midazolam by mouth or triazolam
(used to help you sleep or for anxiety)
- lovastatin, simvastatin or atorvastatin
(used to lower cholesterol)
- pimozide and sertindole (for
conditions affecting thoughts,
feelings and/or behaviour)
- levacetylmethadol - for treatment of
drug abuse (opioid-dependency)
- dihydroergotamine, ergotamine and
eletriptan (for migraine headaches)
- ergometrine (ergonovine) and
methylergometrine
(methylergonovine) used after giving
birth
- quinidine and dofetilide (for irregular
heart beat rhythms)

Take special care with
Sporanox I.V.

Tell your doctor immediately: If you
have any unusual feelings of tingling,
numbness or weakness in your hands
or feet whilst taking Sporanox I.V..
If you experience any hearing loss
symptoms. In very rare cases patients
taking Sporanox have reported
temporary or permanent hearing loss.
You must tell your doctor before you are
given Sporanox I.V. if you suffer from or
have suffered in the past from any of
the following:
• Any liver problems or jaundice
(yellowing of the skin). If your doctor
decides to give you Sporanox I.V. the
dose may have to be changed. Your
doctor may give you instructions on
symptoms to watch out for and ask
you to have your blood checked.
• An allergic reaction to any other
antifungal medicine.
• Heart problems, including heart failure
(also called congestive heart failure or
CHF), Sporanox I.V. could make it
worse. If your doctor decides to give
you Sporanox I.V. you should be told
about the symptoms listed below to
watch out for. If you get any of the
following stop taking Sporanox I.V. and
tell your doctor straight away. These
may be signs of heart failure:
- shortness of breath
- unexpected weight gain
- swelling of your legs or stomach
- feel unusually tired
- wake up short of breath at night
• Are on a low salt diet.
• A kidney disorder, you may be
monitored more closely or your dose
of Sporanox I.V. may have to be
changed.

Taking other medicines

There are some medicines that you
should not take whilst being given
Sporanox IV. These are listed under the
heading “You should not be given
Sporanox I.V. if:”.

Tell your doctor if you are using the
following as they may stop Sporanox I.V.
from working properly:
• rifampicin, rifabutin and isoniazid
(antibiotics used to treat tuberculosis)
• phenytoin, carbamazepine and
phenobarbital (anti-epileptics)
• St John’s Wort (a herbal medicine)
Do not use Sporanox I.V. within 2 weeks
of taking these medicines.
Tell your doctor before taking any of
the following medicines as the dose of
Sporanox I.V. or other treatments may
need to be altered:
• clarithromycin or erythromycin
(anitibiotics for infections)
• medicines that act on the heart and
blood vessels (digoxin, disopyramide
and calcium channel blockers such as
dihydropyridines, verapamil and
cilostazol)
• drugs that slow down blood clotting or
thin the blood, such as warfarin
• methylprednisolone, budesonide,
fluticasone and dexamethasone drugs
given by mouth and injection for
inflammation, asthma and allergies
• cyclosporin, tacrolimus, rapamycin
(also known as sirolimus), which are
usually given after an organ transplant
• medicines used in HIV-infected
patients, such as ritonavir, indinavir
and saquinavir
• medicines for cancer (such as
busulphan, docetaxel, trimetrexate
and a group of medicines known as
vinca alkaloids)
• alfentanil and fentanyl (for pain)
• buspirone, alprazolam, brotizolam and
midazolam when given by injection into
a vein (for anxiety or to help you sleep)
• reboxetine (for depression)
• an antihistamine containing ebastine
• halofantrine (for malaria)
• repaglinide (for diabetes)
• cerivastatin (for lowering levels of
cholesterol)
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including
medicines obtained without a
prescription or herbal medicines.

Children and the elderly

Sporanox I.V. is not normally given to
children or the elderly. Your doctor may
prescribe it in special cases.

Pregnancy

Do not take Sporanox I.V. if you are
pregnant, unless your doctor has told
you to. If you are of child bearing age
and could become pregnant, you
should use contraceptives to make sure
that you do not become pregnant while
you are receiving your medicine. As
Sporanox I.V. remains in the body for
some time after you stop receiving it,
you should continue to use some form
of contraception until your next period
after your treatment with Sporanox I.V.
has finished.
If you do find that you are pregnant after
receiving a course of Sporanox I.V., tell
your doctor straight away.
Before taking any medicine - always tell
your doctor if you are pregnant, think
you might be pregnant or are trying to
become pregnant.

Breast feeding

You should stop breast-feeding before
you are given Sporanox, as small
amounts of the medicine could be
present in your breast milk.

Driving and using machines
Sporanox I.V. can sometimes cause
dizziness, blurred/double vision or
hearing loss. If you have these
symptoms, do not drive or use
machines.

© J-C 2011

GB-IE - AW_72211

3 How you will be given Sporanox I.V.
Your medicine will be given to you by
your doctor or nurse. Sporanox I.V.
concentrate is mixed with the sodium
chloride solution in the bag and is then
given by slow injection into a vein.
This is called an intravenous (I.V.)
infusion and will usually take about an
hour. For the first two days, you will be
given two infusions each day. From Day
three onwards you will be given one
infusion each day.

How much you will be given

Children:
Not recommended.
Elderly:
Not recommended.

If a dose is missed or you are
given too much Sporanox l.V

Since this medicine will be given to you
by a doctor or nurse, it is unlikely that
you will be given too much or that a
dose will be missed. However, if you are
worried, tell your doctor or nurse.

The recommended dosage is as follows:
Adults:
Day 1 and Day 2 of the treatment:
Two 1-hour infusions of 200 mg
Sporanox I.V. will be given each day
as a 60 ml infusion.
From Day 3 onwards:
One 1-hour infusion of 200 mg
Sporanox I.V. will be given each day as
a 60 ml infusion.

4 Possible side effects
Like all medicines, Sporanox I.V. can
cause side effects, although not
everybody gets them.
Medicines can cause serious allergic
reactions.
Stop taking Sporanox I.V. and contact
your doctor immediately if you have:
• any sudden wheeziness, difficulty in
breathing, swelling of the face, rash,
itching (especially affecting the whole
body) or a severe skin disorder
(widespread rashes with peeling skin
and blisters in the mouth, eyes and
genitals, or rashes with small pustules
or blisters).
• severe lack of appetite, feeling sick,
being sick, unusual tiredness,
abdominal (stomach) pain, unusually
dark urine, or pale stools. These may
be symptoms of severe liver problems.
You should also let your doctor know
immediately if you have any of the side
effects below:
• Symptoms that resemble heart failure
such as shortness of breath,
unexpected weight gain, swelling of
the legs, unusual fatigue (tiredness),
repeated waking at night.
• A tingling sensation, sensitivity to light,
numbness or weakness in the limbs.
• Blurred vision/double vision, ringing in
your ears, lose the ability to control
your urine or increased need to urinate
(pass water)
• If you experience any symptoms of
hearing loss
Other side effects include:
Very common side effects (occur in
more than 1 in 10 patients)
• feeling sick (nausea)

Common side effects (occur in less
than 1 in 10 patients) are:
• muscle weakness (possible symptom
of low blood levels of potassium)
• headache, dizziness
• stomach ache, being sick (vomiting),
diarrhoea, constipation
• increases in specific liver function
tests (hepatic enzyme increased),
inflammation of the liver (hepatitis),
yellowing of the skin (jaundice)
• rash, itching
• general swelling
• fever or high temperature
• shortness of breath
Uncommon side effects (occur in less
than 1 in 100 patients) are:
• high blood sugar levels
• unpleasant taste
• muscle pain
The following side effects have been
reported in patients taking Sporanox I.V.
with unknown frequency:
• certain blood disorders which may
increase the risk of bleeding, bruising
or infections
• excess of triglycerides in the blood
• high blood pressure
• indigestion
• hair loss
• painful joints
• menstrual disorders
• erectile dysfunction
• severe upper stomach pain, often with
nausea and vomiting due to
inflammation of the pancreas
(pancreatitis)
If any of these side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.

5 How to store Sporanox I.V.
Keep out of the reach and sight of
children.
Sporanox I.V. will be kept in the hospital
pharmacy.
The product should not be used after
the expiry date printed on the inner and
outer packaging. The expiry date refers
to the last day of that month.
Do not store Sporanox I.V. concentrate
above 25°C.

Store in the original container.
Do not store the bag containing Sodium
Chloride above 25°C. Do not freeze.
Protect the mixed solution from direct
sunlight. Once mixed, the product
should be used immediately.

6 Further Information
What Sporanox I.V. contains:

• The active ingredient in Sporanox I.V.
is itraconazole (10mg of itraconazole
per ml).
• The other ingredients are
hydroxypropyl--cyclodextrin,
propylene glycol, hydrochloric acid
concentrated, sodium hydroxide and
water for injections.

What 0.9% Sodium Chloride
Injection contains:

• Sodium Chloride, water for injections.

What Sporanox I.V. looks like
and the contents of the pack

It is a kit containing a clear, colourless
concentrated solution for intravenous
(I.V.) infusion, which means the solution
needs to be diluted before use.
Sporanox I.V. comes in a 25 millilitre
(ml) ampoule, together with a bag
containing a clear, colourless Sodium
Chloride solution and an extension line.
These two solutions will be mixed
together to give a clear, colourless
solution before they are given directly
into your veins.
One ml of Sporanox I.V. concentrate
contains 10 milligrams (mg) of
itraconazole. When the Sporanox I.V.
concentrate is added to the bag
containing sodium chloride solution,
each ml of the mixed solution contains
3.33 mg itraconazole.
The Sodium Chloride bag is a plastic
polypropylene infusion bag, which
contains 50 ml of Sodium Chloride
solution. One ml of solution contains
9 mg sodium chloride. It is used to
dilute the Sporanox I.V. concentrate
making it easier to be given.

Marketing Authorisation Holder:
Janssen-Cilag Ltd, 50-100 Holmers
Farm Way, High Wycombe,
Buckinghamshire HP12 4EG, UK
Manufacturer:
Sporanox I.V. 10mg/ml concentrate and
solvent for solution for infusion are
manufactured by:
Lusomedicamenta
Sociedade Técnica Farmacêutica S.A.
Estrada Consiglieri Pedroso, 69-B
Queluz
2730-055 Barcarena
Portugal
This medicinal product is authorised
in the member states of the EEA
under the following names:
Germany: SEMPERA®
Spain: SPORANOX®
Ireland: SPORANOX®
Italy: SPORANOX®
Portugal: SPORANOX®
Greece: SPORANOX®
U.K: SPORANOX®
®

Registered trademark

For information in large
print, tape, CD or
Braille, phone 0800 731
8450 (UK) or 1800
709122 (IRE)
This leaflet was last approved in
08/2012

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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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