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VORICONAZOLE PFIZER 200 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): VORICONAZOLE

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Package Leaflet: Information for the patient

Voriconazole 200 mg powder for solution for infusion
Voriconazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
•• Keep this leaflet. You may need to read it again.
•• If you have any further questions, ask your doctor, pharmacist or nurse.
•• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are
the same as yours.
•• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Voriconazole is and what it is used for
2. What you need to know before you take Voriconazole
3. How to use Voriconazole
4. Possible side effects
5. How to store Voriconazole
6. Content of the pack and other information
1. What Voriconazole is and what it is used for
Voriconazole contains the active substance voriconazole.
Voriconazole is an antifungal medicine. It works by killing or
stopping the growth of the fungi that cause infections.
It is used for the treatment of patients (adults and children over the
age of 2) with:
•• invasive aspergillosis (a type of fungal infection due to
Aspergillus sp),
•• candidaemia (another type of fungal infection due to Candida
sp) in non-neutropenic patients (patients without abnormally
low white blood cells count),
•• serious invasive Candida sp. infections when the fungus is
resistant to fluconazole (another antifungal medicine),
•• serious fungal infections caused by Scedosporium sp. or
Fusarium sp. (two different species of fungi).
Voriconazole is intended for patients with worsening, possibly lifethreatening, fungal infections.
Prevention of fungal infections in high risk bone marrow transplant
recipients.
This product should only be used under the supervision of a doctor.
2. What you need to know before you take Voriconazole
Do not take Voriconazole
- If you are allergic to the active ingredient voriconazole, or to
sulfobutylether beta cyclodextrin sodium (listed in section 6).
It is very important that you inform your doctor or pharmacist if
you are taking or have taken any other medicines, even those that
are obtained without a prescription, or herbal medicines.
The medicines in the following list must not be taken during your
Voriconazole treatment:
•• Terfenadine (used for allergy)
•• Astemizole (used for allergy)
•• Cisapride (used for stomach problems)
•• Pimozide (used for treating mental illness)
•• Quinidine (used for irregular heart beat)
•• Rifampicin (used for treating tuberculosis)
•• Efavirenz (used for treating HIV) in doses of 400 mg and
above once daily
•• Carbamazepine (used to treat seizures)
•• Phenobarbital (used for severe insomnia and seizures)
•• Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for
migraine)
•• Sirolimus (used in transplant patients)
•• Ritonavir (used for treating HIV) in doses of 400mg and more
twice daily
•• St. John’s Wort (herbal supplement)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Voriconazole
if:
•• you have had an allergic reaction to other azoles.
•• you are suffering from, or have ever suffered from liver
disease. If you have liver disease, your doctor may prescribe
a lower dose of Voriconazole . Your doctor should also
monitor your liver function while you are being treated with
Voriconazole by doing blood tests.
•• you are known to have cardiomyopathy, irregular heart beat,
slow heart rate or an abnormality of electrocardiogram (ECG)
called ‘long QTc syndrome’.
You should avoid any sunlight and sun exposure while being
treated. It is important to cover sun exposed areas of skin and
use sunscreen with high sun protection factor (SPF), as an
increased sensitivity of skin to the sun’s UV rays can occur. These
precautions are also applicable to children.

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While being treated with Voriconazole :
•• tell your doctor immediately if you develop
° sunburn
° severe skin rash or blisters
° bone pain
If you develop skin disorders as described above, your doctor may
refer you to a dermatologist, who after consultation may decide
that it is important for you to be seen on a regular basis. There is a
small chance that skin cancer could develop with long-term use of
Voriconazole .
Your doctor should monitor the function of your liver and kidney by
doing blood tests.
Children and adolescents
Voriconazole should not be given to children younger than 2 years
of age.
Other medicines and Voriconazole
Please tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including those
that are obtained without a prescription.
•• Some medicines, when taken at the same time as
Voriconazole , may affect the way Voriconazole works or
Voriconazole may affect the way they work.
Tell your doctor if you are taking the following medicine, as
treatment with Voriconazole at the same time should be avoided if
possible:
•• Ritonavir (used for treating HIV) in doses of 100 mg twice
daily
Tell your doctor if you are taking either of the following medicines,
as treatment with Voriconazole at the same time should be avoided
if possible, and a dose adjustment of voriconazole may be required:
•• Rifabutin (used for treating tuberculosis).If you are already
being treated with rifabutin your blood counts and side effects
to rifabutin will need to be monitored.
•• Phenytoin (used to treat epilepsy).If you are already being
treated with phenytoin your blood concentration of phenytoin
will need to be monitored during your treatment with
Voriconazole and your dose may be adjusted.
Tell your doctor if you are taking any of the following medicines, as
a dose adjustment or monitoring may be required to check that the
medicines and/ or Voriconazole are still having the desired effect:
•• Warfarin and other anticoagulants (e.g., phenprocoumon,
acenocoumarol; used to slow down clotting of the blood)
•• Ciclosporin (used in transplant patients)
•• Tacrolimus (used in transplant patients)
•• Sulfonylureas (e.g., tolbutamide, glipizide, and glyburide)
(used for diabetes)
•• Statins (e.g., atorvastatin, simvastatin) (used for lowering
cholesterol)
•• Benzodiazepines (e.g., midazolam, triazolam) (used for severe
insomnia and stress)
•• Omeprazole (used for treating ulcers)
•• Oral contraceptives (if you take Voriconazole whilst using oral
contraceptives, you may get side effects such as nausea and
menstrual disorders)
•• Vinca alkaloids (e.g., vincristine and vinblastine) (used in
treating cancer)
•• Indinavir and other HIV protease inhibitors (used for treating
HIV)
•• Non-nucleoside reverse transcriptase inhibitors (e.g.,
efavirenz, delavirdine, nevirapine) (used for treating HIV)
(some doses of efavirenz can NOT be taken at the same time
as Voriconazole)
•• Methadone (used to treat heroin addiction)
•• Alfentanil and fentanyl and other short-acting opiates such as
sufentanil (painkillers used for surgical procedures)
•• Oxycodone and other long-acting opiates such as
hydrocodone (used for moderate to severe pain)
•• Non-steroidal anti-inflammatory drugs (e.g., ibuprofen,
diclofenac) (used for treating pain and inflammation)
•• Fluconazole (used for fungal infections)
•• Everolimus (used for treating advanced kidney cancer and in
transplant patients)

Pregnancy and breast-feeding
Voriconazole must not be used during pregnancy, unless indicated
by your doctor. Effective contraception must be used in women
of childbearing potential. Contact your doctor immediately if you
become pregnant while being treated with Voriconazole.
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Driving and using machines
Voriconazole may cause blurring of vision or uncomfortable
sensitivity to light. While affected, do not drive or operate any tools
or machines. Tell your doctor if you experience this.
Voriconazole contains sodium
Each vial of Voriconazole contains 217.6 mg of sodium per vial.
This should be taken into consideration if you are on a strictly
controlled sodium diet.
3. How to use Voriconazole
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
Your doctor will determine your dose depending on your weight
and the type of infection you have.
Your doctor may change your dose depending on your condition.
The recommended dose for adults (including elderly patients) is as
follows:
Dose for the first 24 hours
(Loading Dose)
Dose after the first 24 hours
(Maintenance Dose)

Intravenous
6 mg/kg every 12 hours for the
first 24 hours
4 mg/kg twice a day

Depending on your response to treatment, your doctor may
decrease the dose to 3 mg/kg twice daily.
The doctor may decide to decrease the dose if you have mild to
moderate cirrhosis.
Use in children and adolescents
The recommended dose for children and teenagers is as follows:

Dose for the first
24 hours
(Loading Dose)
Dose after the first
24 hours
(Maintenance Dose)

Intravenous
Children aged 2 to
less than 12 years
and teenagers aged
12 to 14 years
weighing less than
50 kg
9 mg/kg every
12 hours for the
first 24 hours

Teenagers aged
12 to 14 years
weighing 50 kg
or more; and all
teenagers older
than 14
6 mg/kg every
12 hours for the
first 24 hours

8 mg/kg twice a day 4 mg/kg twice a day

Depending on your response to treatment, your doctor may
increase or decrease the daily dose.
Voriconazole powder for solution for infusion will be reconstituted
and diluted to the correct concentration by your hospital
pharmacist or nurse. (Please refer to the end of this leaflet for
further information)
This will be given to you by intravenous infusion (into a vein) at a
maximum rate of 3 mg/kg per hour over 1 to 3 hours.
If you or your child are taking Voriconazole for prevention of fungal
infections, your doctor may stop giving Voriconazole if you or your
child develop treatment related side effects.
If a dose of Voriconazole has been forgotten
As you will be given this medicine under close medical supervision,
it is unlikely that a dose would be missed. However tell your doctor
or pharmacist if you think that a dose has been forgotten.
If you stop taking Voriconazole
Voriconazole treatment will continue for as long as your doctor
advises, however duration of treatment with Voriconazole powder
for solution for infusion should be no more than 6 months.
Patients with a weakened immune system or those with difficult
infections may require long-term treatment to prevent the infection
from returning. You may be switched from the intravenous infusion
to tablets once your condition improves.
When Voriconazole treatment is stopped by your doctor you
should not experience any effects.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If any side effects occur, most are likely to be minor and temporary.
However, some may be serious and need medical attention.
Serious side effects – Stop taking Voriconazole and see a doctor
immediately
- Rash
- Jaundice; Changes in blood tests of liver function

- Pancreatitis
Other side effects
Very common: may affect more than 1 in 10 people
- Visual impairment (change in vision including blurred vision,
visual colour alterations, abnormal intolerance to visual
perception of light, colour blindness, eye disorder, halo vision,
night blindness, swinging vision, seeing sparks, visual aura,
visual acuity reduced, visual brightness, loss of part of the
usual field of vision, spots before the eyes)
- Fever
- Rash
- Nausea, vomiting, diarrhoea
- Headache
- Swelling of the extremities
- Stomach pains
- Breathing difficulties
- Elevated liver enzymes
Common: may affect up to 1 in 10 people
- Inflammation of the sinuses, inflammation of the gums, chills,
weakness
- Low numbers of some types, including severe of red (sometimes
immune-related) and/or white blood cells (sometimes with
fever), low numbers of cells called platelets that help the blood
to clot
- Allergic reaction or exaggerated immune response
- Low blood sugar, low blood potassium, low sodium in the blood
- Anxiety, depression, confusion, agitation, inability to sleep,
hallucinations
- Seizures, tremors or uncontrolled muscle movements, tingling
increase in muscle
or abnormal skin sensations,
tone, sleepiness, dizziness
- Bleeding in the eye
- Heart rhythm problems including very fast heartbeat, very slow
heartbeat, fainting
- Low blood pressure, inflammation of a vein (which may be
associated with the formation of a blood clot)
- Acute breathing difficulty, chest pain, swelling of the face
(mouth, lips and around eyes), fluid accumulation in the lungs
- Constipation, indigestion, inflammation of the lips
- Jaundice, inflammation of the liver and liver injury
- Skin rashes which may lead to severe blistering and peeling of
the skin characterized by a flat, red area on the skin that is
covered with small confluent bumps, redness of the skin
- Itchiness
- Hair loss
- Back pain
- Kidney failure, blood in the urine, changes in kidney function
tests
Uncommon: may affect up to 1 in 100 people
- Flu-like symptoms, irritation and inflammation of the
gastrointestinal tract, inflammation of the gastrointestinal tract
causing antibiotic associated diarrhoea, inflammation of the
lymphatic vessels
- Inflammation of the thin tissue that lines the inner wall of the
abdomen and covers the abdominal organ
- Enlarged lymph glands (sometimes painful), failure of blood
marrow, increased eosinophils Depressed function of the adrenal
gland, underactive thyroid gland
- Abnormal brain function, Parkinson-like symptoms, nerve injury
resulting in numbness, pain, tingling or burning in the hands or
feet
- Problems with balance or coordination
- Swelling of the brain
- Double vision, serious conditions of the eye including: pain and
inflammation of the eyes and eyelids, abnormal eye movement,
damage to the optic nerve resulting in vision impairment, optic
disc swelling
- Decreased sensitivity to touch
- Abnormal sense of taste
- Hearing difficulties, ringing in the ears, vertigo
- Inflammation of certain internal organs- pancreas and
duodenum, swelling and inflammation of the tongue
- Enlarged liver, liver failure, gallbladder disease, gallstones
- Joint inflammation, inflammation of the veins under the skin
(which may be associated with the formation of a blood clot)
- Inflammation of the kidney, proteins in the urine, damage to the
kidney
- Very fast heart rate or skipped heartbeats, sometimes with
erratic electrical impulses
- Abnormal electrocardiogram (ECG)
- Blood cholesterol increased, blood urea increased
- Allergic skin reactions (sometimes severe), including lifethreatening skin condition that causes painful blisters and sores
of the skin and mucous membranes, especially in the mouth,
inflammation of the skin, hives, sunburn or severe skin reaction
following exposure to light or sun, skin redness and irritation,
red or purple discoloration of the skin which may be caused by
low platelet count, eczema
- Infusion site reaction
Rare: may affect up to 1 in 1000 people
- Overactive thyroid gland
- Deterioration of brain function that is a serious complication of
liver disease

- Loss of most fibers in the optic nerve, clouding of the cornea,
involuntary movement of the eye
- Bullous photosensitivity
- A disorder in which the body’s immune system attacks part of
the peripheral nervous system
- Heart rhythm or conduction problems (sometimes life
threatening)
- Life threatening allergic reaction
- Disorder of blood clotting system
- Allergic skin reactions (sometimes severe), including rapid
swelling (oedema) of the dermis, subcutaneous tissue, mucosa
and submucosal tissues, itchy or sore patches of thick, red skin
with silvery scales of skin, irritation of the skin and mucous
membranes, life-threatening skin condition that causes large
portions of the epidermis, the skin’s outermost layer, to detach
from the layers of skin below
- Small dry scaly skin patches, sometimes thick with spikes or
‘horns’
Side effects with frequency not known:
- Freckles and pigmented spots
Other significant side effects whose frequency is not known, but
should be reported to your doctor immediately:
- Skin cancer
- Inflammation of the tissue surrounding the bone
- Red, scaly patches or ring-shaped skin lesions that may be a
symptom of an autoimmune disease called cutaneous lupus
erythematosus
Reactions during the infusion have occurred uncommonly with
Voriconazole (including flushing, fever, sweating, increased heart
rate and shortness of breath). Your doctor may stop the infusion if
this occurs.
As Voriconazole has been known to affect the liver and the kidney,
your doctor should monitor the function of your liver and kidney
by doing blood tests. Please advise your doctor if you have any
stomach pains or if your stools have a different consistency.
There have been reports of skin cancer in patients treated with
Voriconazole for long periods of time.
Sunburn or severe skin reaction following exposure to light
or sun was experienced more frequently in children. If you or
your child develops skin disorders, your doctor may refer you
to a dermatologist, who after consultation may decide that it is
important for you or your child to be seen on a regular basis.
Elevated liver enzymes were also observed more frequently in
children.
If any of these side effects persist or are troublesome, please tell
your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Voriconazole
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the label. The expiry date refers to the last day of that month.
Once reconstituted, Voriconazole should be used immediately, but
if necessary may be stored for up to 24 hours at 2°C - 8°C (in a
refrigerator). Reconstituted Voriconazole needs to be diluted with a
compatible infusion solution first before it is infused. (Please refer
to the end of this leaflet for further information).
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Voriconazole contains
- The active substance is voriconazole.
- The other ingredient is sulfobutylether beta cyclodextrin sodium.
Each vial contains 200 mg voriconazole, equivalent to a 10 mg/
ml solution when reconstituted as
directed by your hospital pharmacist or nurse (see the
information at the end of this leaflet).
What Voriconazole looks like and contents of the pack
Voriconazole is presented in single use glass vials as a powder for
solution for infusion.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Fareva Amboise, Zone Industrielle, 29 Route des Industries, 37530
Pocé-sur-Cisse, France.
This leaflet was last revised in 03/2016.
Ref: dVF 7_0

<-----------------------------------------------------------------------------The following information is intended for medical or healthcare
professionals only:
Reconstitution and Dilution information
•• Voriconazole powder for solution for infusion needs to first be
reconstituted with either 19 ml of Water for Injections or 19
ml of 9 mg/ml (0.9%) Sodium Chloride for Infusion to obtain
an extractable volume of 20 ml of clear concentrate containing
10 mg/ml voriconazole.
•• Discard the Voriconazole vial if the vacuum does not pull the
diluent into the vial.
•• It is recommended that a standard 20 ml (non-automated)
syringe be used to ensure that the exact amount (19.0 ml) of
Water for Injections or of 9 mg/ml (0.9%) Sodium Chloride
for Infusion is dispensed.
•• The required volume of the reconstituted concentrate is then
added to a recommended compatible infusion solution listed
below to obtain a final Voriconazole solution containing 0.5 to
5 mg/ml of voriconazole.
•• This medicinal product is for single use only and any unused
solution should be discarded and only clear solutions without
particles should be used.
•• Not for administration as a bolus injection.
•• For storage information, please refer to Section 5 ‘How to
store Voriconazole’.
Required Volumes of 10 mg/ml Voriconazole Concentrate
Volume of Voriconazole Concentrate (10 mg/ml) required for:
Body
3 mg/ kg 4 mg/ kg 6 mg/ kg 8 mg/ kg 9 mg/ kg
Weight dose
dose
dose
dose
dose
(kg)
(number of (number of (number of (number of (number of
vials)
vials)
vials)
vials)
vials)
10
4.0 ml (1) 8.0 ml (1) 9.0 ml (1)
15
6.0 ml (1) 12.0 ml (1) 13.5 ml (1)
20
8.0 ml (1) 16.0 ml (1) 18.0 ml (1)
25
10.0 ml (1) 20.0 ml (1) 22.5 ml (2)
30
9.0 ml (1) 12.0 ml (1) 18.0 ml (1) 24.0 ml (2) 27.0 ml (2)
35
10.5 ml (1) 14.0 ml (1) 21.0 ml (2) 28.0 ml (2) 31.5 ml (2)
40
12.0 ml (1) 16.0 ml (1) 24.0 ml (2) 32.0 ml (2) 36.0 ml (2)
45
13.5 ml (1) 18.0 ml (1) 27.0 ml (2) 36.0 ml (2) 40.5 ml (3)
50
15.0 ml (1) 20.0 ml (1) 30.0 ml (2) 40.0 ml (2) 45.0 ml (3)
55
16.5 ml (1) 22.0 ml (2) 33.0 ml (2) 44.0 ml (3) 49.5 ml (3)
60
18.0 ml (1) 24.0 ml (2) 36.0 ml (2) 48.0 ml (3) 54.0 ml (3)
65
19.5 ml (1) 26.0 ml (2) 39.0 ml (2) 52.0 ml (3) 58.5 ml (3)
70
21.0 ml (2) 28.0 ml (2) 42.0 ml (3) 75
22.5 ml (2) 30.0 ml (2) 45.0 ml (3) 80
24.0 ml (2) 32.0 ml (2) 48.0 ml (3) 85
25.5 ml (2) 34.0 ml (2) 51.0 ml (3) 90
27.0 ml (2) 36.0 ml (2) 54.0 ml (3) 95
28.5 ml (2) 38.0 ml (2) 57.0 ml (3) 100
30.0 ml (2) 40.0 ml (2) 60.0 ml (3) Voriconazole is a single dose unpreserved sterile lyophile.
Therefore, from a microbiological point of view, the reconstituted
solution must be used immediately. If not used immediately, in-use
storage times and conditions prior to use are the responsibility
of the user and would normally not be longer than 24 hours at
2 to 8°C, unless reconstitution has taken place in controlled and
validated aseptic conditions.
Compatible Infusion Solutions:
The reconstituted solution can be diluted with:
Sodium Chloride 9 mg/ml (0.9%) Solution for Injection
Compound Sodium Lactate Intravenous Infusion
5% Glucose and Lactated Ringer’s Intravenous Infusion
5% Glucose and 0.45% Sodium Chloride Intravenous Infusion
5% Glucose Intravenous Infusion
5% Glucose in 20 mEq Potassium Chloride Intravenous Infusion
0.45% Sodium Chloride Intravenous Infusion
5% Glucose and 0.9% Sodium Chloride Intravenous Infusion
The compatibility of Voriconazole with diluents other than listed
above (or listed below under ‘Incompatibilities’) is unknown.
Incompatibilities:
Voriconazole must not be infused into the same line or cannula
concomitantly with other drug infusions, including parenteral
nutrition (e.g., Aminofusin 10% Plus).
Infusions of blood products must not occur simultaneously with
Voriconazole.
Infusion of total parenteral nutrition can occur simultaneously with
Voriconazole but not in the same line or cannula.
Voriconazole must not be diluted with 4.2% Sodium Bicarbonate
Infusion.

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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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