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VORICONAZOLE 200 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): VORICONAZOLE

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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.
• 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 nonneutropenic 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 life-threatening, 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

• I f you are allergic to the active ingredient
voriconazole, or any of the other
ingredients of this medicine (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 course of
voriconazole treatment:














T erfenadine (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:
• y ou 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 heartbeat, slow heart rate or an
abnormality of electrocardiogram (ECG)
called ‘long QTc syndrome’.

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:
• R
 ifabutin (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:
• W
 arfarin 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.

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:
Intravenous
Dose for the first
24 hours (Loading Dose)

6 mg/kg every
12 hours
for the first
24 hours

Dose after the first
24 hours (Maintenance
Dose)

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:

TBC

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.
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:
• R
 itonavir (used for treating HIV) in doses
of 100 mg twice daily

TBC

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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

Intravenous
Children aged Teenagers
2 to less than aged 12 to
12 years and
14 years
teenagers aged weighing
12 to 14 years 50 kg or
weighing less more;
than 50 kg
and all
teenagers
older than
14
9 mg/kg every 6 mg/kg
12 hours
every
for the first
12 hours
24 hours
for the first
24 hours
8 mg/kg twice 4 mg/kg
a day
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.

The following information is intended for healthcare professionals only:

Instructions for use
Reconstitution and Dilution information

• V
 oriconazole 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:
3 mg/kg
4 mg/kg
6 mg/kg
8 mg/kg
9 mg/kg
Body
dose (number dose (number dose (number dose (number dose (number
Weight (kg) of vials)
of vials)
of vials)
of vials)
of 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)
-

Description Voriconazole 200 mg 1
Component Type LeafletInsert
Affiliate Item Code 844678
Superceded Affiliate Item Code 812426
TrackWise PR No. 844678
MA No. PL 04569/1639
Packing Site/Printer N/A
Supplier Code PR844678

Date: 14 MAR 2016

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 276229
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

1

Time: 15:47
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 150 x 888 mm

Body Text Size 9.5 pt
Min Text Size used 9.5 pt

Sign-offs

v1/May 2015

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

• R
 ash
• J aundice; 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 color
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 immunerelated) 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 or abnormal skin
sensations, increase in muscle 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

TBC

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 eosinophil
• Depressed function of the adrenal gland,
underactive thyroid gland
• Abnormal brain function, Parkinsonlike 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 organspancreas 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 life-threatening 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, lifethreatening 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, 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

TBC

If you stop taking 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.
This medicine does not require any
special storage conditions before
reconstitution.
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

• T he active substance is voriconazole.
• The other ingredients are
hydroxypropylbetadex and lactose
monohydrate.
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
Each carton of Voriconazole consists of
one 30 ml vial.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL

Manufacturer(s)

Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania
C/ Castelló nº1, Pol. Las Salinas
08830 Sant Boi de Llobregat, Barcelona
Spain

This leaflet was last approved in
March 2016

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
Lactated Ringer’s 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.

PR844678 / 844678

Description Voriconazole 200 mg 1
Component Type LeafletInsert
Affiliate Item Code 844678
Superceded Affiliate Item Code 812426
TrackWise PR No. 844678
MA No. PL 04569/1639
Packing Site/Printer N/A
Supplier Code PR844678

Date: 14 MAR 2016

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 276229
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

1

Time: 15:47
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 150 x 888 mm

Body Text Size 9.5 pt
Min Text Size used 9.5 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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