VORICONAZOLO 200 mg Порошок Для Инъекционного Раствора

Содержание инструкции

1. Voriconazolo Sandoz GmbH 200 mg powder for solution for infusion
   1. What is Voriconazolo Sandoz GmbH and what is it used for
   2. What you need to know before taking Voriconazolo Sandoz GmbH
   3. What you need to know before you take Voriconazolo Sandoz GmbH
   4. Possible side effects
   5. How to store Voriconazolo Sandoz GmbH
   6. Contents of the pack and other information

Voriconazolo Sandoz GmbH 200 mg powder for solution for infusion

Equivalent Medicinal Product

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Voriconazolo Sandoz GmbH is and what it is used for
• 2. What you need to know before you use Voriconazolo Sandoz GmbH
• 3. How to use Voriconazolo Sandoz GmbH
• 4. Possible side effects
• 5. How to store Voriconazolo Sandoz GmbH
• 6. Contents of the pack and other information

1. What is Voriconazolo Sandoz GmbH and what is it used for

Voriconazolo Sandoz GmbH contains the active ingredient voriconazole. Voriconazolo Sandoz GmbH
is an antifungal medicine. It works by killing fungi that cause infections or stopping
their growth.
It is used for the treatment of patients (adults and children over 2 years of age) suffering from:

• invasive aspergillosis (a type of fungal infection caused by species of Aspergillus),
• candidemia (another type of fungal infection caused by species of Candida) in non-neutropenic patients (patients who do not have an unusually low white blood cell count),
• serious and invasive infections caused by species of Candida, when the fungus is resistant to fluconazole (another antifungal medicine),
• serious fungal infections caused by species of Scedosporiumand Fusarium(two different species of fungi).

Voriconazolo Sandoz GmbH is indicated for patients with worsening and potentially life-threatening fungal infections.
Prevention of fungal infections in patients undergoing high-risk bone marrow transplantation.
This medicine should only be used under the supervision of a doctor.

2. What you need to know before taking Voriconazolo Sandoz GmbH

Do not take Voriconazolo Sandoz GmbH:

• 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 recently
taken or might take any other medicine, including those obtained without a prescription
or herbal products.
The medicines listed below should not be used during treatment with
Voriconazolo Sandoz GmbH:

• Terfenadine (used for allergies)
• Astemizole (used for allergies)
• Cisapride (used for stomach problems)
• Pimozide (used for the treatment of mental illnesses)
• Quinidine (used for irregular heartbeat)
• Ivabradine (used for symptoms of chronic heart failure)
• Rifampicin (used for the treatment of tuberculosis)
• Efavirenz (used for the treatment of HIV) in doses equal to or greater than 400 mg once a day
• Carbamazepine (used for the treatment of seizures)
• Phenobarbital (used for severe insomnia and seizures)
• Ergot alkaloids (e.g.: ergotamine, dihydroergotamine; used for migraines)
• Sirolimus (used for patients undergoing transplantation)
• Ritonavir (used for the treatment of HIV) in doses equal to or greater than 400 mg twice a day
• St. John's Wort (herbal supplement)
• Naloxegol (used to treat constipation specifically caused by pain medications, called opioids, (e.g., morphine, oxycodone, fentanyl, tramadol, codeine))
• Tolvaptan (used to treat hyponatremia (low sodium levels in the blood) or to slow the decline of kidney function in patients with polycystic kidney disease)
• Lurasidone (used to treat depression)
• Venetoclax (used to treat patients with chronic lymphocytic leukemia - CLL)

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Voriconazolo Sandoz GmbH
if:

• you have had an allergic reaction to other azoles;
• you suffer from or have suffered from a liver disease. If you suffer from liver disorders, your doctor may prescribe you a lower dose of Voriconazolo Sandoz GmbH. Your doctor must also check your liver function during treatment with Voriconazolo Sandoz GmbH, by means of blood tests;
• you suffer from cardiomyopathy, irregular heartbeat, slowed heartbeat or an alteration in the electrocardiogram (ECG) called “long QT syndrome”.

You must avoid any exposure to the sun and sunlight during treatment. It is important
to cover the areas of skin exposed to the sun and use a sunscreen with a high protection factor
(SPF), as an increased sensitivity of the skin to UV rays from the sun may occur. These
precautions also apply to children.
During treatment with Voriconazolo Sandoz GmbH:

• immediately inform your doctor if you develop sunburn or severe rash or blistering or bone pain

If you develop skin disorders such as those described above, your doctor may prescribe you a visit to a
dermatologist, according to which it may be appropriate to visit you at regular intervals. There is in fact
a small possibility that with long-term use of Voriconazolo Sandoz GmbH, skin cancer may develop.
If you develop signs of "adrenal insufficiency" in which the adrenal glands do not produce
adequate amounts of some steroid hormones such as cortisol, which can lead to symptoms
such as: chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss,
abdominal pain, please inform your doctor.
If you develop signs of 'Cushing's syndrome' where the body produces too much cortisol hormone
which can lead to symptoms such as: weight gain, fat accumulation between the shoulders, a
rounded face, darkening of the skin of the abdomen, thinning of thighs, breasts and arms,
thinning of the skin, easy bruising, high blood sugar, excessive hair growth,
excessive sweating, please inform your doctor.
Your doctor must check liver and kidney function by performing blood tests.

Children and adolescents
Voriconazolo Sandoz GmbH should not be given to children under 2 years of
age.

Other medicines and Voriconazolo Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine, including those obtained without a prescription.

• Some medicines, when taken at the same time as Voriconazolo Sandoz GmbH, may affect the activity of Voriconazolo Sandoz GmbH or Voriconazolo Sandoz GmbH may affect the activity of these medicines.

Tell your doctor if you are taking the following medicine because, if possible, concomitant treatment with Voriconazolo Sandoz GmbH should be avoided:

• Ritonavir (used for the treatment of HIV) at doses of 100 mg twice a day
• Glasdegib (used for the treatment of cancer) - if you need to use both drugs, the doctor will frequently monitor the heart rate

Tell your doctor if you are taking one of the following medicines because, if possible, concomitant treatment with Voriconazolo Sandoz GmbH should be avoided, and a dose adjustment of voriconazole may be necessary:

• Rifabutin (used for the treatment of tuberculosis). If you are already being treated with rifabutin, the blood cell count and the side effects of rifabutin must be monitored.
• Phenytoin (used for the treatment of epilepsy). If you are already being treated with phenytoin, phenytoin concentrations in the blood must be monitored during treatment with Voriconazolo Sandoz GmbH and the dose you are taking may require adjustment.

Tell your doctor if you are taking one of the following medicines, as it may be necessary
to adjust the dose or monitor to verify that these medicines and/or Voriconazolo Sandoz GmbH
continue to have the desired effect:

• Warfarin and other anticoagulants (e.g.: phenprocoumon, acenocoumarol; used to slow down the blood clotting process)
• Cyclosporine (used in patients undergoing transplantation)
• Tacrolimus (used in patients undergoing transplantation)
• Sulfonylureas (e.g.: tolbutamide, glipizide and gliburide) (used for diabetes)
• Statins (for example atorvastatin, simvastatin) (used to lower cholesterol)
• Benzodiazepines (e.g.: midazolam, triazolam) (used for severe insomnia and stress)
• Omeprazole (used for the treatment of ulcers)
• Oral contraceptives (if you take Voriconazolo Sandoz GmbH while using oral contraceptives, you may experience side effects such as nausea and menstrual disorders)
• Vinca alkaloids (e.g. vincristine and vinblastine) (used for the treatment of cancer)
• Tyrosine kinase inhibitors (e.g., axitinib, bosutinib, cabozantinib, ceritinib, Cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (used for the treatment of cancer)
• Tretinoin (used to treat leukemia)
• Indinavir and other HIV protease inhibitors (used for the treatment of HIV)
• Non-nucleoside reverse transcriptase inhibitors (e.g.: efavirenz, delavirdine, nevirapine) (used for the treatment of HIV) - (some doses of efavirenz CANNOT be taken at the same time as Voriconazolo Sandoz GmbH)
• Methadone (used for the treatment of heroin addiction)
• Alfentanil and fentanyl and other short-acting opioids, such as sufentanil (pain relievers used for surgical techniques)
• Oxycodone and other long-acting opioids, such as hydrocodone (used for the treatment of moderate to severe pain)
• Non-steroidal anti-inflammatory drugs (e.g.: ibuprofen, diclofenac) (used for the treatment of pain and inflammation)
• Fluconazole (used for fungal infections)
• Everolimus (used for the treatment of advanced kidney cancer and in patients undergoing transplantation)
• Letermovir (used to prevent cytomegalovirus (CMV) disease after bone marrow transplantation)
• Ivacaftor: used for the treatment of cystic fibrosis.
• Flucloxacillin (antibiotic used against bacterial infections)

Pregnancy and breastfeeding
Voriconazolo Sandoz GmbH should not be used during pregnancy unless
decided by your doctor. Women of childbearing potential must use adequate contraception.
Contact your doctor immediately if you become pregnant during treatment with Voriconazolo
Sandoz GmbH.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Voriconazolo Sandoz GmbH may cause blurred vision or a bothersome sensitivity to
light. If this happens, you should not drive and should not use tools or machinery. Contact
your doctor in these cases.

Voriconazolo Sandoz GmbH contains sodium and sulfobutylether beta cyclodextrin sodium
This medicine contains 228.7 mg of sodium (the main component of table salt) in each
vial. This is equivalent to 11.4% of the recommended daily intake of sodium for
an adult diet.
This medicine contains 3.4 g of sulfobutylether beta cyclodextrin sodium in each vial.
If you have a kidney condition, you should tell your doctor before taking this medicine.

3. What you need to know before you take Voriconazolo Sandoz GmbH

Take this medicine exactly as your doctor has told you. If you have any doubts
ask your doctor.
The doctor will determine the appropriate dose for you based on your weight and the type of infection you have.
The doctor may adjust the dose based 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
Based on the response to treatment, the doctor may decrease the dose to 3 mg/kg twice a day.
The doctor may decide to reduce the dose if you have mild to moderate cirrhosis.

Use in children and adolescents
The recommended dose in children and adolescents is as follows:

Intravenous route
Children aged between 2
and less than 12 years and
adolescents aged between
12 and 14 years weighing
less than 50 kg
Adolescents aged between
12 and 14
years and weighing 50 kg or more;
all adolescents over 14 years of age

Dose for the first 24 hours
(Loading dose)
9 mg/kg every 12 hours for the
first 24 hours
6 mg/kg every 12 hours for the
first 24 hours

Dose after the first 24 hours
(Maintenance dose)
8 mg/kg twice a day 4 mg/kg twice a day
Based on the response to treatment, the doctor may increase or decrease the daily dose.
Voriconazolo Sandoz GmbH powder for solution for infusion must be reconstituted and diluted
by the pharmacist or the hospital nurse to obtain the correct concentration. (For
The medicine will be given to you by intravenous infusion (into a vein) at a maximum
infusion rate of 3 mg/kg per hour, over 1-3 hours.
If you or your child are taking Voriconazolo Sandoz GmbH for the prevention of
fungal infections, your doctor may decide to stop giving Voriconazolo
Sandoz GmbH if you or your child develop side effects related to the treatment.

If you forget to take a dose of Voriconazolo Sandoz GmbH
Because you will receive this medicine under close medical supervision, it is unlikely that a dose will be missed.
However, if you think a dose has been forgotten, tell your doctor or pharmacist.

If you stop taking Voriconazolo Sandoz GmbH
Treatment with Voriconazolo Sandoz GmbH will continue for as long as your doctor has prescribed;
however, the duration of treatment with Voriconazolo Sandoz GmbH powder for solution for
infusion should not exceed 6 months.
Patients with a weakened immune system or those who have infections that are difficult to
treat may require long-term treatment to prevent the infection from returning.
When your condition improves, you may switch from intravenous treatment to treatment
with tablets.
When treatment with Voriconazolo Sandoz GmbH is stopped at the doctor's decision,
no effects should occur.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If side effects occur, most of them will likely be mild and transient. However, some may be serious and require medical attention.

Serious side effects – Stop using Voriconazolo Sandoz GmbH and consult your doctor
immediately

• Skin rash
• Jaundice; Alteration of liver function tests
• Pancreatitis

Other side effects
Very common(may affect more than 1 in 10 people):

• Impaired vision (altered vision including blurred vision, altered color vision, abnormal intolerance to visual perception of light, color blindness, eye pathology, halo vision, night blindness, oscillating vision, visual sparks, visual aura, reduced visual acuity, visual brightness, partial loss of visual field, spots in front of the eyes)
• Fever
• Skin rashes
• Nausea, vomiting, diarrhea
• Headache
• Swelling of the extremities
• Stomach pain
• Difficulty breathing
• Elevated liver enzymes

Common:(may affect up to 1 in 10 people)

• Inflammation of the paranasal sinuses, inflammation of the gums, chills, fatigue
• Reduction, even severe, in the number of some types of red blood cells (sometimes immune-related) and/or white blood cells (sometimes with fever), reduction in the number of blood cells called platelets that help blood clotting
• Low blood sugar levels, low blood potassium levels, low blood sodium levels
• Anxiety, depression, confusion, agitation, sleep disorders, hallucinations
• Convulsions, tremor or uncontrolled muscle movements, tingling or abnormal skin sensations, increased muscle tone, drowsiness, 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 difficulty breathing, chest pain, swelling of the face (mouth, lips and around the eyes), fluid accumulation in the lungs
• Constipation, indigestion, inflammation of the lips
• Jaundice, inflammation of the liver and liver damage
• Skin rash that may involve blistering and severe skin peeling, characterized by a flat and reddened area of skin with small confluent bumps, skin redness
• Itching
• Hair loss
• Back pain
• Kidney failure, blood in the urine, altered 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 that can cause antibiotic-associated diarrhea, inflammation of the lymphatic vessels
• Inflammation of the thin tissue lining the inner wall of the abdomen and covering the abdominal organ.
• Enlarged lymph nodes (sometimes painful), bone marrow failure, increased eosinophils
• Reduced function of the adrenal glands, reduced activity of the thyroid gland
• Changes in brain function, Parkinson's-like symptoms, nerve damage resulting in numbness, pain, tingling or burning in the hands or feet
• Problems with balance or coordination
• Brain edema
• Double vision, serious eye conditions including: eye and eyelid pain and inflammation, abnormal eye movement, damage to the optic nerve with impaired vision, swelling of the optic disc
• Reduced sensitivity to touch
• Altered taste
• Inflammation of some internal organs, pancreas and duodenum, swelling and inflammation of the tongue
• Enlarged liver, liver failure, gallbladder diseases, gallstones
• Inflammation of the joints, inflammation of the superficial veins (which may be associated with the formation of blood clots)
• Inflammation of the kidneys, presence of protein in the urine, kidney damage
• Very fast heart rate or missed beats, sometimes with irregular electrical impulses
• Altered electrocardiogram (ECG)
• Increased cholesterol, increased blood urea
• Allergic skin reactions (sometimes severe) including a potentially life-threatening skin condition causing blisters and painful sores on the skin and mucous membranes, especially in the mouth, skin inflammation, urticaria, sunburn or severe skin reaction following exposure to light or sun, redness and irritation of the skin, reddish or purplish discoloration of the skin that may be caused by a low platelet count, eczema
• Infusion site reaction

Rare:(may affect up to 1 in 1000 people)

• Hyperactive thyroid gland
• Deterioration of brain function leading to a serious complication of liver disease
• Loss of much of the optic nerve fibers, corneal opacity, involuntary eye movement
• Bullous photosensitivity
• Disorder in which the body's immune system attacks part of the peripheral nervous system
• Heart rhythm or conduction problems (sometimes fatal)
• Potentially life-threatening allergic reaction
• Coagulation system disorders
• Allergic skin reactions (sometimes severe), including rapid swelling (edema) of the dermis, subcutaneous tissue, mucous membranes and submucosal tissues, itchy or painful patches of thickened skin, red skin with silvery scales, skin and mucous membrane irritation, a potentially life-threatening skin condition causing detachment of large areas of the epidermis, the outer layer of skin, from the underlying skin layers
• Small patches of dry, scaly skin, sometimes thick with bumps or ‘horns’

Side effects with unknown frequency:

• Freckles and pigmented spots

Other significant side effects, whose frequency is unknown but which should be reported
immediately to the doctor are:

• Skin cancer
• Inflammation of the tissues surrounding the bones
• Red, scaly or ring-shaped skin lesions that may be symptoms of an autoimmune disease called systemic lupus erythematosus

Injection site reactions have occurred uncommonly, with Voriconazolo
Sandoz GmbH (including hot flashes, fever, sweating, increased heart rate
and shortness of breath). If this occurs, the doctor may decide to stop the infusion.
Because Voriconazolo Sandoz GmbH is known to have effects on the liver and kidneys, the doctor
must monitor liver and kidney function by performing blood tests. Inform your doctor
if you have stomach pain or if your stools have a different consistency than usual.
In patients treated with Voriconazolo Sandoz GmbH for long periods of time, skin tumors have been
reported.
Sunburn or a severe skin reaction following exposure to light or sun has been
reported more frequently in children. If you or your child develops skin disorders, your doctor may refer you/them to a dermatologist who can decide whether it is
important for you or your child to continue regular visits with the dermatologist. Elevated
liver enzymes have also been observed more frequently in children.
If any of these side effects persist or are bothersome, tell your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Voriconazolo Sandoz GmbH

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 and on the package
after the words “Exp”. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
After reconstitution of the solution:
The chemical and physical stability in use of the reconstituted solution has been demonstrated for 24 hours at 2°C-
8°C.
After dilution of the infusion solution:
The chemical and physical stability of the diluted infusion solution has been demonstrated for 3 hours at 20°C-
30°C.
From a microbiological point of view, once reconstituted, the product must be used
immediately. If not used immediately, the storage times and
conditions prior to use are the responsibility of the user and normally do not exceed 24
hours at 2°C-8°C (in a refrigerator), unless the reconstitution has taken place under controlled and validated aseptic conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Voriconazolo Sandoz GmbH contains

• The active ingredient is voriconazole. Each vial contains 200 mg of powder for solution for infusion, equivalent to 10 mg/ml of solution when reconstituted as directed by the hospital pharmacist or nurse (see information at the end of this leaflet).
• The other component is sulfobutylether beta cyclodextrin sodium.

Description of the appearance of Voriconazolo Sandoz GmbH and contents of the pack
Single-use, colorless type I glass vials, closed with lyophilized rubber stoppers and sealed with
aluminum flip-off closures with a plastic disc and inserted into a cardboard box.
Pack sizes:
1, 5, 10 vials in the form of powder for solution for infusion.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Gmbh
Biochemiestrasse, 10
6250 Kundl – Austria
Representative for Italy:
Sandoz SpA
Largo U. Boccioni, 1

• 21040 – Origgio (VA)

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
Sachsen-Anhalt, 39179 Barleben
Germany

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following denominations:
Netherlands
Voriconazol Sandoz 200 mg, powder
for solution for infusion
Austria
Voriconazol Sandoz 200 mg –
Powder for the preparation of an
infusion solution
Belgium Voriconazol Sandoz 200 mg powder
for solution for infusion
Bulgaria
Voriconazole Sandoz 200mg Powder
for solution for infusion
Czech Republic
Vorikonazol Sandoz 200 mg powder
for infusion solution
Voriconazol HEXAL 200 mg Powder
for the preparation of an
infusion solution
ENR 2189283
Denmark Voriconazole Sandoz
Greece Voriconazole /Sandoz
Germany
Spain
Voriconazol Sandoz 200 mg powder
for solution for perfusion EFG
France
Voriconazole Sandoz 200 mg,
powder for solution for
perfusion
Ireland
VoriconazoleRowex 200mg Powder
for Solution for Infusion
Croatia
Vorikonazol Sandoz 200 mg powder
for solution for infusion
Italy Voriconazolo Sandoz Gmbh
Luxembourg
Voriconazol Sandoz 200 mg powder
for solution for perfusion
Norway Voriconazole Sandoz
Poland Voriconazole Sandoz
Portugal Voriconazol Sandoz
Romania
Voriconazol Sandoz 200 mg powder
for perfusable solution
Slovenia
Vorikonazol Sandoz 200 mg powder
for infusion solution
Slovakia
Vorikonazol Sandoz 200 mg powder
for infusion solution
The following information is intended exclusively for physicians or healthcare professionals:

Information on Reconstitution and Dilution

• Voriconazolo Sandoz GmbH powder for solution for infusion must first be reconstituted with 19 ml of water for injections or with 19 ml of a Sodium Chloride 9 mg/ml (0.9%) solution for infusion, to obtain a drawable volume of 20 ml of a clear concentrate, containing 10 mg/ml of voriconazole.
• If the vacuum does not draw the diluent into the Voriconazolo Sandoz GmbH vial, discard the vial.
• It is recommended to use a standard 20 ml syringe (non-automatic) to ensure delivery of the exact amount (19.0 ml) of water for injections or of the Sodium Chloride 9 mg/ml (0.9%) solution for infusion.
• The required volume of reconstituted concentrate is then added to one of the compatible infusion solutions listed below, to obtain a final voriconazole solution containing 0.5-5 mg/ml of voriconazole.
• This medicinal product is for single use only and any solution not used must be discarded; only clear solutions free from particles must be used.
• Not indicated for administration as a bolus injection.
• For information on storage, see section 5, “How to store Voriconazolo Sandoz GmbH”.

Required Volumes of Voriconazole Concentrate 10 mg/ml
Volume of Voriconazole Concentrate (10 mg/ml) required for:
Dose of 3
mg/kg
(number of
vials)
Body
weight
(kg)
Dose of 9
mg/kg
(number 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) - -

Voriconazole is a sterile, single-dose, preservative-free lyophilised powder. Therefore, from a
microbiological point of view, the reconstituted solution must be used immediately. If not used
immediately, storage times and conditions prior to use are the responsibility of the user and
generally do not exceed 24 hours at 2°C-8°C, unless reconstitution has taken place under
controlled and validated aseptic conditions.

Dose of 4
mg/kg
(number of
vials)
Dose of 6
mg/kg
(number of
vials)
Dose of 8
mg/kg
(number of
vials)
Compatible Infusion Solutions
The reconstituted solution can be diluted with:
Sodium Chloride 9 mg/ml (0.9%) Solution for Infusion
Sodium Lactate Compound Solution for Intravenous Infusion
Glucose 5% and Ringer Lactate for Intravenous Infusion
Glucose 5% and Sodium Chloride 0.45% for Intravenous Infusion
Glucose 5% for Intravenous Infusion
Glucose 5% in 20 mEq of Potassium Chloride for Intravenous Infusion
Sodium Chloride 0.45% for Intravenous Infusion
Glucose 5% and Sodium Chloride 0.9% for Intravenous Infusion
The compatibility of Voriconazolo Sandoz GmbH with diluents other than those described above (or
listed below, in the section “Incompatibilities”) is not known.
Incompatibilities:
The solution of Voriconazolo Sandoz GmbH must not be infused in the same line or cannula
together with other infusion drugs including parenteral nutrition (e.g. Aminofusin
10% Plus).
Blood product infusions must not be administered simultaneously with the
administration of Voriconazolo Sandoz GmbH.
Total parenteral nutrition infusion can be administered simultaneously with the
administration of Voriconazolo Sandoz GmbH, but not in the same line or cannula.
Voriconazolo Sandoz GmbH must not be diluted with Sodium Bicarbonate 4.2% infusion.