Package leaflet: Information for the user

Voriconazole Sandoz GmbH 200 mg powder for solution for infusion

Generic medicine
Please read all of this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Voriconazole Sandoz GmbH is and what it is used for
What you need to know before using Voriconazole Sandoz GmbH
How to use Voriconazole Sandoz GmbH
Possible side effects
How to store Voriconazole Sandoz GmbH
Contents of the pack and other information

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

Voriconazolo Sandoz GmbH contains the active substance voriconazole. Voriconazolo Sandoz GmbH is an antifungal medicine. It works by killing the fungi that cause infections or by stopping their growth.
It is used to treat patients (adults and children over 2 years of age) who have:

invasive aspergillosis (a type of fungal infection caused by species of Aspergillus),
candidaemia (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 Scedosporium and Fusarium (two different species of fungi).

Voriconazolo Sandoz GmbH is indicated for patients with progressive and potentially life-threatening fungal infections.
Prevention of fungal infections in high-risk bone marrow transplant patients.
This medicine should only be used under the supervision of a physician.
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2. What you should know before taking Voriconazolo Sandoz GmbH

Do not take Voriconazolo Sandoz GmbH:

if you are allergic to the active substance 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 currently taking, have recently taken, or might take any other medicines, including those obtained without a prescription or herbal products.
The following medicines must not be used during treatment with Voriconazolo Sandoz GmbH:

Terfenadine (used for allergies)
Astemizole (used for allergies)
Cisapride (used for stomach problems)
Pimozide (used to treat mental illnesses)
Quinidine (used for irregular heartbeat)
Ivabradine (used for symptoms of chronic heart failure)
Rifampicin (used to treat tuberculosis)
Efavirenz (used to treat HIV) at doses equal to or greater than 400 mg 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 to treat HIV) at doses equal to or greater than 400 mg twice daily
St. John’s Wort (herbal supplement)
Naloxegol (used to treat constipation specifically caused by pain medicines 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 in kidney function in patients with polycystic kidney disease)
Lurasidone (used to treat depression)
Finerenone (for the treatment of chronic kidney disease)
Eplerenone (for the treatment of heart and/or blood vessel problems)
Voclosporin (for the treatment of immune system disorders)
Venetoclax (used to treat patients with chronic lymphocytic leukemia - CLL)

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

you have had an allergic reaction to other azoles;
you suffer or have suffered from liver disease. If you have liver problems, your doctor may prescribe a lower dose of Voriconazolo Sandoz GmbH. Your doctor should also monitor your liver function during treatment with Voriconazolo Sandoz GmbH through blood tests;

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you suffer from cardiomyopathy, irregular heartbeat, slow heartbeat, or an abnormality on the electrocardiogram (ECG) called "long QTc syndrome".

You must avoid any exposure to sunlight and UV light during treatment. It is important to cover exposed skin areas and use sunscreen with a high sun protection factor (SPF), as increased sensitivity of the skin to UV light may occur. This risk may be further increased by other medicines that make the skin more sensitive to sunlight, such as methotrexate. These precautions also apply to children.
During treatment with Voriconazolo Sandoz GmbH:

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

If you develop skin disorders such as those described above, your doctor may refer you to a dermatologist, who may recommend regular follow-up examinations. Indeed, there is a small possibility that long-term use of Voriconazolo Sandoz GmbH may lead to the development of skin cancer.
If you develop signs of "adrenal insufficiency", in which the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol, which may lead to symptoms such as: chronic or prolonged 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 may lead to symptoms such as: weight gain, fat accumulation between the shoulders, a rounded face, darkening of the abdominal skin, 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 should monitor liver and kidney function through blood tests.
Children and adolescents
Voriconazolo Sandoz GmbH must not be administered to children under 2 years of age.
Other medicines and Voriconazolo Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines, when taken together with Voriconazolo Sandoz GmbH, may affect the activity of Voriconazolo Sandoz GmbH, or Voriconazolo Sandoz GmbH may affect the activity of these medicines.

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

Ritonavir (used to treat HIV) at doses of 100 mg twice daily
Glasdegib (used to treat cancer) – if you need to use both medicines, your doctor will frequently monitor your heart rhythm

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

Rifabutin (used to treat tuberculosis). If you are already being treated with rifabutin, blood cell counts and side effects of rifabutin should be closely monitored.
Phenytoin (used to treat epilepsy). If you are already being treated with phenytoin, blood levels of phenytoin should be monitored during treatment with Voriconazolo Sandoz GmbH, and your dose may require adjustment.

Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be necessary to ensure these medicines and/or Voriconazolo Sandoz GmbH remain effective:

Warfarin and other anticoagulants (e.g.: phenprocoumon, acenocoumarol; used to slow down the blood clotting process)
Cyclosporine (used in transplant patients)
Tacrolimus (used in transplant patients)
Sulfonylureas (e.g.: tolbutamide, glipizide, glyburide) (used for diabetes)
Statins (e.g., atorvastatin, simvastatin) (used to reduce cholesterol)
Benzodiazepines (e.g.: midazolam, triazolam) (used for severe insomnia and anxiety)
Omeprazole (used to treat ulcers)
Oral contraceptives (if you take Voriconazolo Sandoz GmbH while using oral contraceptives, you may experience side effects such as nausea and menstrual disturbances)
Vinca alkaloids (e.g., vincristine, vinblastine) (used to treat cancer)
Tyrosine kinase inhibitors (e.g., axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (used to treat cancer)
Tretinoin (used to treat leukemia)
HIV protease inhibitors (e.g., indinavir) (used to treat HIV)
Non-nucleoside reverse transcriptase inhibitors (e.g.: efavirenz, delavirdine, nevirapine) (used to treat HIV) – (some doses of efavirenz cannot be taken together with Voriconazolo Sandoz GmbH)
Methadone (used to treat heroin addiction)
Alfentanil and fentanyl and other short-acting opioids such as sufentanil (analgesics used in surgical procedures)
Oxycodone and other long-acting opioids such as hydrocodone (used to treat moderate to severe pain)
Non-steroidal anti-inflammatory drugs (e.g.: ibuprofen, diclofenac) (used to treat pain and inflammation)
Fluconazole (used for fungal infections)
Everolimus (used to treat advanced renal cell carcinoma and in transplant patients)
Letermovir (used to prevent cytomegalovirus (CMV) disease after bone marrow transplantation)
Ivacaftor: used to treat cystic fibrosis.

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Flucloxacillin (an antibiotic used against bacterial infections)

Pregnancy and breastfeeding
Voriconazolo Sandoz GmbH must not be used during pregnancy unless specifically decided by your doctor. Women of childbearing potential must use an adequate contraceptive method.
Contact your doctor immediately if you become pregnant during treatment with Voriconazolo Sandoz GmbH.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Voriconazolo Sandoz GmbH may cause blurred vision or increased sensitivity to light. In such cases, you must not drive and must not operate tools or machinery. In these cases, contact your doctor.
Voriconazolo Sandoz GmbH contains sodium and sulfobutylether beta cyclodextrin sodium
This medicine contains 228.7 mg of sodium (a main component of table salt) per vial. This corresponds to 11.4% of the maximum daily sodium intake recommended in a normal adult diet.
This medicine contains 3.4 g of sulfobutylether beta cyclodextrin sodium per vial.
If you have kidney disease, you must inform your doctor before taking this medicine.

3. What you should know before taking Voriconazole Sandoz GmbH

Take this medicine exactly as your doctor has told you. If you have any doubts,
consult your doctor.
Your doctor will determine the appropriate dose for you based on your body weight and the type of infection you have.
Your doctor may adjust the dose according to your condition.
The recommended dose for adults (including elderly patients) is as follows:
Intravenous
Dose for the first 24 hours
6 mg/kg every 12 hours for the first 24 hours
(Loading dose)
Dose after the first 24 hours
4 mg/kg twice daily
(Maintenance dose)
Depending on your response to treatment, your doctor may reduce the dose to 3 mg/kg twice daily.
Your 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
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	Children aged 2 to less than 12 years and adolescents aged 12 to 14 years with body weight below 50 kg	Adolescents aged 12 to 14 years with body weight equal to or greater than 50 kg; all adolescents aged over 14 years
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 daily	4 mg/kg twice daily

Depending on the response to treatment, your doctor may increase or decrease the daily dose.
Voriconazolo Sandoz GmbH powder for solution for infusion must be reconstituted and diluted by a pharmacist or hospital nurse to obtain the correct concentration. (For further information, see the final section of the package leaflet).
The medicine will be administered to you by intravenous infusion (into a vein) at a maximum infusion rate of 3 mg/kg per hour, over a period of 1 to 3 hours.
If you or your child are taking Voriconazolo Sandoz GmbH to prevent fungal infections, your doctor may decide to discontinue administration of Voriconazolo Sandoz GmbH if you or your child develop treatment-related adverse effects.

If you forget a dose of Voriconazolo Sandoz GmbH
Since you will receive this medicine under strict medical supervision, it is unlikely that a dose will be missed. However, if you think a dose has been missed, inform your doctor or pharmacist.

If you stop treatment with Voriconazolo Sandoz GmbH
Treatment with Voriconazolo Sandoz GmbH will continue for as long as your doctor prescribes; however, the duration of treatment with Voriconazolo Sandoz GmbH powder for solution for infusion must not exceed 6 months.
Patients with a weakened immune system or those with difficult-to-treat infections may require long-term treatment to prevent the infection from recurring.
When your condition improves, you may switch from intravenous treatment to tablets.
When treatment with Voriconazolo Sandoz GmbH is discontinued on the doctor’s decision, no adverse effect should occur.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everyone gets them.
If side effects occur, most of these will probably be minor and temporary. However, some may be serious and require immediate medical attention.
Serious side effects – Stop using Voriconazole Sandoz GmbH and consult your doctor
immediately

Rash
Jaundice; abnormal liver function tests
Pancreatitis

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

Visual disturbances (including blurred vision, altered colour vision, abnormal tolerance to light perception, colour blindness, eye disorders, seeing halos, night blindness, oscillating vision, seeing sparks, visual aura, reduced visual acuity, visual brightness, partial loss of visual field, spots in front of the eyes)
Fever
Skin rashes
Nausea, vomiting, diarrhoea
Headache
Swelling of extremities
Stomach pain
Difficulty breathing
Elevated liver enzymes

Common – may affect up to 1 in 10 people:

Sinus inflammation, gum inflammation, chills, fatigue
Decrease, sometimes severe, in the number of certain types of red blood cells (sometimes immune-mediated) 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
Seizures, 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 blood clot formation)
Acute breathing difficulty, chest pain, facial swelling (mouth, lips and around the eyes), fluid accumulation in the lungs
Constipation, indigestion, inflammation of the lips

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Jaundice, liver inflammation and liver damage
Skin rash which may lead to severe blistering and peeling of the skin, characterised by a flat, red area of skin with small merging bumps, skin redness
Itching
Hair loss
Back pain
Kidney failure, blood in urine, abnormal kidney function tests
Sunburn or severe skin reaction following exposure to light or sunlight
Skin cancer

Uncommon – may affect up to 1 in 100 people:

Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, gastrointestinal inflammation which may cause antibiotic-associated diarrhoea, inflammation of lymphatic vessels
Inflammation of the thin tissue lining the abdominal wall and covering abdominal organs
Enlarged lymph nodes (sometimes painful), bone marrow failure, increased eosinophils
Reduced adrenal gland function, reduced thyroid gland activity
Changes in brain function, Parkinson-like symptoms, nerve damage leading to numbness, pain, tingling or burning in hands or feet
Problems with balance or coordination
Brain oedema
Double vision, serious eye conditions including: eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage with visual impairment, swelling of the optic disc
Reduced sensitivity to touch
Altered taste
Inflammation of certain internal organs, pancreas and duodenum, swelling and inflammation of the tongue
Enlarged liver, liver failure, gallbladder diseases, gallstones
Joint inflammation, inflammation of subcutaneous veins (which may be associated with blood clot formation)
Kidney inflammation, presence of protein in urine, kidney damage
Very fast heartbeat or missed beats, sometimes with irregular electrical impulses
Abnormal electrocardiogram (ECG)
Increased cholesterol, increased blood urea
Allergic skin reactions (sometimes severe), including potentially life-threatening skin condition causing blisters and painful sores of the skin and mucous membranes, especially in the mouth, skin inflammation, hives, redness and irritation of the skin, red or purplish skin discolouration which may be caused by low platelet count, eczema
Infusion site reaction
Inflammation of tissues surrounding the bones

Rare – may affect up to 1 in 1,000 people:
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Overactive thyroid gland
Deterioration of brain function leading to a serious complication of liver disease
Loss of most of the optic nerve fibres, 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 disorders
Allergic skin reactions (sometimes severe), including rapid swelling (oedema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues, itchy or painful thickened skin patches, red skin with silvery scales, skin and mucous membrane irritation, potentially life-threatening skin condition causing detachment of large portions of the epidermis, the outer layer of skin, from the underlying skin layers
Small patches of dry, scaly skin, sometimes thickened with tips or 'horns'

Side effects with frequency not known:

Freckles and pigmented spots

Other significant side effects, whose frequency is not known but which should be reported
immediately to your doctor, are:

Red, scaly patches or ring-shaped skin lesions which could be symptoms of an autoimmune disease called systemic lupus erythematosus

Injection site reactions have occurred uncommonly with Voriconazole Sandoz GmbH (including hot flushes, fever, sweating, increased heart rate and breathlessness). If this occurs, your doctor may decide to stop the infusion.
Since Voriconazole Sandoz GmbH is known to affect the liver and kidneys, your doctor should monitor liver and kidney function through blood tests. Inform your doctor if you have stomach pain or if your stools are different from normal.
In patients treated with Voriconazole Sandoz GmbH for long periods, cases of skin cancer have been reported.
Sunburn or a severe skin reaction following exposure to light or sunlight has been reported more frequently in children. If you or your child develops skin problems, your doctor may refer you to a dermatologist, who may decide whether regular follow-up visits are necessary. Elevated liver enzymes have also been observed more frequently in children.
If any of these side effects persist or are bothersome, inform your doctor.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects
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directly via 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 Voriconazole Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the outer packaging after the word “Exp”. The expiry date refers to the last day of that month.
Store below 30°C.

After reconstitution of the solution:
The chemical and physical in-use stability 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 standpoint, once reconstituted, the product should be used immediately. If not used immediately, the storage duration and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2°C–8°C (refrigerated), unless reconstitution has taken place under controlled and validated aseptic conditions.

For further information, please refer to the concluding section of the package leaflet.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Voriconazolo Sandoz GmbH Contains

The active substance 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 caps with plastic discs, packed in cardboard boxes.
Pack sizes:
1, 5, or 10 vials of powder for solution for infusion.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse, 10
6250 Kundl – Austria
Representative in Italy:
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

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 authorized in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following names:
Voriconazol Sandoz 200 mg, poeder
Netherlands
voor oplossing voor infusie
Voriconazole Sandoz 200 mg Powder
Bulgaria
for solution for infusion
Voriconazol HEXAL 200 mg Pulver
zur Herstellung einer
Germany
Infusionslösung
ENR 2189283
Vorikonazol Sandoz 200 mg prašak
Croatia
za otopinu za infuziju
Italy Voriconazolo Sandoz GmbH
Poland Voriconazole Sandoz
Vorikonazol Sandoz 200 mg prašek
Slovenia
za raztopino za infundiranje
Vorikonazol Sandoz 200 mg prášok
Slovakia
na infúzny roztok

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 9 mg/ml (0.9%) Sodium Chloride for Infusion solution to obtain an extractable volume of 20 ml of a clear, concentrated solution containing 10 mg/ml of voriconazole.
If the vacuum does not draw the diluent into the vial, discard the vial.
A standard 20 ml syringe (non-automatic) is recommended to ensure accurate delivery of the required volume (19.0 ml) of Water for Injections or 9 mg/ml (0.9%) Sodium Chloride for Infusion solution.
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 medicine is for single use only; any unused solution must be discarded. Only clear, particle-free solutions should be used.
Not intended for administration as a bolus injection.
For storage information, 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:
Body Weight Dose 3 mg/kg Dose 4 mg/kg Dose 6 mg/kg Dose 8 mg/kg Dose 9 mg/kg
(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 sterile, single-dose lyophilized product without preservatives. Therefore, from a microbiological standpoint, the reconstituted solution should 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, unless reconstitution has been carried out under controlled and validated aseptic conditions.

Compatible Infusion Solutions
The reconstituted solution may be diluted with:
Sodium Chloride 9 mg/ml (0.9%) Solution for Infusion
Sodium Lactate Compound 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% with 20 mEq 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 under "Incompatibilities") is unknown.

Incompatibilities:
The solution of Voriconazolo Sandoz GmbH must not be infused through the same line or cannula together with other infusion drugs, including parenteral nutrition (e.g., Aminofusin 10% Plus).
Blood component infusions must not be administered simultaneously with Voriconazolo Sandoz GmbH.
Total parenteral nutrition infusion may be administered simultaneously with Voriconazolo Sandoz GmbH, but not through the same line or cannula.
Voriconazolo Sandoz GmbH must not be diluted with 4.2% Sodium Bicarbonate infusion.