Voriconazole fresenius kabi

Poland
Brand name Voriconazole fresenius kabi
Form solution for infusion, powder for preparation of
Active substance / Dosage
voriconazole · 200 mg
Prescription type Prescription only
ATC code
Registration number 100351682
Voriconazole fresenius kabi solution for infusion, powder for preparation of

Package leaflet: Information for the user

Voriconazole Fresenius Kabi, 200 mg, powder for solution for infusion
Voriconazolum
Please read all of this leaflet carefully before being given 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 experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

  1. What Voriconazole Fresenius Kabi is and what it is used for
  2. What you need to know before you are given Voriconazole Fresenius Kabi
  3. How Voriconazole Fresenius Kabi is given
  4. Possible side effects
  5. How to store Voriconazole Fresenius Kabi
  6. Contents of the pack and other information

1. What Voriconazole Fresenius Kabi is and what it is used for

Voriconazole Fresenius Kabi contains the active substance voriconazole. Voriconazole Fresenius Kabi
is an antifungal medicine. It works by killing the fungi that cause infections or by stopping their
growth.
This medicine is used to treat patients (adults and children aged 2 years and older) with:

  • invasive aspergillosis (a type of fungal infection caused by fungi of the genus Aspergillus);
  • candidaemia (another type of fungal infection caused by fungi of the genus Candida) in patients without neutropenia (those who do not have a low white blood cell count);
  • serious invasive fungal infections caused by Candida species that are resistant to fluconazole (another antifungal medicine);
  • serious fungal infections caused by Scedosporium and Fusarium species (two different types of fungi).

Voriconazole Fresenius Kabi is intended for use in patients with progressive, potentially life-threatening fungal infections.
The medicine is also used to prevent fungal infections in high-risk patients after bone marrow transplantation.
This medicine should only be used under the supervision of a doctor.

2. Important information before using Voriconazole Fresenius Kabi

When not to use Voriconazole Fresenius Kabi:

  • If the patient is allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6). It is very important to inform the doctor or pharmacist about all medicines currently or recently used by the patient, including those obtained without a prescription or herbal medicines.

Do not use Voriconazole Fresenius Kabi concomitantly with any of the following medicines:

  • Terfenadine (used to treat allergies);
  • Astemizole (used to treat allergies);
  • Cisapride (used for gastrointestinal disorders);
  • Pimozide (used to treat psychiatric disorders);
  • Quinidine (used for heart rhythm disorders);
  • Ivabradine (used to treat symptoms of chronic heart failure);
  • Rifampicin (used to treat tuberculosis);
  • Efavirenz (used to treat HIV infection) at doses of 400 mg or higher once daily;
  • Carbamazepine (used to treat epilepsy);
  • Phenobarbital (used to treat severe insomnia and epilepsy);
  • Ergot alkaloids (e.g. ergotamine, dihydroergotamine, used to treat migraine);
  • Sirolimus (used in organ transplant patients);
  • Ritonavir (used to treat HIV infection) at doses of 400 mg or higher twice daily;
  • St John's wort (Hypericum perforatum L.) (herbal medicine);
  • Naloxegol [used to treat constipation caused by opioid pain medicines (e.g. morphine, oxycodone, fentanyl, tramadol, codeine)];
  • Tolvaptan [used to treat hyponatraemia (low blood sodium levels) or to slow the worsening of kidney function in patients with autosomal dominant polycystic kidney disease];
  • Lurasidone (used to treat depression);
  • Venetoclax [used to treat patients with chronic lymphocytic leukaemia (CLL)].

Warnings and precautions
Before starting treatment with Voriconazole Fresenius Kabi, discuss with your doctor,
pharmacist or nurse if:

  • The patient has previously had an allergic reaction to other azoles;
  • The patient has or has ever had liver disease. In patients with liver disease, the doctor may prescribe a lower dose of Voriconazole Fresenius Kabi. The doctor should also monitor liver function during treatment with Voriconazole Fresenius Kabi through appropriate blood tests;
  • The patient has been diagnosed with cardiomyopathy, heart rhythm disorders, slow heart rate or changes in the electrocardiogram (ECG) known as "prolonged QTc interval".

During treatment, avoid any exposure to sunlight and solar radiation.
It is important to cover skin areas exposed to sunlight and to use sunscreen creams with a high protection factor (SPF), as skin symptoms of photosensitivity (UV) may occur. These precautions also apply to children.
Inform the doctor immediately if the following occur during treatment with Voriconazole Fresenius Kabi:

  • Sunburn;
  • Severe rash or blisters on the skin;
  • Bone pain.

If the skin disorders described above occur, the doctor may refer the patient to a dermatologist, who may decide after consultation that regular visits are necessary. There is a small risk that long-term use of Voriconazole Fresenius Kabi may lead to skin cancer.
Inform the doctor if the patient develops symptoms of "adrenal insufficiency", a condition in which the adrenal glands do not produce sufficient amounts of certain steroid hormones, such as cortisol. These symptoms include: chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain.
Inform the doctor if the patient develops symptoms of "Cushing's syndrome", in which the body produces too much of the hormone cortisol, which may lead to symptoms such as: weight gain, development of a fatty hump between the shoulders, rounded face, darkening of the skin on the abdomen, thighs, chest and arms, thinning of the skin, increased tendency to bruising, elevated blood sugar levels, excessive hair growth, excessive sweating.
The doctor should monitor the patient's liver and kidney function through appropriate blood tests.

Children and adolescents
Voriconazole Fresenius Kabi must not be used in children under 2 years of age.

Voriconazole Fresenius Kabi and other medicines
Inform the doctor or pharmacist about all medicines currently or recently used by the patient, as well as any medicines the patient plans to use, including those available without a prescription.

Some medicines taken concomitantly with Voriconazole Fresenius Kabi may alter its effect, and Voriconazole Fresenius Kabi may also affect the action of other medicines.

Inform the doctor about the use of the following medicine, as concomitant use with Voriconazole Fresenius Kabi should be avoided if possible:

  • Ritonavir (used to treat HIV infection) at a dose of 100 mg twice daily.
  • Glasdegib (used to treat cancers) – if use of both medicines is necessary, the doctor will order frequent monitoring of heart rhythm.

Inform the doctor about the use of any of the following medicines, as concomitant use with Voriconazole Fresenius Kabi should be avoided if possible, and if this is not feasible, a modification of the voriconazole dose may be required:

  • Rifabutin (used to treat tuberculosis). If the patient is being treated with rifabutin, blood parameters and adverse effects of rifabutin should be monitored.
  • Phenytoin (used to treat epilepsy). If the patient is being treated with phenytoin during treatment with Voriconazole Fresenius Kabi, its blood concentration should be monitored and dose adjustment may be necessary.

If the patient is taking any of the following medicines, inform the doctor, as dose adjustment or monitoring may be required to ensure that these medicines and (or) Voriconazole Fresenius Kabi continue to have the expected effect:

  • Warfarin and other anticoagulants (e.g. phenprocoumon, acenocoumarol; used to reduce blood clotting).
  • Cyclosporine (used after organ transplantation).
  • Tacrolimus (used after organ transplantation).
  • Sulfonylureas (e.g. tolbutamide, glipizide, glyburide; used in diabetes).
  • Statins (e.g. atorvastatin, simvastatin; used to reduce cholesterol levels).
  • Benzodiazepines (e.g. midazolam, triazolam; used for severe insomnia and stress).
  • Omeprazole (used to treat gastrointestinal ulcers).
  • Oral contraceptives (if Voriconazole Fresenius Kabi is used concomitantly with oral contraceptives, adverse effects such as nausea and menstrual disorders may occur).
  • Vinca alkaloids (e.g. vincristine, vinblastine; used to treat cancers).
  • Tyrosine kinase inhibitors (e.g. axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (used to treat cancers).
  • Tretinoin (used to treat leukaemia).
  • Indinavir and other HIV protease inhibitors (used to treat HIV infection).
  • Non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz, delavirdine, nevirapine; used to treat HIV infection) – certain doses of efavirenz must not be used concomitantly with Voriconazole Fresenius Kabi.
  • Methadone (used to treat heroin addiction).
  • Alfentanil, fentanyl and other short-acting opioids such as sufentanil (analgesics used during surgical procedures).
  • Oxycodone and other long-acting opioids such as hydrocodone (used for moderate to severe pain).
  • Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, diclofenac; used to treat pain and inflammatory conditions).
  • Fluconazole (used to treat fungal infections).
  • Everolimus (used to treat advanced renal cell carcinoma and in organ transplant patients).
  • Letermovir (used to prevent cytomegalovirus (CMV) disease after haematopoietic stem cell transplantation).
  • Ivacaftor (used to treat cystic fibrosis).
  • Corticosteroids such as prednisolone (used to treat various diseases involving systemic inflammation), inhaled corticosteroids such as budesonide (used to reduce and prevent lung inflammation and swelling), and intranasal corticosteroids (used to treat allergies, nasal congestion and rhinitis).

Pregnancy and breastfeeding
Do not use Voriconazole Fresenius Kabi during pregnancy unless otherwise decided by the doctor.
Women of childbearing potential must use effective contraception during treatment with Voriconazole Fresenius Kabi. If a woman becomes pregnant while taking Voriconazole Fresenius Kabi, she should contact her doctor immediately.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Voriconazole may cause visual disturbances and light sensitivity causing discomfort. If such disturbances occur, the patient should avoid driving and operating machinery. Inform the doctor if these symptoms occur.

Voriconazole Fresenius Kabi contains sodium
This medicine contains up to 69 mg of sodium (the main component of table salt) per vial. This corresponds to 3.45% of the maximum recommended daily sodium intake in the diet of adults.

Voriconazole Fresenius Kabi contains cyclodextrin
This medicine contains 2660 mg of cyclodextrin per vial.
If the patient has kidney disease, he or she should contact the doctor before using this medicine.

3. How to use Voriconazole Fresenius Kabi

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor.
The doctor will determine the dose based on the patient's body weight and type of infection.
The doctor may adjust the dose depending on the patient's health condition.
The recommended dosage for adult patients (including elderly patients) is shown in the table below.

Intravenous administration
Dose during the first 24 hours
(loading dose)
6 mg/kg body weight every 12 hours during the first
24 hours
Dose after the first 24 hours
(maintenance dose)
4 mg/kg body weight twice daily

Depending on the patient's response to treatment, the doctor may reduce the dose to 3 mg/kg body weight twice daily.
If the patient has mild to moderate liver cirrhosis, the doctor may decide to reduce the dose of the medication.
Use in children and adolescents
The recommended dosing in children and adolescents is presented in the table below.

Intravenous administration
Children aged 2 to <12 years
and adolescents aged 12 to
14 years with body weight <50 kg
Adolescents aged 12 to
14 years with body weight ≥50 kg
and adolescents older than
14 years
Dose during the first
24 hours
(loading dose)
9 mg/kg body weight every 12 hours
during the first 24 hours
6 mg/kg body weight every 12 hours
during the first 24 hours
Dose after the first
24 hours
(maintenance dose)
8 mg/kg body weight twice daily4 mg/kg body weight twice daily

Depending on the patient's response to treatment, the doctor may increase or decrease the daily dose.
Voriconazole Fresenius Kabi, as a powder for solution for infusion, will be dissolved by hospital staff before administration, and the resulting solution will be diluted to the appropriate concentration (see information at the end of this leaflet).
The medicine is administered as an intravenous infusion (into a vein) at a maximum rate of 3 mg/kg body weight per hour for 1 to 3 hours.
If the patient is receiving Voriconazole Fresenius Kabi to prevent fungal infections, the treating physician may discontinue administration of this medicine if treatment-related adverse reactions occur.

Missed dose of Voriconazole Fresenius Kabi
Since this medicine is administered under strict supervision of medical personnel, a missed dose is unlikely. However, if a dose is suspected to have been missed, always inform the doctor, pharmacist, or nurse.

Discontinuation of Voriconazole Fresenius Kabi
The duration of treatment with Voriconazole Fresenius Kabi is determined by the physician; however, treatment with Voriconazole Fresenius Kabi should not last longer than 6 months.
In patients with reduced immunity or severe infections, prolonged treatment may be necessary to prevent disease recurrence. If the patient's condition improves, the route of administration of Voriconazole Fresenius Kabi may be changed from intravenous to oral.
If the doctor decides to discontinue treatment with Voriconazole Fresenius Kabi, there is no need to worry about consequences of this discontinuation.
If you have any further questions concerning the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If adverse reactions occur, they are most commonly mild and transient. However, some of them
may be severe and may require medical attention.
Severe adverse reactions – stop using Voriconazole Fresenius Kabi immediately and contact your doctor:

  • rash;
  • jaundice, changes in blood test results related to liver function;
  • pancreatitis (which may present as abdominal pain, nausea, vomiting).

Other adverse reactions
Very common: may affect more than 1 in 10 patients:

  • visual disturbances (vision changes, including blurred vision, colour vision disturbances, photophobia, loss of colour vision, eye disorders, seeing halos, night blindness, feeling of flickering images, seeing sparks, visual aura, reduced visual acuity, bright vision (feeling of seeing through a bright field), loss of part of the normal visual field, floaters);
  • fever;
  • rash;
  • nausea, vomiting, diarrhoea;
  • headache;
  • limb swelling;
  • abdominal pain;
  • difficulty breathing;
  • increased liver enzyme activity.

Common: may affect less than 1 in 10 patients:

  • sinusitis, gingivitis, chills, fatigue;
  • low number of certain types of red blood cells (sometimes immune-mediated, potentially leading to severe consequences) and (or) white blood cells (sometimes accompanied by fever), low platelet count (blood cells that help blood clotting);
  • low blood sugar, low blood potassium, low blood sodium;
  • anxiety, depression, confusion, agitation, insomnia, hallucinations;
  • seizures, tremor or uncontrolled muscle movements, tingling or unusual sensations in the skin, increased muscle tone, somnolence, dizziness;
  • bleeding in the eye;
  • heart rhythm disorders, including very fast heartbeat, very slow heartbeat, fainting;
  • low blood pressure, phlebitis (which may be associated with blood clot formation);
  • acute breathing difficulties, chest pain, facial swelling (oral cavity, lips and around the eyes), fluid accumulation in the lungs;
  • constipation, indigestion, inflammation of the lips;
  • jaundice, hepatitis and liver damage;
  • rashes that may lead to severe blistering and skin peeling, characterised by flat, red areas of skin covered with small, merging bumps, skin redness;
  • itching;
  • hair loss;
  • back pain;
  • kidney failure, blood in urine, changes in kidney function tests.

Uncommon: may affect less than 1 in 100 patients:

  • influenza-like symptoms, irritation and inflammation of the gastrointestinal tract, gastrointestinal inflammation causing antibiotic-associated diarrhoea, lymphangitis;
  • peritonitis (inflammation of the thin membrane lining the inner abdominal wall and covering abdominal organs);
  • enlarged lymph nodes (sometimes painful), bone marrow failure, increased eosinophil count;
  • impaired adrenal function, hypothyroidism;
  • brain function disorders, Parkinson-like symptoms, nerve damage causing numbness, pain, tingling or burning sensations in hands or feet;
  • impaired balance or coordination;
  • brain swelling;
  • double vision, severe eye disorders, including: eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage leading to visual disturbances, optic disc swelling;
  • reduced sensitivity to touch;
  • taste disturbances;
  • hearing loss, tinnitus, labyrinthine vertigo (sensation of spinning);
  • inflammation of certain internal organs – pancreas and duodenum, tongue swelling and inflammation;
  • liver enlargement, liver failure, gallbladder disorders, gallstones;
  • arthritis, phlebitis under the skin (which may be associated with blood clot formation);
  • kidney inflammation, protein in urine, kidney damage;
  • very fast heartbeat or missed beats, sometimes with irregular electrical impulses;
  • abnormal electrocardiogram (ECG) findings;
  • increased blood cholesterol levels, increased blood urea levels;
  • skin allergic reactions (sometimes severe), including life-threatening skin disease characterised by painful blisters with associated skin and mucosal pain, particularly in the oral cavity, dermatitis, urticaria, sunburn or severe skin reaction after exposure to light or sunlight, redness and skin irritation, red or purpuric skin discolorations which may be due to low platelet count, rash;
  • infusion site reaction;
  • allergic reaction or excessive immune response.

Rare: may affect less than 1 in 1,000 patients:

  • hyperthyroidism;
  • worsening of brain function as a severe complication of liver disease;
  • loss of most optic nerve fibres, corneal opacity, involuntary eye movements;
  • blistering rash due to photosensitivity;
  • disorders in which the immune system attacks part of the peripheral nervous system;
  • heart rhythm or conduction disorders (sometimes life-threatening);
  • life-threatening allergic reaction;
  • blood clotting disorders;
  • skin allergic reactions (sometimes severe), including sudden swelling (angioedema) of the dermis, subcutaneous tissue, mucous membranes and submucosal tissues, itchy or painful thickened red patches with silvery scales, skin and mucous membrane irritation, life-threatening skin disease characterised by detachment of large sheets of the epidermis (outer skin layer) from deeper skin layers;
  • small, dry, scaly skin patches, sometimes thickened with sharp projections or "horns".

Frequency not known: cannot be estimated from available data:

  • pigmented spots and patches.

Other important adverse reactions, the frequency of which is unknown but which should be reported to a doctor immediately:

  • skin cancer;
  • inflammation of the tissue surrounding the bone;
  • red, peeling patches or ring-shaped skin lesions, which may indicate an autoimmune disease called cutaneous lupus erythematosus.

During intravenous infusion of voriconazole, uncommon adverse reactions such as hot flushes, fever, excessive sweating, increased heart rate, and shallow breathing have been observed. If these symptoms occur, the doctor may decide to stop the infusion.
Due to the known effects of voriconazole on the liver and kidneys, the doctor should monitor the function of these organs with appropriate blood tests. Patients should consult their doctor if they experience abdominal pain or changes in stool consistency.
Cases of skin cancer have been reported in patients treated with voriconazole for prolonged periods.
Sunburn or severe skin reactions following exposure to light or sunlight occurred more frequently in children. If skin disorders occur, the doctor may refer the patient to a dermatologist, who after consultation may decide that regular dermatological follow-up is necessary. Increased liver enzyme activity has also been observed more frequently in children.
If any of these adverse reactions persist or are bothersome, patients should inform their doctor.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Voriconazole Fresenius Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Unopened vial
No special storage instructions apply for this medicine.
The solution obtained after reconstitution of Voriconazole Fresenius Kabi should be used immediately; however, if necessary, it may be stored for up to 24 hours at 2°C–8°C (in a refrigerator). The prepared concentrate must be diluted with a compatible infusion solution prior to administration (see information at the end of this leaflet).
Medicines should not be disposed of via the sewage system or in 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 Voriconazole Fresenius Kabi contains

  • The active substance is voriconazole.
  • The other components are: hydroxypropylbetadex (degree of substitution: 0.58–0.68), L-arginine, hydrochloric acid 6 N (for pH adjustment), sodium hydroxide 1 N (for pH adjustment).

Each vial contains 200 mg of voriconazole. After reconstitution according to instructions by a
hospital pharmacist or nurse, the concentration of voriconazole is 10 mg/ml (see information at
the end of this leaflet).

What Voriconazole Fresenius Kabi looks like and contents of the pack

Voriconazole Fresenius Kabi is available as a white or almost white, lyophilized powder for solution for infusion, in 25 ml glass vials for single use.

Pack sizes: 1 vial or 20 vials in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany

For further information about this medicinal product, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel.: +48 22 345 67 89

This medicinal product is authorised in the European Economic Area (EEA) member states under the following names:

Belgium Voriconazol Fresenius Kabi 200 mg powder for solution for infusion / poudre pour solution pour perfusion / Pulver zur Herstellung einer Infusionslösung
Bulgaria Voriconazole Fresenius Kabi 200 mg powder for solution for infusion
Croatia Vorikonazol Fresenius Kabi 200 mg, prašak za otopinu za infuziju
Cyprus Voriconazole Fresenius Kabi 200 mg Κόνις για διάλυμα προς έγχυση
Czech Republic Voriconazole Fresenius Kabi
Denmark Voriconazole Fresenius Kabi
Finland Voriconazole Fresenius Kabi
Greece Voriconazole Fresenius Kabi 200 mg Κόνις για διάλυμα προς έγχυση
Spain Voriconazol Fresenius Kabi 200 mg polvo para solución para perfusión
Netherlands Voriconazol Fresenius Kabi 200 mg, poeder voor oplossing voor infusie
Ireland Voriconazole 200 mg powder for solution for infusion
Luxembourg Voriconazol Fresenius Kabi 200 mg Pulver zur Herstellung einer Infusionslösung
Germany Voriconazol Fresenius Kabi 200 mg Pulver zur Herstellung einer Infusionslösung
Norway Voriconazole Fresenius Kabi 200 mg
Poland Voriconazole Fresenius Kabi, 200 mg, proszek do sporządzania roztworu do infuzji
Portugal Voriconazol Fresenius Kabi 200 mg Pó para Solução para Perfusão
Romania Voriconazol Fresenius Kabi 200 mg pulbere pentru soluţie perfuzabilă
Slovakia Voriconazole Fresenius Kabi 200 mg prášok na infúzny roztok
Slovenia Vorikonazol Fresenius Kabi 200 mg prášek za raztopino za infundiranje
Sweden Voriconazole Fresenius Kabi
Hungary Voriconazole Fresenius Kabi 200 mg por oldatos infúzióhoz
United Kingdom Voriconazole 200 mg powder for solution for infusion


Information intended exclusively for healthcare professionals:

Reconstitution and dilution

  • The powder should be dissolved in 19 ml of water for injections or 19 ml of 0.9% (9 mg/ml) sodium chloride solution for infusion to obtain 20 ml of a clear concentrate containing voriconazole at a concentration of 10 mg/ml.
  • If the solvent does not get automatically drawn into the vial due to vacuum, the voriconazole vial should be discarded.
  • To ensure accurate measurement of the volume (19 ml) of water for injections or 0.9% (9 mg/ml) sodium chloride solution for infusion, the use of standard 20 ml (non-automated) syringes is recommended.
  • To obtain an infusion solution with a concentration of 0.5–5 mg/ml, the required volume of concentrate should be added to the recommended compatible infusion solution (see below).
  • This medicinal product is for single use only; any unused portion should be discarded. Only clear, particle-free solutions should be used.
  • Do not administer by rapid intravenous injection (bolus).
  • Storage conditions, see section 5 "How to store Voriconazole Fresenius Kabi."

Required volumes of Voriconazole Fresenius Kabi concentrate 10 mg/ml

Body weight
[kg]
Volume of Voriconazole Fresenius Kabi concentrate (10 mg/ml) required for preparation:
Dose
3 mg/kg b.w.
(number of vials)
Dose
4 mg/kg b.w.
(number of vials)
Dose
6 mg/kg b.w.
(number of vials)
Dose
8 mg/kg b.w.
(number of vials)
Dose
9 mg/kg b.w.
(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)
309.0 ml (1)12.0 ml (1)18.0 ml (1)24.0 ml (2)27.0 ml (2)
3510.5 ml (1)14.0 ml (1)21.0 ml (2)28.0 ml (2)31.5 ml (2)
4012.0 ml (1)16.0 ml (1)24.0 ml (2)32.0 ml (2)36.0 ml (2)
4513.5 ml (1)18.0 ml (1)27.0 ml (2)36.0 ml (2)40.5 ml (3)
5015.0 ml (1)20.0 ml (1)30.0 ml (2)40.0 ml (2)45.0 ml (3)
5516.5 ml (1)22.0 ml (2)33.0 ml (2)44.0 ml (3)49.5 ml (3)
6018.0 ml (1)24.0 ml (2)36.0 ml (2)48.0 ml (3)54.0 ml (3)
6519.5 ml (1)26.0 ml (2)39.0 ml (2)52.0 ml (3)58.5 ml (3)
7021.0 ml (2)28.0 ml (2)42.0 ml (3)
7522.5 ml (2)30.0 ml (2)45.0 ml (3)
8024.0 ml (2)32.0 ml (2)48.0 ml (3)
8525.5 ml (2)34.0 ml (2)51.0 ml (3)
9027.0 ml (2)36.0 ml (2)54.0 ml (3)
9528.5 ml (2)38.0 ml (2)57.0 ml (3)
10030.0 ml (2)40.0 ml (2)60.0 ml (3)

Voriconazole Fresenius Kabi is a preservative-free, sterile lyophilized powder
intended for single-dose administration. Therefore, due to microbiological concerns,
the reconstituted product should be used immediately. If not used immediately, the user is responsible
for the storage time and conditions prior to use. The storage time should not exceed 24 hours at 2°C–8°C (refrigerated), unless reconstitution and dilution were performed under controlled and validated aseptic conditions.
Chemical and physical stability of the reconstituted solution has been demonstrated for 24 hours at temperatures from 2°C to 8°C.
Chemical and physical stability of the diluted solution has been demonstrated for 7 days at temperatures from 2°C to 8°C.

Compatible solutions
The prepared concentrate may be diluted with:

  • 0.9% (9 mg/mL) sodium chloride infusion solution;
  • compound sodium lactate infusion solution for intravenous use;
  • 5% glucose infusion solution for intravenous use;
  • 0.45% sodium chloride infusion solution for intravenous use.

Compatibility of Voriconazole Fresenius Kabi with solutions other than those listed above (or below under "Incompatibilities") is unknown.

Incompatibilities
The Voriconazole Fresenius Kabi solution must not be administered by infusion together with other medicinal products through the same infusion line or cannula (venflon), including parenteral nutrition.
Voriconazole Fresenius Kabi must not be administered simultaneously with any blood-derived product.
Parenteral nutrition infusion may be administered concurrently with Voriconazole Fresenius Kabi, but it must be given through a separate infusion line or cannula (venflon).
Do not use 4.2% sodium bicarbonate infusion solution for intravenous use to dilute Voriconazole Fresenius Kabi.