Voriconazole Accord 200 mg powder for solution for infusion EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Voriconazol Accord 200 mg powder for solution for infusion EFG

Voriconazole

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Voriconazol Accord 200 mg powder for solution for infusion EFG is and what it is used for.
2. What you need to know before using Voriconazol Accord 200 mg powder for solution for infusion EFG.
3. How to use Voriconazol Accord 200 mg powder for solution for infusion EFG.
4. Possible side effects.
5. How to store Voriconazol Accord 200 mg powder for solution for infusion EFG.
6. Contents of the pack and other information.

1. What Voriconazol Accord 200mg powder for solution for infusion EFG is and what it is used for

The active substance of this medicine is voriconazole. It is an antifungal medicine. It works by suppressing or preventing the growth of fungi that cause infections.

It is used for the treatment of patients (adults and children over 2 years of age) with:

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

Voriconazol Accord is used in patients with serious fungal infections that may be life-threatening.

Prevention of fungal infections in high-risk bone marrow transplant recipients.

This medicine should only be used under medical supervision.

2. What you need to know before starting to use Voriconazole Accord 200 mg powder for solution for infusion EFG

Do not use Voriconazol Accord

• if you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6.1).

It is very important that you inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, or herbal medicines.

During treatment with Voriconazol Accord, you must not take the following medicines:

• Terfenadine (used for allergies).
• Astemizole (used for allergies).
• Cisapride (used for digestive problems).
• Pimozide (used for mental disorders).
• Quinidine (used for cardiac arrhythmias).
• Ivabradine (used for symptoms of chronic heart failure).
• Rifampicin (used to treat tuberculosis).
• Efavirenz (used to treat HIV) at doses of 400 mg or higher 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 of 400 mg or higher twice daily.
• St. John’s wort (hypericum, herbal medicine).
• Naloxegol (used to treat constipation specifically caused by painkillers called opioids [e.g., morphine, oxycodone, fentanyl, tramadol, codeine]).
• Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to slow down the decline in kidney function in patients with polycystic kidney disease).
• Lurasidone (used to treat depression).
• Finerenone (used to treat chronic kidney disease).
• Venetoclax (used to treat patients with chronic lymphocytic leukemia [CLL]).

Warnings and precautions

Talk to your doctor or nurse before starting this medicine if:

• you have had an allergic reaction to other azoles.
• you have or have ever had liver disease. If you have liver disease, your doctor may prescribe a lower dose of Voriconazol Accord. Your doctor should also monitor your liver function during treatment with this medicine by performing blood tests.
• you know you have cardiomyopathy, irregular heartbeat, slow heart rate, or an abnormality on the electrocardiogram (ECG) known as “prolonged QTc syndrome.”

You should avoid any exposure to sunlight and UV light during treatment. It is important to cover exposed areas and use sunscreen with a high sun protection factor (SPF), as your skin may become more sensitive to UV rays from the sun. This sensitivity may be further increased by other medicines that make the skin sensitive to sunlight, such as methotrexate. These precautions also apply to children.

While being treated with Voriconazol Accord:

• inform your doctor if you experience

  • sunburn

  • severe skin rash or blisters

  • bone pain

If you develop skin disorders such as those described above, your doctor may refer you to a dermatologist, who may consider it important for you to have regular check-ups. There is a small possibility that long-term use of this medicine may lead to skin cancer.

If you develop signs of “adrenal insufficiency,” in which the adrenal glands do not produce sufficient amounts of certain steroid hormones, such as cortisol, which may cause symptoms such as: prolonged or chronic fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, inform your doctor.

If you experience signs of “Cushing's syndrome,” in which the body produces too much cortisol hormone, which may cause symptoms such as: weight gain, fatty hump between the shoulders, rounded face, darkening of the skin on the abdomen, thighs, breasts, and arms, thin skin, easy bruising, high blood sugar levels, excessive hair growth, or excessive sweating, inform your doctor.

Your doctor should monitor the function of your liver and kidneys by performing blood tests.

Children and adolescents

Voriconazol Accord must not be given to children under 2 years of age.

Using Voriconazol Accord with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

• Some medicines, when used at the same time as Voriconazol Accord, may affect the action of this medicine or this medicine may affect the action of other medicines.

Inform your doctor or pharmacist if you are taking the following medicines, as concomitant treatment with Voriconazol Accord should be avoided if possible:

• Ritonavir (used to treat HIV) at a dose of 100 mg twice daily.
• Glasdegib (used to treat cancer); if you need to take both medicines, your doctor will monitor your heart rhythm frequently.

Inform your doctor if you are taking any of the following medicines, as concomitant treatment with Voriconazol Accord should be avoided if possible, and a dose adjustment of voriconazole may be needed:

• Rifabutin (used to treat tuberculosis). If you are already being treated with rifabutin, your blood count and adverse effects of rifabutin should be monitored.
• Phenytoin (used to treat epilepsy). If you are already being treated with phenytoin, the concentration of phenytoin in your blood should be monitored during treatment with this medicine, and your dose may need to be adjusted.

Tell your doctor if you are taking any of the following medicines, as you may need a dose adjustment or monitoring to ensure these medicines and/or Voriconazol Accord continue to have the desired effect:

• Warfarin and other anticoagulants (e.g.: phenprocoumon, acenocoumarol; used to reduce blood clotting).
• 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 levels).
• Benzodiazepines (e.g.: midazolam, triazolam) (used for severe insomnia and stress).
• Omeprazole (used to treat stomach ulcers).
• Oral contraceptives (if you use Voriconazol Accord while taking oral contraceptives, you may experience adverse effects such as nausea and menstrual disorders).
• 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).
• 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) (some doses of efavirenz must NOT be taken at the same time as Voriconazol Accord).
• Methadone (used to treat heroin addiction).
• Alfentanil, fentanyl, and other short-acting opioids such as sufentanil (analgesics used during surgery).
• 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 to treat fungal infections).
• Everolimus (used to treat advanced kidney cancer and in transplant patients).
• Letermovir (used to prevent cytomegalovirus (CMV) infection after bone marrow transplant).
• Ivacaftor: used to treat cystic fibrosis.
• Flucloxacillin (an antibiotic used against bacterial infections).

Pregnancy and breastfeeding

Do not use Voriconazol Accord during pregnancy unless instructed by your doctor. Women of childbearing age being treated with this medicine should use effective contraception. Contact your doctor immediately if you become pregnant while taking Voriconazol Accord.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Voriconazol Accord may cause blurred vision or discomfort due to increased sensitivity to light. If this occurs, do not drive or operate tools or machinery and inform your doctor.

Voriconazole contains cyclodextrins

This medicine contains 3,595.20 mg of cyclodextrins per vial, equivalent to 179.76 mg/ml when reconstituted in 20 ml. If you have renal impairment, consult your doctor before taking this medicine.

3. How to use Voriconazole Accord 200mg powder for solution for infusion EFG

Follow exactly the instructions for administration of this medicine given by your doctor.

If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the dose depending on your weight and the type of infection you have.

Your doctor may adjust the dose according to your condition.

The recommended dose in adults (including elderly patients) is as follows:

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

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
Children from 2 to less than 12 years of age and adolescents from 12 to 14 years of age weighing less than 50 kg	Adolescents from 12 to 14 years of age weighing 50 kg or more; and all adolescents older than 14 years
Dosing during the first 24 hours (loading dose)	9 mg/kg every 12 hours during the first 24 hours	6 mg/kg every 12 hours during the first 24 hours
Dosing after the first 24 hours (maintenance dose)	8 mg/kg twice daily	4 mg/kg twice daily

Depending on your response to treatment, your doctor may increase or decrease the daily dose.

Voriconazol Accord powder for solution for infusion must be reconstituted and diluted to the correct concentration by hospital pharmacy or nursing staff (for more information, see the end of this leaflet).

It will be administered by intravenous infusion (into a vein) at a maximum rate of 3 mg/kg per hour for 1 to 3 hours.

If you or your child are taking Voriconazol Accord to prevent fungal infections, your doctor may stop treatment if you or your child experience adverse effects related to the treatment.

If you miss a dose of Voriconazol Accord

Since you will be receiving this medicine under close medical supervision, it is unlikely that you will miss a dose. However, inform your doctor or pharmacist if you think a dose has been missed.

If you stop treatment with Voriconazol Accord

Treatment with this medicine should be continued for as long as your doctor considers appropriate. However, the duration of treatment with Voriconazol Accord powder for solution for infusion should not exceed 6 months.

Patients with weakened immune systems or those with complicated infections may require longer treatment courses to prevent the infection from recurring. Once your condition improves, intravenous infusion may be replaced by tablet administration.

When your doctor discontinues treatment with Voriconazol Accord, you should not experience any effects due to stopping the treatment.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

In case of Voriconazol Accord overdose or accidental ingestion

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If any occur, they are most likely to be mild and temporary. However, some may be serious and require immediate medical attention.

Serious adverse effects – Stop using Voriconazole Accord and contact your doctor immediately

• Skin rash
• Jaundice, changes in liver function detected in blood tests
• Pancreatitis

Other adverse effects

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

• Visual disturbances (changes in vision such as blurred vision, color vision disturbances, abnormal intolerance to visual perception of light, color blindness, eye disorder, visual halos, night blindness, oscillating vision, seeing sparks, visual aura, decreased visual acuity, reduced visual clarity, partial loss of normal visual field, spots in the visual field)
• Fever
• Skin rash
• Nausea, vomiting, and diarrhea
• Headache
• Swelling of the limbs
• Stomach pain
• Difficulty breathing
• Elevated liver enzymes

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

• Gastrointestinal inflammation, sinusitis, gum inflammation, chills, weakness
• Low blood cell counts, including severe cases, of certain types of red blood cells (sometimes immune-mediated) or white blood cells (sometimes accompanied by fever), low platelet count affecting blood clotting
• Low blood sugar levels, low blood potassium levels, low blood sodium levels
• Anxiety, depression, confusion, agitation, insomnia, hallucinations
• Seizures, tremors or uncontrolled muscle movements, tingling or abnormal sensations in the skin, increased muscle tone, drowsiness, dizziness
• Ocular hemorrhage
• Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting
• Hypotension, inflammation of veins (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
• Jaundice (yellowing of the skin), liver inflammation, and liver damage
• Skin rashes, which may become severe, with blisters and peeling, characterized by flat, red areas covered with small merging bumps, skin redness – itching
• Alopecia
• Back pain
• Kidney failure, presence of blood in urine, abnormalities in kidney function tests
• Sunburn or severe skin reaction following exposure to light or sun
• Skin cancer

Uncommon (may affect up to 1 in 100 people):

• Flu-like symptoms, irritation and inflammation of the gastrointestinal tract causing antibiotic-associated diarrhea, inflammation of lymphatic vessels
• Inflammation of the thin tissue lining the inner abdominal wall and covering abdominal organs (peritonitis)
• Enlargement (sometimes painful) of lymph nodes, bone marrow failure, increased eosinophils
• Reduced adrenal gland function, underactive thyroid gland
• Abnormal brain function, Parkinson-like symptoms, nerve damage causing numbness, pain, tingling, or burning sensations in hands or feet
• Problems with balance or coordination
• Brain swelling
• Double vision, serious eye disorders such as eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage causing vision disturbances, optic disc inflammation
• Reduced sensitivity to touch
• Disturbance of taste sensation
• Hearing difficulty, ringing in the ears (tinnitus), vertigo
• Inflammation of certain internal organs, pancreas and duodenum, swelling and inflammation of the tongue
• Liver enlargement, liver failure, gallbladder disease, gallstones
• Joint inflammation, inflammation of veins under the skin (which may be associated with blood clot formation)
• Kidney inflammation, protein in urine, kidney damage
• Very rapid heart rate or extrasystoles, sometimes with erratic electrical impulses
• Abnormal electrocardiogram (ECG)
• Elevated blood cholesterol, elevated blood urea
• Skin allergic reactions (sometimes severe), such as skin disorders potentially fatal causing blisters and painful sores on the skin and mucous membranes, especially in the mouth, skin inflammation, hives, skin redness and irritation, reddish or purplish skin discoloration possibly caused by low platelet count, eczema
• Reaction at the infusion site
• Allergic reaction or exaggerated immune response
• Inflammation of the tissue surrounding the bone (periostitis)

Rare (may affect up to 1 in 1,000 people):

• Overactive thyroid gland
• Deterioration of brain function as a serious complication of liver disease
• Loss of most of the optic nerve fibers, corneal opacity, involuntary eye movements
• Blister formation due to photosensitivity
• Disorder in which the immune system attacks part of the peripheral nervous system
• Serious heart rhythm or conduction problems (sometimes potentially life-threatening)
  • Potentially life-threatening allergic reaction
  • Blood clotting disorders
  • Severe skin allergic reactions such as rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal layers, painful and itchy plaques of thickened, red skin with silvery scales, skin and mucous membrane irritation, potentially fatal skin disorder causing large sections of the epidermis (the outermost skin layer) to detach from underlying skin layers
  • Small scaly, dry skin patches, sometimes thick with tips or "horns"

Adverse effects with unknown frequency:

• Freckles and pigmented spots

Other important adverse effects whose frequency is unknown but which must be reported to your doctor immediately:

• Red, scaly patches or ring-shaped skin lesions that may be a sign of an autoimmune disease called cutaneous lupus erythematosus

During infusion, infrequent reactions have occurred with Voriconazole Accord (including facial flushing, fever, sweating, increased heart rate, and difficulty breathing). Your doctor may stop the infusion if this happens.

Since Voriconazole Accord has been observed 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 appear different.

Cases of skin cancer have been reported in patients treated with voriconazole over long periods.

The frequency of sunburn or severe skin reactions following exposure to light or sun was higher in children. If you or your child develop skin disorders, your doctor may refer you to a dermatologist who, after consultation, may decide that regular follow-up is necessary.

If any of these adverse effects persist or become bothersome, inform your doctor.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Voriconazole Accord 200 mg powder for solution for infusion EFG

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 carton after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

After reconstitution, chemical and physical stability have been demonstrated for 24 hours at 2 – 8 °C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and storage conditions prior to use are the responsibility of the user.

After dilution, chemical and physical stability during use have been demonstrated for 6 hours at 25 °C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and storage conditions prior to use are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voriconazole Accord

• The active substance is voriconazole.
• The other components are hydroxypropyl-ß-cyclodextrin (HPBCD) and monohydrate lactose.

Each vial contains 200 mg of voriconazole, equivalent to a 10 mg/ml concentrated solution once reconstituted by hospital pharmacy or nursing staff according to the instructions (see information at the end of this leaflet).

Appearance of the product and pack contents

White, lyophilized powder for infusion solution.

Supplied in single-use glass vials.

Pack containing 1 vial of 30 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6th floor,

08039 Barcelona, Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

Or

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50, 95-200

Pabianice, Poland

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

CZ: Voriconazole Accord 200 mg prášek pro infuzní roztok
DE: Voriconazol Accord 200 mg Pulver zur Herstellung einer Infusionslösung
FR: Voriconazole Accord 200 mg poudre pour solution pour perfusion
ES: Voriconazol Accord 200 mg polvo para solución para perfusión EFG
BG: Voriconazole Accord 200 mg Powder for solution for infusion
HU: Voriconazole Accord 200 mg Por oldatos infúzióhoz
PL: Voriconazole Accord
RO: Voriconazol Accord 200 mg pulbere pentru soluție perfuzabila
SI: Vorikonazol Accord 200 mg prašek za raztopino za infundiranje
AT: Voriconazol Accord 200 mg Pulver zur Herstellung einer Infusionslösung
BE: Voriconazole Accord Healthcare 200 mg, Poeder voor oplossing voor infusie
DK: Voriconazole Accord 200 mg
EE: Voriconazole Accord
FI: Voriconazole Accord 200 mg infuusiokuiva-aine, liuosta varten
IS: Vórikónazóli 200 mg innrennslisstofn, lausn
LV: Voriconazole Accord 200 mg pulveris infuziju škiduma pagatavošanai
LT: Voriconazole Accord 200 mg milteliai infuziniam tirpalui
NL: Voriconazol Accord 200 mg Poeder voor oplossing voor infusie
NO: Voriconazole Accord 200 mg
SE: Voriconazole 200 mg Pulver till infusionsvätska, lösning
CY: Voriconazole Accord 200 mg Powder for solution for infusion
PT: Voriconazol Accord 200 mg
IE: Voriconazole Accord 200 mg Powder for Solution for Infusion

Date of the most recent review of this leaflet: January 2026.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended exclusively for healthcare professionals:

Information on reconstitution and dilution

• Voriconazole Accord powder for infusion solution must be reconstituted with 19 ml of water for injections or 19 ml of sodium chloride 9 mg/ml (0.9%) for infusion to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ml of voriconazole.

• Reconstitution may take up to 4 minutes.

• Discard the Voriconazole Accord vial if the vacuum prevents the solvent from entering the vial.

• Use of a standard 20 ml syringe (non-automated) is recommended to ensure accurate dispensing of the required volume (19.0 ml) of water for injections or sodium chloride 9 mg/ml (0.9%).

• The required volume of reconstituted concentrate is then added to a compatible infusion solution listed below, to obtain a final Voriconazole Accord solution containing 0.5 to 5 mg/ml of voriconazole.

• This medicinal product is for single use only; any unused solution must be discarded, and only clear solutions free from particles should be used.

• Must not be administered as an intravenous bolus.

• For information on storage, see section 5 “Storage of Voriconazole Accord”.

Required volumes of reconstituted Voriconazole Accord concentrate 10 mg/ml

Body weight (kg)	Volume of Voriconazole Accord concentrate (10 mg/ml) required for
Dose of 3 mg/kg (number of vials)	Dose of 4 mg/kg (number of vials)	Dose of 6 mg/kg (number of vials)	Dose of 8 mg/kg (number of vials)	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)	-	-

Voriconazol Accord is a sterile, single-dose lyophilisate without preservatives. After reconstitution, chemical and physical stability has been demonstrated for 24 hours at 2 - 8°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the time and conditions of storage prior to use are the responsibility of the user.

After dilution, in-use chemical and physical stability has been demonstrated for 6 hours at 25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the time and conditions of storage prior to use are the responsibility of the user.

Compatible infusion solutions:

The reconstituted solution may be diluted with:

Sodium chloride 9 mg/ml (0.9%) injection solution
Compound sodium lactate intravenous infusion
5% glucose and Ringer's lactate intravenous infusion
5% glucose and 0.45% sodium chloride intravenous infusion
5% glucose intravenous infusion
5% glucose with 20 mEq potassium chloride intravenous infusion
0.45% sodium chloride intravenous infusion
5% glucose and 0.9% sodium chloride intravenous infusion
Ringer's lactate intravenous infusion

The compatibility of Voriconazol Accord with diluents other than those specifically listed above (or listed below under "Incompatibilities") is unknown.

Incompatibilities:

Voriconazol Accord must not be infused simultaneously through the same line or catheter with other drug infusions, including parenteral nutrition (e.g., Aminofusin 10% Plus).

Concomitant infusion of blood products must not be administered during administration of Voriconazol Accord.

Total parenteral nutrition may be administered simultaneously with Voriconazol Accord, but not through the same line or catheter.

Voriconazol Accord must not be diluted with 4.2% sodium bicarbonate solution.