Voriconazole Hikma 200 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Voriconazole Hikma 200 mg powder for solution for infusion EFG

voriconazole

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

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet (see section 4).

Contents of the leaflet

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

1. What Voriconazol Hikma is and what it is used for

Voriconazol Hikma contains the active substance voriconazole. Voriconazole is an antifungal medicine. It works by killing or stopping the growth of fungi that cause infections.

It is used to treat patients (adults and children aged 2 years and older) 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 Fusarium sp (two different species of fungi).

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

Prevention of fungal infections in haematopoietic stem cell transplant recipients at high risk.

This medicine should only be used under medical supervision.

2. What you need to know before using Voriconazol Hikma

Do not use Voriconazol Hikma

• if you are allergic to voriconazole or to sulfobutylether beta-cyclodextrin sodium (included in section 6).

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

During treatment with Voriconazol Hikma, 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 for the treatment of tuberculosis).
• Efavirenz (used for the treatment of 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 for the treatment of HIV) at doses of 400 mg or higher twice daily.
• St. John’s wort (Hypericum perforatum, herbal remedy).
• 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 for the treatment of patients with chronic lymphocytic leukemia [CLL]).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Voriconazol Hikma if:

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

You must avoid any exposure to sunlight and UV light during treatment. It is important to cover exposed skin and use sunscreen with a high sun protection factor (SPF), as your skin may become more sensitive to UV radiation. These precautions also apply to children.

While being treated with Voriconazol Hikma:

• inform your doctor if you develop

• sunburn

• severe skin rash or blistering

• bone pain

If you develop skin disorders such as those described above, your doctor may refer you to a dermatologist, who may consider regular monitoring necessary. There is a small risk of developing skin cancer with long-term use of Voriconazol Hikma.

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 through blood tests.

Children and adolescents

Voriconazol Hikma must not be administered to children under 2 years of age.

Using Voriconazol Hikma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Some medicines, when used at the same time as Voriconazol Hikma, may affect the action of Voriconazol Hikma or Voriconazol Hikma may affect the action of other medicines.

Inform your doctor if you are using the following medicines, as concomitant treatment with Voriconazol Hikma should be avoided if possible:

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

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

• Rifabutin (used for the treatment of 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 Voriconazol Hikma, 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 Hikma are still effective:

• 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 for the treatment of stomach ulcers).
• Oral contraceptives (if you use Voriconazol Hikma while taking oral contraceptives, you may experience adverse effects such as nausea and menstrual disorders).
• Vinca alkaloids (e.g.: vincristine and 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 Hikma).
• 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 to treat bacterial infections).

Pregnancy and breastfeeding

You must not use Voriconazol Hikma during pregnancy unless specifically instructed by your doctor. Women of childbearing age being treated with Voriconazol must use effective contraception. Contact your doctor immediately if you become pregnant while being treated with Voriconazol Hikma.

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 Hikma 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.

Voriconazol Hikma contains sodium

This medicine contains 217.6 mg of sodium (a main component of table/cooking salt) per vial. This corresponds to 10.9% of the maximum daily recommended intake of sodium for an adult.

Voriconazol Hikma contains cyclodextrins

This medicine contains 3200 mg of cyclodextrins per vial, equivalent to 160 mg/ml when reconstituted in 20 ml. If you have renal impairment, consult your doctor before taking this medicine.

3. How to use Voriconazole Hikma

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the dose based 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 decrease 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
Dose 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
Dose 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.

Voriconazole Hikma powder for solution for infusion must be reconstituted and diluted to the correct concentration by pharmacy or nursing staff at the hospital (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 over 1 to 3 hours.

If you or your child are taking Voriconazole Hikma to prevent fungal infections, your doctor may stop the administration of Voriconazole Hikma if you or your child experience adverse effects related to treatment.

If you forget a dose of Voriconazole Hikma

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 interrupt treatment with Voriconazole Hikma

Treatment with Voriconazole Hikma should be maintained for as long as your doctor considers appropriate; however, the duration of voriconazole treatment 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 Voriconazole Hikma, 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.

4. Possible adverse effects

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

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

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

• Skin rash.
• Jaundice, abnormalities in blood tests assessing liver function.
• Pancreatitis.

Other adverse effects

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

• Visual disturbance (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, perception of 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 extremities.
• Stomach pain.
• Difficulty breathing.
• Elevated liver enzymes.

Common: may affect up to 1 in 10 people:

• Sinusitis, gum inflammation, chills, weakness.
• Low blood 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 skin sensations, increased muscle tone, drowsiness, dizziness.
• Eye 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 sunlight.
• Skin cancer.

Uncommon: may affect up to 1 in 100 people:

• Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, gastrointestinal inflammation causing antibiotic-associated diarrhea, inflammation of lymphatic vessels.
• Inflammation of the thin tissue lining the abdominal wall and covering abdominal organs.
• Enlargement (sometimes painful) of lymph nodes, bone marrow failure, increased eosinophils.
• Reduced adrenal gland function, underactive thyroid gland.
• Abnormal brain function, symptoms resembling Parkinson's disease, 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 leading to vision changes, optic disc inflammation.
• Reduced sensitivity to touch.
• Disturbance in taste sensation.
• Hearing difficulty, 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 high 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 disease, potentially life-threatening causing blisters and painful sores on the skin and mucous membranes, especially in the mouth, skin inflammation, hives, sunburn or severe skin reaction following exposure to light or sunlight, 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.

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.
• Heart rhythm or conduction problems (sometimes potentially fatal).
• Potentially life-threatening allergic reaction.
• Abnormalities in blood clotting.
• Skin allergic reactions (sometimes severe), such as rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal layers, itchy and painful plaques of thickened, red, scaly skin with silvery scales, skin and mucous membrane irritation, potentially life-threatening skin disease causing large portions 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 with unknown frequency, but which must be reported to your doctor immediately:

• Scaly red patches or ring-shaped skin lesions, which may be a sign of an autoimmune disease called cutaneous lupus erythematosus.

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

Since voriconazole 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 have an unusual consistency.

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 sunlight was higher in children. If you or your child develop skin disorders, your doctor may refer you to a dermatologist who, after evaluation, may decide that regular follow-up is necessary. Elevated liver enzymes were also observed more frequently in children.

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Voriconazole Hikma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions. Store it in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voriconazole Hikma

• The active substance is voriconazole.
• The other component is sodium sulfobutylether beta-cyclodextrin.
• Each vial contains 200 mg of voriconazole, equivalent to a 10 mg/ml concentrated solution once reconstituted according to the instructions provided by hospital pharmacy or nursing staff (see information at the end of this leaflet).

Nature of the product and pack sizes

Voriconazole Hikma is a compact white or almost white powder.

Voriconazole Hikma is available in packs containing 1 or 5 vials of powder for solution for infusion.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.º 8, 8A and 8B, Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer

Hikma Italia S.p.A.

Viale Certosa, 10

27100 Pavia

Italy

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

AT / BE / DE / NL Hikma Pharma GmbH Tel: +49 89-45450-302	IT Hikma Italia S.p.A. Tél/Tel: + 39 0382 1751801
BG / CY / CZ / DK / EE / EL / FI / HR / HU / IE / IS / LI / LT / LU / LV / MT / NO / PL / PT / RO / SE / SI / SK Hikma Farmacêutica (Portugal), S.A. Tel.: +351 219 608 410	UK Consilient Health Ltd Tel.: +44(0)203 751 1888
FR Hikma France Tel.: +33(0) 1 87 69 98 43	ES HIKMA ESPAÑA, S.L.U. Tel: + 34 910075141

Date of the most recent review of this summary:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

The following information is intended for medical and healthcare professionals only:

Information on reconstitution and dilution

Voriconazol Hikma powder for solution for infusion 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 a clear, extractable volume of 20 ml of concentrate containing 10 mg/ml of voriconazol.

The use of a standard 20 ml syringe (non-automatic) is recommended to ensure the exact amount (19.0 ml) of Water for Injections or Sodium Chloride 9 mg/ml (0.9%) for Infusion is dispensed.

After reconstitution with 19 ml of Water for Injections or Sodium Chloride 9 mg/ml (0.9%) for Infusion, a clear solution for injection is obtained.

The required volume of the reconstituted concentrate is then added to a compatible infusion solution listed below to obtain a final voriconazol solution containing 0.5 to 5 mg/ml of voriconazol.

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

It must not be administered as an intravenous bolus.

This medicine does not require special temperature storage conditions prior to use. Store in the original packaging to protect from light.

Required volumes of Voriconazol Hikma concentrate 10 mg/ml

Body weight (kg)	Volume of Voriconazole Hikma 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)	12.5 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 (2)	-	-
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 Hikma is a sterile, single-dose, preservative-free lyophilisate.

Stability after reconstitution:

Chemical and physical in-use stability has been demonstrated to be 36 hours at 2°C to 8°C for the reconstituted solution.

Stability after dilution:

Chemical and physical in-use stability of the diluted solution has been demonstrated to be 36 hours at 2°C to 8°C, followed by 3 hours at room temperature.

Therefore, from a microbiological standpoint, the solution should be used immediately after reconstitution. If not used immediately, the time and storage conditions prior to use are the responsibility of the user, and the solution should be stored at 2°C to 8°C (in a refrigerator) for a maximum of 24 hours, 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%) injection solution
Intravenous infusion of compound sodium lactate
5% glucose and Ringer's lactate infusion solution
5% glucose with 0.45% sodium chloride for intravenous infusion
5% glucose infusion solution
5% glucose with 20 mEq potassium chloride for intravenous infusion
0.45% sodium chloride infusion solution
5% glucose with 0.9% sodium chloride for intravenous infusion

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

Incompatibilities:

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

Blood products must not be infused simultaneously during administration of Voriconazole Hikma.

Total parenteral nutrition may be administered simultaneously with Voriconazole Hikma, but not through the same line or cannula.

Voriconazole Hikma must not be diluted with 4.2% sodium bicarbonate solution.