Package leaflet: Information for the user

Voriconazole SaneXcel, 200 mg, powder for solution for infusion
Voriconazolum
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 further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

1. What Voriconazole SaneXcel is and what it is used for

Voriconazole SaneXcel contains the active substance voriconazole. Voriconazole SaneXcel is an antifungal medicine. It works by killing the fungi causing infection or by inhibiting their growth.
The 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 spp.),
candidaemia (another type of fungal infection caused by fungi of the genus Candida spp.) in patients without concomitant neutropenia (patients who do not have reduced numbers of white blood cells),
serious, invasive fungal infections caused by fungi of the genus Candida spp. that are resistant to fluconazole (another antifungal medicine),
serious fungal infections caused by fungi of the genus Scedosporium spp. and Fusarium spp. (two different types of fungi).

Voriconazole SaneXcel is intended for patients with progressive, potentially life-threatening fungal infections.
The medicine is also indicated for the prevention of fungal infections in high-risk patients following bone marrow transplantation.
This medicine should only be used under the supervision of a doctor.

2. Important information before using Voriconazole SaneXcel

When not to use Voriconazole SaneXcel:

if the patient is allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).

During treatment with Voriconazole SaneXcel, the following medicines must not be taken:

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 for symptoms of chronic heart failure)
Rifampicin (used to treat tuberculosis)
Efavirenz (used to treat HIV infections) at doses of 400 mg or higher once daily
Carbamazepine (used to treat epilepsy)
Phenobarbital (used for insomnia and epilepsy treatment)
Ergot alkaloids (e.g. ergotamine, dihydroergotamine; used for migraine)
Sirolimus (used in transplant medicine)
Ritonavir (used to treat HIV infections) at doses of 400 mg or higher twice daily
St John’s wort (a herbal remedy)
Naloxegol (used to treat constipation caused by painkillers called opioids (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 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 SaneXcel, discuss with your doctor, pharmacist,
or nurse if:

the patient has previously experienced an allergic reaction to other azoles;
the patient has or has ever had liver disease. In case of liver disease, the doctor may prescribe a lower dose of Voriconazole SaneXcel. The doctor should also monitor liver function during treatment by ordering blood tests;
the patient has been diagnosed with cardiomyopathy, irregular heartbeat, slow heart rate, or changes in the electrocardiogram (ECG) known as “prolonged QTc interval”.

During treatment, avoid any exposure to sunlight. It is important to wear protective clothing against sunlight and to use sunscreen products with a high sun protection factor (SPF), as photosensitivity reactions 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 Voriconazole SaneXcel:

inform the doctor immediately if any of the following occur:
o sunburn
o severe skin rash or blisters
o bone pain

If the patient develops the skin disorders described above, the doctor may refer the patient to a dermatologist, who may, after consultation, decide on the need for regular follow-up visits. There is a small risk that long-term use of Voriconazole SaneXcel may lead to skin cancer.
If the patient develops symptoms of “adrenal insufficiency”, in which the adrenal glands do not produce sufficient amounts of certain steroid hormones such as cortisol, leading to symptoms such as: 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, leading 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, increased sweating, inform the doctor.
The doctor should monitor the patient’s liver and kidney function through blood tests.

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

Voriconazole SaneXcel and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines taken together with Voriconazole SaneXcel may alter its effect, and Voriconazole SaneXcel may also affect the action of other medicines.
Tell your doctor if you are taking the following medicine, as its concomitant use with Voriconazole SaneXcel should be avoided if possible:

Ritonavir (used to treat HIV infections) 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.

Tell your doctor if you are taking any of the following medicines, as their concomitant use with Voriconazole SaneXcel should be avoided if possible (if concomitant use is necessary, the dose of voriconazole may need to be adjusted):

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 Voriconazole SaneXcel treatment, its blood concentration should be monitored and dose adjustment considered.

Tell your doctor if you are taking any of the following medicines, as dose adjustment or monitoring of these medicines and/or Voriconazole SaneXcel may be necessary to ensure continued effectiveness:

Warfarin and other anticoagulants (e.g. phenprocoumon, acenocoumarol; used to reduce blood clotting)
Cyclosporine (used in transplant patients)
Tacrolimus (used in transplant patients)
Sulfonylurea derivatives (e.g. tolbutamide, glipizide, glyburide) (used in diabetes)
Statins (e.g. atorvastatin, simvastatin) (used to lower cholesterol levels)
Benzodiazepines (e.g. midazolam, triazolam) (used for severe insomnia and stress)
Omeprazole (used to treat ulcers)
Oral contraceptives (if Voriconazole SaneXcel is taken together with oral contraceptives, adverse effects such as nausea and menstrual irregularities may occur)
Vinca alkaloids (e.g. vincristine, vinblastine) (used in cancer treatment)
Tyrosine kinase inhibitors (e.g. axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (used in cancer treatment)
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) (some doses of efavirenz must not be used concomitantly with Voriconazole SaneXcel)
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 or 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 transplant patients)
Letermovir (used to prevent cytomegalovirus (CMV) disease after haematopoietic stem cell transplantation)
Ivacaftor (used to treat cystic fibrosis)
Flucloxacillin (an antibiotic used to treat bacterial infections)

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Voriconazole SaneXcel must not be used during pregnancy unless otherwise decided by the doctor.
Women of childbearing potential must use an effective method of contraception during treatment with Voriconazole SaneXcel. If pregnancy occurs during treatment with Voriconazole SaneXcel, contact the doctor immediately.

Driving and operating machinery
Voriconazole SaneXcel may cause blurred vision or abnormal reaction to light. If these symptoms occur, do not drive or operate any tools or machinery. Contact your doctor if such disturbances occur.

Voriconazole SaneXcel contains sodium
This medicine contains 88.74 mg of sodium (the main component of table salt) in each vial. This corresponds to 4.44% of the maximum recommended daily sodium intake in the adult diet.
The maximum recommended daily dose of this medicine for an adult contains 372.71 mg of sodium (present in table salt). This corresponds to 18.64% of the maximum recommended daily sodium intake in the adult diet.
Consult your doctor or pharmacist if the patient requires 5 or more vials per day for a prolonged period, especially if a low-salt (low-sodium) diet has been recommended.

Voriconazole SaneXcel contains hydroxypropylbetadex
Each vial contains 2400 mg of hydroxypropylbetadex.
If the patient has kidney disease, talk to the doctor before taking this medicine.

3. How to use Voriconazole SaneXcel

This medicine should always be used as directed by the doctor. If in doubt, consult
the doctor.
The doctor determines the dose based on body weight and type of infection.
The doctor may adjust the dose depending on the patient's condition.
The recommended dose for adults (including elderly patients) is given below:

	Intravenous
Dose for 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 response to treatment, the physician may reduce the dose to 3 mg/kg body weight twice daily.
The physician may decide to reduce the dose of the medicinal product if mild to moderate liver cirrhosis is diagnosed.
Use in children and adolescents
This medicinal product must not be used in children under 2 years of age.
The recommended dose for children and adolescents is given below:

	Intravenous
	Children aged 2 to 12 years and adolescents aged 12 to 14 years with body weight below 50 kg	Adolescents aged 12 to 14 years with body weight of 50 kg or more; and adolescents above 14 years of age
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 daily	4 mg/kg body weight twice daily

Depending on the response to treatment, the doctor may increase or decrease the daily dose.
The medicine Voriconazole SaneXcel, powder for solution for infusion, will be reconstituted before administration, and the resulting solution will be diluted to the appropriate concentration by a hospital pharmacist or nurse. (More information can be found at the end of this leaflet).
The medicine will be administered by intravenous infusion at a maximum rate of 3 mg/kg body weight per hour for 1 to 3 hours.
If the patient or their child is receiving Voriconazole SaneXcel to prevent fungal infections, and treatment-related adverse reactions occur, the doctor may discontinue administration of Voriconazole SaneXcel.
Missed dose of Voriconazole SaneXcel
Since the medicine will be administered under strict supervision of medical personnel, a missed dose seems unlikely. However, if a dose is suspected to have been missed, always inform the doctor or pharmacist.
Stopping Voriconazole SaneXcel
The duration of treatment with Voriconazole SaneXcel is determined by the doctor; however, treatment with Voriconazole SaneXcel, powder for solution for infusion, should not last longer than 6 months.
Patients with weakened immunity or severe infections may require prolonged treatment to prevent recurrence of infection. If the patient's health improves, they may switch from intravenous infusion to tablets.
If the doctor decides to discontinue treatment with Voriconazole SaneXcel, there is no need to worry about the consequences of stopping.
If you have any further questions regarding 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 mostly mild and transient. However, some of them may be serious and may require medical intervention.
Severe adverse reactions – Discontinue use of Voriconazole SaneXcel and contact your doctor immediately if any of the following symptoms occur:

Rash
Jaundice; changes in blood test results related to liver function
Pancreatitis

Other adverse reactions
Very common: may occur in more than 1 in 10 people

Visual disturbances (changes in vision, including blurred vision, changes in color vision, abnormal light sensitivity, loss of color vision, eye disorders, seeing halos, night blindness, perception of flickering images, seeing sparks, visual aura, reduced visual acuity, bright vision, loss of part of the normal visual field, floaters)
Fever
Rash
Nausea, vomiting, diarrhea
Headache
Peripheral edema
Abdominal pain
Difficulty breathing
Increased liver enzyme activity

Common: may occur in no more than 1 in 10 people

Sinusitis, gingivitis, chills, fatigue
Low levels of certain types of blood cells, including severe cases, red blood cells (sometimes immune-mediated), and (or) white blood cells (sometimes associated with fever), low platelet count (which help blood clot)
Low blood sugar, low blood potassium, low blood sodium
Anxiety, depression, confusion, agitation, insomnia, hallucinations
Seizures, tremor or uncontrolled muscle movements, tingling or unusual skin sensations, increased muscle tone, drowsiness, dizziness
Eye hemorrhage
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 eyes), fluid accumulation in the lungs
Constipation, indigestion, cheilitis
Jaundice, hepatitis, and liver damage
Skin rashes that may lead to severe blistering and skin peeling characterized by flat, red areas on the skin covered with small, coalescing papules, skin redness
Itching
Hair loss
Back pain
Kidney failure, blood in urine, changes in kidney function tests
Sunburn or severe skin reaction after exposure to light or sunlight
Skin cancer

Uncommon: may occur in no more than 1 in 100 people

Influenza-like symptoms, irritation and inflammation of the gastrointestinal tract, antibiotic-associated diarrhea due to gastrointestinal inflammation, lymphangitis
Inflammation of the thin tissue lining the abdominal cavity and covering abdominal organs (peritonitis)
Enlarged lymph nodes (sometimes painful), bone marrow failure, increased eosinophil count
Adrenal gland dysfunction, hypothyroidism
Brain function disorders, symptoms resembling Parkinson's disease, nerve damage causing numbness, pain, tingling or burning sensations in hands or feet
Impaired balance or coordination
Brain edema
Double vision, severe eye disorders, including: eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage leading to vision disturbances, optic disc edema
Decreased sensitivity to touch
Taste disturbances
Hearing loss, tinnitus, dizziness
Inflammation of certain internal organs – pancreas and duodenum, tongue swelling and inflammation
Enlarged liver, liver failure, gallbladder disorders, gallstones
Arthritis, phlebitis under the skin (which may be associated with blood clot formation)
Kidney inflammation, proteinuria, kidney damage
Very rapid heartbeat or skipped heartbeats, sometimes with abnormal electrical impulses
Abnormal electrocardiogram (ECG) findings
Increased blood cholesterol levels, increased blood urea levels
Skin allergic reactions (sometimes severe), including life-threatening skin disease characterized by painful blisters with associated skin and mucous membrane pain, particularly in the oral cavity, dermatitis, urticaria, skin redness and irritation, red or purplish skin discolorations that may be caused by low platelet count, rash
Infusion site reaction
Allergic reaction or excessive immune response
Inflammation of the tissue surrounding the bone (periostitis)

Rare: may occur in no more than 1 in 1,000 people

Hyperthyroidism
Worsening of brain function, which is a serious complication of liver disease
Loss of most of the optic nerve fibers, corneal opacity, involuntary eye movements
Bullous rash due to photosensitivity
Disorders in which the body's immune system attacks part of the peripheral nervous system
Heart rhythm or conduction disorders (sometimes life-threatening)
Life-threatening allergic reaction
Blood coagulation disorders
Skin allergic reactions (sometimes severe), including sudden swelling (acute edema) of the dermis, subcutaneous tissue, mucous membranes, and submucosal tissues, itchy or painful thickened, red skin patches with silvery scales, skin and mucous membrane irritation, life-threatening skin disease involving detachment of large sheets of the epidermis (outer skin layer) from deeper skin layers
Small, dry, scaly skin lesions, sometimes thickened with sharp projections or "horns"

Frequency not known (frequency cannot be estimated from available data):

Freckles and pigmented spots

Other important adverse reactions with unknown frequency, which should be reported to a doctor immediately:

Red, peeling skin patches or ring-shaped skin lesions, which may be symptoms of an autoimmune disease called cutaneous lupus erythematosus

During intravenous infusion of Voriconazole SaneXcel, adverse symptoms (hot flushes, fever, sweating, rapid heartbeat, and shortness of breath) occurred uncommonly. If these symptoms occur, the doctor may decide to discontinue the infusion.
Due to the known effects of Voriconazole SaneXcel on the liver and kidneys, the doctor will order monitoring of these organs' function through appropriate blood tests. You should also inform your doctor if you experience abdominal pain or changes in stool consistency.
Cases of skin cancer have been reported in patients treated with Voriconazole SaneXcel for prolonged periods.
Sunburn or severe skin reactions after exposure to light or sunlight occurred more frequently in children. If skin disorders occur in a patient, the doctor may refer them to a dermatologist, who may, after consultation, decide that regular dermatological check-ups are necessary. Increased liver enzyme activity has also been observed more frequently in children.
If any of these adverse reactions persist or become bothersome, inform your doctor.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Voriconazole SaneXcel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and vial after EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions for the medicine prior to opening.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 72 hours at 25°C and at 2°C–8°C.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately,
the responsibility for storage conditions and duration prior to use lies with the user, and the storage time of the concentrate should not exceed 24 hours at 2°C–8°C (in a refrigerator), provided the powder has been dissolved under controlled and validated aseptic conditions. Before administration, the reconstituted Voriconazole SaneXcel must be diluted with a compatible infusion solution. (More information can be found at the end of this leaflet.)
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Voriconazole SaneXcel contains

The active substance is voriconazole. Each vial contains 200 mg of voriconazole. After reconstitution, each mL of solution contains 10 mg of voriconazole.
The other components are: hydroxypropylbetadex, sodium chloride, hydrochloric acid concentrated (for pH adjustment).

What Voriconazole SaneXcel looks like and contents of the pack
Each carton contains one or ten vials. Voriconazole SaneXcel is a white or almost white lyophilised powder for infusion solution in a 25 mL clear type I glass vial, closed with a grey chlorobutyl rubber stopper and an aluminium cap with a plastic red flip-off seal.
Marketing Authorisation Holder
J.J. Bishop Health a.s.
Rybná 682/14, Staré Město
110 00 Prague 1
Czech Republic
e-mail: [email protected]
Manufacturer
Pharmathen S.A.
Dervenakion 6
153 51 Pallini Attiki
Greece
Anfarm Hellas S.A.
61st Km National Road Athens Lamia
320 09 Schimatari
Greece
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria: Вориконазол SaneXcel 200 mg прах за инфузионен разтвор
Voriconazole SaneXcel 200 mg powder for solution for infusion
Czech Republic: Voriconazole SaneXcel
Poland: Voriconazole SaneXcel
Slovakia: Voriconazole SaneXcel
Hungary: Voriconazol SaneXcel 200 mg por oldatos infúzióhoz
Romania: Voriconazol SaneXcel 200 mg pulbere pentru soluție perfuzabilă
Information intended for healthcare professionals only:
Reconstitution and dilution instructions

Voriconazole SaneXcel powder for infusion solution must be reconstituted with 19 mL of water for injections or 19 mL of 9 mg/mL (0.9%) sodium chloride for injections to obtain 20 mL of a clear concentrate containing 10 mg/mL of voriconazole.
The vial of Voriconazole SaneXcel should be discarded if the solvent does not get drawn in spontaneously during reconstitution due to the vacuum present in the vial.
To ensure accurate measurement of the volume (19 mL) of water for injections or 9 mg/mL (0.9%) sodium chloride for injections, the use of standard 20 mL (non-automated) syringes is recommended.
To obtain the final Voriconazole SaneXcel solution containing 0.5 mg/mL to 5 mg/mL of voriconazole, the required volume of reconstituted concentrate should be added to the recommended compatible infusion solution listed below.
This medicine is intended for single use only, and any unused portion of the solution should be discarded. Only clear solutions free from particulate matter should be used.
The solution is not intended for rapid intravenous bolus injection.
Storage instructions are provided in section 5 "How to store Voriconazole SaneXcel".

Required volumes of Voriconazole SaneXcel concentrate, 10 mg/mL

Body weight (kg)	Volume of Voriconazole SaneXcel concentrate (10 mg/mL) required to prepare:
Body weight (kg)	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)
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)

The medicine Voriconazole SaneXcel is a single-dose, preservative-free, sterile lyophilisate. Therefore, from a microbiological standpoint, the reconstituted solution must be used immediately. If the solution is not used immediately, the user is responsible for the storage time and conditions prior to use, and the storage time of the solution should not exceed 24 hours at 2°C–8°C (in a refrigerator), provided the powder was reconstituted under controlled and validated aseptic conditions. Before administration, Voriconazole SaneXcel must be dissolved in a compatible infusion solution.

Compatible infusion solutions:

The reconstituted solution may be diluted in:

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

Compatibility of Voriconazole SaneXcel with solutions other than those listed above (or mentioned in the section “Incompatibilities” below) has not been established.

Incompatibilities:

Voriconazole SaneXcel must not be co-administered with other medicinal products in the same infusion line or intravenous access, including parenteral nutrition (e.g., Aminofusin 10% Plus).

Voriconazole SaneXcel must not be administered simultaneously with blood products.

Parenteral nutrition infusions may be administered concurrently with Voriconazole SaneXcel, but not through the same intravenous access or cannula.

4.2% sodium bicarbonate infusion solution must not be used to dissolve Voriconazole SaneXcel.

Voriconazole sanexcel