Package leaflet: Information for the user

Voriconazole hameln, 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, as 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

What Voriconazole hameln is and what it is used for
Important information before using Voriconazole hameln
How to use Voriconazole hameln
Possible side effects
How to store Voriconazole hameln
Contents of the pack and other information

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

Voriconazole hameln contains the active substance voriconazole. Voriconazole is an antifungal medicine. It works by killing the fungi causing infections or by inhibiting their growth.
The medicine is used to treat patients (adults and children aged over 2 years) 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 white blood cell counts),
serious, invasive fungal infections caused by Candida spp. fungi resistant to fluconazole (another antifungal medicine),
serious fungal infections caused by Scedosporium spp. and Fusarium spp. fungi (two different fungal species).
Voriconazole is intended for patients with progressive, life-threatening fungal infections.
The medicine is also indicated for prophylaxis of fungal infections in high-risk patients following bone marrow transplantation.
This medicine should only be used under the supervision of a physician.

2. Important information before using Voriconazole hameln

When not to use Voriconazole hameln

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 tell your doctor or pharmacist about all medicines currently or recently taken by the patient, including those obtained without a prescription or herbal medicines.
The following medicines must not be taken during treatment with Voriconazole hameln:

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 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 patients),
ritonavir (used to treat HIV infections) at doses of 400 mg or higher twice daily,
St. John’s wort (herbal product),
naloxegol [used to treat constipation caused by opioid pain medicines (e.g. morphine, oxycodone, fentanyl, tramadol, codeine)],
tolvaptan [used to treat hyponatremia (low blood sodium levels) or to slow 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 leukaemia (CLL)].

Warnings and precautions
Before starting treatment with voriconazole, discuss this 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. The doctor should also monitor liver function during treatment with voriconazole by ordering 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. It is important to wear protective clothing and use sunscreen products with a high sun protection factor (SPF) against ultraviolet (UV) radiation, as photosensitivity reactions may occur. These 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,
contact your doctor immediately if you experience:
sunburn
severe skin rash or blisters
bone pain
If the patient develops the skin disorders described above, the doctor may refer the patient to a dermatologist, who may recommend regular follow-up visits. There is a small risk that long-term use of voriconazole may lead to the development of skin cancer.
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, which may lead to symptoms such as: chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, inform your doctor.
If the patient develops symptoms of "Cushing's syndrome", a condition 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, inform your doctor.
The doctor should regularly monitor the patient's liver and kidney function by ordering blood tests.
Children and adolescents
Voriconazole hameln must not be used in children under 2 years of age.
Voriconazole hameln and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take, including those obtained without a prescription.
Some medicines taken together with voriconazole may alter its effect, and voriconazole may also affect the action of other medicines.
Inform your doctor if you are taking the following medicine, as concomitant use with voriconazole 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 co-administration is necessary, the doctor will order frequent monitoring of heart rhythm.

Inform your doctor if you are taking any of the following medicines, as concomitant use with voriconazole should be avoided if possible (if this is not possible, dose adjustment of voriconazole 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 voriconazole treatment, its blood concentration should be monitored and dose adjustment considered.

Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring of these medicines and/or voriconazole may be necessary to ensure they remain 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 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 ulcers),
oral contraceptives (if voriconazole is used together with oral contraceptives, adverse effects such as nausea and menstrual irregularities 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) (some doses of efavirenz must not be used together with voriconazole),
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 kidney cancer and in transplant patients),
letermovir [used to prevent cytomegalovirus (CMV) disease after bone marrow 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.
Voriconazole hameln must not be used during pregnancy unless the doctor decides otherwise.
Women of childbearing potential must use effective contraception during treatment with Voriconazole hameln. If pregnancy occurs during treatment with Voriconazole hameln, contact your doctor immediately.
Driving and operating machinery
Voriconazole hameln may cause visual disturbances or abnormal reaction to light. In such cases, driving and operating machinery should be avoided. Contact your doctor if such disturbances occur.
Voriconazole hameln 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 dietary sodium intake for adults.
Inform your doctor or pharmacist if the patient requires 5 or more vials daily for a prolonged period, especially if a low-salt (low-sodium) diet has been recommended.
Voriconazole hameln contains hydroxypropylbetadex
This medicine contains 2,400 mg of hydroxypropylbetadex in each vial, equivalent to 120 mg/mL when reconstituted in 20 mL of clear concentrate.
If the patient has kidney disease, he or she should contact the doctor before using this medicine.

3. How to use Voriconazole hameln

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

	Intravenous
Loading dose (first 24 hours)	6 mg/kg body weight every 12 hours during the first 24 hours
Maintenance dose (after first 24 hours)	4 mg/kg body weight twice daily

Depending on the response to treatment, the physician may reduce the daily dose to 3 mg/kg body weight twice daily.
In case of mild to moderate liver cirrhosis, the physician may decide to reduce the dose of the medicinal product.
Use in children and adolescents
The usually recommended dosing for children and adolescents is presented in the table below:

	Intravenous
	Children aged 2 to 12 years and adolescents aged 12 to 14 years weighing less than 50 kg	Adolescents aged 12 to 14 years weighing 50 kg or more and adolescents aged over 14 years
Loading dose (first 24 hours)	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
Maintenance dose (after the first 24 hours)	8 mg/kg body weight twice daily	4 mg/kg body weight twice daily

Depending on the response to treatment, the physician may increase or decrease the daily dose.
Voriconazole hameln, powder for solution for infusion, will be prepared by a nurse or pharmacist (see information provided at the end of the leaflet).
The medicine will be administered by intravenous infusion at a maximum rate of 3 mg/kg body weight per hour over 1 to 3 hours.
If the patient is receiving Voriconazole hameln to prevent fungal infections, in case of treatment-related adverse reactions, the treating physician may discontinue administration of Voriconazole hameln.
Missed dose of Voriconazole hameln
Since the medicine will be administered under strict medical supervision, a missed dose seems unlikely. However, if a dose is suspected to have been missed, always inform the physician or pharmacist.
Discontinuation of Voriconazole hameln treatment
The duration of Voriconazole hameln treatment is determined by the physician; however, treatment with Voriconazole hameln, powder for solution for infusion, should not exceed 6 months.
Patients with impaired immunity or severe infections may require long-term treatment to prevent disease recurrence. Upon clinical improvement, the route of administration of Voriconazole hameln may be switched from intravenous to oral.
If the physician decides to discontinue therapy, there is no need to worry about consequences of stopping the treatment.
If you have any further questions concerning the use of this medicine, consult your physician, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, they are mostly mild and temporary. However, some of them may be serious and may require medical intervention.
Severe side effects – stop taking Voriconazole hameln immediately and contact your doctor
Rash
Jaundice; changes in blood test results related to liver function
Pancreatitis

Other side effects
Very common: (may occur in more than 1 in 10 people):

Visual disturbances (vision changes, including blurred vision, colour vision changes, abnormal light sensitivity, loss of colour vision, eye disorders, seeing halos, night blindness, image vibration, seeing sparks, visual aura, reduced visual sharpness, bright vision, loss of part of the normal field of vision, floaters)
Fever
Rash
Nausea, vomiting, diarrhoea
Headache
Peripheral oedema
Abdominal pain
Breathing difficulties
Increased liver enzyme activity

Common: (may occur in not 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 levels of platelets, which help blood clotting
Low blood sugar levels, low blood potassium levels, low blood sodium levels
Anxiety, depression, confusion, agitation, insomnia, hallucinations
Seizures, tremor or uncontrolled muscle movements, tingling or unusual skin sensations, increased muscle tone, somnolence, dizziness
Eye bleeding
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
Rashes that may lead to severe blistering and skin peeling characterised by flat, red areas covered with small merging bumps, skin redness
Itching
Hair loss
Back pain
Kidney failure, blood in urine, changes in kidney function tests
Sunburn or severe skin reaction following exposure to light or sunlight
Skin cancer

Uncommon: (may occur in not more than 1 in 100 people):

Flu-like symptoms, gastrointestinal irritation and inflammation, antibiotic-associated diarrhoea 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, Parkinson-like symptoms, nerve damage causing numbness, pain, tingling or burning sensations in hands or feet
Balance or coordination disorders
Brain oedema
Double vision, severe eye diseases, including: eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage leading to vision disturbances, optic disc swelling
Reduced sensitivity to touch
Taste disturbances
Hearing loss, tinnitus, vertigo
Inflammation of certain internal organs – pancreas and duodenum, tongue swelling and inflammation
Liver enlargement, liver failure, gallbladder diseases, gallstones
Arthritis, phlebitis under the skin (which may be associated with blood clot formation)
Nephritis, proteinuria, kidney damage
Very fast 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 characterised by painful blisters with accompanying skin and mucous membrane pain, particularly in the oral cavity, dermatitis, urticaria, redness and skin irritation, red or purple skin discolourations which may be caused by low platelet count, rash
Reaction at the infusion site
Allergic reaction or excessive immune response
Inflammation of the tissue surrounding the bone (periostitis)

Rare: (may occur in not 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 fibres, corneal opacity, involuntary eye movements
Bullous 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 coagulation disorders
Skin allergic reactions (sometimes severe), including sudden swelling (sudden oedema) of the dermis, subcutaneous tissue, mucous membranes and submucosal tissues, itchy or painful patches of thickened, red skin with silvery scales, skin and mucous membrane irritation, life-threatening skin disease characterised by peeling off 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):

Freckles and pigmented spots

Other important side effects, the frequency of which is unknown but 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 hameln, uncommon occurrences of adverse reactions have been observed (hot flushes, fever, sweating, increased heart rate, and shortness of breath). If these symptoms occur, the doctor may decide to discontinue the infusion.
Due to the known effects of Voriconazole hameln 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 hameln for prolonged periods.
Sunburn or severe skin reactions following 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 after consultation may decide that regular dermatological check-ups are necessary. Increased liver enzyme activity has also been observed more frequently in children.
If any of these side effects persist or become bothersome, inform your doctor.

Reporting of side effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
Side effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Voriconazole hameln

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and vial label after EXP. The expiry date refers to the last day of the specified month.
Unopened vial
No special storage precautions are required for the medicine prior to opening.
Product after reconstitution and dilution:
Chemical and physical in-use stability has been demonstrated for 72 hours at 25 °C and at 2 – 8 °C. From a microbiological standpoint, the product should be used immediately. If the concentrate is 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 (refrigerator), provided the powder was dissolved/diluted under controlled and validated aseptic conditions.
Reconstituted Voriconazole hameln should be diluted in a compatible infusion solution immediately before infusion (Further information can be found at the end of this leaflet).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

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

What Voriconazole hameln looks like and contents of the pack
Each pack contains 1 vial. Voriconazole hameln is a white or almost white lyophilized powder for solution for infusion in a 25 mL clear type I glass vial, closed with a grey chlorobutyl rubber stopper type I, sealed with an aluminium seal and a plastic red flip-off cap.

Marketing Authorisation Holder
hameln pharma gmbh
Inselstrasse 1
317 87 Hameln
Germany
Tel.: +49 171 766 2789

Manufacturer
Anfarm Hellas S.A.
61 Km National Road Athens Lamia
320 09 Schimatari Viotias
Greece
Pharmathen S.A.
6, Dervenakion street
Pallini 153 51 Attiki
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Voriconazol hameln 200 mg Pulver zur Herstellung einer Infusionslösung
Belgium Voriconazol hameln 200 mg poeder voor oplossing voor infusie/Pulver zur Herstellung einer Infusionslösung/poudre pour solution pour perfusion
Bulgaria Вориконазол hameln 200mg Прах за инфузионен разтвор
Czech Republic Voriconazole hameln
Denmark Voriconazole „hameln”
Finland Voriconazole hameln 200 mg infuusiokuiva-aine, liuosta varten
Ireland Voriconazole 200mg powder for solution for infusion
Netherlands Voriconazol hameln 200 mg poeder voor oplossing voor infusie
Germany Voriconazol hameln 200 mg Pulver zur Herstellung einer Infusionslösung
Norway Voriconazole hameln
Poland Voriconazole hameln
Portugal Voriconazol hameln 200 mg pó para solução para perfusão
Romania Voriconazol hameln 200 mg pulbere pentru soluţie perfuzabilă
Slovakia Voriconazole hameln 200 mg prášok na infúzny roztok
Slovenia Vorikonazol hameln 200 mg prašek za raztopino za infundiranje
Sweden Voriconazole hameln 200 mg pulver till infusionsvätska, lösning
Italy Voriconazolo hameln

Information intended exclusively for professional medical personnel:

Voriconazole hameln, 200 mg, powder for solution for infusion
Information on reconstitution and dilution:

Voriconazole hameln powder for solution for infusion should be dissolved in 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 Voriconazole hameln vial should be discarded if the solvent is not spontaneously drawn in by the vacuum present in the vial during introduction.
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 an infusion solution containing 0.5 mg/mL to 5 mg/mL of voriconazole, the required volume of the prepared concentrate should be added to the recommended compatible infusion solution (see below).
This medicinal product is for single use only. Any unused solution should be discarded. Do not use solutions that are not clear or contain any cloudiness or particulate matter.
The solution is not intended for rapid intravenous injection (bolus).
Information on storage is provided in section 5 "How to store Voriconazole hameln".

Required volumes of Voriconazole hameln concentrate 10 mg/mL

Body weight (kg)	Volume of Voriconazole hameln concentrate (10 mg/mL) required for:
Body weight (kg)	dose of 3 mg/kg b.w. (number of vials)	dose of 4 mg/kg b.w. (number of vials)	dose of 6 mg/kg b.w. (number of vials)	dose of 8 mg/kg b.w. (number of vials)	dose of 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)

Voriconazole hameln is an unconserved, sterile lyophilisate intended for single use. From a microbiological point of view, the solution should therefore be used immediately after reconstitution and dilution. If the concentrate is not used immediately, the user is responsible for the storage time and conditions prior to use. The storage time of the concentrate should not exceed 24 hours at a temperature of 2 °C – 8 °C, provided that reconstitution/dilution was carried out under controlled and validated aseptic conditions.
Reconstituted Voriconazole hameln should be diluted in a compatible infusion fluid immediately before infusion.
Compatible solutions for preparing the infusion solution:
The concentrate may be diluted with:
9 mg/mL (0.9%) sodium chloride injection solution
sodium lactate infusion solution
5% glucose and Ringer's lactate infusion solution
5% glucose with 0.45% sodium chloride infusion solution
5% glucose infusion solution
5% glucose with 20 mEq potassium chloride infusion solution
0.45% sodium chloride infusion solution
5% glucose and 0.9% sodium chloride infusion solution
Compatibility of Voriconazole hameln with solutions other than those listed above (or in the section "Incompatibilities" below) has not been established.
Incompatibilities:
Voriconazole hameln must not be administered together with other medicinal products in the same infusion line or intravenous access, including parenteral nutrition (e.g., Aminofusin 10% Plus).
Voriconazole hameln should not be used concomitantly with blood products.
Administration of parenteral nutrition infusions may occur simultaneously with voriconazole, but not through the same intravenous access or cannula.
4.2% sodium bicarbonate infusion solution must not be used for dilution of Voriconazole hameln.