Voriconazole fosun pharma

Package leaflet: Information for the user

Voriconazole Fosun Pharma, 200 mg, powder for solution for infusion
Voriconazolum
Please read all of this leaflet carefully before use, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor 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, tell your doctor or nurse. See section 4.

Contents of the leaflet

1. What Voriconazole Fosun Pharma, 200 mg is and what it is used for
2. Important information before taking Voriconazole Fosun Pharma, 200 mg
3. How to use Voriconazole Fosun Pharma, 200 mg
4. Possible side effects
5. How to store Voriconazole Fosun Pharma, 200 mg
6. Contents of the pack and other information

1. What Voriconazole Fosun Pharma, 200 mg is and what it is used for

Voriconazole Fosun Pharma, 200 mg contains the active substance voriconazole. Voriconazole Fosun Pharma, 200 mg is an antifungal medicine. It works by killing the fungi causing infections or by inhibiting their growth.
This medicine is used to treat patients (adults and children over 2 years of age) 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. that are resistant to fluconazole (another antifungal medicine),
• serious fungal infections caused by Scedosporium spp. and Fusarium spp. (two different types of fungi).

Voriconazole Fosun Pharma, 200 mg 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 after bone marrow transplantation.
This medicine should only be used under the supervision of a doctor.

2. Important information before taking Voriconazole Fosun Pharma, 200 mg

When not to take Voriconazole Fosun Pharma, 200 mg

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

It is very important to inform your doctor or pharmacist about all medicines currently or recently
taken, even those available without a prescription or herbal medicines.
During treatment with Voriconazole Fosun Pharma, 200 mg, 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),
• 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 (Hypericum perforatum) (herbal medicine),
• Venetoclax (used to treat patients with chronic lymphocytic leukemia).

Warnings and precautions
Before starting treatment with Voriconazole Fosun Pharma, 200 mg, discuss with your
doctor 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 Fosun Pharma, 200 mg. The doctor should also monitor liver function during treatment with Voriconazole Fosun Pharma, 200 mg by ordering appropriate 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 use sunscreen products with a high sun protection factor (SPF) against ultraviolet (UV) radiation, as photosensitivity reactions may occur. These precautions also apply to children.
During treatment with Voriconazole Fosun Pharma, 200 mg:

• Inform your doctor immediately if any of the following occur:
• Sunburn,
• Severe skin rash or blistering,
• Bone pain.

If the patient develops the skin disorders described above, the doctor may refer the patient to a dermatologist, who after consultation may recommend regular follow-up visits. There is a small risk that long-term use of Voriconazole Fosun Pharma, 200 mg 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 your doctor.
The doctor should monitor the patient’s liver and kidney function by ordering blood tests.
Children and adolescents
Voriconazole Fosun Pharma, 200 mg must not be used in children under 2 years of age.
Voriconazole Fosun Pharma, 200 mg and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Some medicines taken together with Voriconazole Fosun Pharma, 200 mg may alter its effect, and Voriconazole Fosun Pharma, 200 mg may also affect the action of other medicines.
Inform your doctor if taking the following medicine, as concomitant use with Voriconazole Fosun Pharma, 200 mg should be avoided if possible:

• Ritonavir (used to treat HIV infections) at a dose of 100 mg twice daily.

Inform your doctor if taking any of the following medicines, as concomitant use with Voriconazole Fosun Pharma, 200 mg should be avoided if possible (if this is not feasible, dose adjustment of voriconazole may be necessary):

• 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 taking any of the following medicines, as dose adjustment or monitoring of these medicines and/or Voriconazole Fosun Pharma, 200 mg may be necessary to ensure continued efficacy:

• Warfarin and other anticoagulants (e.g. phenprocoumon, acenocoumarol) (used to reduce blood clotting),
• Cyclosporine (used after organ transplantation),
• Tacrolimus (used after organ transplantation),
• Sulfonylurea derivatives (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 Fosun Pharma, 200 mg is taken together with oral contraceptives, adverse effects such as nausea and menstrual irregularities may occur),
• Vinca alkaloids (Vinca) (e.g. vincristine, vinblastine) (used in cancer treatment),
• Indinavir and other HIV protease inhibitors (used to treat HIV infection),
• Non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz, delavirdine, nevirapine) (used to treat HIV infection) (certain doses of efavirenz must NOT be taken together with Voriconazole Fosun Pharma, 200 mg),
• 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 for fungal infections),
• Everolimus (used to treat advanced renal cell carcinoma and in transplant patients),
• Tolvaptan [used to treat hyponatremia (low blood sodium levels) or to slow the progression of kidney function decline in patients with autosomal dominant polycystic kidney disease],
• Letermovir (used to prevent cytomegalovirus infection after bone marrow transplantation),
• Naloxegol (used to treat constipation caused by opioid pain medicines such as morphine, oxycodone, fentanyl, tramadol, codeine),
• Ivacaftor (used to treat cystic fibrosis),
• Corticosteroids, including inhaled corticosteroids (used to treat asthma).

Pregnancy and breastfeeding
Voriconazole Fosun Pharma, 200 mg must not be used during pregnancy unless otherwise decided by the doctor. Women of childbearing potential must use effective methods of contraception during treatment. If pregnancy occurs during treatment with Voriconazole Fosun Pharma, 200 mg, contact your doctor immediately.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Voriconazole Fosun Pharma, 200 mg may cause visual disturbances or abnormal reaction to light. In such cases, patients should not drive or operate machinery.
Contact your doctor if such disturbances occur.
Voriconazole Fosun Pharma, 200 mg contains sodium and cyclodextrin
This medicine contains 217.6 mg of sodium (the main component of table salt) per vial. This corresponds to 11% of the maximum recommended daily dietary intake of sodium for adults.
This medicine contains sodium sulfobutyl ether beta-cyclodextrin (cyclodextrin). Each vial contains 3.2 g of sodium sulfobutyl ether beta-cyclodextrin. If the patient has kidney disease, consult your doctor before taking this medicine.

3. How to use Voriconazole Fosun Pharma 200 mg

This medicine should always be used exactly as directed by the doctor. If in doubt, consult the doctor.
The doctor will determine the dose based on body weight and type of infection.
The usual recommended dosage for adults (including elderly patients)
is shown in the table below:

Depending on the response to treatment, the doctor may reduce the daily dose to 3 mg/kg body weight twice daily.
In cases of mild or moderate liver cirrhosis, the doctor may decide to reduce the dose of the medication.
Use in children and adolescents
The usual recommended dosing in children and adolescents is presented in the table below:

Depending on the response to treatment, the doctor may increase or decrease the daily dose.
The Voriconazole Fosun Pharma 200 mg powder for solution for infusion will be dissolved and the resulting solution diluted to the appropriate concentration by a nurse or hospital pharmacist prior to administration (see information provided at the end of this leaflet).
The medicine will be administered as an intravenous infusion at a maximum rate of 3 mg/kg body weight per hour over 1 to 3 hours.
If a patient is receiving Voriconazole Fosun Pharma 200 mg to prevent fungal infections, the treating physician may discontinue administration of Voriconazole Fosun Pharma 200 mg in case of treatment-related adverse reactions.
Voriconazole Fosun Pharma 200 mg must not be administered to children under 2 years of age.
Administration of a higher than recommended dose of Voriconazole Fosun Pharma 200 mg
Since the medicine will be administered under strict supervision of medical personnel, administration of a higher than recommended dose seems unlikely. However, if an overdose is suspected, always inform the doctor or nurse immediately.
Missed administration of Voriconazole Fosun Pharma 200 mg
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 nurse immediately.
Discontinuation of Voriconazole Fosun Pharma 200 mg
The duration of treatment with Voriconazole Fosun Pharma 200 mg will be determined by the doctor. However, treatment with Voriconazole Fosun Pharma 200 mg powder for solution for infusion should not last longer than 6 months.
Patients with impaired immunity or severe infections may require long-term treatment to prevent disease recurrence. When clinical improvement occurs, the route of administration may be changed from intravenous to oral.
If the doctor decides to discontinue treatment with Voriconazole Fosun Pharma 200 mg, there is no need to worry about consequences of discontinuation.
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 experiences 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 Fosun Pharma, 200 mg immediately and contact your doctor:

• 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 patients):

• visual disturbances (changes in vision, including blurred vision, changes in color vision, abnormal light intolerance, inability to see colors, eye disorders, seeing halos, night blindness, sensation of image vibration, seeing sparks, visual aura, reduced visual acuity, bright vision, loss of part of the normal visual field, floaters),
• fever,
• rash,
• nausea, vomiting, diarrhea,
• headache,
• swelling of limbs,
• abdominal pain,
• difficulty breathing,
• increased liver enzyme activity.

Common (may occur in no more than 1 in 10 patients):

• sinusitis, gingivitis, chills, fatigue,
• low count of certain types of blood cells, including severe cases, red blood cells (sometimes immune-mediated) and (or) white blood cells (sometimes accompanied by fever), low platelet count (blood cells involved in clotting),
• low blood sugar, low blood potassium, low blood sodium,
• anxiety, depression, confusion, agitation, insomnia, hallucinations,
• seizures, tremor or uncontrolled muscle movements, tingling or unusual skin sensations, increased muscle tone, drowsiness, dizziness,
• eye bleeding,
• heart rhythm disorders, including very rapid 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 (inflammation of the lips),
• jaundice, hepatitis, and liver damage,
• skin rashes which may lead to severe reactions with blistering and skin peeling characterized by flat red areas covered with small confluent papules, skin redness,
• itching,
• hair loss,
• back pain,
• kidney failure, blood in urine, changes in kidney function tests.

Uncommon (occur in no more than 1 in 100 patients):

• influenza-like symptoms, gastrointestinal irritation and inflammation, antibiotic-associated colitis, lymphangitis,
• inflammation of the thin tissue lining the abdominal cavity and covering abdominal organs (peritonitis),
• lymph node enlargement (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 (peripheral neuropathy),
• balance or coordination disturbances,
• cerebral edema,
• double vision, severe eye diseases including eye and eyelid inflammation, abnormal eye movements, optic nerve damage leading to visual 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,
• liver enlargement, liver failure, gallbladder diseases, gallstones,
• arthritis, superficial thrombophlebitis (which may be associated with blood clot formation),
• nephritis, proteinuria, kidney damage,
• very rapid heartbeat or skipped heartbeats, sometimes with abnormal electrical impulses,
• abnormal electrocardiogram (EKG) findings,
• increased blood cholesterol, increased blood urea,
• skin allergic reactions (sometimes severe), including life-threatening skin disease characterized by painful blisters with painful skin and mucous membrane involvement, particularly in the oral cavity, dermatitis, urticaria, sunburn or severe skin reaction after exposure to light or sun, skin redness and irritation, red or purple skin discolorations which may be caused by low platelet count, rash,
• infusion site reaction,
• allergic reaction or excessive immune response.

Rare (occur in no more than 1 in 1,000 patients):

• hyperthyroidism,
• worsening of brain function, which is a severe complication of liver disease,
• loss of most optic nerve fibers, corneal opacity, involuntary eye movements,
• blistering rash due to photosensitivity,
• disorders in which the immune system attacks parts of the peripheral nervous system,
• cardiac arrhythmias or conduction disorders (sometimes life-threatening),
• life-threatening allergic reaction,
• blood coagulation disorders,
• skin allergic reactions (sometimes severe), including sudden swelling (acute edema) of 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, scaling skin patches, sometimes thickened with sharp projections or "horns".

Not known (frequency cannot be estimated from available data):

• freckles and pigmented spots.

Other important adverse reactions, frequency unknown, but which must be reported to the doctor immediately:

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

During intravenous infusion of Voriconazole Fosun Pharma, 200 mg, adverse symptoms occurred uncommonly (hot flushes, fever, sweating, increased heart rate, and shortness of breath). If these symptoms occur, the doctor may decide to stop the infusion.

Due to the known effects of Voriconazole Fosun Pharma, 200 mg on the liver and kidneys, the doctor will order monitoring of the function of these organs through appropriate blood tests. You should also inform the doctor if abdominal pain or changes in stool consistency occur.

Cases of skin cancer have been reported in patients treated with Voriconazole Fosun Pharma, 200 mg for a prolonged period.

Sunburn or severe skin reactions after exposure to light or sunlight occurred more frequently in children. If skin disorders occur, the doctor may refer the patient 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 symptoms occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: +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 Fosun Pharma 200 mg

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the cardboard box. The expiry date refers to the last day of the stated month.
Chemical and physical in-use stability has been demonstrated for 24 hours at a temperature of 2°C to 8°C.
From a microbiological standpoint, unless the method of opening precludes the risk of microbiological contamination, the reconstituted and diluted solution should be used immediately. If the solution is not used immediately, responsibility for the storage conditions and duration prior to use lies with the user.
Before administration, the reconstituted Voriconazole Fosun Pharma 200 mg must first be diluted with a compatible infusion solution. (see information at the end of this leaflet).
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Voriconazole Fosun Pharma, 200 mg contains

• The active substance is voriconazole.
• The other ingredient is: sodium sulfobutyl ether beta-cyclodextrin.

Each vial contains 200 mg of voriconazole, which when reconstituted by a nurse or hospital pharmacist corresponds to a solution with a concentration of 10 mg/ml (see information at the end of this leaflet).

What Voriconazole Fosun Pharma, 200 mg looks like and contents of the pack
Voriconazole Fosun Pharma, 200 mg is supplied in single-use colorless glass vials as a white lyophilisate in the form of a cake or powder for solution for infusion. Voriconazole Fosun Pharma, 200 mg, powder for solution for infusion, is available in a cardboard box containing 1 vial.

Marketing Authorisation Holder and Importer
Fosun Pharma Sp. z o.o.
ul. Zajęcza 15
00-351 Warsaw
Poland
Tel.: +48 22 244 11 05

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Voriconazol Fosun Pharma
Belgium: Voriconazol Fosun Pharma 200 mg Pulver zur Herstellung einer Infusionslösung / Voriconazol Fosun Pharma 200 mg poeder voor oplossing voor infusie / Voriconazol Fosun Pharma 200 mg poudre pour solution pour perfusion
Germany: Voriconazol Fosun Pharma 200 mg Pulver zur Herstellung einer Infusionslösung
France: Voriconazole Fosun Pharma
Italy: Voriconazolo Fosun Pharma
Netherlands: Voriconazol Fosun Pharma
Poland: Voriconazole Fosun Pharma
Portugal: Voriconazole Fosun Pharma
Spain: Voriconazole Fosun Pharma

Information intended exclusively for healthcare professionals:

Voriconazole Fosun Pharma, 200 mg, powder for solution for infusion:

• The powder must be dissolved in 19 ml of water for injections or 19 ml of 0.9% (9 mg/ml) sodium chloride solution for injections to obtain 20 ml of a clear concentrate containing 10 mg/ml of voriconazole.
• If the vacuum (reduced pressure) in the vial does not allow the solvent to enter, such a vial of Voriconazole Fosun Pharma, 200 mg must be discarded. To ensure accurate measurement of the volume (19 ml) of water for injections or 0.9% (9 mg/ml) sodium chloride solution for injections, the use of standard 20 ml (non-automatic) syringes is recommended.
• To administer, the required volume of the prepared concentrate should be added to the recommended compatible infusion solution (details in the table below) to obtain the final solution of Voriconazole Fosun Pharma, 200 mg containing 0.5–5 mg/ml of voriconazole.
• This product is intended for single use only; any unused portion of the solution must be discarded. Only clear solutions free from any particulate matter should be administered.
• The solution is not intended for rapid intravenous injection (bolus).
• Information regarding storage is provided in section 5, "How to store Voriconazole Fosun Pharma, 200 mg".

Required volumes of Voriconazole Fosun Pharma, 200 mg concentrate (10 mg/ml)

Voriconazole Fosun Pharma 200 mg is an unconserved, sterile lyophilisate for single use.
Therefore, from a microbiological point of view, the prepared solution should be used immediately. If the solution is not used immediately, the user is responsible for storage conditions and duration prior to use.
Compatible solutions for preparing infusion solutions:
The prepared concentrate may be diluted in:
9 mg/ml (0.9%) sodium chloride solution for injection,
sodium lactate solution for intravenous infusion,
5% glucose solution for intravenous infusion,
Ringer's lactate solution for intravenous infusion,
5% glucose in 0.45% sodium chloride solution for intravenous infusion,
5% glucose in 20 mEq potassium chloride solution for intravenous infusion,
0.45% sodium chloride solution for intravenous infusion,
5% glucose and 0.9% sodium chloride solution for intravenous infusion.
Compatibility of Voriconazole Fosun Pharma 200 mg with solutions other than those listed above (or mentioned in the section "Incompatibilities" below) has not been established.
Incompatibilities:
Voriconazole Fosun Pharma 200 mg 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).
Blood products should not be used concomitantly with Voriconazole Fosun Pharma 200 mg.
Parenteral nutrition infusions may be administered simultaneously with voriconazole, but not through the same intravenous access or cannula.
4.2% sodium bicarbonate solution for intravenous infusion must not be used to dilute Voriconazole Fosun Pharma 200 mg.