Voriconazole Fosun Pharma

Package Leaflet: Information for the User

Voriconazole Fosun Pharma, 200 mg, Powder for Solution for Infusion

Voriconazole

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medication has been prescribed specifically for you. 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 those not listed in this package leaflet, inform your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Voriconazole Fosun Pharma, 200 mg and what is it used for
• 2. Important Information Before Taking Voriconazole Fosun Pharma, 200 mg
• 3. How to Take Voriconazole Fosun Pharma, 200 mg
• 4. Possible Side Effects
• 5. How to Store Voriconazole Fosun Pharma, 200 mg
• 6. Contents of the Package and Other Information

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

Voriconazole Fosun Pharma, 200 mg contains the active substance voriconazole. Voriconazole Fosun Pharma, 200 mg is an antifungal medication. It works by killing fungi that cause infections or by stopping them from growing.

The medication is used to treat patients (adults and children over 2 years of age) with:

• invasive aspergillosis (a type of fungal infection caused by Aspergillus spp.),
• candidemia (another type of fungal infection caused by Candida spp.) in patients without accompanying neutropenia (patients who do not have a decreased number of white blood cells),
• severe, invasive fungal infections caused by Candida spp. that are resistant to fluconazole (another antifungal medication),
• severe 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, life-threatening fungal infections.

The medication is also intended to prevent fungal infections in patients at high risk after bone marrow transplantation.

This medication 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 medication (listed in section 6).

It is very important to inform the doctor or pharmacist about all medications currently or recently taken, including those available without a prescription or herbal remedies.

During treatment with Voriconazole Fosun Pharma, 200 mg, do not take the following medications:

• Terfenadine (used to treat allergies),
• Astemizole (used to treat allergies),
• Cisapride (used to treat stomach disorders),
• Pimozide (used to treat mental illnesses),
• Quinidine (used to treat 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 to treat insomnia and epilepsy),
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine used to treat migraines),
• Sirolimus (used in transplantation),
• Ritonavir (used to treat HIV infections) at doses of 400 mg or higher twice daily,
• St. John's Wort (Hypericum perforatum) (herbal remedy),
• 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 had an allergic reaction to other azoles in the past,
• the patient has or has had liver disease. In the case of liver disease, the doctor may prescribe a lower dose of Voriconazole Fosun Pharma, 200 mg. The doctor should also monitor the patient's liver function during treatment with Voriconazole Fosun Pharma, 200 mg by ordering blood tests,
• the patient has been diagnosed with cardiomyopathy, irregular heart rhythm, slow heart rate, or changes in the electrocardiogram (ECG) called "prolonged QTc interval".

During treatment, avoid any exposure to sunlight. It is essential to wear protective clothing and use sunscreen with a high sun protection factor (SPF) when exposed to sunlight, as sensitivity to sunlight may occur. These precautions also apply to children.

During treatment with Voriconazole Fosun Pharma, 200 mg:

• inform your doctor immediately if you experience:
• sunburn,
• severe skin rash or blisters,
• bone pain.

If the patient experiences the above-mentioned skin disorders, the doctor may refer the patient to a dermatologist, who may decide on the need for regular follow-up visits after consultation. There is a small risk that long-term use of Voriconazole Fosun Pharma, 200 mg may cause skin cancer.

If the patient experiences symptoms of "adrenal insufficiency", in which the adrenal glands do not produce enough of certain steroid hormones, such as cortisol, which can lead 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 should not be used in children under 2 years of age.

Voriconazole Fosun Pharma, 200 mg and Other Medications

Inform your doctor about all medications the patient is currently taking or plans to take, including those available without a prescription.

Some medications taken with Voriconazole Fosun Pharma, 200 mg may change its effect, and Voriconazole Fosun Pharma, 200 mg may affect the action of other medications.

Inform your doctor about taking the following medication, as it should be avoided if possible:

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

Inform your doctor about taking any of the following medications, as their dose may need to be modified if taken with Voriconazole Fosun Pharma, 200 mg:

• Rifabutin (used to treat tuberculosis). If the patient is being treated with rifabutin, monitor blood parameters and rifabutin side effects.
• Phenytoin (used to treat epilepsy). If the patient is being treated with phenytoin while taking voriconazole, monitor phenytoin blood levels and consider dose adjustment.

Inform your doctor about taking any of the following medications, as their dose or monitoring may need to be adjusted to ensure they remain effective:

• 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, and gliburide) (used to treat diabetes),
• Statins (e.g., atorvastatin, simvastatin) (used to lower cholesterol levels),
• Benzodiazepines (e.g., midazolam, triazolam) (used to treat severe insomnia and stress),
• Omeprazole (used to treat ulcers),
• Oral contraceptives (if Voriconazole Fosun Pharma, 200 mg is used with oral contraceptives, side effects such as nausea, menstrual disorders may occur),
• Vinca alkaloids (e.g., vincristine and vinblastine) (used to treat cancer),
• HIV protease inhibitors (e.g., indinavir) (used to treat HIV infection),
• Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (used to treat HIV infection) (some doses of efavirenz should not be used with Voriconazole Fosun Pharma, 200 mg),
• Methadone (used to treat heroin addiction),
• Alfentanil, fentanyl, and other short-acting opioids (e.g., sufentanil) (pain medications used during surgical procedures),
• Oxycodone and other long-acting opioids (e.g., 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 patients after transplants),
• Tolvaptan (used to treat hyponatremia or to slow the worsening of kidney function in patients with polycystic kidney disease),
• Letermovir (used to prevent cytomegalovirus infection after bone marrow transplantation),
• Naloxegol (used to treat opioid-induced constipation),
• Ivacaftor (used to treat cystic fibrosis),
• Corticosteroids, including inhaled corticosteroids (used to treat asthma).

Pregnancy and Breastfeeding

Voriconazole Fosun Pharma, 200 mg should not be used during pregnancy unless the doctor decides otherwise. During treatment, women of childbearing age must use effective methods of contraception. If pregnancy occurs during treatment with Voriconazole Fosun Pharma, 200 mg, inform your doctor immediately.

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medication.

Driving and Operating Machines

Voriconazole Fosun Pharma, 200 mg may cause vision disturbances or abnormal reactions to light. In such cases, do not drive or operate machines.

Inform your doctor if you experience such disturbances.

Voriconazole Fosun Pharma, 200 mg Contains Sodium and Cyclodextrin

The medication contains 217.6 mg of sodium (the main component of table salt) per vial. This corresponds to 11% of the maximum recommended daily sodium intake in adults.

This medication contains sodium sulfobutylbetadex, a cyclodextrin. Each vial contains 3.2 g of sodium sulfobutylbetadex. If the patient has kidney disease, consult your doctor before taking this medication.

3. How to Take Voriconazole Fosun Pharma, 200 mg

Always take this medication exactly as your doctor has told you. If you are unsure, consult your doctor.

The doctor will decide on the dose based on the patient's weight and the type of infection.

Recommended Dosage in Adults (Including Elderly Patients)

Depending on the response to treatment, the doctor may reduce the daily dose to 3 mg/kg body weight twice daily.

In the case of mild or moderate liver cirrhosis, the doctor may decide to reduce the dose of the medication.

Administration in Children and Adolescents

Recommended dosage in children and adolescents:

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

Voriconazole Fosun Pharma, 200 mg, powder for solution for infusion, will be reconstituted and diluted to the appropriate concentration by a nurse or hospital pharmacist (see information at the end of the package leaflet).

The medication 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 taking Voriconazole Fosun Pharma, 200 mg to prevent fungal infections and experiences side effects related to treatment, the doctor may discontinue the medication.

Voriconazole Fosun Pharma, 200 mg should not be administered to children under 2 years of age.

Administration of a Higher Than Recommended Dose of Voriconazole Fosun Pharma, 200 mg

Given that the medication will be administered under close medical supervision, administration of a higher than recommended dose is unlikely. However, if a higher than recommended dose is suspected, inform your doctor or nurse immediately.

Missed Dose of Voriconazole Fosun Pharma, 200 mg

Given that the medication will be administered under close medical supervision, missing a dose is unlikely. However, if a dose is missed, inform your doctor or nurse immediately.

Discontinuation of Voriconazole Fosun Pharma, 200 mg

The doctor will decide how long the patient will be treated with Voriconazole Fosun Pharma, 200 mg. However, treatment with Voriconazole Fosun Pharma, 200 mg, powder for solution for infusion, should not exceed 6 months.

Patients with impaired immune systems or severe infections may require long-term treatment to prevent relapse of the disease. If there is clinical improvement, the route of administration may be changed from intravenous to oral.

If the doctor decides to discontinue Voriconazole Fosun Pharma, 200 mg, do not be concerned about the consequences of discontinuation.

If you have any further doubts about the use of this medication, consult your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Voriconazole Fosun Pharma, 200 mg can cause side effects, although not everybody gets them.

If side effects occur, they are usually mild and temporary. However, some of them can be serious and may require medical attention.

Severe Side Effects - Discontinue Voriconazole Fosun Pharma, 200 mg and Consult Your Doctor Immediately:

• rash,
• jaundice, changes in liver function test results,
• pancreatitis.

Other Side Effects

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

• vision disturbances (changes in vision, including blurred vision, changes in color vision, abnormal light intolerance, loss of color vision, eye disorders, seeing flashes of light, night blindness, sensation of image vibration, seeing sparks, visual aura, decreased visual acuity, bright vision, loss of part of the usual field of vision, floaters in front of the eyes),
• fever,
• rash,
• nausea, vomiting, diarrhea,
• headache,
• peripheral edema,
• abdominal pain,
• breathing difficulties,
• increased liver enzyme activity,

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

• sinusitis, gingivitis, chills, weakness,
• low numbers of certain types of blood cells, including severe cases, red blood cells (sometimes due to an immune response) and/or white blood cells (sometimes with fever), low platelet count, which helps blood clot,
• low blood sugar, low potassium levels, low sodium levels,
• anxiety, depression, feeling confused, agitation, insomnia, hallucinations,
• seizures, tremors or uncontrolled muscle movements, tingling or abnormal sensations on the skin, increased muscle tension, drowsiness, dizziness,
• eye bleeding,
• heart rhythm disturbances, including very rapid or very slow heart rate, fainting,
• low blood pressure, vein inflammation (which may be associated with blood clot formation),
• acute breathing difficulties, chest pain, facial swelling (of the mouth, lips, and around the eyes), fluid accumulation in the lungs,
• constipation, indigestion, mouth inflammation,
• jaundice, liver inflammation, and liver damage,
• skin rashes that can lead to severe reactions with blisters and skin peeling, characterized by flat, red areas on the skin covered with small, weeping bumps, redness of the skin,
• itching,
• hair loss,
• back pain,
• kidney failure, proteinuria, kidney damage.

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

• flu-like symptoms, gastrointestinal irritation and inflammation, antibiotic-associated diarrhea, lymphangitis,
• inflammation of the thin tissue lining the abdominal cavity and surrounding the abdominal organs,
• lymph node enlargement (sometimes painful), bone marrow failure, increased eosinophil count,
• adrenal gland disorders, hypothyroidism,
• brain disorders, Parkinson's disease-like symptoms, nerve damage causing numbness, pain, tingling, or burning sensations in the hands or feet (peripheral neuropathy),
• balance or coordination disorders,
• brain edema,
• double vision, severe eye disorders, including pain and inflammation of the eyes and eyelids, abnormal eye movements, optic nerve damage leading to vision disturbances, optic disc swelling,
• decreased sensitivity to touch,
• taste disorders,
• hearing loss, ringing in the ears, dizziness,
• inflammation of certain internal organs - pancreas and duodenum, tongue inflammation and swelling,
• liver enlargement, liver failure, gallbladder disease, gallstones,
• joint inflammation, vein inflammation under the skin (which may be associated with blood clot formation),
• kidney inflammation, proteinuria, kidney damage,
• very rapid or skipped heartbeats, sometimes with abnormal electrical impulses,
• abnormal electrocardiogram (ECG),
• increased cholesterol levels, increased urea levels in the blood,

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

• hyperthyroidism,
• liver brain disease, a severe complication of liver disease,
• loss of most of the optic nerve fibers, corneal clouding, involuntary eye movements,
• blistering rash due to sunlight sensitivity,
• disorders in which the immune system attacks part of the peripheral nervous system,
• heart rhythm disturbances or conduction disorders (sometimes life-threatening),
• life-threatening allergic reaction,
• blood clotting disorders,
• skin allergic reactions (sometimes severe), including sudden swelling (sudden swelling) of the skin, subcutaneous tissue, mucous membranes, and submucosal tissues, itching or painful patches of thickened, red skin with silver scales, skin irritation and mucous membrane irritation, life-threatening skin disease characterized by peeling of large areas of the epidermis (outer layer of the skin) from the underlying layers,
• small, dry, flaking skin patches, sometimes thickened with sharp protrusions or "horns".

Unknown frequency (cannot be estimated from the available data):

• skin pigmentation and spots.

Other important side effects, the frequency of which is unknown, but which should be reported to the doctor immediately:

• skin cancer,
• inflammation of the tissue surrounding the bone,
• red, flaking patches or ring-shaped skin lesions, which may be a sign of an autoimmune disease called cutaneous lupus erythematosus.

During infusion of Voriconazole Fosun Pharma, 200 mg, the following side effects have been reported uncommonly:

Inform your doctor or pharmacist if you experience any side effects, including those not listed in this package leaflet.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Voriconazole Fosun Pharma, 200 mg

Store at a temperature below 25°C.

Keep the medication out of sight and reach of children.

Do not use this medication after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.

Chemical and physical stability for 24 hours at a temperature of 2°C to 8°C has been demonstrated.

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the reconstituted and diluted solution should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user.

Before administration, the reconstituted Voriconazole Fosun Pharma, 200 mg should be diluted with a compatible infusion solution. (See information at the end of the package leaflet).

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This 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 ingredients are betadex sulfobutyl ether sodium.

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

What Voriconazole Fosun Pharma, 200 mg Looks Like and Contents of the Package

Voriconazole Fosun Pharma, 200 mg is available as a white lyophilisate in a single-dose vial made of colorless glass.

Voriconazole Fosun Pharma, 200 mg, powder for solution for infusion, is available in a carton containing 1 vial.

Marketing Authorization Holder and Importer

Fosun Pharma Sp. z o.o.

ul. Zajęcza 15

00-351 Warsaw

Poland

Phone: +48 22 244 11 05

This Medicinal Product is Authorized in the Member States of the European Economic Area 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

Date of Last Revision of the Package Leaflet:

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Information Intended for Healthcare Professionals Only:

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

• The powder should be reconstituted with 19 ml of water for injection or 19 ml of 0.9% (9 mg/ml) sodium chloride injection solution to obtain 20 ml of a clear concentrate containing 10 mg/ml of voriconazole.
• If the vacuum (reduced pressure) in the vial does not cause the solvent to be introduced into the vial, such a vial of Voriconazole Fosun Pharma, 200 mg should be discarded. To ensure accurate measurement of the volume (19 ml) of water for injection or 0.9% (9 mg/ml) sodium chloride injection solution, it is recommended to use standard 20 ml (non-automatic) syringes.
• To administer the required volume of the reconstituted concentrate, add it to the recommended compatible infusion solution (details in the table below) to obtain a 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 solution should be discarded. Only clear solutions without the presence of any solid particles should be administered.
• The solution is not intended for rapid intravenous injection (bolus).
• Information on storage is included 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 a non-sterile, sterile lyophilisate intended for single use.

Therefore, from a microbiological point of view, the reconstituted solution should be used immediately. If the solution is not used immediately, the storage times and conditions before use are the responsibility of the user.

Compatible Infusion Solutions:

The reconstituted concentrate can be diluted in:

9 mg/ml (0.9%) sodium chloride injection solution,

sodium lactate injection solution for intravenous infusion,

5% glucose solution and Ringer's lactate solution for intravenous infusion,

5% glucose solution with 0.45% sodium chloride injection solution for intravenous infusion,

5% glucose solution for intravenous infusion,

5% glucose solution with 20 mEq potassium chloride injection solution for intravenous infusion,

0.45% sodium chloride injection solution for intravenous infusion,

5% glucose solution and 0.9% sodium chloride injection solution for intravenous infusion.

The compatibility of Voriconazole Fosun Pharma, 200 mg with other solutions (or those listed in the "Incompatibilities" section below) is not established.

Incompatibilities:

Voriconazole Fosun Pharma, 200 mg should not be administered with other medications in the same infusion line or intravenous access, including parenteral nutrition (e.g., Aminofusin 10% Plus).

Voriconazole Fosun Pharma, 200 mg should not be used with blood products.

Administration of intravenous infusions for parenteral nutrition may occur simultaneously with voriconazole, but not through the same intravenous access or cannula.

4.2% sodium bicarbonate injection solution should not be used to dilute Voriconazole Fosun Pharma, 200 mg.