Voriconazole Seacross 200 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Voriconazole Seacross 200 mg powder for solution for infusion EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Voriconazol Seacross 200 mg powder for solution for infusion contains the active substance voriconazol. Voriconazol is an antifungal medicine. It works by killing or stopping the growth of fungi that cause infections.

It is used to treat patients (adults and children aged 2 years and older) with:

• invasive aspergillosis (a type of fungal infection caused by Aspergillus sp),
• candidaemia (another type of fungal infection caused by Candida sp) in non-neutropenic patients (patients who do not have an abnormally low white blood cell count),
• serious invasive infections caused by Candida sp., when the fungus is resistant to fluconazole (another antifungal medicine),
• serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi).

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

Prevention of fungal infections in bone marrow transplant recipients at high risk.

This medicine should only be used under medical supervision.

2. What you need to know before using Voriconazol Seacross

Do not use Voriconazol Seacross

• If you are allergic to the active substance voriconazole or to sodium sulfobutylether beta-cyclodextrin (included in section 6).

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

During treatment with voriconazole, you must not take the following medicines:

• Terfenadine (used for allergies).
• Astemizole (used for allergies).
• Cisapride (used for digestive problems).
• Pimozide (used for mental disorders).
• Quinidine (used for cardiac arrhythmias).
• Ivabradine (used for symptoms of chronic heart failure).
• Rifampicin (used to treat tuberculosis).
• Efavirenz (used to treat HIV) at doses of 400 mg or higher once daily.
• Carbamazepine (used to treat seizures).
• Phenobarbital (used for severe insomnia and seizures).
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraine).
• Sirolimus (used in transplant patients).
• Ritonavir (used to treat HIV) at doses of 400 mg or higher twice daily.
• St. John’s wort (herbal medicine).
• Naloxegol (used to treat constipation specifically caused by opioid analgesics [e.g., morphine, oxycodone, fentanyl, tramadol, codeine]).
• Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to slow down the decline in kidney function in patients with polycystic kidney disease).
• Lurasidone (used to treat depression).
• Finerenone (used to treat chronic kidney disease).
• Venetoclax (used for the treatment of patients with chronic lymphocytic leukemia [CLL]).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting this medicine if:

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

You should avoid any exposure to sunlight and ultraviolet (UV) light during treatment. It is important to cover exposed areas and use sunscreen with a high sun protection factor (SPF), as your skin may become more sensitive to UV rays from the sun. This sensitivity may be further increased by the use of other medicines that make the skin more sensitive to sunlight, such as methotrexate. These precautions also apply to children.

While being treated with voriconazole:

• Inform your doctor immediately if you develop:
  • Sunburn
  • Severe skin rash or blisters
  • Bone pain

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

If you experience signs of “adrenal insufficiency,” in which the adrenal glands do not produce sufficient amounts of certain steroid hormones such as cortisol, which may cause symptoms such as: chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, inform your doctor.

If you experience signs of “Cushing's syndrome,” in which the body produces too much cortisol hormone, which may cause symptoms such as: weight gain, fatty hump between the shoulders, rounded face, darkening of the skin on the abdomen, thighs, breasts, and arms, thin skin, easy bruising, high blood sugar levels, excessive hair growth, or excessive sweating, inform your doctor.

Your doctor should monitor the function of your liver and kidneys through blood tests.

Children and adolescents

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

Other medicines and Voriconazol Seacross

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those without a prescription.

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

Inform your doctor if you are taking the following medicines, as concomitant treatment with this medicine should be avoided if possible:

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

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

• Rifabutin (used to treat tuberculosis). If you are already being treated with rifabutin, your blood count and adverse effects of rifabutin should be monitored.
• Phenytoin (used to treat epilepsy). If you are already being treated with phenytoin, the concentration of phenytoin in your blood should be monitored during treatment with voriconazole, and your dose may need to be adjusted.

Tell your doctor if you are taking any of the following medicines, as you may need a dose adjustment or monitoring to ensure these medicines and/or voriconazole 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 for 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 stomach ulcers).
• Oral contraceptives (if you use voriconazole while taking oral contraceptives, you may experience adverse effects such as nausea and menstrual disorders).
• Vinca alkaloids (e.g., vincristine, vinblastine; used to treat cancer).
• Tyrosine kinase inhibitors (e.g., axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib; used to treat cancer).
• Tretinoin (used to treat leukemia).
• Indinavir and other HIV protease inhibitors (used to treat HIV infection).
• Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine; used to treat HIV infection) (some doses of efavirenz must not be taken at the same time as this medicine).
• Methadone (used to treat heroin addiction).
• Alfentanil, fentanyl, and other short-acting opioids such as sufentanil (analgesics used during surgery).
• Oxycodone and other long-acting opioids such as hydrocodone (used to treat moderate to severe pain).
• Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac; used to treat pain and inflammation).
• Fluconazole (used to treat fungal infections).
• Everolimus (used to treat advanced renal cell carcinoma and in transplant patients).
• Letermovir (used to prevent cytomegalovirus [CMV] infection after bone marrow transplant).
• Ivacaftor (used to treat cystic fibrosis).
• Flucloxacillin (an antibiotic used to treat bacterial infections).

Pregnancy and breastfeeding

Do not use this medicine during pregnancy unless specifically instructed by your doctor. Women of childbearing potential receiving voriconazole should use effective contraception. Contact your doctor immediately if you become pregnant during treatment with this medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

Voriconazole may cause blurred vision or discomfort due to increased sensitivity to light. If this occurs, do not drive or operate tools or machinery, and inform your doctor.

Voriconazol Seacross contains sodium

This medicine contains 221 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 11% of the maximum daily intake of sodium recommended for an adult.

Voriconazol Seacross contains cyclodextrin

This medicine contains 3,200 mg of cyclodextrin per vial, equivalent to 160 mg/ml when reconstituted in 20 ml. If you have renal impairment, consult your doctor before taking this medicine.

3. How to use Voriconazole Seacross

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor again.

Your doctor will determine the dose based on your weight and the type of infection you have.

Your doctor may adjust your dose according to your condition.

The recommended dose in adults (including elderly patients) is as follows:

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

Your doctor may decide to reduce the dose if you have mild to moderate cirrhosis.

Use in children and adolescents

The recommended dose in children and adolescents is as follows:

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

This medicine must be reconstituted and diluted to the correct concentration by pharmacy or nursing staff at the hospital (for more information, see the end of this leaflet).

It will be administered by intravenous infusion (into a vein) at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.

If you or your child are using this medicine to prevent fungal infections, your doctor may stop administering voriconazole if you or your child experience treatment-related adverse effects.

If you take more Voriconazol Seacross than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget a dose of Voriconazol Seacross

Since you will be receiving this medicine under close medical supervision, it is unlikely that you will forget a dose. However, inform your doctor or pharmacist if you think you have missed a dose.

If you stop treatment with Voriconazol Seacross

Treatment with voriconazole should be continued for as long as your doctor considers appropriate. However, the duration of treatment with this medicine should not exceed 6 months.

Patients with weakened immune systems or those with complicated infections may require longer treatment courses to prevent the infection from recurring. Once your condition improves, the intravenous infusion may be replaced by oral tablets.

When your doctor discontinues treatment with voriconazole, you should not experience any effects due to stopping the medicine.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

If any of the adverse effects occur, they are most likely to be mild and temporary. However, some may be serious and require immediate medical attention.

Serious adverse effects – Stop using voriconazole and contact your doctor immediately

• Skin rash.
• Jaundice, changes in blood tests monitoring liver function.
• Pancreatitis.

Other adverse effects

Very common: may affect more than 1 in 10 people

• Visual disturbance (changes in vision such as blurred vision, color vision disturbances, abnormal sensitivity to light, color blindness, eye disorders, visual halos, night blindness, fluctuating vision, perception of sparks, visual aura, reduced visual acuity, reduced visual clarity, partial loss of normal visual field, spots in the visual field).
• Fever.
• Skin rash.
• Nausea, vomiting, and diarrhea.
• Headache.
• Swelling of the extremities.
• Stomach pain.
• Difficulty breathing.
• Elevated liver enzymes.

Common: may affect up to 1 in 10 people

• Sinusitis, gum inflammation, chills, weakness.
• Low blood counts, including severe cases, of certain types of red blood cells (sometimes immune-mediated) and/or white blood cells (sometimes accompanied by fever), low platelet count affecting blood clotting.
• Low blood sugar, low blood potassium, low blood sodium.
• Anxiety, depression, confusion, agitation, insomnia, hallucinations.
• Seizures, tremors or uncontrolled muscle movements, tingling or abnormal sensations in the skin, increased muscle tone, drowsiness, dizziness.
• Ocular hemorrhage.
• Heart rhythm problems including very fast or very slow heartbeat, fainting.
• Hypotension, vein inflammation (which may be associated with blood clot formation).
• Acute breathing difficulty, chest pain, facial swelling (mouth, lips, and around the eyes), fluid accumulation in the lungs.
• Constipation, indigestion, lip swelling.
• Jaundice, liver inflammation, and liver damage.
• Skin rashes, which may become severe, with blistering and peeling, characterized by flat red areas covered with small merging bumps, skin redness.
• Itching.
• Alopecia.
• Back pain.
• Kidney failure, presence of blood in urine, abnormalities in kidney function tests.
• Sunburn or severe skin reaction following exposure to light or sun.
• Skin cancer.

Uncommon: may affect up to 1 in 100 people

• Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, gastrointestinal inflammation causing antibiotic-associated diarrhea, inflammation of lymphatic vessels.
• Inflammation of the thin tissue lining the abdominal wall and covering abdominal organs.
• Enlargement (sometimes painful) of lymph nodes, bone marrow failure, increased eosinophils.
• Reduced adrenal gland function, underactive thyroid gland.
• Abnormal brain function, Parkinson-like symptoms, nerve damage causing numbness, pain, tingling, or burning sensations in hands or feet.
• Problems with balance or coordination.
• Brain swelling.
• Double vision, serious eye disorders such as eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage causing vision changes, optic disc inflammation.
• Decreased sensitivity to touch.
• Taste disturbances.
• Hearing difficulty, ringing in the ears, vertigo.
• Inflammation of certain internal organs, pancreas and duodenum, tongue swelling and inflammation.
• Enlarged liver, liver failure, gallbladder disease, gallstones.
• Joint inflammation, vein inflammation under the skin (which may be associated with blood clot formation).
• Kidney inflammation, protein in urine, kidney damage.
• Very high heart rate or extrasystoles, sometimes with erratic electrical impulses.
• Abnormal electrocardiogram (ECG).
• Elevated blood cholesterol, elevated blood urea.
• Skin allergic reactions (sometimes severe), such as skin disorders, potentially life-threatening conditions causing blisters and painful sores on the skin and mucous membranes, especially in the mouth, skin inflammation, hives, skin redness and irritation, reddish or purplish skin discoloration possibly due to low platelet count, eczema.
• Reaction at the infusion site.
• Allergic reaction or exaggerated immune response.
• Inflammation of tissue surrounding the bone.

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

• Overactive thyroid gland.
• Deterioration of brain function as a serious complication of liver disease.
• Loss of most of the optic nerve fibers, corneal opacity, involuntary eye movements.
• Blister formation due to photosensitivity.
• Disorder in which the immune system attacks part of the peripheral nervous system.
• Heart rhythm or conduction problems (sometimes potentially fatal).
• Potentially life-threatening allergic reaction.
• Blood clotting disorders.
• Skin allergic reactions (sometimes severe), such as rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal layers, itchy and painful thickened red skin plaques with silvery scales, skin and mucous membrane irritation, potentially life-threatening skin disorder causing large areas of the epidermis, the outermost skin layer, to detach from underlying skin layers.
• Small scaly, dry skin patches, sometimes thick with tips or "horns."

Adverse effects with unknown frequency:

• Freckles and pigmented spots.

Other important adverse effects with unknown frequency, but which must be reported to your doctor immediately:

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

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

Since voriconazole has been observed to affect the liver and kidneys, your doctor should monitor liver and kidney function through blood tests. Inform your doctor if you have stomach pain or if your stools have an unusual consistency.

Cases of skin cancer have been reported in patients treated with voriconazole over long periods.

The frequency of sunburn or severe skin reactions following exposure to light or sun was higher in children. If you or your child develop skin disorders, your doctor may refer you to a dermatologist who, after evaluation, may recommend regular follow-up. Elevated liver enzymes were also observed more frequently in children.

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

Reporting of adverse effects

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

5. Storage of Voriconazole Seacross

Keep this medicine out of the sight and reach of children.

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

After reconstitution, this medicine must be used immediately; however, if necessary, it may be stored for up to 24 hours at 2 °C - 8 °C (in the refrigerator). The reconstituted medicine must first be diluted with a compatible intravenous diluent before infusion (for further information, see the end of this leaflet).

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voriconazol Seacross

• The active substance is voriconazole.
• The other component is sodium sulfobutylether beta-cyclodextrin (see section 2; Voriconazol Seacross contains cyclodextrin and sodium).

Each vial contains 200 mg of voriconazole, which corresponds to a 10 mg/mL solution once reconstituted according to the instructions provided by hospital pharmacy or nursing staff (see information at the end of this leaflet).

Appearance of the product and contents of the pack

Voriconazol Seacross is presented as a powder for solution for infusion in single-use glass vials.

Marketing Authorization Holder and Manufacturer

Seacross Pharma (Europe) Limited

POD 13, The Old Station House

15A Main Street, Blackrock

Dublin, A94 T8P8

Ireland

Local Representative

Pharmavic Ibérica, S.L.

C/ Compositor Lehmberg Ruiz

6 Edificio Ibiza, Office 7

29007 Málaga, (Spain)

Tel: 676295501

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this summary: January 2026

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

Information on reconstitution and dilution

• Voriconazol Seacross powder for solution for infusion must be reconstituted with 19 ml of water for injections or 19 ml of sodium chloride 9 mg/ml (0.9%) for infusion to obtain an extractable volume of 20 ml of a clear concentrate containing 10 mg/ml of voriconazole.
• Discard the vial if the vacuum does not allow the solvent to enter the vial.
• The use of a standard 20 ml syringe (non-automatic) is recommended to ensure the exact volume (19.0 ml) of water for injections or sodium chloride 9 mg/ml (0.9%) for infusion is dispensed.
• The required volume of reconstituted concentrate is then added to a compatible infusion solution from those listed below, to obtain a final solution of this medicine containing 0.5 to 5 mg/ml of voriconazole.
• This medicinal product is for single use only, and any unused solution must be discarded. Only clear solutions free from particles should be used.
• Must not be administered as a bolus.
• For information on storage, see section 5 “Conservation of Voriconazol Seacross”.

Required volumes of Voriconazol Seacross concentrate 10 mg/ml

Voriconazole Seacross is a single-dose sterile lyophilized preparation without preservatives. Therefore, from a microbiological standpoint, the solution should be used immediately after reconstitution. If not used immediately, the responsibility for the storage time and conditions prior to use lies with the user, and the solution must be stored between 2 and 8°C for a maximum of 24 hours, unless reconstitution has been carried out under controlled and validated aseptic conditions.

After reconstitution: Chemical and physical in-use stability has been demonstrated to be 24 hours when stored between 2°C and 8°C.

After dilution: Chemical and physical in-use stability has been demonstrated to be 7 days between 2°C and 8°C, and 72 hours at 25°C.

Compatible infusion solutions:

The reconstituted solution may be diluted with:

• Sodium chloride injection 9 mg/ml (0.9%)
• Sodium lactate compound intravenous infusion
• 5% glucose and Ringer lactate intravenous infusion
• 5% glucose and 0.45% sodium chloride intravenous infusion
• 5% glucose intravenous infusion
• 5% glucose with 20 mEq potassium chloride intravenous infusion
• 0.45% sodium chloride intravenous infusion
• 5% glucose and 0.9% sodium chloride intravenous infusion

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

Incompatibilities:

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

Hemoderivatives must not be infused simultaneously during voriconazole administration.

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

This medicinal product must not be diluted with 4.2% sodium bicarbonate solution.