Voriconazol normon 200 mg polvo para solucion para perfusion efg
Introduction
Leaflet: information for the user
Voriconazole Normon 200mg powder for solution for infusion EFG
Read this leaflet carefully before you start 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 questions, consult your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
1. What is Voriconazol Normon and what is it used for
Voriconazol Normon contains the active ingredient voriconazol. Voriconazol Normon is an antifungal medication. It acts by eliminating or preventing the growth of fungi that cause infections.
It is used to treat patients (adults and children aged 2 years or older) with:
- invasive aspergillosis (a type of fungal infection produced byAspergillussp.),
- candidemia (another type of fungal infection produced byCandidasp.) in non-neutropenic patients (patients with a normal white blood cell count),
- serious invasive infections produced byCandidasp., when the fungus is resistant to fluconazol (another antifungal medication),
- serious fungal infections produced byScedosporiumsp.or byFusariumsp.(two different species of fungi).
Voriconazol is used in patients with serious fungal infections that can put their lives at risk.
Prevention of fungal infections in bone marrow transplant recipients with a high risk.
This medication must be used only under medical supervision.
2. What you need to know before starting to use Voriconazole Normon
- if you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).
It is very important that you inform your doctor, pharmacist or nurse if you are using or have recently used other medicines, including those purchased without a prescription, or herbal remedies.
During treatment with this medicine, do not take the following medicines:
- Terfenadine (used for allergies).
- Astemizol (used for allergies).
- Cisapride (used for digestive problems).
- Pimozide (used for mental disorders).
- Quinidine (used for heart arrhythmias).
- Ivabradine (used for symptoms of chronic heart failure).
- Rifampicin (used for tuberculosis treatment).
- Efavirenz (used for HIV treatment) at doses of 400mg and above once a day.
- Carbamazepine (used to treat seizures).
- Phenobarbital (used for severe insomnia and seizures).
- Alkaloids of ergot (e.g. ergotamine, dihydroergotamine; used for migraines).
- Sirolimus (used in patients who have received a transplant).
- Ritonavir (used for HIV treatment) at doses of 400mg and above twice a day.
- St. John's Wort (hypericum, herbal remedy).
- Naloxegol (used to treat constipation caused specifically by painkillers,
- called opioids [e.g. morphine, oxycodone, fentanyl, tramadol, codeine]).
- Tolvaptan (used to treat hyponatremia [low sodium levels in the blood] or to slow the deterioration of kidney function in patients with polycystic kidney disease).
- Lurasidone (used to treat depression),
- Venetoclax (used for the treatment of patients with chronic lymphocytic leukemia [CLL]).
Warnings and precautions
Consult your doctor, pharmacist or nurse before starting to use this medicine if you:
- have had an allergic reaction to other azoles.
- have or have 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 while you are taking voriconazole by doing blood tests.
- know that you have heart disease, irregular heartbeats, slow heart rate or an abnormality on an electrocardiogram (ECG) called "prolonged QTc syndrome".
You should avoid any exposure to the sun and sunlight during treatment. It is essential to cover exposed areas and use a high-factor sunscreen, as you may be more sensitive to UV rays from the sun. These precautions also apply to children.
Inform your doctor immediately if you experience the following symptoms while taking this medicine:
- sunburn;
- severe skin rash or blisters;
- bone pain.
If you develop skin disorders such as those described above, your doctor may refer you to a dermatologist, who after consultation may consider it necessary to have you examined regularly. There is a small chance that you may develop skin cancer with long-term use of voriconazole.
If you develop signs of "adrenal insufficiency" where 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" where the body produces too much cortisol hormone which may cause symptoms such as: weight gain, hump of fat between the shoulders, rounded face, darkening of the skin of the abdomen, thighs, breasts, and arms, thin skin, easy bruising, high blood sugar, excessive hair growth or excessive sweating, inform your doctor.
Your doctor should monitor your liver and kidney function by doing blood tests.
Children and adolescents
Voriconazole should not be administered to children under 2 years of age.
Other medicines and Voriconazol Normon
Inform your doctor or pharmacist if you are taking, have taken or used recently or may need to take any other medicine.
Some medicines, when used at the same time as voriconazole, may affect the action of voriconazole or vice versa.
Inform your doctor if you are using the following medicines, as simultaneous treatment with voriconazole should be avoided if possible:
- Ritonavir (used for HIV treatment) at doses of 100mg twice a day.
- Glasdegib (used for cancer treatment); if you need to use both medicines, your doctor will monitor your heart rate frequently.
Inform your doctor if you are using any of the following medicines, as simultaneous treatment with voriconazole should be avoided as much as possible, and you may need to adjust the dose of voriconazole:
- Rifabutin (used for tuberculosis treatment). If you are already taking rifabutin, you will need to monitor your blood count and rifabutin side effects.
- Phenytoin (used to treat epilepsy). If you are already taking phenytoin, you will need to monitor the concentration of phenytoin in your blood during your treatment with voriconazole and may need to adjust your dose.
Inform your doctor if you are taking any of the following medicines, as you may need to adjust your dose or monitor to ensure that these medicines and/or voriconazole continue to produce the desired effect:
- Warfarin and other anticoagulants (e.g. phenprocoumon, acenocoumarol; used to reduce blood clotting).
- Ciclosporin (used in patients who have received a transplant).
- Tacrolimus (used in patients who have received a transplant).
- Sulfonylureas (e.g. tolbutamide, glipizide and glibenclamide) (used for diabetes).
- Statins (e.g. atorvastatin, simvastatin) (used to reduce cholesterol levels).
- Benzodiazepines (e.g. midazolam, triazolam) (used for severe insomnia and stress).
- Omeprazole (used for stomach ulcer treatment).
- Oral contraceptives (if you use voriconazole while taking oral contraceptives, you may experience side effects such as nausea and menstrual disorders).
- Alkaloids of vincristine (e.g. vincristine and vinblastine) (used to treat cancer).
- Indinavir and other HIV protease inhibitors (used to treat HIV infection).
- Inhibitors of tyrosine kinase (e.g. axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (used to treat cancer).
- Tretinoin (used to treat leukemia).
- Inhibitors of non-nucleoside reverse transcriptase (e.g. efavirenz, delavirdine and nevirapine) (used to treat HIV infection) (some doses of efavirenz CANNOT be taken at the same time as voriconazole).
- Methadone (used to treat heroin addiction).
- Alfentanil, fentanyl and other short-acting opioids such as sufentanil (painkillers used for 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 kidney cancer and in patients who have received a transplant).
- Letermovir (used to prevent cytomegalovirus (CMV) infection after a bone marrow transplant).
- Ivacaftor: used to treat cystic fibrosis.
- Flucloxacillin (antibiotic used to treat bacterial infections).
Pregnancy and breastfeeding
You should not use this medicine during pregnancy unless your doctor tells you to. Women of childbearing age taking Voriconazol Normon 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and operating machines
Voriconazol Normon may cause blurred vision or discomfort due to increased sensitivity to light. If this happens, do not drive or operate tools or machines and inform your doctor.
Voriconazol Normon contains sodium
This medicine contains 35.38 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.76% of the maximum daily sodium intake recommended for an adult.
Voriconazol Normon contains cyclodextrins
This medicine contains 3200 mg of hydroxypropylbetadex in each vial, equivalent to 160 mg/ml in the reconstituted solution with 20 ml.
Do not use in children under 2 years of age unless recommended by your doctor.
If you have kidney problems, consult your doctor before taking this medicine.
3. How to use Voriconazole Normon
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Your doctor will determine the dose based on your weight and the type of infection you have. Your doctor may change your dose based on your situation.
The recommended dose in adults (including elderly patients) is as follows:
Intravenous route | |
Dose during the first 24 hours (loading dose) | 6mg/kg every 12 hours during the first 24 hours |
Dose after the first 24 hours (maintenance dose) | 4mg/kg twice a day |
Depending on your response to treatment, your doctor may reduce the dose to 3mg/kg twice a day.
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:
Intravenous route | ||
Children aged 2 to less than 12 years and adolescents aged 12 to 14 years who weigh less than 50kg | Adolescents aged 12 to 14 years who weigh 50kg or more; and all adolescents older than 14 years | |
Dose during the first 24 hours(loading dose) | 9mg/kg every 12 hours during the first 24 hours | 6mg/kg every 12 hours during the first 24 hours |
Dose after the first 24 hours(maintenance dose) | 8mg/kg twice a day | 4mg/kg twice a day |
Depending on your response to treatment, your doctor may increase or decrease the daily dose.
This medication must be reconstituted and diluted to the correct concentration by hospital pharmacy or nursing staff (for more information see section 5 and the end of this leaflet).
It will be administered through intravenous infusion (in vein) at a maximum rate of 3mg/kg per hour for 1 to 3 hours.
If you or your child are taking this medication for the prevention of fungal infections, your doctor may stop administering it if you or your child experience adverse effects related to treatment.
If you forgot to use Voriconazol Normon
Given that you will receive this medication under close medical supervision, it is unlikely that you will forget a dose. However, inform your doctor or pharmacist if you think you have forgotten a dose.
If you interrupt treatment with Voriconazol Normon
Treatment with this medication should be continued for as long as your doctor considers necessary, but the treatment duration should not exceed 6 months.
Patients with compromised immune systems or those with complicated infections may require longer treatments to prevent the infection from recurring. Once your condition improves, you can substitute intravenous infusion with oral tablets.
When your doctor stops treatment with voriconazole, you should not experience any effects related to treatment interruption.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any occur, it is likely to be mild and temporary. However, some may be serious and require medical attention.
Severe side effects — Stop using this medicine and seek medical attention immediately
- Skin rash.
- Jaundice, changes in liver function blood tests.
- Pancreatitis.
Other side effects
Frequent side effects (may affect more than 1 in 10 people):
- Visual disturbance (change in vision, such as blurred vision, visual color disturbances, abnormal light perception intolerance, color blindness, eye disorder, halo vision, night blindness, oscillating vision, spark vision, visual aura, decreased visual acuity, visual clarity, partial loss of usual visual field, visual field spots).
- Fever.
- Skin rash.
- Nausea, vomiting, and diarrhea.
- Headache.
- Swelling of the extremities.
- Abdominal pain.
- Difficulty breathing.
- Elevated liver enzymes.
Common side effects (may affect up to 1 in 10 people):
- Sinusitis, gum inflammation, chills, weakness.
- Low count, including severe, of some types of red or white blood cells in the blood, low platelet count that helps blood to clot.
- Allergic reaction or excessive immune response.
- Low blood sugar, low potassium levels in the blood, low sodium levels in the blood.
- Anxiety, depression, confusion, agitation, insomnia, hallucinations.
- Seizures, tremors, or uncontrolled muscle movements, tingling or abnormal sensations in the skin, increased muscle tone, drowsiness, dizziness.
- Eye hemorrhage.
- Cardiac rhythm problems that include very fast heart rate, very slow heart rate, fainting.
- Hypotension, inflammation of the veins (which may be associated with blood clot formation).
- Acute difficulty breathing, chest pain, facial swelling (mouth, lips, and around the eyes), fluid retention in the lungs.
- Constipation, indigestion, lip inflammation.
- Jaundice (yellow skin discoloration), liver inflammation, and liver damage.
- Skin eruptions, which can be severe, with blisters and peeling, characterized by a flat, red area covered with small protuberances that converge, skin redness.
- Itching.
- Alopecia.
- Back pain.
- Renal failure, blood in urine, changes in renal function tests.
Rare side effects (may affect up to 1 in 1,000 people):
- Hyperactive thyroid gland.
- Deterioration of brain activity as a severe complication of liver disease.
- Loss of most of the optic nerve fibers, corneal opacity, involuntary eye movements.
- Blister formation due to photosensitivity.
- Condition in which the immune system attacks part of the peripheral nervous system.
- Cardiac rhythm problems or conduction (sometimes potentially fatal).
- Potentially fatal allergic reaction.
- Blood coagulation disorders.
- Severe skin reactions (sometimes fatal), such as rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal layers, pruritic and painful skin plaques with thickened and inflamed skin, skin irritation and mucous membrane irritation, potentially fatal skin disease that causes large areas of the epidermis, the skin's outermost layer, to peel off from the layers of skin beneath it.
- Small, dry, scaly skin patches, sometimes thick and with points or "horns".
Side effects of unknown frequency:
- Moles and pigmented spots.
Other important side effects whose frequency is unknown, but which should be reported to the doctor immediately:
- Skin cancer.
- Inflammation of the tissue surrounding the bone.
- Red, scaly, or ring-shaped skin lesions that may be a symptom of an autoimmune disease called lupus erythematosus.
During perfusion, infrequently, reactions with voriconazole (including facial redness, fever, sweating, increased heart rate, and difficulty breathing) have occurred. The doctor may interrupt the perfusion if this happens.
Since voriconazole has been observed to affect the liver and kidneys, your doctor should monitor liver and renal function through blood tests. Inform your doctor if you have abdominal pain or if your stools have a different consistency.
Cases of skin cancer have been reported in patients treated with voriconazole for long periods of time.
The frequency of sunburns or severe skin reactions after exposure to light or the sun was higher in children. If you or your child experience skin problems, your doctor may refer you to a dermatologist who, after consultation, can decide whether it is necessary for you or your child to undergo regular follow-up. Elevated liver enzymes were also observed more frequently in children.
If any of these side effects persist or are bothersome, inform your doctor.
Reporting side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Voriconazole Normon
Store below 25°C.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the label or in the box after CAD. The expiration date is the last day of the month indicated.
Once reconstituted, Voriconazole Normon must be used immediately, although, if necessary, it can be stored for up to 24 hours between 2°Cand8°C (in a refrigerator). Reconstituted Voriconazole Normon must be diluted first with a compatible infusion diluent before being infused. (For more information, see the end of this leaflet).
Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you do not need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Voriconazole Normon
- The active ingredient is voriconazole.
- The other components are hydroxypropylbetadex and sodium chloride.
Each vial contains 200mg of voriconazole, which is equivalent to a concentrated solution of 10mg/ml once reconstituted following the instructions indicated by the pharmacy or nursing staff of the hospital (see the information at the end of this leaflet).
Appearance of the product and contents of the package
Voriconazole Normon is presented in the form of a lyophilized, sterile, preservative-free single-dose powder for solution for infusion in glass vials for single use.
Holder of the marketing authorization and responsible for manufacturing
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6
28760, Tres Cantos – Madrid (Spain)
Last review date of this leaflet:May 2023
The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.
The following information is intended only for doctors and healthcare professionals:
Information on reconstitution and dilution:
- Voriconazole Normon powder for solution for infusion needs to be reconstituted with 19ml of water for injection or 19ml of sodium chloride 9mg/ml (0.9%) for infusion to obtain a volume of 20ml of a clear concentrate containing 10mg/ml of voriconazole.
- Discard the vial of Voriconazole Normon if the vacuum does not allow the solvent to be introduced into the vial.
- It is recommended to use a standard 20ml syringe (not automatic) to ensure that the exact amount (19.0ml) of water for injection or sodium chloride 9mg/ml (0.9%) is used.
- The required volume of reconstituted concentrate is then added to one of the following compatible infusion solutions to obtain a final solution of Voriconazole Normon containing 0.5 to 5mg/ml of voriconazole.
- This medicine is for single use only and any unused solution must be discarded, only transparent solutions without particles should be used.
- Do not inject in a bolus. Infuse at a maximum rate of 3mg/kg per hour.
- For information on storage, see section 5 “Storage of Voriconazole Normon”.
Required volumes of Voriconazole Normon concentrate 10mg/ml
Body weight (kg) | Volume of Voriconazole Normon concentrate (10mg/ml) required for | ||||
Dose of 3mg/kg (number of vials) | Dose of 4mg/kg (number of vials) | Dose of 6mg/kg (number of vials) | Dose of 8mg/kg (number of vials) | Dose of 9mg/kg (number of vials) | |
10 | - | 4.0ml (1) | - | 8.0ml (1) | 9.0ml (1) |
15 | - | 6.0ml (1) | - | 12.0ml (1) | 13.5ml (1) |
20 | - | 8.0ml (1) | - | 16.0ml (1) | 18.0ml (1) |
25 | - | 10.0ml (1) | - | 20.0ml (1) | 22.5ml (2) |
30 | 9.0ml (1) | 12.0ml (1) | 18.0ml (1) | 24.0ml (2) | 27.0ml (2) |
35 | 10.5ml (1) | 14.0ml (1) | 21.0ml (2) | 28.0ml (2) | 31.5ml (2) |
40 | 12.0ml (1) | 16.0ml (1) | 24.0ml (2) | 32.0ml (2) | 36.0ml (2) |
45 | 13.5ml (1) | 18.0ml (1) | 27.0ml (2) | 36.0ml (2) | 40.5ml (3) |
50 | 15.0ml (1) | 20.0ml (1) | 30.0ml (2) | 40.0ml (2) | 45.0ml (3) |
55 | 16.5ml (1) | 22.0ml (2) | 33.0ml (2) | 44.0ml (3) | 49.5ml (3) |
60 | 18.0ml (1) | 24.0ml (2) | 36.0ml (2) | 48.0ml (3) | 54.0ml (3) |
65 | 19.5ml (1) | 26.0ml (2) | 39.0ml (2) | 52.0ml (3) | 58.5ml (3) |
70 | 21.0ml (2) | 28.0ml (2) | 42.0ml (3) | - | - |
75 | 22.5ml (2) | 30.0ml (2) | 45.0ml (3) | - | - |
80 | 24.0ml (2) | 32.0ml (2) | 48.0ml (3) | - | - |
85 | 25.5ml (2) | 34.0ml (2) | 51.0ml (3) | - | - |
90 | 27.0ml (2) | 36.0ml (2) | 54.0ml (3) | - | - |
95 | 28.5ml (2) | 38.0ml (2) | 57.0ml (3) | - | - |
100 | 30.0ml (2) | 40.0ml (2) | 60.0ml (3) | - | - |
This medicine is a lyophilized, sterile, preservative-free single-dose powder. From a microbiological point of view, the solution must be used immediately after reconstitution. If not used immediately, the time and conditions for storage before use are the responsibility of the user, and it should be maintained between 2°C and 8°C for a maximum period of 24 hours, unless the reconstitution has been carried out in controlled and validated aseptic conditions.
Compatible infusion solutions:
The reconstituted solution can be diluted with:
- Solution for injection of sodium chloride 9mg/ml (0.9%).
- Intravenous infusion of lactate sodium compound.
- Glucose solution 5% and Ringer lactate for intravenous infusion.
- Glucose solution 5% and sodium chloride 0.45% for intravenous infusion.
- Glucose solution 5% for intravenous infusion.
- Glucose solution 5% in 20mEq of potassium chloride for intravenous infusion.
- Sodium chloride 0.45% solution for intravenous infusion.
- Glucose solution 5% and sodium chloride 0.9% for intravenous infusion.
The compatibility of voriconazole with other diluents other than those specifically mentioned above (or mentioned below in “Incompatibilities”) is unknown.
Incompatibilities:
Voriconazole Normon should not be infused in the same vein or cannula simultaneously with other drug infusions, including parenteral nutrition (e.g. Aminofusin 10% Plus).
Simultaneous infusion of blood derivatives should not be performed with the administration of Voriconazole Normon.
Parenteral nutrition can be infused simultaneously with the administration of Voriconazole Normon, but not in the same vein or cannula.
Voriconazole Normon should not be diluted with sodium bicarbonate solution 4.2%.
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