Voriconazole hameln

Package Leaflet: Information for the User

Voriconazole hameln, 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, as You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor, Pharmacist, or Nurse.
• This Medication has been Prescribed for a Specific Person. Do Not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, including those not Mentioned in this Package Leaflet, Inform a Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents

• 1. What is Voriconazole hameln and what is it Used for
• 2. Important Information Before Using Voriconazole hameln
• 3. How to Use Voriconazole hameln
• 4. Possible Side Effects
• 5. How to Store Voriconazole hameln
• 6. Package Contents and Other Information

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

Voriconazole hameln Contains the Active Substance Voriconazole. Voriconazole is an Antifungal Medication. It Works by Killing Fungi that Cause Infections or by Inhibiting their Growth.
The Medication is Used to Treat Patients (Adults and Children Over 2 Years Old) with:
Invasive Aspergillosis (a Type of Fungal Infection Caused by Fungi of the Genus Aspergillus spp.),
Candidemia (Another Type of Fungal Infection Caused by Fungi of the Genus Candidaspp.) in Patients Without Accompanying Neutropenia (Patients Without a Decreased Number of White Blood Cells),
Severe, Invasive Fungal Infections Caused by Fungi of the Genus Candidaspp.Resistant to Fluconazole (Another Antifungal Medication),
Severe Fungal Infections Caused by Fungi of the Genus Scedosporium spp.and Fusarium spp.(Two Different Species of Fungi).
Voriconazole is Intended for Patients with Progressive, Life-Threatening Fungal Infections.
The Medication is Also Intended to Prevent Fungal Infections in High-Risk Patients After Bone Marrow Transplantation.
This Medication Should Only be Used Under the Supervision of a Doctor.

2. Important Information Before Using Voriconazole hameln

When Not to Use Voriconazole hameln

• If the Patient is Allergic to Voriconazole or any of the Other Ingredients of this Medication (Listed in Section 6)

It is Very Important to Inform the Doctor or Pharmacist About all Medications the Patient is Currently Taking or has Recently Taken, Including those Available Without a Prescription or Herbal Medications.
During Treatment with Voriconazole hameln, the Following Medications Should Not be Taken:

• Terfenadine (Used to Treat Allergies),
• Astemizole (Used to Treat Allergies),
• Cisapride (Used to Treat Stomach Disorders),
• Pimozide (Used to Treat Mental Illness),
• 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 Patients After Transplants),
• Ritonavir (Used to Treat HIV Infections) at Doses of 400 mg or Higher Twice Daily,
• St. John's Wort (a Herbal Product),
• Naloxegol [Used to Treat Constipation Caused by Opioid Pain Medications (e.g., Morphine, Oxycodone, Fentanyl, Tramadol, Codeine)],
• Tolvaptan [Used to Treat Hyponatremia (a Condition of Low Sodium Levels in the Blood) or to Slow the Worsening of Kidney Function in Patients with Autosomal Dominant Polycystic Kidney Disease],
• Lurasidone (Used to Treat Depression),
• Venetoclax [Used to Treat Patients with Chronic Lymphocytic Leukemia (CLL)].

Warnings and Precautions

Before Starting Voriconazole, Discuss the Following with a Doctor, Pharmacist, or Nurse:
If the Patient has Experienced an Allergic Reaction to Other Azoles in the Past.
If the Patient has or has had Liver Disease. In the Case of Liver Disease, the Doctor may Prescribe a Lower Dose of Voriconazole. The Doctor should also Monitor the Patient's Liver Function During Voriconazole Treatment by Ordering Blood Tests.
If the Patient has been Diagnosed with Cardiomyopathy, Heart Rhythm Disorders, Slow Heart Rate, or Changes in the Electrocardiogram (ECG) Known as "Prolonged QTc Interval".
Avoid Exposure to Sunlight During Treatment. It is Important to Wear Protective Clothing and Use Sunscreen with a High Sun Protection Factor (SPF) when Exposed to Sunlight, as Sensitivity to Sunlight may Occur. This Sensitivity may be Increased by Other Medications that Make the Skin More Sensitive to Sunlight, such as Methotrexate. These Precautions Apply to Children as Well.
During Voriconazole Treatment, Inform the Doctor Immediately if the Following Occur:
Sunburn
Severe Skin Rash or Blisters
Bone Pain
If the Patient Experiences any of the Above Skin Disorders, the Doctor may Refer the Patient to a Dermatologist, who may Decide on the Need for Regular Follow-Up Visits. There is a Small Risk that Long-Term Use of Voriconazole may Cause Skin Cancer.
If the Patient Experiences Symptoms of "Adrenal Insufficiency"; a Condition in which the Adrenal Glands do not Produce Enough of Certain Steroid Hormones, such as Cortisol; which may Lead to Symptoms such as: Chronic or Prolonged Fatigue, Muscle Weakness, Loss of Appetite, Weight Loss, Abdominal Pain, Inform the Doctor.
If the Patient Experiences Symptoms of "Cushing's Syndrome", a Condition in which the Body Produces too Much of the Hormone Cortisol, which may Lead to Symptoms such as: Weight Gain, Appearance of a Hump of Fat Between the Shoulder Blades, Rounded Face, Darkening of the Skin on the Abdomen, Thighs, Chest, and Arms, Thinning of the Skin, Increased Susceptibility to Bruising, Increased Blood Sugar Levels, Excessive Hair Growth, Excessive Sweating, Inform the Doctor.
The Doctor should Regularly Monitor the Patient's Liver and Kidney Function by Ordering Blood Tests.

Children and Adolescents

Voriconazole hameln Should Not be Used in Children Under 2 Years Old.

Voriconazole hameln and Other Medications

Inform the Doctor or Pharmacist About all Medications the Patient is Currently Taking or Plans to Take, Including those Available Without a Prescription.
Certain Medications Taken at the Same Time as Voriconazole may Change its Effect, and Voriconazole may Affect the Action of Other Medications.
Inform the Doctor About the Use of the Following Medication, as it Should be Avoided if Possible:

• Ritonavir (Used to Treat HIV Infections) at a Dose of 100 mg Twice Daily.
• Glasdegib (Used to Treat Cancer) - if Both Medications are Necessary, the Doctor will Order Frequent Heart Rhythm Monitoring.

Inform the Doctor About the Use of any of the Following Medications, as it may be Necessary to Avoid their Concurrent Use with Voriconazole (if this is not Possible, the Dose of Voriconazole may Need to be Adjusted):

• Rifabutin (Used to Treat Tuberculosis). If the Patient is Being Treated with Rifabutin, Monitor Blood Parameters and Adverse Reactions to Rifabutin.
• Phenytoin (Used to Treat Epilepsy). If the Patient is Being Treated with Phenytoin During Voriconazole Treatment, Monitor Phenytoin Blood Levels and Consider Adjusting the Dose.

Inform the Doctor About the Use of any of the Following Medications, as it may be Necessary to Adjust or Monitor the Dosing of these Medications and/or Voriconazole to Ensure they Continue to have the Desired Effect:

• Warfarin and Other Anticoagulant Medications (e.g., Phenprocoumon, Acenocoumarol; Used to Reduce Blood Clotting),
• Cyclosporine (Used in Patients After Transplants),
• Tacrolimus (Used in Patients After Transplants),
• 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 is Used Concurrently with Oral Contraceptives, Adverse Reactions such as Nausea, Menstrual Disorders may Occur),
• Vinca Alkaloids (e.g., Vincristine and 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),
• HIV Protease Inhibitors (e.g., Indinavir) (Used to Treat HIV Infections),
• Non-Nucleoside Reverse Transcriptase Inhibitors (e.g., Efavirenz, Delavirdine, Nevirapine) (Used to Treat HIV Infections), (Certain Doses of Efavirenz Should Notbe Used Concurrently with Voriconazole),
• Methadone (Used to Treat Heroin Addiction),
• Alfentanil, Fentanyl, and Other Short-Acting Opioids, such as Sufentanil (Pain Medications Used During Surgical Procedures),
• Oxycodone and Other Long-Acting Opioids, such as Hydrocodone (Used to Treat Moderate to Severe Pain),
• Non-Steroidal Anti-Inflammatory Medications (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 After Transplants),
• Letermovir [Used to Prevent Cytomegalovirus (CMV) Disease After Bone Marrow Transplantation],
• Ivacaftor (Used to Treat Cystic Fibrosis),
• Flucloxacillin (an Antibiotic Used to Treat Bacterial Infections).

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or Plans to Become Pregnant, they Should Consult a Doctor or Pharmacist Before Using this Medication.
Voriconazole hameln Should Not be Used During Pregnancy, Unless the Doctor Decides Otherwise.
During Treatment with Voriconazole hameln, Women of Childbearing Age Must Use Effective Contraception. If Pregnancy Occurs During Treatment with Voriconazole hameln, the Patient Should Immediately Consult a Doctor.

Driving and Operating Machinery

Voriconazole hameln may Cause Vision Disturbances or Abnormal Reactions to Light.
In Such Cases, the Patient Should Not Drive or Operate Machinery. The Patient Should Consult a Doctor if Such Disturbances Occur.

Voriconazole hameln Contains Sodium

This Medication Contains 88.74 mg of Sodium (a Major Component of Table Salt) per Vial. This is Equivalent to 4.44% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.
Inform the Doctor or Pharmacist if the Patient Needs 5 or More Vials per Day for an Extended Period, Especially if they have been Advised to Follow a Low-Sodium Diet.

Voriconazole hameln Contains Hydroxypropylbetadex

This Medication Contains 2,400 mg of Hydroxypropylbetadex per Vial, which is Equivalent to 120 mg/mL if Reconstituted in 20 mL of Clear Concentrate.
If the Patient has Kidney Disease, they Should Consult a Doctor Before Using this Medication.

3. How to Use Voriconazole hameln

This Medication Should Always be Used as Directed by the Doctor. In Case of Doubts, Consult a Doctor.
The Doctor will Decide on the Dose of the Medication Based on the Patient's Body Weight and the Type of Infection.
The Doctor may Change the Recommended Dose Depending on the Patient's Clinical Condition.
The Usual Recommended Dosage for Adults (Including Elderly Patients) is Presented in the Following Table:

Depending on the Response to Treatment, the Doctor may Reduce the Daily Dose to 3 mg/kg Body Weight Twice Daily.
In Case of Mild to Moderate Liver Cirrhosis, the Doctor may Decide to Reduce the Dose of the Medication.

Use in Children and Adolescents

The Usual Recommended Dosage for Children and Adolescents is Presented in the Following Table:

Depending on the Response to Treatment, the Doctor may Increase or Decrease the Daily Dose.
Voriconazole hameln, Powder for Solution for Infusion, will be Prepared by a Nurse or 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 for 1 to 3 Hours.
If the Patient is Taking Voriconazole hameln to Prevent Fungal Infections and Experiences Adverse Reactions Related to Treatment, the Treating Doctor may Discontinue Voriconazole hameln Administration.

Missing a Dose of Voriconazole hameln

Since the Medication will be Administered Under the Close Supervision of Medical Personnel, Missing a Dose is Unlikely. However, if a Dose is Missed, Inform the Doctor or Pharmacist.

Discontinuing Voriconazole hameln

The Doctor will Decide How Long the Patient will Receive Voriconazole hameln; However, Treatment with Voriconazole hameln, 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 Clinical Improvement Occurs, the Route of Administration of Voriconazole hameln may be Changed from Intravenous to Oral.
If the Doctor Decides to Discontinue Treatment, there is No Need to Worry About the Consequences of Stopping the Medication.
In Case of Any Further Doubts About the Use of this Medication, Consult a Doctor, Pharmacist, or Nurse.

4. Possible Side Effects

Like all Medications, Voriconazole hameln can Cause Side Effects, although not Everybody Gets them.
If Side Effects Occur, they are Usually Mild and Transient. However, some of them can be Serious and may Require Medical Intervention.

Severe Side Effects – Discontinue Voriconazole hameln and Consult a Doctor Immediately

Rash
Jaundice; Changes in Liver Function Test Results
Pancreatitis

Other Side Effects

Very Common: (May Occur in More than 1 in 10 People):

• Vision Disturbances (Changes in Vision, Including Blurred Vision, Changes in Color Vision, Abnormal Light Sensitivity, Color Blindness, Eye Disorders, Glowing Vision, Night Blindness, Feeling of Shimmering, Seeing Sparks, Visual Aura, Decreased Visual Acuity, Bright Vision, Loss of Part of the Normal Field of Vision, Floaters)
• Fever
• Rash
• Nausea, Vomiting, Diarrhea
• Headache
• Peripheral Edema
• Abdominal Pain
• Breathing Difficulties
• Increased Liver Enzyme Activity

Common: (May Occur in Up to 1 in 10 People):

• Sinusitis, Gingivitis, Chills, Weakness
• Low Levels of Certain Types of Blood Cells, Including Red Blood Cells (Sometimes Due to an Immune Reaction) and/or White Blood Cells (Sometimes Accompanied by Fever), and/or Platelets, which Help Blood to Clot
• Low Blood Sugar Levels, Low Potassium Levels, Low Sodium Levels
• Anxiety, Depression, Confusion, Agitation, Insomnia, Hallucinations
• Seizures, Tremors or Uncontrolled Muscle Movements, Tingling or Abnormal Sensations in the Skin, Increased Muscle Tension, Drowsiness, Dizziness
• Bleeding in the Eye
• Heart Rhythm Disorders, Including Very Fast or Very Slow Heartbeats, Fainting
• Low Blood Pressure, Inflammation of the Veins (Which may be Associated with Blood Clot Formation)
• Acute Breathing Difficulties, Chest Pain, Facial Swelling (of the Mouth, Lips, and Area Around the Eyes)
• Constipation, Indigestion, Inflammation of the Lips
• Jaundice, Liver Inflammation, and Liver Damage
• Rashes that may Lead to Severe Blistering and Peeling of the Skin, Characterized by a Flat, Red Area on the Skin Covered with Small, Merging Bumps, Reddening of the Skin
• Itching
• Hair Loss
• Back Pain
• Kidney Failure, Blood in the Urine, Changes in Kidney Function Tests
• Sunburn or Severe Skin Reactions to Light or Sun Exposure
• Skin Cancer

Uncommon: (May Occur in Up to 1 in 100 People):

• Flu-Like Symptoms, Irritation and Inflammation of the Gastrointestinal Tract, Antibiotic-Associated Diarrhea, Inflammation of the Lymphatic Vessels
• Inflammation of the Thin Tissue Lining the Abdominal Cavity and Covering the Abdominal Organs
• Enlarged Lymph Nodes (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
• Balance or Coordination Disorders
• Brain Swelling
• Double Vision, Severe Eye Disorders, Including Eye Pain and Inflammation, Abnormal Eye Movements, Damage to the Optic Nerve Affecting Vision, Swelling of the Optic Nerve
• Decreased Sensitivity to Touch
• Taste Disorders
• Hearing Impairment, Ringing in the Ears, Dizziness
• Inflammation of Certain Internal Organs - Pancreas and Duodenum, Swelling and Inflammation of the Tongue
• Enlargement of the Liver, Liver Failure, Gallbladder Disorders, Gallstones
• Joint Inflammation, Inflammation of the Veins Under the Skin (Which may be Associated with Blood Clot Formation)
• Kidney Inflammation, Protein in the Urine, Kidney Damage
• Very Fast or Missed Heartbeats, Sometimes with Abnormal Electrical Impulses
• Abnormal Electrocardiogram (ECG) Readings
• Increased Cholesterol Levels in the Blood, Increased Urea Levels in the Blood

Rare: (May Occur in Up to 1 in 1,000 People):

• Overactive Thyroid Gland
• Worsening of Brain Function, a Severe Complication of Liver Disease
• Loss of Most of the Nerve Fibers in the Optic Nerve, Corneal Clouding, Involuntary Eye Movements
• Blisters Due to Sunlight Sensitivity
• Disorders in which the Immune System Attacks Part of the Peripheral Nervous System
• Heart Rhythm Disorders or Conduction Disorders (Sometimes Life-Threatening)
• Life-Threatening Allergic Reaction
• Blood Clotting Disorders
• Skin Allergic Reactions (Sometimes Severe), Including a Life-Threatening Skin Condition Characterized by the Formation of Blisters and Peeling of the Skin, Itching or Painful Skin Rashes, Inflammation of the Skin and Mucous Membranes, a Life-Threatening Skin Condition Characterized by Peeling of Large Areas of the Skin, Small, Dry, Flaking Skin Patches, Sometimes Thickened with Sharp Projections or "Horns"

Frequency Not Known: (Cannot be Estimated from Available Data):

• Pigmentation and Skin Spots

Other Important Side Effects, the Frequency of which is Not Known, but which Should be Reported to a Doctor Immediately:

• Red, Flaking, or Ring-Shaped Skin Changes, which may be a Sign of an Autoimmune Disease Called Cutaneous Lupus Erythematosus

During Infusion of Voriconazole hameln, the Following Adverse Reactions have been Reported: (Flushes, Fever, Sweating, Increased Heart Rate, and Shortness of Breath). If these Symptoms Occur, the Doctor may Decide to Discontinue the Infusion.
Due to the Known Effect of Voriconazole hameln on the Liver and Kidneys, the Doctor will Order Monitoring of these Organs' Function through Blood Tests. The Patient Should also Inform the Doctor if they Experience Abdominal Pain or Changes in Stool Consistency.
There have been Reports of Skin Cancer in Patients Treated with Voriconazole hameln for a Long Time.
Sunburn or Severe Skin Reactions to Light or Sun Exposure have been Reported More Frequently in Children. If the Patient Experiences Skin Disorders, the Doctor may Refer them to a Dermatologist, who may Decide on the Need for Regular Follow-Up Visits. Increased Liver Enzyme Activity has also been Observed More Frequently in Children.
If any of these Side Effects Persist or are Troublesome, Inform a Doctor.

Reporting Side Effects

If any Side Effects Occur, Including those not Mentioned in this Package Leaflet, Inform a Doctor, Pharmacist, or Nurse.
Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 hameln

Keep the Medication out of Sight and Reach of Children.
Do not Use this Medication After the Expiration Date Stated on the Packaging and Vial Label After: EXP. The Expiration Date Refers to the Last Day of the Specified Month.
Unopened Vial
There are no Special Storage Instructions for the Medication Before Opening.
Reconstituted and Diluted Product:

Chemical and Physical Stability has been Demonstrated for 72 Hours at 25°C and at 2-8°C. From a Microbiological Point of View, the Product Should be Used Immediately. If the Concentrate is not Used Immediately, the User is Responsible for the Storage Conditions and the Storage Time should not Exceed 24 Hours at 2-8°C (Refrigerator), Provided that Reconstitution/Dilution was Carried out Under Controlled and Validated Aseptic Conditions.
The Medication Should not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Voriconazole hameln Contains

The Active Substance of the Medication is Voriconazole.
Each Vial Contains 200 mg of Voriconazole. After Reconstitution, each mL of Solution Contains 10 mg of Voriconazole.
Other Ingredients of the Medication are Hydroxypropylbetadex, Sodium Chloride, Hydrochloric Acid (to Adjust pH)

What Voriconazole hameln Looks Like and Contents of the Package

Each Package Contains 1 Vial. Voriconazole hameln is a White or Off-White Freeze-Dried Powder for Solution for Infusion in a 25 mL Type I Glass Vial with a Grey Rubber Stopper Type I, an Aluminium Seal, and a Red Plastic Flip-Off Cap.

Marketing Authorization Holder

hameln pharma gmbh
Inselstrasse 1
31787 Hameln
Germany
Phone: +49 171 766 2789

Manufacturer

Anfarm Hellas S.A.
61 Km National Road Athens Lamia
32009 Schimatari Viotias
Greece
Pharmathen S.A.
6, Dervenakion street
Pallini 15351 Attiki
Greece

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria
Voriconazol hameln 200 mg Powder for Solution for Infusion
Belgium
Voriconazol hameln 200 mg Powder for Solution for Infusion/Pulver zur Herstellung einer Infusionslösung/Powder for Solution for Infusion
Bulgaria
Вориконазол hameln 200mg Прах за инфузионен разтвор
Czech Republic
Voriconazole hameln
Denmark
Voriconazole "hameln"
Finland
Voriconazole hameln 200 mg Powder for Solution for Infusion
Ireland
Voriconazole 200mg Powder for Solution for Infusion
Netherlands
Voriconazol hameln 200 mg Powder for Solution for Infusion
Germany
Voriconazol hameln 200 mg Pulver zur Herstellung einer Infusionslösung
Norway
Voriconazole hameln
Poland
Voriconazole hameln
Portugal
Voriconazol hameln 200 mg Powder for Solution for Infusion
Romania
Voriconazol hameln 200 mg Pulbere pentru soluţie perfuzabilă
Slovakia
Voriconazole hameln 200 mg Powder for Solution for Infusion
Slovenia
Vorikonazol hameln 200 mg Prašek za raztopino za infundiranje
Sweden
Voriconazole hameln 200 mg Powder for Solution for Infusion
Italy
Voriconazolo hameln

Date of Last Revision of the Package Leaflet: {MM/YYYY}

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Information Intended for Healthcare Professionals Only:

Reconstitution and Dilution Information:

• Voriconazole hameln Powder for Solution for Infusion Should be Reconstituted in 19 mL of Water for Injection or 19 mL of 9 mg/mL (0.9%) Sodium Chloride Injection to Obtain 20 mL of a Clear Concentrate Containing 10 mg/mL of Voriconazole.
• The Vial of Voriconazole hameln Should be Discarded if the Solvent is not Drawn into the Vial Due to the Existing Vacuum.
• To Ensure Accurate Measurement of the Volume (19 mL) of Water for Injection or 9 mg/mL (0.9%) Sodium Chloride Injection, it is Recommended to Use Standard 20 mL (Non-Automatic) Syringes.
• To Obtain a Solution for Infusion Containing 0.5 mg/mL to 5 mg/mL of Voriconazole, the Required Volume of the Reconstituted Concentrate Should be Added to a Compatible Infusion Solution (See Below).
• This Medicinal Product is for Single Use Only. Any Unused Solution Should be Discarded. Do not Use Cloudy Solutions or those Containing Particulate Matter.
• The Solution is not Intended for Rapid Intravenous Injection (Bolus).
• Information on Storage is Provided in Section 5 "How to Store Voriconazole hameln".

Required Volumes of Voriconazole hameln Concentrate 10 mg/mL
Voriconazole hameln is a Non-Preserved, Sterile Lyophilisate Intended for Single Use. From a Microbiological Point of View, the Solution for Infusion Should be Used Immediately After Reconstitution and Dilution. If the Concentrate is not Used Immediately, the User is Responsible for the Storage Conditions and the Storage Time should not Exceed 24 Hours at 2-8°C, Provided that Reconstitution/Dilution was Carried out Under Controlled and Validated Aseptic Conditions.

Reconstituted Voriconazole hameln Should be Diluted in a Compatible Infusion Solution Immediately Before Infusion.

Compatible Infusion Solutions:

The Concentrate can be Diluted in:
9 mg/mL (0.9%) Sodium Chloride Injection
Sodium Lactate Injection
5% Glucose and Lactated Ringer's Solution for Infusion
5% Glucose and 0.45% Sodium Chloride Solution for Infusion
5% Glucose Solution for Infusion
5% Glucose Solution with 20 mEq Potassium Chloride for Infusion
0.45% Sodium Chloride Solution for Infusion
5% Glucose and 0.9% Sodium Chloride Solution for Infusion
Compatibility of Voriconazole hameln with Other Solutions, other than those Listed Above (or in the "Incompatibilities" Section Below), has not been Established.

Incompatibilities:

Voriconazole hameln Should not be Administered Concurrently with Other Medications in the Same Intravenous Line or Catheter, Including Parenteral Nutrition (e.g., Aminofusin 10% Plus).
Voriconazole hameln Should not be Used Concurrently with Blood Products.
Administration of Intravenous Infusions for Parenteral Nutrition may be Carried out Concurrently with Voriconazole, but not Through the Same Intravenous Access or Catheter.
4.2% Sodium Bicarbonate Solution for Infusion Should not be Used to Dilute Voriconazole hameln.