Bg pattern

SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION

Prescription review online

Prescription review online

A doctor will review your case and decide whether a prescription is medically appropriate.

Talk to a doctor about this medicine

Talk to a doctor about this medicine

Discuss your symptoms and possible next steps in a quick online consultation.

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

Show original

Introduction

Package Leaflet: Information for the User

Silibinina Viatris 350 mg Powder for Solution for Infusion

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

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Silibinina Viatris and what is it used for
  2. What you need to know before you use Silibinina Viatris
  3. How to use Silibinina Viatris
  4. Possible side effects
  5. Storage of Silibinina Viatris
  6. Contents of the pack and further information

1. What is Silibinina Viatris and what is it used for

Silibinina is an antidote for amatoxin (the main toxin of the poisonous mushroom Amanita phalloides), and it works by blocking the uptake of amatoxin by liver cells (hepatocytes), thus interrupting the enterohepatic circulation of the toxin and promoting its elimination.

Silibinina Viatris is indicated for the treatment of Amanita phalloides poisoning.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use Silibinina Viatris

Do not use Silibinina Viatris

  • If you are allergic to the active substance silibinina or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

  • A strict control of the electrolyte and acid-base balance, as well as the fluid balance of patients undergoing treatment with silibinina, must be maintained.
  • If you are on a low-sodium diet, inform your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take silibinina.

Other medicines and Silibinina Viatris

No interactions with other medicines have been reported.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There are no clinical data on the use of silibinina in pregnant women. Animal studies do not show direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition, or postnatal development. If silibinina is considered necessary in a pregnant woman, it should be administered with caution.

Silibinina Viatris contains sodium

This medicine contains 34 mg of sodium (a major component of table/cooking salt) per vial. This is equivalent to 1.7% of the maximum recommended daily intake of sodium for an adult.

Driving and using machines

No effects on driving or using machines have been reported.

3. How to use Silibinina Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

This medicine will always be administered by a healthcare professional.

The administration of this medicine will be by intravenous infusion.

Recommended dose:

Unless your doctor indicates otherwise, the recommended dose is 4 intravenous infusions of 2 hours each, with a 4-hour interval between them, while controlling fluid balance.

Duration of treatment:

The infusions should continue for several days until the complete disappearance of symptoms.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very rare side effects (may affect up to 1 in 10,000 people):

  • Feeling of heat (flush) during infusion.

Side effects of unknown frequency (cannot be estimated from the available data):

  • Fever.
  • Increased bilirubin in the blood.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Silibinina Viatris

No special storage conditions are required.

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Once reconstituted, the solution is stable for 6 hours at 30°C and 24 hours at 2-8°C.

6. Contents of the pack and further information

Composition of Silibinina Viatris

One vial for infusion contains 598.5 mg of lyophilized product:

The active substance is 528.5 mg of silibinina-C-2',3-dihydrogensuccinate disodium, equivalent to 350 mg of silibinina.

The other ingredients are inulin.

Appearance and pack contents

Silibinina Viatris is presented in packs containing 4 vials for infusion, each containing 598.5 mg of lyophilized product.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

MADAUS GmbH

Lütticher Strasse, 5

53842 – Troisdorf

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of last revision of this leaflet:March 2025

This information is intended only for healthcare professionals:

  • Infusions with silibinina should be started as soon as possible after poisoning, even without waiting for the diagnosis of mushroom poisoning to be confirmed.
  • The recommended dose is 20 mg of silibinina per kg of body weight and day, divided into 4 intravenous infusions of 2 hours each, with a 4-hour interval between them, while controlling fluid balance. In each infusion, 5 mg of silibinina per kg of body weight will be administered. Thus, for the treatment of a 70 kg patient, one vial (350 mg of silibinina) will be needed for each infusion.
  • Instructions for reconstitution:
  • The contents of the vial are dissolved with a minimum of 35 ml of the infusion solution to be administered (0.9% sodium chloride solution or 5% glucose solution).
  • The required amount of reconstituted solution (1 ml = 10 mg silibinina) is added to the rest of the saline or glucose solution, depending on the patient's weight.
  • Once reconstituted, the solution is stable for 6 hours at 30°C and 24 hours at 2-8°C.
  • The administration of the preparation should be by intravenous infusion over 2 hours.
  • After an interval of 4 hours, another infusion of the same duration (2 hours) will be performed, so that in 24 hours, 4 infusions will be carried out. This regimen should be continued until the complete disappearance of symptoms of poisoning.
  • Precautions:
  • A strict control of the electrolyte and acid-base balance, as well as the fluid balance of patients undergoing treatment with this medicine, must be maintained.
  • According to the recommended daily dose of 20 mg of silibinina per kg of body weight and the corresponding amount of saline solution needed for its dissolution, up to approximately 0.39 mmol of sodium per kg of body weight/day will be administered.
  • Extracorporeal detoxification measures, such as hemoperfusion or hemodialysis, should be performed during the intervals when the infusion is not being administered, in order to avoid the elimination of silibinina from the bloodstream as much as possible.
  • The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

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

Online doctors for SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION

Discuss questions about SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (2)
Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

Camera Book a video appointment
€55
5.0 (77)
Doctor

Sergey Ilyasov

Psychiatry 7 years exp.

Dr Sergey Ilyasov is an experienced neurologist and qualified psychiatrist who provides online consultations for adults and adolescents. Combining deep neurological expertise with a modern psychiatric approach, he ensures comprehensive diagnostics and effective treatment for a wide range of conditions affecting both physical and mental health.

Dr. Ilyasov helps patients in the following cases:

  • Chronic headaches (migraine, tension-type headache), back pain, neuropathic pain, dizziness, numbness in limbs, coordination disorders.
  • Anxiety disorders (panic attacks, generalized anxiety disorder), depression (including atypical and treatment-resistant forms), sleep disturbances (insomnia, hypersomnia, nightmares), stress, burnout.
  • Chronic pain syndromes and psychosomatic symptoms (e.g., irritable bowel syndrome related to stress, vegetative-vascular dystonia).
  • Behavioral disorders and concentration difficulties in adolescents (including ADHD, autism spectrum disorders), nervous tics.
  • Memory impairments, phobias, obsessive-compulsive disorder (OCD), emotional swings, and support for post-traumatic stress disorder (PTSD).

Thanks to his dual specialization in neurology and psychiatry, Dr Sergey Ilyasov offers integrated and evidence-based care for complex conditions requiring a multidisciplinary approach. His consultations focus on accurate diagnosis, development of an individualized treatment plan (including pharmacotherapy and psychotherapeutic methods), and long-term support adapted to each patient's unique needs.

Book an online consultation with Dr. Sergey Ilyasov to receive qualified assistance and improve your well-being today.

Camera Book a video appointment
€89
5.0 (137)
Doctor

Taisiia Proida

Psychiatry 7 years exp.

Dr. Taisiia Proida is a psychiatrist and cognitive behavioural therapist (CBT), and a member of the European Psychiatric Association. She offers online consultations for adults aged 18 and over, combining evidence-based medicine with an individualised approach to mental health care.

She specialises in consultations and ongoing support for a wide range of mental health concerns, including:

  • Mood disorders: depression, bipolar disorder, postpartum depression.
  • Anxiety disorders: generalised anxiety, OCD, panic attacks, phobias.
  • Post-traumatic stress disorder (PTSD) and complex PTSD.
  • Attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). Assessment is provided only after an initial psychiatric evaluation and during a follow-up appointment.
  • Personality disorders and emotional instability.
  • Cyclothymia and mood fluctuations.
  • Schizophrenia spectrum and related conditions.

Dr. Proida combines clinical expertise with an empathetic approach, offering structured support based on evidence-based practices. Her work integrates CBT techniques with medical management, with a focus on anxiety and depressive disorders.

She works with clients from different countries and cultural backgrounds, adapting her communication style and recommendations to individual needs. With experience in international clinical trials (Pfizer, Merck), she values clarity, trust, and collaborative partnership in patient care.

Camera Book a video appointment
€120
5.0 (2)
Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

Camera Book a video appointment
€55

Frequently Asked Questions

Is a prescription required for SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION?
SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
Who manufactures SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION?
SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION is manufactured by Viatris Healthcare Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to SILIBININA VIATRIS 350 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION?
Other medicines with the same active substance () include LEGALON 150 mg CAPSULES, SILARINE 80 mg HARD CAPSULES, CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
bg-pattern-dark

Stay informed about Oladoctor

News about new services, product updates and useful information for patients.

Follow us on social media