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.

0.0 (0)
Doctor

Chikeluo Okeke

General medicine 4 years exp.

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

Common reasons for consultation:

  • General internal medicine concerns and initial health assessment.
  • Acute symptoms such as fever, cough, infections, pain, or weakness.
  • Chronic conditions and treatment adjustment.
  • Blood pressure issues, fatigue, metabolic concerns.
  • Preventive consultations and routine check-ups.
  • Interpretation of laboratory results and medical reports.
  • Medical advice for patients receiving care online.

Dr Okeke is known for his clear communication, calm approach, and cultural awareness. He listens carefully, explains medical decisions in a structured way, and supports patients in making informed choices about their health.

Online consultations with Dr Chikeluo Okeke offer reliable internal medicine care without geographic limitations, focused on medical relevance, clarity, and patient comfort.

Camera Book a video appointment
€60
0.0 (0)
Doctor

Andreea Mateescu

Paediatrics 8 years exp.

Dr Andreea Mateescu is a board-certified paediatrician with 7 years of clinical experience. She graduated from Carol Davila University of Medicine and Pharmacy in Bucharest, Romania, and completed her paediatric residency at INSMC Alessandrescu-Rusescu. She also holds additional training in general ultrasound diagnostics.

Dr Mateescu focuses on providing high-quality, evidence-based medical care for children, with a strong emphasis on prevention, healthy development, and long-term wellbeing. She believes that clear, empathetic communication with both children and parents is essential for building trust and ensuring effective care.

Online consultations with Dr Mateescu are suitable for:

  • preventive check-ups and monitoring of growth and development;
  • vaccination planning, including personalised and catch-up schedules;
  • assessment of psychomotor, emotional, and physical development;
  • diagnosis and management of acute and chronic paediatric conditions;
  • nutritional guidance for infants and children, including formula selection when medically indicated;
  • care for children with complex or rare conditions;
  • practical guidance and ongoing support for parents.
Dr Mateescu works with patience, empathy, and professionalism, ensuring that each child receives attentive, individualised care. Her goal is to support healthy, balanced development while helping parents feel confident and well-informed at every stage of their child’s care.
Camera Book a video appointment
€60
0.0 (0)
Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
Camera Book a video appointment
€58
5.0 (148)
Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

Camera Book a video appointment
€50
2
...

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