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ZOFETRON

ZOFETRON

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Doctor

Tomasz Grzelewski

Dermatology21 years of experience

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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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 ZOFETRON

INSTRUCTIONS for medical use of the medicinal product FLUMAZENIL-VISTA (FLUMAZENIL-VISTA)

Composition

active substance: flumazenil; 1 ml of solution contains 0.1 mg of flumazenil; excipients: sodium chloride, disodium edetate, glacial acetic acid, sodium hydroxide, water for injections.

Pharmaceutical form

Solution for injection.

Main physical and chemical properties

Transparent, colorless solution.

Pharmacotherapeutic group

Other therapeutic agents. Antidotes. ATC code V03AB25.

Pharmacological properties

Pharmacodynamics
Mechanism of action

Flumazenil is a benzodiazepine antagonist, an imidazobenzodiazepine derivative that, through competitive interaction, specifically blocks the effects of substances acting on the benzodiazepine receptor in the central nervous system (CNS). There have been reports of neutralization of paradoxical benzodiazepine reactions.

Pharmacodynamic effects

Experiments conducted on animals have shown that flumazenil does not block the effects of benzodiazepine receptor agonists, such as barbiturates, mimetics of gamma-aminobutyric acid, and adenosine receptor antagonists. Flumazenil blocks the action of non-benzodiazepine agonists, such as cyclopyrrolones (zoplicone) and triazolopyridazines. The hypnotic-sedative effects of benzodiazepines quickly disappear (within 1-2 minutes) after intravenous administration of flumazenil. Depending on the difference in elimination time between the agonist and antagonist, the effect may recur within several hours. Flumazenil may have slight agonistic (e.g., anticonvulsant) activity. Clinical efficacy and safety. Animal studies have shown that with prolonged treatment with flumazenil, a withdrawal syndrome developed, including seizures.

Pharmacokinetics
Distribution

Flumazenil is a weakly lipophilic base. Flumazenil is bound to approximately 50% of plasma proteins, of which 2/3 are bound to albumin. Flumazenil is intensely distributed in the extracellular space. During the distribution phase, the concentration of flumazenil in plasma decreases with a half-life of 4-5 minutes. The volume of distribution at steady-state concentration is 0.9-1.1 L/kg.

Metabolism

Flumazenil undergoes intensive metabolism in the liver. The most important inactive metabolite in plasma (in free form) and urine (in free and conjugated form) is carboxylic acid. The results of pharmacological tests have shown that this metabolite does not have agonistic or antagonistic benzodiazepine activity.

Elimination

Flumazenil is almost completely excreted in the urine. This indicates complete breakdown of the active substance in the body. Studies with a radiolabeled drug have shown that complete excretion occurs within 72 hours: 90-95% with urine and 5-10% with feces. Elimination is rapid, as evidenced by a short half-life (40-80 minutes). The total clearance of flumazenil is 0.8-1.0 L/h/kg, and metabolism occurs mainly in the liver.

Clinical characteristics

Indications

The medicinal product is used to partially or completely eliminate the central sedative effects of benzodiazepines in adults and children over 1 year of age. It can be used in anesthesia and intensive care.

Contraindications
  • Increased sensitivity to the active substance or to any of the components of the medicinal product.
  • Treatment of potentially life-threatening conditions with benzodiazepines (e.g., control of intracranial pressure or epileptic status).
  • Severe intoxication caused by cyclic antidepressants (seizures, focal seizures, QRS prolongation, arrhythmia, mydriasis, anticholinergic symptoms).
Interaction with other medicinal products and other types of interactions

Interaction studies were conducted only in adult patients. Flumazenil suppresses the central effects of benzodiazepines by competitive inhibition at the receptor level. It also blocks the action of non-benzodiazepine agonists (e.g., zoplicone, triazolopyridazines) on benzodiazepine receptors. However, flumazenil does not block the action of medicinal products that do not work through this mechanism. No interaction with other CNS depressants has been observed.

Special instructions

Monitoring

When using flumazenil to eliminate sedation caused by benzodiazepines, it is necessary to monitor the dose, vital signs (electrocardiogram (ECG)), pulse, oximetry, concentration of the patient's attention, and other vital signs (such as heart rate, respiratory rate, and blood pressure) for a long time, as well as the duration of the effect of the used benzodiazepine for the occurrence of symptoms of repeated sedation, difficulty breathing, or other signs of residual benzodiazepine effect.

Anxiety

It is necessary to carefully select the dosage of flumazenil for patients who suffer from preoperative anxiety or have a history of chronic or episodic anxiety.

Postoperative pain

Postoperative pain should be taken into account. It may be better to keep the patient sedated.

Pediatric use

Due to the likelihood of repeated sedation and difficulty breathing in children who have been sedated with midazolam, it is necessary to carefully monitor them for at least 2 hours after administration of flumazenil.

Overdose

Symptoms. Even when used in higher doses than recommended (up to 100 mg of flumazenil), symptoms of overdose have not been observed.

Adverse reactions

Immune system disorders
oftenhypersensitivity reactions, anaphylactic shock
Psychiatric disorders
oftenanxiety, insomnia, drowsiness, emotional lability
rarelyfear
frequency unknownpsychic changes, euphoria, fatigue, pathological crying, aggressive reactions, panic attacks; withdrawal syndrome: agitation, anxiety, emotional lability, confusion, sensory disturbances
Nervous system disorders
oftenheadache, vertigo, agitation, tremor, dry mouth, rapid breathing, speech disorders, paresthesia
rarelyseizures (mainly in patients with epilepsy, severe liver failure, especially after treatment with benzodiazepines or in case of overdose with several medicinal products)
frequency unknownspontaneous movements
Eye disorders
oftendiplopia, strabismus, increased lacrimation
Ear and labyrinth disorders
rarelyhearing impairment
Cardiovascular disorders
oftenincreased heart rate, flushing, hypotension, orthostatic hypertension, transient hypertension (upon awakening)
rarelytachycardia or bradycardia, extrasystole
Respiratory, thoracic, and mediastinal disorders
rarelydyspnea, cough, nasal congestion, chest pain
Gastrointestinal disorders
very oftennausea (during anesthesia, especially when used with opioids)
oftenvomiting (during anesthesia, especially when used with opioids), hiccups
Skin and subcutaneous tissue disorders
oftenincreased sweating
rarelypallor
frequency unknownheat flushes to the face
General disorders and administration site conditions
oftenfatigue, pain at the injection site
rarelytrembling
frequency unknownincreased pain sensation, weight gain, chills

Shelf life

3 years.

Storage conditions

No special storage conditions are required for the medicinal product. Store in a place inaccessible to children.

Packaging

5 ml in an ampoule; 5 or 10 ampoules in a cardboard pack.

Release category

By prescription.

Manufacturer

LABORATORIO REIG JOFRÉ, S.A.

Location of the manufacturer and its business address

C/Gran Capitán, 10, Sant Joan Despí, Barcelona, 08970, Spain

Alternatives to ZOFETRON in other countries

The best alternatives with the same active ingredient and therapeutic effect.

Alternative to ZOFETRON in Іспанія

Dosage form: РОЗЧИН ДЛЯ ІН'ЄКЦІЙ, 2 мг/мл
Active substance: ondansetron
Manufacturer: Kalceks As
Prescription required
Dosage form: РОЗЧИН ДЛЯ ІН'ЄКЦІЙ, 2 мг/мл
Active substance: ondansetron
Prescription required
Dosage form: РОЗЧИН ДЛЯ ІН'ЄКЦІЙ, 2 мг/мл
Active substance: ondansetron
Prescription required
Dosage form: ТАБЛЕТКА, 4 мг
Active substance: ondansetron
Prescription required
Dosage form: ТАБЛЕТКА, ЩО ШВИДКО РОЗЧИНЯЄТЬСЯ В РОТІ/ЛІОТАБ, 4 мг ондансетрону гідрохлориду дигідрат
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Prescription required
Dosage form: ТАБЛЕТКА, 8 мг
Active substance: ondansetron
Manufacturer: Dari Pharma S.L.
Prescription required

Alternative to ZOFETRON in Польща

Dosage form: Розчин, 0,16 мг/мл
Active substance: ondansetron
Prescription required
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Active substance: ondansetron
Prescription required
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Active substance: ondansetron
Manufacturer: AS Kalceks
Prescription required
Dosage form: Розчин, 8 мг
Active substance: ondansetron
Importer: Accord Healthcare Polska Sp. z o.o. Accord Healthcare Single Member S.A. Laboratori Fundació Dau Pharmadox Healthcare Ltd.
Prescription required
Dosage form: Розчин, 4 мг
Active substance: ondansetron
Importer: Accord Healthcare Polska Sp. z o.o. Accord Healthcare Single Member S.A. Laboratori Fundació Dau Pharmadox Healthcare Ltd.
Prescription required
Dosage form: Розчин, 0,16 мг/мл
Active substance: ondansetron
Manufacturer: B. Braun Medical S.A.
Prescription required

Online doctors for ZOFETRON

Discuss dosage, side effects, interactions, contraindications, and prescription renewal for ZOFETRON – subject to medical assessment and local rules.

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Tomasz Grzelewski

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Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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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.

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