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GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION

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About the medicine

How to use GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION

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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.

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Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Granisetron Kabi 1 mg/ml solution for injection EFG

Read all of this leaflet carefully before you start using 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, pharmacist, or nurse.
  • 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 experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

  1. What is Granisetron Kabi and what is it used for
  2. What you need to know before you use Granisetron Kabi
  3. How to use Granisetron Kabi
  4. Possible side effects

5 Conservation of Granisetron Kabi

  1. Contents of the pack and other information

1. What is Granisetron Kabi and what is it used for

Granisetron Kabi contains the active substance granisetron. This belongs to a group of medicines called serotonin receptor antagonists, 5-HT3, or antiemetics, which prevent or treat nausea and vomiting.

Granisetron Kabi is indicated for the prevention and treatment of nausea and vomiting (feeling of discomfort) caused by certain treatments, such as chemotherapy or radiotherapy in anticancer therapy, as well as for the treatment and prevention of postoperative nausea and vomiting.

The solution for injection is indicated in adults and in children from 2 years of age.

Doctor consultation

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2. What you need to know before you use Granisetron Kabi

Do not use Granisetron Kabi

  • if you are allergic to granisetron or any of the other ingredients of this medicine (see section 6).

If you are not sure, consult your doctor, pharmacist, or nurse before receiving the injection.

Warnings and precautions

Before using Granisetron Kabi, talk to your doctor, pharmacist, or nurse if:

  • you have problems with constipation due to intestinal obstruction.
  • you have heart problems, are receiving anticancer medications that can be harmful to your heart, and/or have some disorder of salt levels such as potassium, sodium, or calcium (electrolyte disturbances).

you are taking another medicine from the group of "5-HT3 receptor antagonists".

This group includes dolasetron and ondansetron, used, like Granisetron Kabi, for the treatment and prevention of nausea and vomiting.

Serotonin Syndrome is a rare but potentially life-threatening reaction that can occur with granisetron (see section 4). The reaction can occur if you take granisetron alone but is more likely to occur if you take granisetron with other certain medications (in particular fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).

Using Granisetron Kabi with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is because Granisetron Kabi may interact with some medicines. Also, some medicines may interact with this injection.

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine:

  • medicines used to treat irregular heartbeats, other

medicines "antagonists of the 5-HT3 receptors" such as dolasetron or ondansetron (see "Warnings and precautions")

  • phenobarbital, a medicine used to treat epilepsy
  • ketoconazole, a medicine used to treat fungal infections
  • erythromycin, an antibiotic used to treat bacterial infections
    • SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
    • SNRIs (serotonin and norepinephrine reuptake inhibitors) used to treat depression and/or anxiety, including venlafaxine, duloxetine.

Pregnancy and breastfeeding

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

Driving and using machines

Granisetron Kabi is not expected to affect your ability to drive or use machines.

Granisetron Kabi contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, so it is essentially "sodium-free".

3. How to use Granisetron Kabi

The injection will be given to you by your doctor or nurse.

The dose of Granisetron Kabi varies from one patient to another. It depends on age, weight, and whether you are taking other medicines to prevent or treat nausea and vomiting. Your doctor will decide how much to administer.

Granisetron Kabi can be given as an injection into the veins (intravenously).

Prevention of nausea or vomiting after radiotherapy or chemotherapy

You will be given the injection before starting radiotherapy or chemotherapy. The injection into the veins (intravenously) will last between 30 seconds and 5 minutes, and the usual dose is between 1 and 3 mg. The medicine can be diluted before injection.

Treatment of nausea or vomiting after radiotherapy or chemotherapy

The injection will last between 30 seconds and 5 minutes, and the usual dose is between 1 and 3 mg. The medicine can be diluted before injection into the veins (intravenously). To stop the discomfort, you may receive more injections after the first dose. There must be at least 10 minutes between each dose. The maximum dose of Granisetron Kabi will be 9 mg per day.

Combination with corticosteroids

The effect of the injection may be increased with the use of other medicines, called corticosteroids. It can be 8-20 mg of dexamethasone, administered before the start of radiotherapy or chemotherapy treatment, or 250 mg of methylprednisolone administered before the start of chemotherapy and again immediately after finishing it.

Treatment of nausea or vomiting after an operation

The injection into the veins (intravenously) will last between 30 seconds and 5 minutes, and the usual dose is 1 mg. The maximum dose of Granisetron Kabi is 3 mg per day.

Use in children

Use in children for the prevention or treatment of nausea or vomiting after radiotherapy or chemotherapy

Granisetron Kabi is given by injection into the veins (intravenously) as described above, with the dose adjusted according to the child's weight. The injections are diluted and administered before radiotherapy or chemotherapy and last 5 minutes. Children may receive a maximum of 2 doses per day, with at least 10 minutes between each dose.

Use in children for the prevention or treatment of nausea or vomiting after an operation

This injection should not be given for the treatment of nausea or discomfort after an operation.

If you use more Granisetron Kabi than you should

Because this injection is given by a doctor or nurse, it is unlikely that you will receive more than the dose you should. However, if you are concerned, talk to your doctor or nurse. Symptoms of overdose include a mild headache (cephalalgia). You will be treated according to your symptoms.

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

Medicine questions

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4. Possible side effects

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

If you notice any of the following side effects, you should see your doctor immediately:

  • allergic reactions (anaphylaxis). The signs can include swelling of the throat, or your face, lips, and mouth, and difficulty breathing or swallowing.

Other side effects that may occur while taking this medicine are:

Very common: may affect more than 1 in 10 people

  • headache
  • constipation. Your doctor will monitor your condition.

Common: may affect up to 1 in 10 people

  • difficulty sleeping (insomnia)
  • through blood tests, changes in liver function are shown

Uncommon: may affect up to 1 in 100 people

  • skin rash or an allergic reaction or hives. The signs can include red spots that itch
  • changes in heartbeats (rhythm) and changes in the ECG (electrocardiogram)

Rare: may affect up to 1 in 1,000 people

  • abnormal involuntary movements, such as tremors, muscle stiffness, and muscle contractions
  • Serotonin Syndrome. The signs could include fever, sweating, chills, diarrhea, nausea, vomiting, muscle spasms, tremors, or stiffness, hyperactive reflexes, loss of coordination, rapid heartbeat, changes in blood pressure, confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Reporting of side effects

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

5. Conservation of Granisetron Kabi

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.

Store in the original packaging to protect from light.

  • Do not freeze.
  • Once opened, Granisetron Kabi should be used immediately.
  • Once diluted, Granisetron Kabi should be used immediately. If not used immediately, the ready-to-use solution should be stored at 25°C, protected from sunlight, and used within the next 24 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Granisetron Kabi

  • The active substance is granisetron (as hydrochloride).

Each ml of Granisetron Kabi solution for injection contains 1 mg of granisetron (as hydrochloride).

  • Other ingredients are citric acid (monohydrate), hydrochloric acid, sodium chloride, water for injections, sodium hydroxide to adjust the pH (acidity).

Appearance and packaging

Granisetron Kabi is a clear and colorless solution.

The box may contain 5 or 10 glass ampoules. The ampoules contain 1 ml or 3 ml of Granisetron Kabi 1 mg/ml solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

FRESENIUS KABI ESPAÑA, S.A.U.

Marina, 16-18 - 08005 (Barcelona)

Spain

Manufacturer:

Labesfal – Laboratórios Almiro S.A. (Fresenius Kabi Group)

Zona Industrial do Lagedo, 3465-157 Santiago de Besteiros

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium Granisetron Fresenius Kabi 1mg/ml, oplossing voor injectie / solution injectable / Injektionslösung

Czech Republic Granisetron Kabi 1 mg/ml, injekcní roztok

Germany Granisetron Kabi 1 mg/ml Injektionslösung

Finland Granisetron Fresenius Kabi 1 mg/ml injektioneste, liuos

Italy Granisetron Kabi 1 mg/ml soluzione iniettabile

Luxembourg Granisetron Kabi 1 mg/ml Injektionslösung

Netherlands Granisetron Fresenius Kabi 1mg/ml, oplossing voor injectie

Portugal Granissetrom Kabi

Romania Granisetron Kabi 1 mg/ml solutie injectabila

Sweden Granisetron Fresenius Kabi 1 mg/ml injektionsvätska, lösning

Slovakia Granisetron Kabi 1 mg/ml, injekcný roztok

United Kingdom Granisetron 1 mg/ml solution for injection

This leaflet was last revised inSeptember 2020

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

www.aemps.gob.es.”

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This information is intended only for healthcare professionals:

Instructions for dilution:

For single use. The unused quantity should be discarded.

The injections and infusions diluted should be inspected visually for particles before administration. They should only be used if the solution is clear and free of particles.

Adults:The contents of a 1 ml ampoule can be diluted up to a volume of 5 ml; the contents of a 3 ml ampoule can be diluted up to a volume of 15 ml.

Granisetron Kabi can also be diluted in 20 - 50 ml of compatible infusion fluid and administered over 5 minutes as an intravenous infusion in any of the following solutions:

Sodium chloride 0.9% p/v solution

Glucose 5% p/v solution

Ringer's lactate solution

No other diluents should be used.

Use in pediatric population

Children from 2 years of age or older:To prepare the dose of 10 - 40 μg/kg, the appropriate volume is withdrawn and diluted in an infusion fluid (as for adults) up to a total volume of 10 to 30 ml.

As a general precaution, Granisetron Kabi should not be mixed in the solution with other medicines.

Granisetron Kabi 1 mg/ml is compatible with Dexamethasone dihydrogen phosphate at a concentration of 10-60 µg/ml of Granisetron and 80-480 µg/ml of Dexamethasone phosphate diluted in Sodium chloride 0.9% or Glucose 5% solution for 24 hours.

Shelf life of the medicinal product:

3 years

Once the medicinal product is opened, it should be used immediately.

Ideally, intravenous infusions of Granisetron Kabi should be prepared at the time of administration. After dilution or when the container is first opened, the shelf life is 24 hours if stored at room temperature (25°C) under normal indoor lighting protected from direct sunlight. It should not be used after 24 hours. If it is to be stored after preparation, the infusions of Granisetron Kabi should be prepared under appropriate aseptic conditions.

Special precautions for storage

Store the ampoules in the outer packaging to protect from light. Do not freeze.

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

Online doctors for GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION

Discuss questions about GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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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)
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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.
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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

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
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  • food and medication allergies
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  • 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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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
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  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55
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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.

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€50

Frequently Asked Questions

Is a prescription required for GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION?
GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION?
The active ingredient in GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION is granisetron. This information helps identify medicines with the same composition but different brand names.
Who manufactures GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION?
GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION is manufactured by Fresenius Kabi España, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION 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 GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION 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 GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION?
Other medicines with the same active substance (granisetron) include GRANISETRON ALTAN 3 mg/50 ml SOLUTION FOR INFUSION, GRANISETRON AUROVITAS SPAIN 1 mg FILM-COATED TABLETS, GRANISETRON NORMON 1 mg/1 ml INJECTABLE SOLUTION. 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.
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