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FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION

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About the medicine

How to use FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION

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.

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Introduction

Package Leaflet: Information for the User

Fetcroja 1 g powder for concentrate for solution for infusion

cefiderocol

Read all of this leaflet carefully before you are given 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 nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Fetcroja and what is it used for

Fetcroja contains the active substance cefiderocol. It is an antibiotic that belongs to a group of antibiotics called cephalosporins. Antibiotics help fight bacteria that cause infections.

Fetcroja is used in adults to treat infections caused by certain types of bacteria when other antibiotics cannot be used.

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 are given Fetcroja

Do not use Fetcroja

  • if you are allergic to cefiderocolor to any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to other antibioticsknown as cephalosporins;
  • if you have had a severe allergic reaction to certain antibiotics,such as penicillins or carbapenems. This can include severe skin peeling; swelling of the hands, face, feet, lips, tongue or throat; or difficulty swallowing or breathing.
  • Tell your doctorif any of these points apply to you.

Warnings and precautions

Talk to your doctor or nurse before you are given Fetcroja:

  • if you have ever had an allergic reaction to other antibiotics.See also the previous section «Do not use Fetcroja»;
  • if you have kidney problems.Your doctor will adjust your dose to make sure you do not receive too much or too little medicine;
  • if you get diarrheaduring your treatment;
  • if you have ever had seizures.
  • Talk to your doctor or nursebefore you are given Fetcroja.

New infection

Although Fetcroja can combat certain bacteria, there is a possibility that you may get a different infection caused by another microorganism during or after treatment. Your doctor will closely monitor you for any new infection and give you another treatment if necessary.

Blood/laboratory tests

If you need to have any blood/laboratory tests, tell your doctor that you are taking Fetcroja, as you may get an abnormal result. With a test called «Coombs test», the presence of antibodies that can destroy red blood cells or that can be affected by your immune system's response to Fetcroja is sought. Fetcroja can also produce false positive results in urine tests with test strips (proteins in urine or diabetes markers).

Children and adolescents

Fetcroja must not be given to children and adolescents under 18 years of age, as it is not known if it is safe to use the medicine in these age groups.

Other medicines and Fetcroja

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

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 you are given this medicine.

Driving and using machines

Fetcroja does not affect your ability to drive or use machines.

Fetcroja contains sodium

This medicine contains 7.64 mmol (176 mg) of sodium per vial. The daily dose is 2.1 g, just above the maximum daily intake of 2 g of sodium recommended by the WHO for an adult. Talk to your doctor before you are given Fetcroja if you are on a low-sodium diet.

3. How to use Fetcroja

Your doctor or nurse will give you this medicine by infusion (drip) into a vein over 3 hours, 3 times a day. The recommended dose is 2 g.

The number of days you will receive treatment with Fetcroja depends on the type of infection you have and how the infection is going.

If you feel pain at the site where Fetcroja is being administered to your vein, tell your doctor or nurse.

People with kidney problems

If you have kidney problems, talk to your doctor before you are given Fetcroja. Your doctor will adjust your dose of Fetcroja.

If you are given too much Fetcroja

A doctor or nurse will give you Fetcroja, so it is unlikely that you will be given the wrong dose. If you think you have been given too much Fetcroja, tell your doctor or nurse immediately.

If you miss a dose of Fetcroja

If you think you have missed a dose of Fetcroja, tell your doctor or nurse immediately.

If you have any other questions about the use of this medicine, ask your doctor or nurse.

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.

Serious side effects

Tell your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

  • Severe allergic reaction: signs include sudden swelling of the lips, face, throat or tongue; a severe skin rash or other severe skin reactions; difficulty swallowing or breathing. This reaction can be life-threatening.
  • Diarrhea that gets worse or does not go away, or stools that contain blood or mucus. This can happen during treatment or after stopping treatment. If this happens, do not take medicines that slow down or stop bowel movements.
  • Tell your doctorimmediately if you notice any of the above serious side effects.

Other side effects

Tell your doctor or nurse if you notice any of the following side effects.

Common

(may affect up to 1 in 10 people)

  • Nausea or vomiting.
  • Swelling, redness and/or pain around the needle where the medicine is administered into a vein.
  • Fungal infections, e.g. candidiasis.
  • Increased levels of liver enzymes; seen in blood tests.
  • Cough.
  • Rash with small bumps.
  • Severe intestinal infection called Clostridioides difficilecolitis. Symptoms include watery diarrhea, abdominal pain, fever, etc.
  • Increased creatinine in blood.

Uncommon

(may affect up to 1 in 100 people)

  • Increased urea in blood.
  • Allergy to Fetcroja.

Frequency not known

(frequency cannot be estimated from the available data)

  • Decreased number of certain white blood cells (neutrophil granulocytes).
  • Discoloration of urine (chromaturia).

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fetcroja

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 label. The expiry date is the last day of the month stated.

Store the vials in a refrigerator (between 2°C and 8°C).

Store in the original packaging to protect from light.

6. Contents of the pack and other information

What Fetcroja contains

  • The active substance is cefiderocol sulfate tosylate, equivalent to 1 g of cefiderocol.
  • The other excipients are sucrose, sodium chloride, and sodium hydroxide.

Appearance and packaging

Fetcroja is a white to off-white powder for concentrate for solution for infusion in a vial. It is available in packs of 10 vials.

Marketing authorisation holder and manufacturer

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

For further information about this medicine, contact the local representative of the marketing authorisation holder:

AT, BE, BG, CY, CZ, DK, EE, EL, FI, HR, HU, IE, IS, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK

Shionogi B.V. Tel/Tel./ Te?./ Tlf./ Tél/ Puh/ Sími/ Τηλ:

+31 (0)20 703 8327

[email protected]

Germany

Shionogi GmbH

Tel: + 49 (0)30 2062980 66

[email protected]

Spain

Shionogi SLU

Tel: + 34 911 239 258

[email protected]

Italy

Shionogi Srl

Tel: + 39 06 94 805 118

[email protected]

France

Shionogi SAS

Tel: +33 (0) 186655806

[email protected]

Date of last revision of this leaflet: 01/2025

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

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This information is intended only for healthcare professionals:

Each vial is for single use only.

The powder should be reconstituted with 10 ml of sodium chloride 9 mg/ml (0.9%) injection solution or 5% glucose injection solution, which is drawn from 100 ml bags that will be used to prepare the final infusion solution, and the vials should be gently shaken to dissolve the powder. The vials should be left to stand until the foam generated on the surface disappears (usually within 2 minutes). The final volume of the reconstituted solution in the vial will be approximately 11.2 ml (warning: the reconstituted solution must not be injected directly).

To prepare the required doses, the appropriate volume of reconstituted solution should be withdrawn from the vial according to the table below. Add the withdrawn volume to the infusion bag containing the remaining 100 ml of sodium chloride 9 mg/ml (0.9%) injection solution or 5% glucose injection solution, visually inspect the resulting solution with the diluted medicine in the infusion bag for particles or color change before use. Do not use solutions that have changed color or have visible particles.

Preparation of cefiderocol doses

Dose of

Number of vials of

Volume to be

Total volume of cefiderocol

cefiderocol

1 g of cefiderocol

withdrawn from the vials

solution needed for further dilution

to be reconstituted

in at least 100 ml of

sodium chloride 0.9% injection solution

or 5% glucose injection solution

2 g

2 vials

11.2 ml (complete contents) of both vials

22.4 ml

1.5 g

2 vials

11.2 ml (complete contents) of the first vial and 5.6 ml of the second vial

16.8 ml

1 g

1 vial

11.2 ml (complete contents)

11.2 ml

0.75 g

1 vial

8.4 ml

8.4 ml

Standard aseptic techniques should be followed to prepare and administer the solution.

This medicine should not be mixed with other medicines except for those mentioned above in this section. If it is not possible to avoid combined treatment with another medicine and Fetcroja, administration should not be in the same syringe or infusion solution. It is recommended to properly clean the intravenous lines between the administration of different medicines.

Disposal of unused medicine and all materials that have come into contact with it should be in accordance with local regulations.

Online doctors for FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION

Discuss questions about FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
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
  • 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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€80
5.0 (140)
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
0.0 (0)
Doctor

Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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€55
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.

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Frequently Asked Questions

Is a prescription required for FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION?
FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION 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 FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION?
The active ingredient in FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION is cefiderocol. This information helps identify medicines with the same composition but different brand names.
Who manufactures FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION?
FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION is manufactured by Shionogi B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION 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 FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION 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 FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION?
Other medicines with the same active substance (cefiderocol) include CEFTAROLINA FOSAMILO QILU 600 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION, ZERBAXA 1 g/0.5 g POWDER FOR CONCENTRATE FOR INFUSION SOLUTION, ZEVTERA 500 mg POWDER FOR CONCENTRATE FOR INFUSION 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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