FETCROJA 1 Г Порошок для концентрата для инфузионного раствора
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Инструкция по применению FETKROJA
Содержание инструкции
Fetcroja 1 g powder for concentrate for solution for infusion
cefiderocol
Read this leaflet carefully before you receive this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet
- 1. What Fetcroja is and what it is used for
- 2. What you need to know before you receive Fetcroja
- 3. How Fetcroja is used
- 4. Possible side effects
- 5. How to store Fetcroja
- 6. Contents of the pack and other information
1. What is Fetcroja and what is it used for
Fetcroja contains the active ingredient cefiderocol, an antibiotic medicine that belongs to a group
of antibiotics called cephalosporins. Antibiotics help to fight bacteria that cause
infections.
Fetcroja is used in adults for the treatment of infections caused by certain types of bacteria
when other antibiotics cannot be used.
2. What you need to know before you receive 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 antibioticsin the past, such as penicillins or carbapenems. This may include severe skin peeling, swelling of the hands, face, feet, lips, tongue or throat, or difficulty swallowing or breathing. ➔ Tell your doctorif this applies to you.
Warnings and precautions
Talk to your doctor or nurse before you receive Fetcroja:
- if you have ever had an allergic reaction to other antibiotics. See also the section above “Do not use Fetcroja”;
- if you have kidney problems. Your doctor will adjust the dose to make sure you do not receive too much or too little medicine;
- if you suffer from diarrhoeaduring treatment;
- if you have ever had seizures. ➔ Talk to your doctor or nursebefore you receive Fetcroja.
New infection
Even though Fetcroja can fight some bacteria, there is a possibility that a different infection, caused by another organism, may develop during or after treatment.
Your doctor will monitor you closely to detect any new infections and will give you another treatment if
necessary.
Blood/laboratory tests
Tell your doctor that you are receiving treatment with Fetcroja if you need to have blood/laboratory tests, because they may give abnormal results. A test called “Coombs’ test” looks for antibodies that can destroy red blood cells or that may be affected by your body’s response to Fetcroja. Fetcroja can also produce
false positive results in urine tests using dipsticks (protein in urine or markers for
diabetes).
Children and adolescents
Fetcroja must not be given to children and adolescents under 18 years of age, because it is not
known whether use of the medicine is safe 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, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before receiving 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 total daily dose is
2.1 g, slightly above the maximum recommended daily intake by the WHO which
corresponds to 2 g of sodium for an adult. Talk to your doctor before receiving Fetcroja if you are following
a low-sodium diet.
3. How Fetcroja is used
The doctor or nurse will administer this medicine to you via an infusion (an intravenous drip) into a
vein over 3 hours, three times a day. The usual recommended dose is 2 g.
The number of days you will receive treatment with Fetcroja depends on the type of infection and how
the infection progresses.
If you experience pain at the site where the Fetcroja infusion enters the vein, inform your doctor or
nurse.
People with kidney problems
If you have kidney problems, consult your doctor before receiving Fetcroja. The doctor will adjust the dose of
Fetcroja.
If you receive more Fetcroja than you should
Fetcroja will be administered by a doctor or nurse, so it is unlikely that you will receive
an incorrect dose. Immediately inform your doctor or nurse if you believe you have been
given an excessive dose of Fetcroja.
If you miss a dose of Fetcroja
If you think you have not been given a dose of Fetcroja, immediately inform your doctor or
nurse.
If you have any doubts about the use of this medicine, ask your doctor or nurse.
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 – urgent medical treatment may be needed:
- severe allergic reaction- signs include sudden swelling of the lips, face, throat or tongue; severe skin rash or other serious skin reactions; difficulty swallowing or breathing. This reaction can be life-threatening;
- diarrhoeathat gets worse or does not go away, or presence of blood or mucus in your stools. This can happen during treatment or after it has stopped. If this happens, do not take medicines that stop or slow down bowel movements. ➔ tell your doctorimmediately if you notice any of the serious side effects described above.
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)
- Feeling sick (nausea) or being sick (vomiting)
- Swelling, redness and/or pain around the area where the needle was inserted for giving the medicine into a vein
- Yeast infections, such as thrush
- Increased levels of liver enzymes, shown in blood tests
- Cough
- Skin rash, with small bumps
- Serious bowel infection, known as Clostridioides difficilecolitis. Symptoms include watery diarrhoea, stomach pain, fever, etc.
- Increased creatinine values in the blood
Uncommon
( may affect up to 1 in 100 people)
- Increased urea values in the blood
- Allergy to Fetcroja
Not known
(the frequency cannot be estimated from the available data)
- Reduced number of specific white blood cells (neutrophils)
- Abnormal urine colour (chromaturia)
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store 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
refers to the last day of that month.
Store the intact vials in a refrigerator (2°C – 8°C).
Store in the original package to protect the medicine from light.
6. Contents of the pack and other information
What Fetcroja contains
- The active ingredient is cefiderocol tosylate sulfate, equivalent to 1 g of cefiderocol.
- The other ingredients are sucrose, sodium chloride and sodium hydroxide.
Description of the appearance of Fetcroja and contents of the pack
Fetcroja is a powder for concentrate for solution for infusion, of a colour from white to off-white,
contained 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 on 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./ Teл./ Tlf./ Tél/ Puh/
Sími/ Τηλ:
+31 (0)20 703 8327
[email protected]
Deutschland
Shionogi GmbH
Tel: + 49 (0)30 2062980 66
[email protected]
España
Shionogi SLU
Tel: + 34 911 239 258
[email protected]
Italia
Shionogi Srl
Tel: + 39 06 94 805 118
[email protected]
France
Shionogi SAS
Tel: +33 (0) 186655806
[email protected]
Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/
---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:
Each vial is for single use only.
The powder must be reconstituted with 10 mL of sodium chloride 9 mg/mL (0.9%) injectable solution
or 5% dextrose injectable solution taken from 100 mL bags which will be used to
prepare the final infusion solution and must be gently swirled for dissolution. The
vial or vials must remain in an upright position 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 (attention: the reconstituted solution is not intended for
direct injection).
To prepare the required doses, the appropriate volume of reconstituted solution must be withdrawn from
the vial or vials as described in the following table. Add the withdrawn volume to the bag for
infusion containing the remainder of the 100 mL of sodium chloride 9 mg/mL (0.9%) injectable solution,
or 5% dextrose injectable solution, visually inspect the diluted medicine solution in the infusion bag
for the presence of particulate matter and colour change before use. Do not use solutions whose colour has
changed or solutions with visible particles.
Preparation of cefiderocol doses
| Dose of cefiderocol | Number of cefiderocol 1 g vials to be reconstituted | a Volume to be withdrawn from the reconstituted vial or vials n | Total volume of cefiderocol solution required for further dilution in at least 100 mL of sodium chloride 0.9% solution or dextrose 5% solution |
| 2 g | 2 vials | a 11.2 mL (entire contents) from both vials | 22.4 mL |
| 1.5 g | 2 vials | i l 11.2 mL (entire contents) from the first vial AND 5.6 mL from the second vial | 16.8 mL |
| 1 g | 1 vial | a 11.2 mL (entire contents) | 11.2 mL |
| 0.75 g | t 1 vial | 8.4 mL | 8.4 mL |
Standard aseptic techniques must be used for the preparation and administration of the solution.
This medicine must not be mixed with other medicines except for those mentioned in
the preceding paragraph. If treatment with a combination of another medicine and Fetcroja
is unavoidable, administration must not take place in the same syringe or the same infusion
solution. It is recommended to flush the intravenous lines thoroughly between administrations of
different medicines.
Unused medicine and waste derived from such medicine must be disposed of in accordance
with current local regulations.
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- Страна регистрации
- Форма выпускаPowder for concentrate for infusion solution, 1 G
- Код АТХJ01DI04
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги FETKROJAФорма выпуска: Powder for concentrate and solution for infusion, 600 MGДействующее вещество: Цефтаролин фосамилПроизводитель: QILU PHARMA SPAIN S.L.Отпускается по рецептуФорма выпуска: Powder and solvent for injectable solution, 500 MGДействующее вещество: ceftobiprole medocarilПроизводитель: ADVANZ PHARMA LIMITEDОтпускается по рецептуФорма выпуска: Powder for intravenous infusion solution, 600 MGДействующее вещество: Цефтаролин фосамилПроизводитель: PFIZER IRELAND PHARMACEUTICALSОтпускается по рецепту
Аналоги FETKROJA в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог FETKROJA в Испания
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
FETKROJA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество FETKROJA — cefiderocol. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
FETKROJA производится компанией SHIONOGI BV. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения FETKROJA с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить FETKROJA в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (cefiderocol) включают KEFTAROLINA FOSAMIL QILU, MABELIO, TSINFORO. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
