Инструкция по применению TOBRAMIKINA IBI
Содержание инструкции
Tobramicina Ibi 100 mg/2 ml injectable solution, 150 mg/2 ml injectable solution
Tobramicina sulfate
Generic medicine
Read this leaflet carefully before you start to use this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again
- If you have any questions, ask your doctor, pharmacist or nurse
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Tobramicina Ibi is and what it is used for
- 2. What you need to know before you use Tobramicina Ibi
- 3. How to use Tobramicina Ibi
- 4. Possible side effects
- 5. How to store Tobramicina Ibi
- 6. Contents of the pack and other information
1. What is Tobramicina Ibi and what is it used for
Tobramicina Ibi is an antibiotic (aminoglycoside) that is used for the treatment of
urinary tract infections, blood (septicemia), bones, skin, soft tissues,
gastrointestinal tract, central nervous system (meningitis) and bronchi and
lungs (lower respiratory tract), caused by microorganisms sensitive to the medicine. It is
considered a second-choice drug in infections from E. Coliand from Staphylococcus.
2. What you need to know before you take Tobramicina Ibi
Do not take Tobramicina Ibi
- If you are allergic to tobramycin or any of the other ingredients of this medicine (listed in section 6)
- If you are allergic to other antibiotics of the same type (aminoglycosides)
- If you are pregnant and breastfeeding
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Tobramicina Ibi.
If you or your family members have a mitochondrial mutation disease (a condition caused by
variants in the genome of the mitochondria, the parts of cells that contribute to producing
energy) or hearing loss due to taking antibiotic medicines, certain mitochondrial mutations may increase the risk of hearing loss with this product.
Tobramycin can have a harmful effect on the kidneys and the auditory nerve, so during
therapy the doctor will carefully monitor your health condition to avoid the onset of
such damage.
Harmful effects on the kidneys and hearing ability manifest mainly in patients
who have kidney function problems or who have developed reduced kidney function during the
taking of the drug or who have taken the drug at dosages that are too high
and for a period of time longer than recommended.
Effects on hearing can occur both during therapy and after the
end of treatment.
Harmful manifestations for the kidneys rarely occur in the first few days of therapy and
are generally reversible.
The doctor may ask you to undergo urine and blood tests to check the
kidney function and tests to check your hearing. Blood levels of tobramycin will also be checked
periodically.
The doctor will avoid administering tobramycin together with other medicines that can
damage the kidneys and hearing (in particular Amikacin, Streptomycin, Neomycin, Kanamycin,
Gentamicin and Paromomycin, Cephaloridine, Viomycin, Polymyxin B, Colistin, Cisplatin and
Vancomycin) or with medicines that increase urine flow (e.g. furosemide and ethacrinic acid).
Other neurotoxic manifestations include numbness, tingling
skin sensation, muscle spasms and convulsions.
If you have extensive burns, blood levels of tobramycin will be monitored to administer
the correct dose of medicine.
In case of anesthesia, inform the anesthesiologist that you are taking tobramycin.
Children
Tobramicina Ibi should be administered with caution in premature infants and in the
neonatal age due to the immaturity of the kidneys in these subjects.
Other medicines and Tobramicina Ibi
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
The simultaneous administration of drugs that increase urine production (diuretics such as furosemide and ethacrinic acid) should be avoided due to potential
damage to hearing.
The association of tobramycin with other antibiotics potentially harmful to hearing and to the
kidneys (such as some antibiotics such as streptomycin, kanamycin, gentamicin, cephaloridine,
polymyxin B and colistin) may lead to a summation of the harmful effects.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Tobramycin can cause harm to the fetus if administered during pregnancy.
In pregnant women and during breastfeeding, the product is contraindicated
as it can be toxic to the fetus and newborn.
Driving and using machines
Tobramicina Ibi has no effects on the ability to drive and use machines.
Tobramicina Ibi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodiumper dose, i.e. it is
essentially "sodium-free".
Tobramicina Ibi contains sodium metabisulfite
Rarely it may cause serious hypersensitivity reactions and bronchospasm.
3. How to take Tobramicina Ibi
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Paediatric population
Intramuscular administration
Children: the recommended dose is 3 to 5 mg/kg per day divided into equal doses every 8-12 hours.
Newborns: the recommended dose is 2 mg/kg every 12 hours, for subjects weighing between 1,500
and 2,500 grams
Adults
Intramuscular administration
In patients with normal renal function, the recommended dose of tobramycin is 1 mg/kg
every eight hours. The usual duration of treatment is 7-10 days. Doses up to 5 mg/kg per
day may be required by patients with very severe infections. This dosage should
be reduced to 3 mg/kg per day as soon as possible.
The doctor will adjust the dosage of the medicine if you have reduced kidney function.
Do not mix with other medicines in the same syringe.
Intravenous administration
Intravenous administration of tobramycin is recommended when intramuscular
administration is not possible.
For information regarding intravenous administration performed by healthcare professionals
Method of administration
Tobramicina can be administered intramuscularly and intravenously.
If you take more Tobramicina Ibi than you should
Immediately inform your doctor in case of overdose or adverse reactions.
If you forget to take Tobramicina Ibi
Do not take a double dose to make up for a missed dose.
If you stop taking Tobramicina Ibi
If you have any doubts about the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
While the risk of side effects is low in patients with normal kidney function,
when the duration of therapy is not prolonged and the recommended dosages are not exceeded,
it is higher in the elderly, in patients with reduced kidney function or in those
who are treated with higher doses than recommended.
Among the adverse reactions characteristic of this type of antibiotic, the following have been reported:
- dizziness
- involuntary eye movements (nystagmus)
- ringing in the ears
- hearing loss
- increased nitrogen concentration in the blood (azotemia)
- decreased normal daily urine output (oliguria).
Other adverse reactions probably attributable to tobramycin:
- decrease in red blood cells or hemoglobin, or both, in the blood (anemia)
- decrease in a type of white blood cells in the blood (granulocytopenia)
- decrease in platelets in the blood (thrombocytopenia)
- fever
- sudden and transient skin rashes (rash)
- itching
- urticaria
- nausea
- vomiting
- diarrhea
- headache
- deep sleep (lethargy)
- mental confusion and disorientation
- pain at the injection site.
The following may be reported with the use of tobramycin:
- increased values in the blood of certain liver enzymes (SGOT-SGPT)
- increased values in the blood of a muscle enzyme (lactate dehydrogenase)
- decreased calcium in the serum
- decreased magnesium value in the serum
- decreased sodium value in the serum
- decreased potassium value in the serum
- decreased number of white blood cells in the blood (leukopenia)
- increased number of white blood cells in the blood (leukocytosis)
- increased number of a certain type of white blood cells in the blood (eosinophilia).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Tobramicina Ibi
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 pack after
“Exp”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Tobramicina Ibi contains
Vial of 100 mg
- The active ingredient is tobramycin sulfate 152.4 mg (equivalent to tobramycin 100 mg)
- The other ingredients are: phenol, sodium metabisulfite, sodium edetate, water for injection.
Vial of 150 mg
- The active ingredient is tobramycin sulfate 228.6 mg (equivalent to tobramycin 150 mg)
- The other ingredients are: phenol, sodium metabisulfite, sodium edetate, water for injection.
Description of the appearance of Tobramicina Ibi and package contents
Injectable solution for intramuscular and intravenous use.
1 Vial of 100 mg/2 ml
1 Vial of 150 mg/2 ml
Marketing authorization holder and manufacturer
AIC Holder
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
Via Fossignano, 2 – 04011 Aprilia (LT)
e-mail: [email protected]
Manufacturer
Biologici Italia Laboratories S.r.l. – via F. Serpero, 2 – 20060 Masate (MI)
The following information is intended exclusively for doctors or healthcare
professionals
Tobramicina Ibi is compatible with most solvents for i.v. use currently
used but is not compatible with heparin solutions and may interact chemically with
β-lactam compounds.
Tobramicina Ibi is not compatible with infusion solutions containing alcohol, with
sargramostim and with clindamycin phosphate if diluted with injectable glucose solution.
Tobramicina Ibi is physically incompatible with carbenicillin
Extemporaneous combinations of tobramycin with other drugs are not recommended.
Intravenous administration:intravenous administration of
tobramycin is recommended when intramuscular administration is not possible. The concentration should not
usually exceed 1 mg of tobramycin per ml (0.1%) of solvent. For
intravenous administration in adults, dilute in 50-100 ml of physiological saline or 5% glucose and infuse for a period of 1-2 hours. In children, proportionally lower doses of
solvent are used.
The duration of administration should be 1-2 hours. The intravenous dosage is
equal to the intramuscular dosage.
The doctor will adjust the dosage of the medicine if renal function is reduced.
Do not mix with other drugs in the same intravenous line.
- Страна регистрации
- Форма выпускаInjectable solution, 100 MG/2 ML
- Код АТХJ01GB01
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги TOBRAMIKINA IBIФорма выпуска: Injectable solution, 100 MG/ 2 MLДействующее вещество: ТобрамицинПроизводитель: FISIOPHARMA S.R.L.Отпускается по рецептуФорма выпуска: Inhalation powder, hard capsule, 28 mgДействующее вещество: ТобрамицинПроизводитель: Viatris Healthcare LimitedОтпускается по рецептуФорма выпуска: Solution for nebulization, 300 MG/5 MLДействующее вещество: ТобрамицинПроизводитель: SUN PHARMACEUTICAL INDUSTRIES (EUROPE) B.V.Отпускается по рецепту
Аналоги TOBRAMIKINA IBI в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог TOBRAMIKINA IBI в Польша
Аналог TOBRAMIKINA IBI в Украина
Аналог TOBRAMIKINA IBI в Испания
Врачи онлайн по TOBRAMIKINA IBI
Обсудите применение TOBRAMIKINA IBI и возможные следующие шаги — по оценке врача.
Получите рецепт на TOBRAMIKINA IBI онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
TOBRAMIKINA IBI не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество TOBRAMIKINA IBI — Тобрамицин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
TOBRAMIKINA IBI производится компанией ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI S.P.A.. 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 TOBRAMIKINA IBI 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 TOBRAMIKINA IBI 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 (Тобрамицин) включают BRAMIKIL, TOBI PODALER, TOBRAMIKINA SUN. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















