ISORAM 4 % Инфузионный раствор
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Инструкция по применению ISORAM
Содержание инструкции
ISORAM 4%, solution for infusion
Amino acid solution
Read 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 questions, ask your doctor or nurse.
- If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.
Contents of this leaflet:
- 1. What ISORAM is and what it is used for
- 2. What you need to know before you use ISORAM
- 3. How to use ISORAM
- 4. Possible side effects
- 5. How to store ISORAM
- 6. Contents of the pack and other information
1. What is ISORAM and what is it used for
ISORAM contains amino acids (substances used by your body for protein production).
ISORAM is a solution for parenteral nutrition, meaning it is administered through a vein.
ISORAM is indicated in patients who:
- have undergone trauma or surgery (Mechanical trauma - Surgical trauma - Post-operative course - Septic states - Post-traumatic stress conditions in cirrhotic patients).
- suffer from a severe brain disease caused by a severe liver disease (Hepatic encephalopathy).
2. What you need to know before using ISORAM
Do not take ISORAM
- if you are allergic to amino acids or to any of the other ingredients of this medicine (listed in section 6).
- if you suffer from a congenital disease (present from birth) that does not allow for correct metabolism of amino acids
Warnings and precautions
Consult your doctor or nurse before using ISORAM.
When used in children under 2 years of age, the solution (in bottles and administration sets) must be protected from exposure to light until the administration is completed. Exposure of Isoram to ambient light, especially after the addition of trace elements and/or vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposure.
- Your doctor will subject you to frequent blood tests/checks during treatment.
- Inform your doctor if:
- - if you suffer from liver problems (hepatic insufficiency)
- - if you suffer from severe lung problems (pulmonary embolism) and heart problems, such as heart attack and heart failure
- - if fever, chills and reactions at the access site (where the infusion needle is inserted) occur during treatment.
Other medicines and ISORAM
Tell your doctor if you are taking, have recently taken or might take any other medicine.
No interactions are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before this medicine is administered to you.
Clinical data on the risk during pregnancy and breastfeeding are not available.
Your doctor will prescribe Isoram only if absolutely necessary.
Driving and operating machinery
Not applicable
3. How to use ISORAM
Dosage
The duration of treatment and the dose will be established by the doctor based on your following characteristics:
your age, your weight, your state of health and your nutritional status, your daily requirement
of nutrients
Method of administration
When used in children under 2 years of age, the solution (in bottles and administration sets) must be protected from light exposure until the completion of
administration (see section 2).
This medicine must be administered intravenously.
If you take more ISORAM than you should
In case of overdose, hypervolemia (increased fluid volume in the body),
electrolyte disturbances (altered salt levels in the blood), acidosis (altered blood pH),
and increased urea in the blood (azotemia) may occur. In this case, the doctor will subject you to specific laboratory
tests and institute appropriate therapy.
If you have any doubts about the use of this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the following side effects is not known (cannot be estimated from the available data).
Allergic reactions (anaphylactic and anaphylactoid reactions),
Urticaria
Headache,
Convulsions
Tachycardia (increased heart rate),
Cyanosis (bluish discoloration of the skin and mucous membranes)
Shock,
Hypotension (low blood pressure),
Hypertension (high blood pressure),
Breathing difficulties,
Hypoxia (oxygen deficiency),
Stridor (noisy breathing),
Dyspnea (difficulty breathing),
Sensation of constriction in the throat,
Hyperventilation (increased breathing rate),
Vomiting,
Nausea,
Oral paresthesia (tingling around the mouth),
Oropharyngeal pain (pain in the mouth and throat),
Abdominal pain
Hyperammonemia,
Hepatic failure, Hepatic cirrhosis, Hepatic fibrosis, Cholestasis, Hepatic steatosis, Cholecystitis, Cholelithiasis
(liver problems),
Rash (skin irritation),
Pruritus (itching),
Erythema (skin redness),
Arthralgia (joint pain),
Myalgia (muscle pain),
Thrombosis at the infusion site,
Phlebitis at the infusion site,
Pain at the infusion site,
Erythema (redness) at the infusion site,
Heat at the infusion site,
Swelling at the infusion site,
Induration at the infusion site,
Generalized edema (fluid retention),
Pyrexia (fever),
Chills,
Hot flashes,
Pallor,
Alteration of some blood tests (increased blood bilirubin, increased liver enzymes,
altered azotemia),
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. 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 ISORAM
When used in children under 2 years of age, the solution (in bottles and administration sets) must be protected from light exposure until the administration is completed (see section 2).
Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the label after Exp.
The expiry date refers to the last day of that month.
The expiry date stated on the packaging refers to the product in intact packaging, correctly stored.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What ISORAM contains
- The active ingredients in 1000 ml of solution are:L-Arginine 3.20 g L-Isoleucine 6.03 g L-Leucine 15.00 g L-Valine 18.21 g Total Amino Acids 42.44 g/l Total Nitrogen 5.45 g/l Total theoretical Osmolarity 353 mOsm/l Acetates (as HCO) 19 mEq/l pH (corrected with glacial Acetic Acid) 5.5 - 7.0
- The other component is water for injections
Description of the appearance of ISORAM and contents of the pack
ISORAM is presented as an infusion solution in a 500 ml bottle.
The following pack is available:
20 bottles 500 ml
Marketing Authorisation Holder and Manufacturer
BAXTER S.p.A.
Via del Serafico 89
- 00142 - Rome
Manufacturer
Bieffe Medital S.p.A.
Via Nuova Provinciale
23034 Grosotto (So)
---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for doctors or healthcare professionals:
Dosage and Administration
The start and duration of parenteral nutrition, as well as the dosage (dose and frequency of
administration) depend on the following patient characteristics:
- age, weight, clinical condition,
- nitrogen requirement,
- ability to metabolize the constituents of Isoram,
- daily protein requirement and supplementary nutrition that can be provided via parenteral and/or enteral route. Since Isoram is a product to be used in the context of a metabolic resuscitation or nutrition program, it should rarely be used without a caloric support and the indicated dosages should be considered indicative, and may vary considerably depending on how many calories are administered and the caloric source. Generally, the indicated dosages assume a concomitant caloric intake of at least 20-25 Cal/Kg/day. Hepatic encephalopathy1-2 bottles of 500 ml for intravenous infusion, corresponding to 500 - 1000 ml of solution. Other indicationsThe solution should be used, unless there are particular clinical conditions, in association with other amino acid solutions; in this case, the recommended dosage is 1-3 bottles of 250 ml, corresponding to 250 - 750 ml of solution. Daily administration is recommended, unless otherwise advised by a doctor; however, the most rational way to use the product is continuous infusion of the product 24 hours a day. If used for intermittent administration, a single bottle or bag of 500 ml should be infused over a time not less than 4 hours (infusion rate equal to 30 drops/minute). Administration should be continued as long as there is a need for nutritional or metabolic support for the patient.
Method of administration
Isoram is intended for intravenous use. The preferred method is central venous infusion, but peripheral
infusion is also possible.
The osmolarity of a specific infusion solution must be taken into consideration when
considering peripheral administration.
The flow rate must be adjusted taking into account the dose administered, the daily volumetric
intake and the duration of the infusion.
Special populations
Children
The safety and efficacy of Isoram in children has not been established.
Elderly
The dosage must be established with caution, as it must take into account a possible reduction in
cardiac, renal or hepatic function, concomitant diseases or pharmacological therapies.
Patients with renal insufficiency
Administer with caution as nitrogen tolerance may be altered and it may be necessary to adjust the
dosage. In these patients, fluid and electrolyte balance must be carefully
monitored.
Patients with impaired liver function
Amino acid solutions should be used with caution in patients with pre-existing liver disease or
hepatic insufficiency. Careful monitoring is necessary to identify possible symptoms of
hyperammonemia.
Incompatibilities
Additives may be incompatible with Isoram.
Excessive addition of calcium and phosphate increases the risk of calcium phosphate precipitation.
Special precautions for disposal and handling
Confirm the integrity of the container. Use only if the container is undamaged and if the solution
is clear and colorless or slightly yellow.
Following temperature fluctuations, amino acid crystals may form on the neck of the bottle.
In this case, before administering the solution, vigorously shake the
solution and possibly heat in a water bath at 37°C until the crystals are completely dissolved.
When used in children under 2 years of age, the solution (in bottles and administration sets) must be protected from exposure to light until the administration is completed.
Special warnings and precautions for use:
Exposure to light of solutions for parenteral intravenous nutrition, especially after
the addition of trace elements and/or vitamins, can cause the generation of peroxides and other degradation products. When used in children under 2 years of age, Isoram must be protected from
ambient light until the administration is completed.
- Ensure that the solution reaches room temperature before use
- Observe aseptic conditions
- For single use only.
- Do not reconnect partially used infusions.
- Inspect the final solution to check for changes in color and particles.
- Do not connect containers in series to avoid gaseous embolism due to possible residual air contained in the primary container.
Special precautions for disposal and handling:
When used in children under 2 years of age, protect from exposure to light until
completion of administration. Exposure of Isoram to ambient light, especially after
the addition of trace elements and/or vitamins, generates peroxides and other degradation products that can
be reduced by protecting from exposure to light.
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- Страна регистрации
- Форма выпускаInfusion solution, 4 %
- Код АТХB05BA01
- 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 ISORAMФорма выпуска: Infusion solution, 500 MLДействующее вещество: аминокислотыПроизводитель: MONICO S.P.A.Отпускается по рецептуФорма выпуска: Infusion solution, 4 G/100 MLДействующее вещество: аминокислотыПроизводитель: INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.Отпускается по рецептуФорма выпуска: Infusion solution, 500 MLДействующее вещество: аминокислотыПроизводитель: BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI S.P.A.Отпускается по рецепту
Аналоги ISORAM в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог ISORAM в Польша
Аналог ISORAM в Украина
Аналог ISORAM в Испания
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
ISORAM требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ISORAM — аминокислоты. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ISORAM производится компанией BAXTER 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 ISORAM 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 ISORAM 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 (аминокислоты) включают AMINOAKIDI A KATENA RAMIFIKATA MONIKO, AMINOAKIDI A KATENA RAMIFIKATA, AMINOAKIDI KR BIOINDUSTRIA L.I.M.. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
