BASALFLEX 1000 ML Инфузионный раствор
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Инструкция по применению BASALFLEX
Содержание инструкции
- What you need to know before using Basalflex
- How to use Basalflex
- Possible side effects
- How to store Basalflex
- Contents of the pack and other information
Basalflex, solution for infusion
Amino acids/glucose/electrolytes
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 or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
- 1. What Basalflex is and what it is used for
- 2. Before you use Basalflex
- 3. How to use Basalflex
- 4. Possible side effects
- 5. How to store Basalflex
- 6. Contents of the pack and other information
- 1. What Basalflex is and what it is used forThe product contains nutrients called amino acids, salts (electrolytes) and glucose, which are essential for the body for growth or healing, and calories in the form of carbohydrates.
This product is administered into a vein (infusion) because you are unable to eat
sufficiently or cannot be fed through a tube.
Basalflex is specifically indicated for patients in a mild to moderate catabolic state, a condition
in which patients burn their energy reserves, proteins, etc. faster than they can
replenish them.
2. What you need to know before using Basalflex
Do not use Basalflex
- if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from a congenital error of amino acid metabolism and need to follow a specific protein diet
- if you have very high blood sugar levels that require more than 6 units of insulin per hour to keep under control;
- if you have too high levels of acidic substances in the blood (acidosis)
- if you have bleeding in the brain or spinal cord;
- if you suffer from severe liver failure (severe hepatic insufficiency)
- if you suffer from severe kidney failure (severe renal insufficiency) without resorting to artificial kidney treatment (hemofiltration or dialysis)
Like other medicines of the same type, Basalflex should not be administered in case of:
- heart attack (myocardial infarction) in an acute phase or stroke
- any poorly controlled metabolic disorder, such as unconsciousness (coma) of unknown origin or insufficient oxygen supply to the tissues or decompensated diabetes mellitus
- potentially life-threatening disorders of blood circulation, such as those that can occur, for example, in case of collapse or shock, fluid accumulation in the lungs (pulmonary edema) or disturbances of the fluid balance
Basalflex should not be administered to newborns, infants and children under two years of age.
Warnings and precautions
Consult a healthcare professional before using Basalflex
- if you have impaired heart or kidney function
- if you have fluid or electrolyte imbalances or acid-base imbalances, such as low fluid and salt content in the body (hypotonic dehydration) or low levels of sodium or potassium in the blood
- if you have blood sugar levels that are too high.
Your daily dose will be established and monitored with particular caution in case of disorders of the
function of the kidneys, liver, adrenal glands, heart or lungs.
The doctor will also use particular caution in case of damage to the blood-brain barrier, because
this medicine may cause an increase in pressure inside the skull or spinal cord.
If you are in a state of severe malnutrition, intravenous nutrition will be carried out gradually with
particular caution, with adequate monitoring and with the necessary supply of electrolytes, in particular potassium,
magnesium and phosphate.
This medicine contains glucose (a sugar) and may therefore affect blood sugar levels. It is possible
that blood samples may need to be taken to verify this.
If the infusion is accidentally interrupted suddenly, blood sugar levels may also drop
sharply.
The doctor will take this into particular account if your ability to metabolize glucose is reduced (e.g.
if you suffer from diabetes) or when the solution is administered to children under 3 years of age. Therefore, the
blood sugar will be carefully monitored especially after the infusion is stopped.
Therefore, blood sugar must be carefully monitored especially after the infusion is stopped.
In addition, monitoring of blood electrolyte levels, fluid balance, acid-base balance and, in case of long-term administration, blood cell count, coagulation and kidney and liver function are necessary.
The doctor will ensure that your fluid and electrolyte needs are met. In addition to Basalflex,
you will receive other nutrients (food) to fully meet your needs.
As with all intravenous solutions, strict aseptic precautions must be observed for the infusion of Basalflex.
Children and adolescents
In the event of a sudden drop in your child's blood sugar following the sudden interruption
of the infusion, also refer to the previous section “Warnings and precautions”.
The doctor will not administer Basalflex to children under two years of age.
Other medicines and Basalflex
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Basalflex can interact with other medicines. Tell your doctor if you are taking any of the following
medicines:
- medicines used to treat inflammation (corticosteroids);
- hormonal preparations that affect fluid balance (adrenocorticotropic hormone [ACTH]);
- medicines that promote urine flow, such as spironolactone, triamterene or amiloride;
- medicines used to treat high blood pressure (ACE inhibitors), such as captopril and enalapril
- medicines used to treat high blood pressure or heart problems (angiotensin II receptor antagonists), such as losartan and valsartan
- medicines used in organ transplantation, such as cyclosporine and tacrolimus. Pregnancy, breastfeeding and fertilityIf you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, you will only receive this medicine if your doctor considers it absolutely
necessary for your recovery.
Breastfeeding
Breastfeeding is not recommended if the woman needs intravenous nutrition.
Fertility
No data are available.
Driving and operating machinery
This medicine is usually administered to immobilized patients, for example in hospital or clinic.
This condition excludes driving and operating machinery. However, the medicine itself does not
alter the ability to drive or operate machinery.
3. How to use Basalflex
This medicine will be administered to you by intravenous infusion (drip), i.e. through a
small cannula inserted directly into a large vein.
The solution must always be brought to room temperature before infusion.
The doctor will determine the amount of medicine you need and the duration of treatment.
The recommended daily dose for adults is up to 40 mL of infusion solution per kg of body
weight. The doctor will determine the exact dose.
Use in children and adolescents
There are special dosage criteria for children and adolescents aged between 2 and 17 years. The doctor
will determine the dose based on these criteria.
If you receive more Basalflex than you should
With correct administration, it is unlikely that you will receive an excessive dose of this medicine.
However, if you receive an excessive amount, the following effects may occur:
- too high levels of body fluids (overhydration)
- excessively high amount of urine (polyuria)
- disturbances in the composition of salts in the body (electrolyte imbalances)
- water in the lungs (pulmonary edema)
- loss of amino acids in the urine and disturbances in amino acid balance
- accumulation of acidic substances in the blood (metabolic acidosis)
- malaise, vomiting, chills, headache
- high levels of nitrogen in the blood (hyperammonemia)
- blood glucose levels too high (hyperglycemia)
- glucose in the urine (glycosuria)
- lack of fluids (dehydration)
- blood concentration much higher than normal (hyperosmolality)
- state of unconsciousness due to extremely high blood sugar (hyperglycemic-hyperosmolar coma). If any of these symptoms occur, the infusion will be stopped immediately. The doctor will determine the additional treatment you will need to receive. The infusion will not be resumed until your condition has improved.
If you have any questions about the use of this medicine, ask your healthcare professional.
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4. Possible side effects
Like all medicines, Basalflex can cause side effects, although not everybody gets them.
Side effects are mainly due to an overdose or too rapid infusion, and generally
disappear at the end of the infusion.
Rare (may affect up to 1 in 1,000 people).
- Feeling unwell (Nausea), vomiting and loss of appetite.
If these side effects occur, treatment should be discontinued, or the doctor may
decide to continue it at lower doses.
Reporting of side effects
If any of the side effects gets worse, or if you notice any side effects,
including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects
you can help provide more information on the safety of this medicine.
5. How to store Basalflex
Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Keep the bag in the outer packaging to protect the medicine from light.
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.
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6. Contents of the pack and other information
What Basalflex contains
- The active ingredients are amino acids, glucose and electrolytes. After mixing, each bag contains:
|
| |
| Isoleucine | 1.88 g | 3.76 g |
| Leucine | 2.50 g | 5.00 g |
| Lysine hydrochloride equivalent to lysine | 2.27 g 1.82 g | 4.54 g 3.64 g |
| Methionine | 1.56 g | 3.12 g |
| Phenylalanine | 2.81 g | 5.62 g |
| Threonine | 1.45 g | 2.90 g |
| Tryptophan | 0.46 g | 0.92 g |
| Valine | 2.08 g | 4.16 g |
| Arginine monoglutamate equivalent to arginine equivalent to glutamic acid | 3.98 g 2.16 g 1.82 g | 7.96 g 4.32 g 3.64 g |
| Histidine hydrochloride monohydrate equivalent to histidine | 1.35 g 1.00 g | 2.70 g 2.00 g |
| Alanine | 3.88 g | 7.76 g |
| Aspartic acid | 1.20 g | 2.40 g |
| Glutamic acid | 0.98 g | 1.96 g |
| Glycine | 1.32 g | 2.64 g |
| Proline | 2.72 g | 5.44 g |
| Serine | 2.40 g | 4.80 g |
| Magnesium acetate tetrahydrate | 1.23 g | 2.46 g |
| Sodium acetate trihydrate | 3.20 g | 6.40 g |
| Potassium dihydrogen phosphate | 1.74 g | 3.48 g |
| Potassium hydroxide | 0.96 g | 1.92 g |
| Sodium hydroxide | 0.10 g | 0.20 g |
| Glucose monohydrate equivalent to glucose | 137.5 g 125.0 g | 275.0 g 250.0 g |
| Sodium chloride | 1.40 g | 2.80 g |
| Calcium chloride dihydrate | 0.53 g | 1.06 g |
- Other ingredients are citric acid monohydrate and water for injections.
| Electrolytes |
|
|
| Sodium | 49.9 mmol | 99.8 mmol |
| Potassium | 30.0 mmol | 60.0 mmol |
| Calcium | 3.6 mmol | 7.2 mmol |
| Magnesium | 5.7 mmol | 11.4 mmol |
| Chloride | 50.0 mmol | 100.0 mmol |
| Phosphate | 12.8 mmol | 25.6 mmol |
| Acetate | 35.0 mmol | 70.0 mmol |
|
| |
| Amino acid content | 32 g | 64 g |
| Nitrogen content | 4.6 g | 9.2 g |
| Carbohydrate content | 125 g | 250 g |
|
| |
| Energy supply in the form of amino acids [kJ (kcal)] | 536 (128) | 1.071 (256) |
| Energy supply in the form of carbohydrates [kJ (kcal)] | 2.092 (500) | 4.184 (1.000) |
| Total energy supply [kJ (kcal)] | 2.628 (628) | 5.255 (1.256) |
| Theoretical osmolarity [mOsm/L] | 1.150 | 1.150 |
| pH | 4.8 – 6.0 | 4.8 – 6.0 |
Description of the appearance of Basalflex and contents of the pack
This medicine is a solution for infusion to be administered directly into a vein through a
small cannula.
Basalflex is supplied in a two-compartment infusion bag. The lower compartment contains
glucose, while the upper compartment contains the amino acid solution. The glucose and
amino acid solutions are clear and colourless or slightly yellowish.
The product is supplied in plastic bags with two compartments containing:
- 1.000 ml (400 ml of amino acid solution + 600 ml of glucose solution)
- 2.000 ml (800 ml of amino acid solution + 1.200 ml of glucose solution) Pack sizes: 5×1.000 ml, 5×2.000 ml Not all pack sizes may be marketed. Marketing authorisation holder and manufacturer
- B. Braun Melsungen AG Carl-Braun-Straße 1 Postal address 34212 Melsungen, Germany 34209 Melsungen, Germany Tel.: +49-5661-71-0 Fax: +49-5661-71-4567
_______________________________________________________________________________________
The following information is intended exclusively for doctors or healthcare professionals:
The solution must always be brought to room temperature before infusion.
Use Basalflex only if the solution is clear and the bag is intact. After the infusion, any residual
solution must never be stored for future use.
Preparation of the mixture
Immediately before use, the internal septum separating the two compartments must be opened to
allow aseptic mixing of the components.
Remove the bag from the protective bag and proceed as follows:
- Spread out the bag and place it on a rigid surface.
- Open the septum by pressing with both hands.
- Briefly mix the contents of the bag. An additional connector allows the addition of supplements to Basalflex. Strict aseptic precautions must be observed when adding other solutions or lipid emulsions to Basalflex. Lipid emulsions can be easily added using a specific transfer set.
Maximum infusion rate
The maximum infusion rate for adults, children and adolescents aged between 2 and 17 years is
2.0 mL per kg of body weight per hour.
Storage after mixing the contents
Basalflex should be administered preferably immediately after mixing the two solutions, but if immediate
administration is not possible, under certain circumstances it can be stored for a
maximum of 7 days at room temperature and for a maximum of 14 days in a refrigerator at 2 - 8 °C
(including the time of administration). Partially used containers must not be
stored for future use.
- Страна регистрации
- Форма выпускаInfusion solution, 1000 ML
- Код АТХB05BA10
- 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 BASALFLEXФорма выпуска: Infusion solution, 10%Действующее вещество: combinationsПроизводитель: B. BRAUN MELSUNGEN AGОтпускается по рецептуФорма выпуска: Infusion solution, 1000 MLДействующее вещество: combinationsПроизводитель: BAXTER S.P.A.Отпускается по рецептуФорма выпуска: Emulsion for intravenous infusion, 1085 MLДействующее вещество: combinationsПроизводитель: BAXTER S.P.A.Отпускается по рецепту
Аналоги BASALFLEX в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог BASALFLEX в Испания
Аналог BASALFLEX в Польша
Аналог BASALFLEX в Украина
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
BASALFLEX требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество BASALFLEX — combinations. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
BASALFLEX производится компанией B. BRAUN MELSUNGEN AG. 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 BASALFLEX 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 BASALFLEX 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 (combinations) включают AMIXAL, KLINIMIX, FINOMEL. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
