PERIFLEX 1000 ML Infusion solution
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Інструкція із застосування PERIFLEX
Зміст інструкції
- What is Periflex and what is it used for
- What you need to know before using Periflex
- How to use Periflex
- Possible side effects
- How to store Periflex
- Contents of the pack and other information
Periflex, solution for infusion
Amino acids/glucose/electrolytes
Read this leaflet carefully before you use 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 pharmacist.
- This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
- 1. What Periflex is and what it is used for
- 2. What you need to know before using Periflex
- 3. How to use Periflex
- 4. Possible side effects
- 5. How to store Periflex
- 6. Contents of the pack and other information
1. What is Periflex and what is it used for
The 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 to you intravenously (infusion) because you are unable to eat
sufficiently or cannot be fed through a tube.
Periflex 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 Periflex
Do not use Periflex
- if you are allergic to the active ingredients or to 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 blood glucose levels that are too high and require more than 6 units of insulin per hour to keep them 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 treatment with an artificial kidney (hemofiltration or dialysis). Like other medicines of the same type, Periflex should not be administered in case of:
- heart attack (myocardial infarction) in acute phase or stroke
- any poorly controlled metabolic disorder, such as unconsciousness (coma) of unknown origin or insufficient oxygen supply to the tissues or uncontrolled diabetes mellitus
- potentially fatal 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
Periflex should not be administered to newborns, infants and children under two years of age.
Warnings and precautions
- Consult a healthcare professional before using Periflex if you have impaired heart or kidney function;
- if you have disturbances of the fluid or electrolyte balance or of the acid-base balance, for example a low content of fluids and salts 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 use particular caution also in case of damage to the blood-brain barrier, because
this medicine could 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 checks and with the necessary supply of electrolytes, in particular potassium,
magnesium and phosphate.
This medicine contains glucose (a sugar) and may therefore affect blood glucose levels. It is possible
that blood samples may need to be taken to verify this.
If the infusion is suddenly interrupted accidentally, blood glucose levels may also drop
sharply. The doctor will take this into account in particular if your ability to metabolize
glucose is reduced (for example if you suffer from diabetes) or when the solution is administered to children
under 3 years of age.
Therefore, blood glucose must be carefully monitored especially after the interruption of the infusion.
In addition, checks of blood electrolyte levels, fluid balance, acid-base balance and blood cell counts, coagulation and kidney and liver function are necessary.
The doctor will ensure that your fluid and electrolyte needs are met. In addition to Periflex,
you will receive other nutrients (food) to fully meet your needs.
Infusion into peripheral veins can cause inflammation of the vein due to a blood clot. The
doctor will check the infusion site every day.
As happens with all intravenous solutions, strict aseptic precautions must be observed for the infusion of Periflex.
Children and adolescents
In the event of a sudden drop in your child's blood glucose following the sudden interruption
of the infusion, also refer to the previous paragraph “Warnings and precautions”.
The doctor will not administer Periflex to children under two years of age.
Other medicines and Periflex
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
.
Periflex can interact with other medicines. Tell your doctor if you are taking or receiving any of the following medicines:
- medicines used for the treatment of inflammation (corticosteroids);
- hormonal preparations that affect fluid balance (adrenocorticotropic hormone “ACTH”);
- medicines that promote urine flow (diuretics), such as spironolactone, triamterene or amiloride;
- medicines for the treatment of high blood pressure (ACE inhibitors), such as captopril and enalapril
- medicines used for the treatment of 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 fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, you will receive this medicine only if the doctor deems 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.
Не впевнені, чи підходить вам цей лікарський засіб?
Обговоріть симптоми та можливі варіанти лікування з лікарем онлайн.
3. How to use Periflex
This medicine will be administered to you by intravenous infusion (drip), i.e. through a small cannula inserted directly into a vein. It can be administered into small (peripheral) or large (central) veins.
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 have received more Periflex 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 (hyperhydration)
- excessively high amount of urine (polyuria)
- disorders of the salt composition 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)
- discomfort, nausea, vomiting, chills, headache
- high levels of nitrogen in the blood (hyperammonemia)
- too high blood glucose levels (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 must be stopped immediately. The doctor will determine the additional treatment you will need. The infusion will not be resumed until your condition has improved.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are mainly due to an overdose or too rapid an infusion, and generally
disappear at the end of the infusion.
Common (may affect up to 1 in 10 people)
- Irritation of the vein, inflammation of the vein wall at the infusion site (phlebitis, thrombo-phlebitis)
Rare (may affect up to 1 in 1,000).
- Discomfort (Nausea), vomiting and decreased appetite.
If these side effects occur, treatment should be discontinued, or the doctor may
decide to continue it at lower doses.
If signs of vein irritation or inflammation of the vein walls appear, the doctor
may change the infusion site.
Reporting of side effects
If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet,
including those not listed in this package leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help to provide more information on the safety of this medicine.
Виникли питання під час прийому ліків?
Обговоріть свої симптоми та лікування з лікарем онлайн.
5. How to store Periflex
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 bag and label. The expiry date refers to the last day of the month.
6. Contents of the pack and other information
What Periflex contains
- The active ingredients are amino acids, glucose and electrolytes. After mixing, each bag contains:
- Other ingredients are citric acid monohydrate and water for injections.
|
| |
| Isoleucine | 2.34 g | F 4.68 g |
| Leucine | 3.13 g | 6.26 g |
| Lysine hydrochloride equivalent to lysine | 2.84 g 2.27 g | l 5.68 g 4.54 g |
| Methionine | 1.96 g | e 3.92 g |
| Phenylalanine | 3.51 g | 7.02 g |
| Threonine | 1.82 g | d 3.64 g |
| Tryptophan | 0.57 g | 1.14 g |
| Valine | 2.60 g | 5.20 g |
| Arginine monoglutamate equivalent to arginine equivalent to glutamic acid | a 4.98 g n 2.70 g 2.28 g | 9.96 g 5.40 g 4.56 g |
| Histidine hydrochloride monohydrate equivalent to histidine | a 1.69 g 1.25 g | 3.38 g 2.50 g |
| Alanine | i 4.85 g | 9.70 g |
| Aspartic acid | 1.50 g | 3.00 g |
| Glutamic acid | l 1.22 g | 2.44 g |
| Glycine | a 1.65 g | 3.30 g |
| Proline | 3.40 g | 6.80 g |
| t Serine | 3.00 g | 6.00 g |
| I Magnesium acetate tetrahydrate | 0.86 g | 1.72 g |
| Sodium acetate trihydrate | 1.56 g | 3.12 g |
| a Potassium dihydrophosphate | 0.78 g | 1.56 g |
| Potassium hydroxide | 0.52 g | 1.04 g |
| i Sodium hydroxide | 0.50 g | 1.00 g |
| z Glucose monohydrate equivalent to glucose | 88.0 g 80.0 g | 176.0 g 160.0 g |
| n Sodium chloride | 0.17 g | 0.34 g |
| Calcium chloride dihydrate | 0.37 g | 0.74 g |
| Electrolytes |
|
|
| Sodium | 27.0 mmol | 54.0 mmol |
| A Potassium | 15.0 mmol | 30.0 mmol |
| Calcium | 2.5 mmol | 5.0 mmol |
| Magnesium | 4.0 mmol | 8.0 mmol |
| Chloride | 31.6 mmol | 63.2 mmol |
| Phosphate | 5.7 mmol | 11.4 mmol |
| Acetate | 19.5 mmol | 39.0 mmol |
|
| |
| Amino acid content | 40 g | 80 g |
| Nitrogen content | 5.7 g | 11.4 g |
| Carbohydrate content | 80 g | 160 g |
|
| |
| Energy supply in the form of amino acids [kJ (kcal)] | 669 (160) | F
|
| Energy supply in the form of carbohydrates [kJ (kcal)] |
| l
|
| Total energy supply [kJ (kcal)] |
| e
|
| Theoretical osmolarity [mOsm/L] | 900 | d 900 |
Description of the appearance of Periflex and contents of the pack
This medicine is a solution for infusion to be administered directly into a vein through a
small cannula.
Periflex 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, colourless or slightly straw-coloured.
The product is supplied in two-compartment plastic bags 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) Packs: 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 Periflex only if the solution is clear and the bag is intact. After infusion, any residual solution must never be stored for future use.
Preparation of the mixture
Immediately before use, the 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:
- Lay the bag flat and place it on a rigid surface.
- Open the septum by pressing with both hands.
- Briefly mix the contents of the bag. An additional port allows the addition of supplements to Periflex. Strict aseptic precautions must be observed when adding other solutions or lipid emulsions to Periflex. 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
2.5 mL per kg of body weight per hour.
Storage after mixing the contents
Periflex 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.
- Країна реєстрації
- Лікарська формаInfusion solution, 1000 ML
- Код АТХB05BA10
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до PERIFLEXЛікарська форма: Infusion solution, 10%Діюча речовина: combinationsВиробник: B. BRAUN MELSUNGEN AGПотрібен рецептЛікарська форма: Infusion solution, 1000 MLДіюча речовина: combinationsВиробник: B. BRAUN MELSUNGEN AGПотрібен рецептЛікарська форма: Infusion solution, 1000 MLДіюча речовина: combinationsВиробник: BAXTER S.P.A.Потрібен рецепт
Аналоги PERIFLEX в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог PERIFLEX у Іспанія
Аналог PERIFLEX у Польща
Аналог PERIFLEX у Україна
Лікарі онлайн щодо PERIFLEX
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на PERIFLEX онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
PERIFLEX потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у PERIFLEX — combinations. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
PERIFLEX виробляється компанією B. BRAUN MELSUNGEN AG. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування PERIFLEX з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати PERIFLEX у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (combinations) включають AMIXAL, BASALFLEX, KLINIMIX. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
