SPECIALFLEX 1000 ML Roztwór do infuzji
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Treść ulotki
- What is Specialflex and what is it used for
- How to use Specialflex
- Possible side effects
- How to store Specialflex
- Contents of the pack and other information
Specialflex 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 Specialflex is and what it is used for
- 2. What you need to know before you use Specialflex
- 3. How to use Specialflex
- 4. Possible side effects
- 5. How to store Specialflex
- 6. Contents of the pack and other information
1. What is Specialflex 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.
- 2.This product is administered to you intravenously (infusion) because you are unable to eat sufficiently or cannot be fed with a tube. Specialflex is specifically indicated for adults and children between 2 and 17 years of age in a moderate to severe catabolic state, a condition in which patients burn their energy reserves, proteins, etc. faster than they can replenish them. What you need to know before using SpecialflexDo not use Specialflex
- 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 metabolic error of amino acids and must follow a particular protein diet
- if you have blood glucose levels that are too high and require more than 6 units of insulin per hour to keep under control
- if you have excessively 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, Specialflex should not be administered in case of:
- heart attack (myocardial infarction) in an acute phase or stroke
- any poorly controlled metabolic disorder, for example unconsciousness (coma) of unknown origin or insufficient oxygen supply to the tissues or uncontrolled diabetes mellitus
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- potentially fatal circulatory disorders, such as those that can occur, for example, in the event of collapse or shock, fluid accumulation in the lungs (pulmonary edema) or fluid balance disorders. Specialflex should not be administered to newborns, infants or children under two years of age. Warnings and precautions
Consult a healthcare professional before using Specialflex
- if you have impaired heart or kidney function
- if you have fluid or electrolyte imbalances or acid-base imbalances, 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 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 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
suddenly. The doctor will take this into particular consideration 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 infusion is stopped.
In addition, blood electrolyte levels, fluid balance, acid-base balance and, in case of long-term administration, blood cell count, coagulation and
kidney and liver function need to be monitored.
The doctor will ensure that your fluid and electrolyte needs are met. In addition to Specialflex,
you will receive other nutrients (foods) to fully meet your needs.
As with all intravenous solutions, strict
aseptic precautions must be observed for the infusion of Specialflex.
Children and adolescents
In the event of a sudden drop in blood glucose in your child following the sudden interruption
of the infusion, also refer to the previous paragraph “Warnings and precautions”.
The doctor will not administer Specialflex to children under two years of age.
Other medicines and Specialflex
Tell your doctor if you are taking, have recently taken or may take any other medicines.
Specialflex may interact with other medicines. Tell your doctor if you are taking 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 used 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 fertilityIf you are pregnant, suspect 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 only receive this medicine if the doctor deems it absolutely necessary
for your recovery.
Breastfeeding
Breastfeeding is not recommended if the woman needs parenteral nutrition.
Fertility
No data are available.
Driving and operating machinery
This medicine is normally 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 vehicles or use machinery.
3. How to use Specialflex
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 25 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 Specialflex 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 salt composition in the body (electrolyte imbalances)
- water in the lungs (pulmonary edema)
- loss of amino acids in the urine and disturbances of amino acid balance
- accumulation of acidic substances in the blood (metabolic acidosis)
- discomfort, vomiting, chills, headache
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- high levels of nitrogen in the blood (hyperammonemia)
- blood glucose values too high (hyperglycemia)
- glucose in the urine (glycosuria)
- lack of fluids (dehydration)
- blood concentration much higher than normal (hyperosmolarity)
- 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 doubts about the use of this medicine, ask your healthcare professional.
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4. Possible side effects
Like all medicines, Specialflex 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.
Rare (may affect up to 1 in 1,000 people).
- Discomfort (Nausea), vomiting and decreased appetite.
- Excessive amount of urine (polyuria)
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 these 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 provide more information on the safety of this medicine.
5. How to store Specialflex
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 Specialflex after the expiry date which is stated on the bag and on the carton label. The expiry
date refers to the last day of the month.
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6. Contents of the pack and other information
What Specialflex contains
- The active ingredients are amino acids, glucose and electrolytes. After mixing, each bag contains:
|
| |
| g Isoleucine | 4.11 g | 6.17 g |
| Leucine | 5.48 g | 8.22 g |
| A Lysine hydrochloride equivalent to lysine | 4.97 g 3.98 g | 7.46 g 5.97 g |
| Methionine | 3.42 g | 5.13 g |
| Phenylalanine | 6.15 g | 9.23 g |
| Threonine | 3.18 g | 4.77 g |
| Tryptophan | 1.00 g | 1.50 g |
| Valine | 4.54 g | 6.81 g | r m a c | |
| Arginine monoglutamate equivalent to arginine equivalent to glutamic acid | 8.72 g 4.73 g 3.99 g | 13.08 g 7.10 g 5.99 g | ||
| Histidine hydrochloride monohydrate equivalent to histidine | 2.96 g 2.19 g | 4.44 g 3.29 g | ||
| Alanine | 8.49 g | 12.74 g | ||
| Aspartic acid | 2.63 g | 3.95 g | ||
| Glutamic acid | 2.15 g | 3.23 g | ||
| Glycine | 2.89 g | 4.34 g | ||
| Proline | 5.95 g | 8.93 g | ||
| Serine | 5.25 g | 7.88 g | ||
| Magnesium acetate tetrahydrate | 1.08 g | 1.62 g | ||
| Sodium acetate trihydrate | 1.63 g | a 2.45 g | ||
| Potassium dihydrogen phosphate | 2.00 g | 3.00 g | ||
| Potassium hydroxide | 0.62 g | F 0.93 g | ||
| Sodium hydroxide | 1.14 g | 1.71 g | ||
| Calcium chloride dihydrate | 0.60 g | 0.90 g | ||
| Glucose monohydrate equivalent to glucose | 264.0 g 240.0 g | l e 396.0 g 360.0 g | ||
| Calcium chloride dihydrate | 0.60 g | 0.90 g | ||
- The excipients are citric acid monohydrate and water for injections.
| Electrolytes | n
|
|
| Sodium | 40.5 mmol | 60.8 mmol |
| Potassium | a 25.7 mmol | 38.6 mmol |
| Calcium | 4.1 mmol | 6.2 mmol |
| Magnesium | i 5.0 mmol | 7.5 mmol |
| Chloride | l 49.5 mmol | 74.3 mmol |
| a Phosphate | 14.7 mmol | 22.1 mmol |
| Acetate | 22.0 mmol | 33.0 mmol |
|
| |
| a Amino acid content | 70 g | 105 g |
| Nitrogen content | 10 g | 15 g |
| i Carbohydrate content | 240 g | 360 g |
|
| |
| n Energy contribution from amino acids [kJ (kcal)] |
|
|
| e Energy contribution from carbohydrates [kJ (kcal)] |
|
|
| g Total energy contribution [kJ (kcal)] |
|
|
| Theoretical osmolarity [mOsm/L] |
|
|
| pH | 4.8 – 6.0 | 4.8 – 6.0 |
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Description of the appearance of Specialflex and contents of the pack
This medicine is a solution for infusion to be administered directly into a vein through a small
cannula.
Specialflex 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 plastic bags with two compartments containing:
- 1.000 ml (500 ml of amino acid solution + 500 ml of glucose solution)
- 1.500 ml (750 ml of amino acid solution + 750 ml of glucose solution) Pack sizes: 5×1.000 ml, 5×1.500 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
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The following information is intended exclusively for doctors or healthcare professionals:
The solution must always be brought to room temperature before infusion.
Use Specialflex 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 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:
- 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 connector allows for the addition of supplements to Specialflex. Strict aseptic precautions must be observed when adding other solutions or lipid emulsions to Specialflex. Lipid emulsions can be easily added using a specific transfer set. Maximum infusion rateThe maximum infusion rate for adults, children and adolescents between 2 and 17 years of age is 1.0 mL per kg of body weight per hour.
Storage after mixing the contents
Specialflex should preferably be administered 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.
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- Kraj rejestracji
- Postać farmaceutycznaInfusion solution, 1000 ML
- Kod ATCB05BA10
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki SPEKIALFLEXPostać farmaceutyczna: Infusion solution, 10%Substancja czynna: combinationsProducent: B. BRAUN MELSUNGEN AGWymaga receptyPostać farmaceutyczna: Infusion solution, 1000 MLSubstancja czynna: combinationsProducent: B. BRAUN MELSUNGEN AGWymaga receptyPostać farmaceutyczna: Infusion solution, 1000 MLSubstancja czynna: combinationsProducent: BAXTER S.P.A.Wymaga recepty
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SPEKIALFLEX wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w SPEKIALFLEX jest combinations. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
SPEKIALFLEX jest produkowany przez B. BRAUN MELSUNGEN AG. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie SPEKIALFLEX jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić SPEKIALFLEX w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (combinations) to m.in. AMIXAL, BASALFLEX, KLINIMIX. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
