Lipoflex special sin electrolitos emulsion para perfusion efg
Инструкция по применению Lipoflex special sin electrolitos emulsion para perfusion efg
Introduction
Prospect: information for the user
Lipoflex special without electrolytesemulsion for EFG perfusion
Read this prospect carefully before starting to use this medication, because it contains important information for you.
- Keep this prospect, as you may need to read it again.
If you have any doubts, consult your doctor, pharmacist, or nurse. - This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.
1. What isLipoflex special without electrolytesand for what it is used
2. What you need to know before starting to useLipoflex special without electrolytes
3. How to useLipoflex special without electrolytes
4. Possible adverse effects
5. Conservation ofLipoflex special without electrolytes
6. Contents of the package and additional information
1. What is Lipoflex special without electrolytes and for what it is used
Lipoflex special without electrolytescontains liquids and substances called amino acids and fatty acids that are essential for the growth or recovery of the organism. It also contains calories in the form of carbohydrates and fats.
This medicationwithout electrolytesis administered when there is an inability to ingest food normally.There are many situations in which this can occur, such as, for example, in the recovery phases of surgical interventions, traumas, or burns, or when there is an inability to absorb food in the stomach and intestine.
This emulsion can be administered to adults, adolescents, and children over 2years of age.
2. What you need to know before starting to use Lipoflex special without electrolytes
No useLipoflex special without electrolytes
?If you are allergic to any of the active ingredients, egg, peanut, or soy, or to any of the other components of this medication (listed in section6),
?This medication should not be administered to newborns, infants, and children under two years of age.
Similarly, do not useethis medication if you have any of the following conditions:
?potentially life-threatening blood circulation problems, such as those that may occur in cases of collapse or shock,
?myocardial infarction or stroke,
?severe coagulation disorder, risk of hemorrhage (severe coagulopathy, exacerbating hemorrhagic diathesis),
?blockage of blood vessels by blood clots or fat (embolia),
?severe liver insufficiency,
?altered bile flow (intrahepatic cholestasis),
?severe renal insufficiency where dialysis equipment is not available,
?alterations in the composition of body salts,
?deficit or excess of fluids in your body,
?fluid in your lungs (pulmonary edema),
?severe heart failure,
?certain metabolic disorders, such as:
–excessive lipids (fats) in the blood,
–congenital disorders of amino acid metabolism,
–abnormally high blood sugar levels that require more than 6 units of insulin per hour to control,
–metabolic alterations that may occur after surgical interventions or trauma,
–unknown origin coma,
–insufficient oxygen supply to tissues,
–abnormally high levels of acids in the blood.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to useLipoflex special without electrolytes.
Inform your doctor if:
?You haveheart, liver, or kidney problems,
?Youpresent certain types of metabolic disorders, such as diabetes, abnormal blood lipid levels, and disorders in the body's fluid and salt composition or acid-base balance.
Se will closely monitor you to detect the first signs of an allergic reaction (such as fever, chills, skin rash, or shortness of breath) when you receive this medication.
You will undergo additional monitoring and tests, such as various blood sample examinations, to ensure that your body adequately absorbs the administered foods.
This medication is an electrolyte-free solution. Healthcare personnel may also take measures to ensure that your body's fluid and electrolyte needs are met. In addition toLipoflex special without electrolytes, you may receive additional nutrients (food) to fully meet your needs.
Children
This medication should not be administered to newborns, infants, or children under two years of age.
Use ofLipoflex special without electrolyteswith other medications
Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.
Lipoflex special without electrolytesmay interact with some medications. Inform your doctor, pharmacist, or nurse if you are taking or receiving any of the following medications:
?insulin,
?heparin,
?medications that prevent unwanted blood coagulation, such as warfarin or other coumarin derivatives.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacistbefore using this medication. If you are pregnant, you will receive this medication only if your doctor or pharmacist considers it absolutely necessary for your recovery. There are no available data on the use ofLipoflex special without electrolytesin pregnant women.
It is not recommended to breastfeed in mothers treated with parenteral nutrition.
Driving and operating machinery
Ethis medication is usually administered to patients who are immobile, for example, in a hospital or clinic, which excludes the possibility of driving or operating machinery. However, this medication itself does not affect the ability to drive or operate machinery.
Lipoflex special without electrolytescontains sodium.
This medication contains less than 1mmol of sodium (23mg) per multi-chamber bag; that is, it is essentially “sodium-free”.
3. How to use Lipoflex special without electrolytes
This medication is administered through intravenous infusion (drop by drop), that is, through a small tube directly into a vein. This medication will only be administered through one of your large veins (central veins).
Your doctor or pharmacist will decide how much of this medication you need and for how long you will require treatment with it.
Use in children
This medication should not be administered to newborns, infants, and small children under two years of age.
Your doctor will decide how much of this medication your child needs and for how long your child will require treatment with this medication.
If you use moreLipoflex special without electrolytesthan you should
If you have received too much of this medication, you may experience the so-called "overload syndrome" and the following symptoms:
• Excess fluids and electrolyte imbalances,
• Fluid in your lungs (pulmonary edema),
• Loss of amino acids through urine and imbalances in amino acid levels,
• Vomiting, nausea,
• Chills,
• High blood sugar levels,
• Glucose in urine,
• Fluid deficiency,
• Blood much more concentrated than normal (hyperosmolality),
• Alteration or loss of consciousness due to extremely high blood sugar levels,
• Enlargement of the liver(hepatomegaly) with or without jaundice,
• Enlargement of the spleen (splenomegaly),
• Deposition of fat in internal organs,
• Abnormal values in liver function tests,
• Reduction in red blood cell count (anemia),
• Reduction in white blood cell count (leucopenia),
• Reduction in platelet count (thrombocytopenia),
• Increase in immature red blood cells (reticulocytosis),
• Breakdown of blood cells (hemolysis),
• Bleeding or tendency to bleed,
• Alterations in blood coagulation (as can be seen by changes in bleeding time, coagulation time, prothrombin time, etc.),
• Fever,
• High levels of fats in the blood,
• Loss of consciousness.
If any of the following occur, the infusion should be stopped immediately.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
The following side effects may be serious. If you experience any of the following side effects, inform your doctor immediately, who will stop administering this medicine:
Rare (may affect up to 1 in 1,000 people):
?allergic reactions such as, for example, skin reactions, shortness of breath, swelling of the lips, mouth, and throat, difficulty breathing,
Other side effects include:
Possibly frequent (may affect up to 1 in 100 people):
?nausea,vomiting, loss of appetite,
Rare (may affect up to 1 in 1,000 people):
?increased tendency of blood coagulation,
?blue discoloration of the skin,
?shortness of breath,
?headache,
?flushing,
?redness of the skin (erythema),
?sweating,
?chills,
?sensation of cold,
?high body temperature,
?drowsiness,
?chest, back, bone, or lumbar region pain,
?decrease or increase in blood pressure.
Very rare (may affect up to 1 in 10,000 people):
?abnormally high levels of sugar or fat in the blood,
?high levels of acidic substances in your blood,
?an excess of lipids may cause overload syndrome; for more information, see the heading “If you use moreLipoflex special sin electrolitesthan you should” in section3. Symptoms usually disappear when infusion is interrupted.
Frequency not known (cannot be estimated from available data):
?decrease in white blood cell count (leucopenia),
?decrease in platelet count (thrombocytopenia),
?bile flow alterations (cholestasis).
Reporting of side effects
If you experience any type of side effect, consult yourdoctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this prospectus.
You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es).
5. Conservation of Lipoflex special without electrolytes
Keep this medication out of the sight and reach of children.
Do not store at a temperature above25°C.
Do not freeze. Discard the bag if it has been accidentally frozen.
Store the bag in the outer packaging to protect it from light.
Do not use this medication after the expiration date appearing on the label. The expiration date is the last day of the month indicated.
6. Contents of the packaging and additional information
Composition ofLipoflex special without electrolytes
The active ingredients of the ready-to-use mixture are:
| From the upper chamber (glucose solution) | in 1,000ml | in 625ml | in 1,250ml | in 1,875ml |
| Glucose monohydrate | 158.4g | 99.00g | 198.0g | 297.0g |
| equivalent to glucose | 144.0g | 90.00g | 180.0g | 270.0g |
| From the middle chamber (fat emulsion) | in 1,000ml | in 625ml | in 1,250ml | in 1,875ml |
| Refined soybean oil | 20.00g | 12.50g | 25.00g | 37.50g |
| Medium-chain triglycerides | 20.00g | 12.50g | 25.00g | 37.50g |
| From the lower chamber (amino acid solution) | in 1,000ml | in 625ml | in 1,250ml | in 1,875ml |
| Isoleucine | 3.284g | 2.053g | 4.105g | 6.158g |
| Leucine | 4.384g | 2.740g | 5.480g | 8.220g |
| Lysine monohydrate equivalent to lysine | 3.576g | 2.235g 1.990g | 4.470g 3.979g | 6.705g 5.969g |
| Methionine | 2.736g | 1.710g | 3.420g | 5.130g |
| Phenylalanine | 4.916g | 3.073g | 6.145g | 9.218g |
| Threonine | 2.540g | 1.588g | 3.175g | 4.763g |
| Tryptophan | 0.800g | 0.500g | 1.000g | 1.500g |
| Valine | 3.604g | 2.253g | 4.505g | 6.758g |
| Arginine | 3.780g | 2.363g | 4.725g | 7.088g |
| Histidine | 1.752g | 1.095g | 2.190g | 3.285g |
| Alanine | 6.792g | 4.245g | 8.490g | 12.73g |
| Aspartic acid | 2.100g | 1.313g | 2.625g | 3.938g |
| Glutamic acid | 4.908g | 3.068g | 6.135g | 9.203g |
| Glycine | 2.312g | 1.445g | 2.890g | 4.335g |
| Proline | 4.760g | 2.975g | 5.950g | 8.925g |
| Serine | 4.200g | 2.625g | 5.250g | 7.875g |
| in 1,000ml | in 625ml | in 1,250ml | in 1,875ml | |
| Amino acid content | 56.0g | 35.0g | 70.1g | 105.1g |
| Nitrogen content | 8g | 5g | 10g | 15g |
| Carbohydrate content | 144g | 90g | 180g | 270g |
| Lipid content | 40g | 25g | 50g | 75g |
| Total energy | 1.590kJ (380kcal) | 995kJ (240kcal) | 1.990kJ (475kcal) | 2.985kJ (715kcal) |
| Energy from carbohydrates | 2.415kJ (575kcal) | 1.510kJ (360kcal) | 3.015kJ (720kcal) | 4.520kJ (1.080kcal) |
| Energy from amino acids | 940kJ (225kcal) | 585kJ (140kcal) | 1.170kJ (280kcal) | 1.755kJ (420kcal) |
| Total non-protein energy | 4.005kJ (955kcal) | 2.505kJ (600kcal) | 5.005kJ (1.195kcal) | 7.505kJ (1.795kcal) |
| Total energy | 4.945kJ (1.180kcal) | 3.090kJ (740kcal) | 6.175kJ (1.475kcal) | 9.260kJ (2.215kcal) |
| Osmolality | 1.840mOsm/kg | 1.840mOsm/kg | 1.840mOsm/kg | 1.840mOsm/kg |
| Theoretical osmolality | 1.330mOsm/l | 1.330mOsm/l | 1.330mOsm/l | 1.330mOsm/l |
| pH | 5.0‑6.0 | 5.0‑6.0 | 5.0‑6.0 | |
