infusion solution, emulsion
What StructoKabiven is and what it is used for
Along with salts, trace elements, and vitamins, StructoKabiven works as part of a balanced intravenous nutritional supply that meets your entire nutritional needs.
StructoKabiven is an emulsion and is given as a drip ( intravenous infusion ). The medicine consists of amino acids (the building blocks of proteins), glucose, fats, and salts in a plastic bag.
What you need to know before you get StructoKabiven
You should not receive StructoKabiven
- if you are allergic to any of the active substances or any other ingredient of this medicine (listed in section 6),
- if you are allergic to products containing eggs, soy, or peanuts. The product contains soybean oil,
- if you have too high-fat levels in the blood ( hyperlipidemia ),
- if you have severe liver disease,
- if you have blood clotting problems (coagulation disorder or hemophagocytic syndrome),
- if your body has difficulty using amino acids,
- if you suffer from severe kidney disease and lack access to dialysis,
- if you are in acute shock,
- if you have elevated blood sugar levels (hyperglycemia),
- if you have elevated blood levels of the salts ( electrolytes ) contained in StructoKabiven,
- if you have fluid in your lungs ( acute pulmonary edema),
- if you have too much fluid in your body (hyperhydration),
- if you have untreated heart failure,
- if you have too little fluid in your body ( hypotonic dehydration ),
- in unstable conditions, e.g. after serious injuries, untreated diabetes, acute heart attack, metabolic acidosis (disorder in the metabolism that produces too much acid in the blood), severe infection (severe blood poisoning), or coma.
Warnings and precautions
Talk to your doctor before receiving StructoKabiven if you have:
- kidney disease,
- diabetes,
- pancreatitis (inflammation of the pancreas),
- liver disease,
- hypothyroidism (problems with the thyroid gland),
- sepsis (severe infection, blood poisoning).
Your doctor may need to take blood tests on you regularly to make sure the Structokabiven treatment is working properly.
Children
StructoKabiven is not intended for newborn babies or children younger than 2 years. For children aged 2 to 11 years, there is no experience of treatment with StructoKabiven.
Other medicines and StructoKabiven
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Tell your doctor if you are taking
- a medicine called heparin which is used to prevent the formation and facilitate the dissolution of blood clots,
- blood-thinning drugs (coumarin derivatives) as vitamin K1, which is found in soybean oil, can affect the clotting ability of the blood,
- insulin for the treatment of diabetes.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this medicine.
StructoKabiven should only be used during pregnancy after special consideration.
Women treated with StruktoKabiven should not breastfeed.
Driving ability and use of machinery
No effects on the ability to drive and use machines are expected.
StructoKabiven contains soybean oil
This medicinal product contains soybean oil, which in rare cases may cause serious allergic reactions. Cross-allergic reactions have been observed between soybean and peanut.
How you are given StructoKabiven
Your doctor determines the dose based on your body weight and body function. StructoKabiven will be given to you by healthcare professionals. Your medicine will only be given through a central vein.
You may be monitored during the treatment.
If you have received too much StructoKabiven
It is unlikely that you will be given too much medicine, as the healthcare staff will monitor you during treatment. Effects of an overdose can be nausea, fever, vomiting, chills, sweating, and fluid retention. Hyperglycemia (elevated blood sugar levels) and electrolyte disturbances have also been reported.
If you receive too high a dose of StructoKabiven, there is a risk that you will ingest too much fat. This is called “fat overload syndrome”. More information can be found in section 4, “Potential side effects”.
If you experience any of the symptoms described above or think you have been given too much StructoKabiven, tell your doctor or nurse straight away. Infusion one will be interrupted or continued but with a lower dosage. Symptoms usually disappear when the infusion is stopped or when the infusion rate is reduced.
If you have further questions about the use of this product, contact your healthcare professional.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell the healthcare staff immediately if during the infusion you develop a fever, rash, swollen tongue or throat, difficulty breathing, chills, sweating, nausea, or vomiting. These symptoms may be an allergic reaction caused by the drug.
Other side effects include:
Uncommon (may affect up to 1 in 100 people): more than usual enzymes that show how the liver is working, nausea, headache, and increased body temperature.
Rare (may affect up to 1 in 1,000 people): palpitations ( tachycardia ), high blood pressure.
Very rare (may affect up to 1 in 10,000 people): breathing difficulties, diarrhea, rash, back pain, dizziness.
“Fat overload syndrome”
If your body has problems dealing with fat because you have received too much StructoKabiven, you may suffer from “fat overload syndrome”. The problem can also occur due to a rapid change in your condition (eg kidney problems or an infection ). Possible symptoms are fever, high-fat content in the blood ( hyperlipidemia ), the cells and tissues, disorders in various organs, and coma. The symptoms usually disappear if the infusion is stopped.
Excess amino acids
This can occur when the infusion rate is increased and the level of amino acids is exceeded. Possible symptoms are nausea, vomiting, chills, sweating, and an increase in body temperature. If you have kidney problems, your doctor may want to do a blood test to check the amount of nitrogen-containing substances in your blood.
Excess glucose
This can occur when your body has difficulty getting rid of glucose, causing blood sugar levels to be too high (hyperglycemia).
How the StructoKabiven should be stored
- Keep this medicine out of the sight and reach of children.
- Store at a maximum of 25°C.
- Do not freeze.
- Leave the outer bag on during storage.
- Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
What the StructoKabiven contains
| 986 ml | 1477 ml | 1970 ml | Per 1000 ml | |
| Amino acid solution with electrolyte | 500 ml | 750 ml | 1000 ml | 508 ml |
| Glucose 420 mg/ml | 298 ml | 446 ml | 595 ml | 302 ml |
| Fat emulsion | 188 ml | 281 ml | 375 ml | 190 ml |
| Which corresponds to the following total content: | ||||
| The active substances are: | 986 ml | 1477 ml | 1970 ml | Per 1000 ml |
| Purified structured triglyceride | 38 g | 56 g | 75 g | 38.5 g |
| Glucose (as monohydrate) | 125 g | 187 g | 250 g | 127 g |
| Alanine | 7.0 g | 10.5 g | 14.0 g | 7.1 g |
| Arginine | 6.0g | 9.0 g | 12.0 g | 6.1 g |
| Glycine | 5.5 g | 8.2 g | 11.0 g | 5.6 g |
| Histidine | 1.5 g | 2.2 g | 3.0 g | 1.5 g |
| Isoleucine | 2.5 g | 3.8g | 5.0 g | 2.5 g |
| Leucine | 3.7g | 5.6 g | 7.4g | 3.8g |
| Lysine (as acetate) | 3.3g | 5.0 g | 6.6 g | 3.4g |
| Methionine | 2.2 g | 3.2 g | 4.3g | 2.2 g |
| Phenylalanine | 2.6 g | 3.8g | 5.1 g | 2.6 g |
| Proline | 5.6 g | 8.4g | 11.2 g | 5.7 g |
| Serine | 3.2 g | 4.9 g | 6.5 g | 3.3g |
| Taurine | 0.5g | 0.75 g | 1.0 g | 0.5g |
| The threonine | 2.2 g | 3.3g | 4.4g | 2.2 g |
| Tryptophan | 1.0 g | 1.5 g | 2.0 g | 1.0 g |
| Tyrosine | 0.20g | 0.30g | 0.40g | 0.20g |
| The election | 3.1 g | 4.6 g | 6.2 g | 3.1 g |
| Calcium Chloride (as Calcium Chloride Dihydrate) | 0.28g | 0.42g | 0.56 g | 0.28g |
| Sodium glycerophosphate (as hydrate) | 2.1 g | 3.1 g | 4.2 g | 2.13 g |
| Magnesium sulfate (as Magnesium sulfate heptahydrate) | 0.60g | 0.90 g | 1.2 g | 0.61g |
| Potassium chloride | 2.2 g | 3.4g | 4.5 g | 2.3g |
| Sodium acetate (as sodium acetate trihydrate) | 1.7g | 2.6 g | 3.4g | 1.7g |
| Zinc sulfate (as Zinc sulfate heptahydrate) | 0.0065 g | 0.0097 g | 0.013g | 0.0066 g |
Other ingredients are:
Glycerol
Purified egg phospholipids
Sodium hydroxide ( pH adjustment)
Glacial acetic acid ( pH adjustment)
Hydrochloric acid ( pH adjustment)
What the StructoKabiven looks like and the contents of the package
The glucose and amino acid solutions are clear, colorless, or slightly yellow, and free of particles. The fat emulsion is white and homogeneous.
Pack sizes:
1 x 986 ml, 4 x 986 ml
1 x 1477 ml, 4 x 1477 ml
1 x 1970 ml, 2 x 1970 ml (Excel), 4 x 1970 ml (Biofine)
Not all pack sizes may be marketed.
Manufacturer:
Fresenius Kabi AB
751 74 Uppsala,
or
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz, Austria