infusion solution, emulsion
Read this leaflet carefully before you start using this medicine. It contains information that is important to you.
- Save this information, you may need to read it again.
- If you have further questions, ask your doctor, pharmacist, or nurse.
- If you get side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. See section 4.
In this leaflet you will find information on:
1. What SmofKabiven Electrolyte Free is and what it is used for
2. What you need to know before using SmofKabiven Electrolyte Free
3. How to use SmofKabiven Electrolyte Free
4. Possible side effects
5. How SmofKabiven Electrolyte Free should be stored
6. Contents of the packaging and other information
1. What SmofKabiven Electrolyte Free is and what it is used for
SmofKabiven Electrolytefree is an emulsion and is given as a drip ( intravenous infusion ). The medicine consists of amino acids (building blocks of proteins), glucose (carbohydrates), and lipids (fats) in a plastic bag and can be given to adults and children 2 years of age or older.
SmofKabiven Electrolyte Free is given to you by health care personnel when nutritional supply is otherwise impossible, insufficient, or inappropriate.
What you need to know before using SmofKabiven Electrolyte Free
Do not use SmofKabiven Electrolyte Free
- if you are allergic to active substances or any other ingredient of this medicine (listed in section 6).
- if you are allergic to fish or eggs
- if you are allergic to peanuts or soy, do not use this medicine. SmofKabiven Electrolyte Free contains soybean oil.
- if you have abnormally high levels of fats in your blood (severe hyperlipidemia)
- if you have severe liver disease
- if you have problems affecting blood clotting (coagulation disorder)
- if you have a disorder of the body’s ability to convert and break down amino acids
- if you suffer from severe kidney failure and lack access to dialysis
- if you are in acute shock
- if you have elevated and untreated blood sugar levels (hyperglycemia)
- if you have fluid in your lungs ( acute pulmonary edema )
- in case of overhydration (hyperhydration)
- in untreated heart failure
- if you have a disorder of your blood clotting system (haemophagocytic syndrome)
- in unstable conditions, e.g. after serious injuries, untreated diabetes, heart attack, stroke, blood clots, metabolic acidosis (disorder in the metabolism that produces too much acid in the blood), blood poisoning, in a coma, and in case of too little fluid in the body (hypotonic dehydration ).
- for children under 2 years of age
Warnings and precautions
Talk to your doctor before using SmofKabiven Electrolyte Free if you have:
- kidney failure,
- diabetes,
- pancreatitis (inflammation of the pancreas),
- liver failure,
- hypothyroidism (thyroid problem),
- sepsis (blood poisoning).
If during the infusion you develop a fever, rash, swelling, shortness of breath, cold sweats, nausea, or vomiting, tell a healthcare professional immediately, as these symptoms may be due to an allergic reaction or to the fact that you have received too much medicine.
Your doctor may need to check your blood regularly e.g. liver function.
Children and young people
SmofKabiven Electrolyte Free is not intended for newborn babies or children younger than 2 years. SmofKabiven Electrolyte Free can be given to children who are 2 to 18 years old.
Other medicines and SmofKabiven Electrolyte-free
Tell your doctor or pharmacist if you are using, have recently used, or may be thinking about using other medicines, including non-prescription ones.
Pregnancy and breastfeeding
Data from the use of SmofKabiven Electrolyte Free during pregnancy and breastfeeding are missing. SmofKabiven Electrolyte Free should therefore only be given to pregnant or breastfeeding women if the doctor deems it necessary. Use of SmofKabiven Electrolyte Free can be considered during pregnancy and breastfeeding if your doctor considers it so.
Driving ability and use of machinery
Not relevant because the medicine is given in a hospital.
How to use SmofKabiven Electrolyte Free
Always use this medicine exactly as directed by your doctor. Consult a doctor if you are unsure.
Your doctor will adapt the dosage to you individually based on your body weight and body function. SmofKabiven Electrolyte Free will be given to you by healthcare professionals.
If you have used too much SmofKabiven Electrolyte Free
It is unlikely that you will receive too much medicine, as SmofKabiven Electrolyte Free is given to you by healthcare professionals.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people): Slight increase in body temperature.
Uncommon (may affect up to 1 in 100 people): Increased liver levels in the blood, loss of appetite, nausea, vomiting, chills, dizziness, and headache.
Rare (may affect up to 1 in 1,000 people): Low or high blood pressure, shortness of breath, palpitations ( tachycardia ). Hypersensitivity reaction (can cause symptoms such as swelling, fever, drop in blood pressure, skin rash, hives (raised red areas), redness, headache). Experience of heat or cold. Pale skin. Bluish lips and skin (due to low oxygen in the blood). Pain in the neck, back, bones, chest, and lower back.
How SmofKabiven Electrolyte Free should be stored
Keep this medicine out of the sight and reach of children.
Store in the outer bag. Store at a maximum of 25ºC. Do not freeze.
Use before the expiry date stated on the label on the bag and outer packaging. The expiration date is the last day of the specified month.
Contents of the packaging and other information
Contents declaration
| The active substances are: | g per 1000 ml |
|---|---|
| Alanine | 7.1 |
| Arginine | 6.1 |
| Glycine | 5.6 |
| Histidine | 1.5 |
| Isoleucine | 2.5 |
| Leucine | 3.8 |
| Lysine (as acetate) | 3.4 |
| Methionine | 2.2 |
| Phenylalanine | 2.6 |
| Proline | 5.7 |
| Serine | 3.3 |
| Taurine | 0.5 |
| The threonine | 2.2 |
| Tryptophan | 1.0 |
| Tyrosine | 0.20 |
| The election | 3.1 |
| Glucose (as monohydrate) | 127 |
| Soybean oil, refined | 11.4 |
| Triglyceride er, medium chain | 11.4 |
| Olive oil, refined | 9.5 |
| Fish oil, rich in omega-3 fatty acids | 5.7 |
Other ingredients are glycerol, purified egg phospholipids, all – rac -α-Tocopherol, sodium hydroxide ( pH adjustment), sodium oleate, acetic acid ( pH adjustment), hydrochloric acid ( pH adjustment), and water for injections.
Appearance and package sizes of the medicine
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 493 ml, 6 x 493 ml
1 x 986 ml, 4 x 986 ml
1 x 1477 ml, 4 x 1477 ml
1 x 1970 ml, 4 x 1970 ml
1 x 2463 ml, 3 x 2463 ml
Manufacturer :
Fresenius Kabi AB, 751 74 Uppsala, Sweden
Fresenius Kabi Austria GmbH, 8055 Graz, Austria