infusion solution, emulsion

What Kabiven is and what it is used for

The kabiven consists of a three-chamber bag with an outer bag. Kabiven contains amino acids (building blocks of proteins), fats, glucose, and salts. When you can not eat normally, this drug provides energy (in the form of sugar and fat) and amino acids directly into your blood.

Kabiven works as part of a balanced intravenous nutrition supply which, together with additional salts, trace elements, and vitamins, satisfies your entire need for nutrition.

What you need to know before you are given Kabiven

You should not get Kabiven

  • if you are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to products containing eggs, soy or peanuts
  • if you have too high levels of fats (like cholesterol ) in your blood
  • if you have severe liver failure
  • if you are in acute shock (due to severe blood loss or allergic reaction )
  • if you have a defect in the blood coagulation system (haemophagocytic syndrome) or if you have problems that affect the blood’s ability to coagulate
  • if you have a disorder of your body’s ability to convert and break down proteins and amino acids
  • if you suffer from kidney failure
  • if you have hyperglycaemia ( too much blood sugar ) that requires treatment with more than 6 units of insulin per hour
  • if you have elevated levels of salts ( electrolytes ) in your blood
  • if you suffer from metabolic acidosis (the amount of acid in the body fluids and tissues is too large)
  • in case of overhydration (hyperhydration)
  • if you have fluid in your lungs ( acute pulmonary edema )
  • if you are in a coma
  • in heart disease
  • if you are dehydrated and have low salinity in your blood
  • in severe sepsis (a condition in which the body fights a serious infection )

Warnings and cautions

Talk to your doctor before giving Kabiven if you have:

  • impaired liver function
  • untreated diabetes
  • problems with the body’s ability to use fat
  • kidney problems
  • problems with the pancreas
  • thyroid problems – hypothyroidism ( toxic goiter )
  • blood poisoning ( sepsis , a condition in which the body fights a serious infection )
  • problems getting rid of salts ( electrolytes )
  • a condition where there is not enough oxygen for your body cells
  • increased osmotic pressure in the blood ( serum )

If you develop a fever, rash, chills, or shortness of breath during an infusion, tell your healthcare provider immediately, as these symptoms may be due to an allergic reaction or that you have been given too much medicine (see section 4).

This medicine may affect the results of other tests that you undergo. You must tell your doctor if you are undergoing any tests while taking Kabiven.

Your doctor may need to take regular blood tests to make sure that Kabiven treatment is working properly.

Children

Kabiven should not be given to newborns or children under two years of age.

Other medicines and Kabiven

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking

  • a drug called heparin which is used to prevent the formation and facilitate the dissolution of blood clots
  • the drug warfarin because Vitamin K1 found in soybean oil can affect blood clotting ability
  • insulin for the treatment of diabetes

Pregnancy and breastfeeding

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 taking this medicine.

There is no experience with the use of Kabiven during pregnancy and lactation. Kabiven should therefore only be given to pregnant or lactating women if the doctor deems it necessary.

Driving and using machines

Kabiven is not expected to affect your ability to drive or use machines.

How Kabiven is given

This medicine will only be given to you by infusion into a central vein. Your body weight in kilograms and your body’s ability to use fat and sugar determine the dosage of one of Kabiven and the bag size used. Kabiven will be slowly given into a blood vessel for 12-24 hours. Your doctor will determine the correct dosage for you or your child. You may be monitored during treatment.

Use for children

Kabiven is not adapted for the treatment of newborns or children under two years of age.

If you take more Kabiven than you should

It is unlikely that you will receive too much medicine, as healthcare professionals will monitor you during treatment. The effects of an overdose can be nausea, vomiting, sweating, and fluid retention. Hyperglycaemia (too much sugar in the blood) and disturbances in the salt balance have also been reported. In the event of an overdose, there is a risk of absorbing too much fat. This is called “fat overload syndrome”. See section 4 “Possible side effects” for more information. If you experience any of the symptoms described above or think you have had too much Kabiven, tell your doctor or nurse immediately. Infusion one will be discontinued or dosage one will be reduced. Usually, the symptoms disappear when the infusion is stopped or dosage and reduced.

If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Kabiven can cause an allergic reaction (very rare, may affect up to 1 in 10,000 users). Tell your doctor immediately if:

Other side effects include:

Common side effects are (may affect up to 1 in 10):

  • small increase in body temperature.

Less common side effects are (may affect up to 1 in 100):

  • overindulge
  • fatigue
  • magont
  • headache
  • nausea and vomiting
  • elevated liver levels in the blood (your doctor will tell you if this happens)

Very rare side effects are (may affect up to 1 in 10 000 users):

  • low or high blood pressure
  • respiratory distress
  • prolonged, painful erection in men
  • problem with the blood

Fat overload syndrome
This can occur when your body has problems using fat because you have received too much Kabiven. It can also occur when your condition suddenly changes (such as in kidney problems or an infection ). Possible symptoms are fever, increased fat levels in the blood, cells, and tissues, disorders of various organs, and coma. All these symptoms disappear if the infusion is stopped.

How to store Kabiven

Keep this medicine out of the sight and reach of children.

The medical staff is responsible for the correct storage, use, and disposal of Kabiven.
Do not store above 25 ° C. Do not freeze. Always store in the outer bag.

Do not use this medicine after the expiry date which is stated on the label of the sachet and the outer carton.

Do not use it if the bag leaks.

For single use only. Any remaining mixture should be discarded.

Contents of the pack and other information

Content declaration

The kabiven consists of a three-chamber bag. Each bag contains the following different volumes depending on the package size:

  2566 ml 2053 ml 1540 ml 1026 ml
Glucose ( Glucose 190 mg / ml) 1316 ml 1053 ml 790 ml 526 ml
Amino acids and electrolytes (Vitamin 18 Novum) 750 ml 600 ml 450 ml 300 ml
Fat emulsion (Intralipid 200 mg / ml) 500 ml 400 ml 300 ml 200 ml

The active substances are:
Soybean oil, purified 100 g 80 g 60 g 40 g
Glucose monohydrate 275 g 220 g 165 g 110 g
   -equivalent glucose (anhydrous) 250 g 200 g 150 g 100 g
Alanine 12.0 g 9.6 g 7.2 g 4.8 g
Arginine 8.5 g 6.8 g 5.1 g 3.4 g
Aspartic acid 2.6 g 2.0 g 1.5 g 1.0 g
Phenylalanine 5.9 g 4.7 g 3.6 g 2.4 g
Glutamic acid 4.2 g 3.4 g 2.5 g 1.7 g
Glycine 5.9 g 4.7 g 3.6 g 2.4 g
Histidine 5.1 g 4.1 g 3.1 g 2.0 g
Isoleucine 4.2 g 3.4 g 2.5 g 1.7 g
Leucine 5.9 g 4.7 g 3.6 g 2.4 g
Lysine hydrochloride 8.5 g 6.8 g 5.1 g 3.4 g
   -corresponding lysine 6.8 g 5.4 g 4.1 g 2.7 g
Methionine 4.2 g 3.4 g 2.5 g 1.7 g
Proline 5.1 g 4.1 g 3.1 g 2.0 g
Serine 3.4 g 2.7 g 2.0 g 1.4 g
Troponin 4.2 g 3.4 g 2.5 g 1.7 g
Tryptophan 1.4 g 1.1 g 0.86 g 0.57 g
Tyrosine 0.17 g 0.14 g 0.10 g 0.07 g
Valin 5.5 g 4.4 g 3.3 g 2.2 g
Calcium chloride 2 H 2 O 0.74 g 0.59 g 0.44 g 0.29 g
   -equivalent calcium chloride 0.56 g 0.44 g 0.33 g 0.22 g
Sodium glycerophosphate (anhydrous) 3.8 g 3.0 g 2.3 g 1.5 g
Magnesium sulfate 7 H 2 O 2.5 g 2.0 g 1.5 g 0.99 g
   -corresponding magnesium sulfate 1.2 g 0.96 g 0.72 g 0.48 g
Potassium chloride 4.5 g 3.6 g 2.7 g 1.8 g
Sodium acetate 3 H 2 O 6.1 g 4.9 g 3.7 g 2.5 g
   -equivalent sodium acetate 3.7 g 2.9 g 2.2 g 1.5 g

Other ingredients are

purified egg phospholipids,

glycerol,

sodium hydroxide,

acetic acid,

water for injections.

What the medicine looks like and contents of the pack

The glucose and amino acid solutions are clear, colorless, or faintly yellow and the fat emulsion is white. The kabiven consists of a three-chamber bag and an outer bag. An oxygen absorber is placed between the inner bag and the outer bag, which must be discarded before use. The inner bag is separated into three chambers by openable weak welds (closures). The contents of the three chambers must be mixed before use, by opening the weak welds.

Pack sizes:

1 x 1026 ml, 4 x 1026 ml

1 x 1540 ml, 4 x 1540 ml

1 x 2053 ml, 4 x 2053 ml

1 x 2566 ml, 3 x 2566 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi AB

751 74 Uppsala

Manufacturer

Fresenius Kabi AB, 751 74 Uppsala, Sweden

Muhammad Nadeem

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