infusion solution, emulsion

What Kabiven Perifer is and what it is used for

Kabiven Peripheral consists of a three-chamber bag having an outer bag. Kabiven Peripheral contains amino acids (protein building blocks), fat, 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 Peripheral functions as part of balanced intravenous nutrition together with further salts, trace elements, and vitamins you satisfy all your nutrition needs.

What you need to know before you are given Kabiven Perifer

You should not get Kabiven Perifer

  • 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 you are given Kabiven Peripheral 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 you are receiving Kabiven Peripheral.

Your doctor may do regular blood tests to ensure that the treatment with Kabiven Peripheral is working properly.

Children

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

Other drugs and Kabiven Peripher

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.

Experience with the use of Kabiven Peripheral in pregnancy and lactation is lacking. Kabiven Peripheral should therefore be given to pregnant or lactating women if the doctor after careful consideration finds it necessary to give intravenous nutrition ( parenteral nutrition ).

Driving and using machines

Kabiven Peripheral should not affect your ability to drive and use machines.

How Kabiven Perifer is given

This medicine will only be given to you by infusion (drip into a vein). Your body weight in kilograms and your body’s ability to use fat and sugar will determine the dosage of Kabiven Peripheral and which bag size is used. Kabiven Peripheral will be given slowly into a vein 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 Peripheral is not suited for treating newborns or children under two years of age.

If you take more Kabiven Perifer 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 believe that you have received too much Kabiven Peripheral, say immediately to your doctor or nurse. Infusion one will be discontinued or dosage one will be reduced. Usually, the symptoms disappear when infused one is discontinued or the dosing one is 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 Peripheral can cause an allergic reaction (very rare, may affect up to 1 in 10 000). 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
  • inflammation of the vein where Kabiven Peripheral given

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

Fettöverbelastingssyndrom
This can happen when your body has problems using fat, because of having too much Kabiven Peripheral. 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 Perifer

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 Peripheral.
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

What Kabiven Perifer contains

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

  2400 ml 1920 ml 1440 ml
Glucose ( Glucose 110 mg / ml) 1475 ml 1180 ml 885 ml
Amino acids and electrolytes (Vitamin 18 Novum) 500 ml 400 ml 300 ml
Fat emulsion (Intralipid 200 mg / ml) 425 ml 340 ml 255 ml

The active substances are:
Soybean oil, purified 85 g 68 g 51 g
Glucose monohydrate 178 g 143 g 107 g
   corresponding glucose (anhydrous) 162 g 130 g 97 g
Alanine 8.0 g 6.4 g 4.8 g
Arginine 5.6 g 4.5 g 3.4 g
Aspartic acid 1.7 g 1.4 g 1.0 g
Phenylalanine 4.0 g 3.2 g 2.4 g
Glutamic acid 2.8 g 2.2 g 1.7 g
Glycine 4.0 g 3.2 g 2.4 g
Histidine 3.4 g 2.7 g 2.0 g
Isoleucine 2.8 g 2.2 g 1.7 g
Leucine 4.0 g 3.2 g 2.4 g
Lysine hydrochloride 5.6 g 4.5 g 3.4 g
   corresponding to lysine 4.5 g 3.6 g 2.7 g
Methionine 2.8 g 2.2 g 1.7 g
Proline 3.4 g 2.7 g 2.0 g
Serine 2.2 g 1.8 g 1.4 g
Troponin 2.8 g 2.2 g 1.7 g
Tryptophan 0.95 g 0.76 g 0.57 g
Tyrosine 0.12 g 0.092 g 0.069 g
Valin 3.6 g 2.9 g 2.2 g
Calcium chloride 2 H 2 O 0.49 g 0.39 g 0.29 g
   corresponding to calcium chloride 0.37 g 0.30 g 0.22 g
Potassium chloride 3.0 g 2.4 g 1.8 g
Magnesium sulfate 7 H 2 O 1.6 g 1.3 g 0.99 g
   corresponding magnesium sulfate 0.80 g 0.64 g 0.48 g
Sodium acetate 3 H 2 0 4.1 g 3.3 g 2.5 g
   corresponding sodium acetate 2.4 g 2.0 g 1.5 g
Sodium glycerophosphate (anhydrous) 2.5 g 2.0 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. Kabiven Peripheral 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 1440 ml, 4 x 1440 ml

1 x 1920 ml, 4 x 1920 ml

1 x 2400 ml, 3 x 2400 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

Muhammad Nadeem

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