Smofkabiven Peripheral

What SmofKabiven Peripheral looks like and contents of the pack: Glucose- and amino acid solutions are clear, colourless or slightly yellow and free from particles. The lipid emulsion is white and homogenous.
What SmofKabiven Peripheral contains: The active substances (g per 1000 ml) are Glucose (as monohydrate) 71 g, Alanine 4.4 g, Arginine 3.8 g, Glycine 3.5 g, Histidine 0.93 g, Isoleucine 1.6 g, Leucine 2.3 g, Lysine (as acetate) 2.1 g, Methionine 1.3 g, Phenylalanine 1.6 g, Proline 3.5 g, Serine 2.1 g, Taurine 0.32 g, Threonine 1.4 g, Tryptophan 0.63 g, Tyrosine 0.12 g, Valine 2.0 g, Calcium chloride (as dihydrate) 0.18 g, Sodium glycerophosphate (as hydrate) 1.3 g, Magnesium sulphate (as heptahydrate) 0.38 g, Potassium chloride 1.4 g, Sodium acetate (as trihydrate) 1.1 g, Zinc sulphate (as heptahydrate) 0.004 g, Soya-bean oil, refined 8.5 g, Medium-chain triglycerides 8.5 g, Olive oil, refined 7.0 g, Fish oil, rich in omega-3-acids 4.2 g.
Excipients/Inactive Ingredients: The other ingredients are: glycerol, purified egg phospholipids, all-rac-α-tocopherol, sodium hydroxide (pH-adjustment), sodium oleate, acetic acid glacial (pH-adjustment) and water for injections.

SmofKabiven Peripheral is an emulsion for infusion given into the blood by a drip (intravenous infusion). The product contains glucose (carbohydrates), amino acids (components used to build proteins), salts (electrolytes) and lipids (fat) in a plastic bag.
A health care professional will give SmofKabiven Peripheral when other forms of feeding are not good enough or have not worked.

The doctor will decide on the dose for the patient individually depending on the body weight and function. SmofKabiven Peripheral will be given to the patient by a health care professional.
If the patient gets more SmofKabiven Peripheral than they should: It is unlikely that the patient will receive too much medicine as SmofKabiven Peripheral is given to the patient by a health care professional.
Method of administration: Intravenous use, infusion into a peripheral or a central vein.
To provide total parenteral nutrition, trace elements, vitamins and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven Peripheral) should be added to SmofKabiven Peripheral according to the patients need.
Infusion rate: The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acid 0.1 g/kg bw/h, and for fat 0.15 g/kg bw/h.
The infusion rate should not exceed 3.0 ml/kg bw/h (corresponding to 0.21 g glucose, 0.10 g amino acids, and 0.08 g fat/kg bw/h). The recommended infusion period is 14-24 hours.

Do not use SmofKabiven Peripheral: If the patient is allergic (hypersensitive) to any of the ingredients of SmofKabiven Peripheral.
If the patient is allergic to fish or egg.
If the patient is allergic to peanuts or soya, they should not use this product. SmofKabiven Peripheral contains soya-bean oil.
If the patient has too much fat in the blood (hyperlipidemia).
If the patient has serious liver disease.
If the patient has blood clotting problems (coagulation disorders).
If the body has problems using amino acids.
If the patient has serious kidney disease without access to dialysis.
If the patient is in acute shock.
If the patient has too much sugar in the blood (hyperglycaemia) which is uncontrolled.
If the patient has high blood (serum) levels of the salts (electrolytes) included in SmofKabiven Peripheral.
If the patient has fluid in the lungs (acute pulmonary oedema).
If the patient has too much body fluid (hyperhydrated).
If the patient has heart failure that is not treated.
If the patient has a defect in the blood clotting system (hemophagocytic syndrome).
If the patient is in an unstable condition, such as after serious trauma, uncontrolled diabetes, acute heart attack, stroke, blood clot, metabolic acidosis (a disturbance resulting in too much acid in the blood), serious infection (severe sepsis), coma and if the patient doesn't have enough body fluid (hypotonic dehydration).

Tell the doctor if the patient has: kidney problems; diabetes mellitus; pancreatitis (inflammation of the pancreas); liver problems; hypothyroidism (toxic goiter); sepsis (serious infection).
If the patient during the infusion gets fever, rash, swelling, difficulty in breathing, chills, sweating, nausea or vomiting, tell the health care professional immediately because these symptoms might be caused by an allergic reaction or that the patient has been given too much of the medicine.
The doctor may regularly need to check the blood for liver function tests and other values.
SmofKabiven Peripheral is not meant for newborn babies or children younger than 2 years of age. At the moment, there is no experience of the use of SmofKabiven Peripheral in children from 2 to 11 years old.
To avoid risks associated with too rapid infusion rates, it is recommended to use a continuous and well-controlled infusion, if possible, by using a volumetric pump.
Since an increased risk of infection is associated with the use of any peripheral vein, strict aseptic precautions should be taken to avoid any contamination especially during catheter insertion.
Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver and enzyme tests should be monitored.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.
SmofKabiven Peripheral should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.
Thrombophlebitis may occur if peripheral veins are used for infusions. The catheter insertion site should be evaluated daily for local signs of thrombophlebitis.
Driving and using machines: Not relevant as the medicine is given at the hospital.

Pregnancy and breast-feeding: Data from using SmofKabiven Peripheral during pregnancy or breast-feeding is lacking. SmofKabiven Peripheral should therefore be given to pregnant or breast-feeding women only if the doctor finds it necessary. The use of SmofKabiven may be considered during pregnancy and breastfeeding, as advised by the doctor.

Like all medicines, SmofKabiven Peripheral can cause side effects, although not everybody gets them.
Common (occurs in more than one in 100 patients): a slightly raised body temperature.
Uncommon (occurs in less than 1 in 100 patients but in more than 1 in 1000 of patients): high blood (plasma) levels of compounds from the liver, lack of appetite, nausea, vomiting, chills, dizziness and headache.
Rare (occurs in less than 1 in 1000 of patients but in more than 1 in 10000 patients): low or high blood pressure, difficulty in breathing, fast heart beat (tachycardia). Hypersensitivity reactions (that can give symptoms like swelling, fever, fall in blood pressure, skin rashes, wheals (raised red areas), flushing, headache). Sensations of hot and cold. Pain in the neck, back, bones and breast. Paleness. Light blue coloured lips and skin (because of too less oxygen in the blood).
If any of these side effects occurs, or if the patient notices any side effects not listed in this monograph, contact a doctor or a pharmacist.

Tell the doctor if the patient has or recently has taken some medicines, even without prescription.

Precautions for disposal: Do not use if package is damaged.
Use only if the amino acid and glucose solutions are clear and colourless or slightly yellow and the lipid emulsion is white and homogenous. The contents of the three separate chambers have to be mixed before use, and before any additions are made via the additive port.
After separation of the peelable seals the bag should be inverted on a number of occasions to ensure a homogenous mixture, which does not show any evidence of phase separation.
For single use only. Any unused solution remaining after infusion should be discarded.
Compatibility: Only medicinal or nutrition solutions for which compatibility has been documented may be added to SmofKabiven Peripheral. Compatibility for different additives and the storage time of the different admixtures will be available upon request.
Additions should be made aseptically.
Instructions for use: 1. Removal of overpouch: To remove overpouch, hold the bag horizontally and tear from the notch close to the ports along the upper edge.
Then simply tear the long side, pull off the overpouch and discard it along with the oxygen absorber.
2. Mixing: Place the bag on a flat surface.
Roll up the bag tightly from the handle side towards the ports, firstly with the right hand and then applying a constant pressure with the left hand until the vertical seals are broken. The vertical peel seals open due to the pressure of the fluid.
The peel seals can also be opened before removing the overpouch.
Note: The liquids mix easily although the horizontal seal remains closed.
Mix the contents of the three chambers by inverting the bag three times until the components are thoroughly mixed.
3. Finalising the preparation: Place the bag on a flat surface again. Shortly before injecting the additives, break off the tamper-evident arrow flag from the white additive port.
Note: The membrane in the additive port is sterile.
Hold the base of the additive port. Insert the needle, inject the additives (with known compatibility) through the centre of the injection site.
Mix thoroughly between each addition by inverting the bag three times. Use syringes with needles of 18-23 gauge and a length of max. 40 mm.
Shortly before inserting the infusion set, break off the tamper evident arrow flag from the blue infusion port.
Note: The membrane in the infusion port is sterile.
Use a non-vented infusion set or close the air-inlet on a vented set.
Hold the base of the infusion port.
Push the spike through the infusion port.
The spike should be fully inserted to secure it in place.
Note: The inner part of the infusion port is sterile.
4. Hanging up the bag: Hang the bag up by the hole below the handle.

Store in overpouch. Do not store above 25°C. Do not freeze.
Shelf-life after mixing: Chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for 36 hours at 25°C. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.
Shelf-life after mixing with additives: From a microbiological point of view, the product should be used immediately when additions have been made. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user. The storage time should normally not be longer than 24 hours at 2-8°C.

Parenteral Nutritional Products

B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.

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