PERIVEN - PACKAGE LEAFLET - LEAFLETS

Home / leaflets / 2021

Periven - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Glucose, Amino Acids, Electrolytes, Lipids

Periven - Emulsion for infusion

Indications Why is Periven used? What is it for?

Periven consists of a bag with three compartments and an overpouch. Periven contains the following medicines: amino acid solution (building blocks of proteins), lipid solution, glucose solution and electrolyte solution. It supplies energy (such as sugar and lipids) and amino acids into the bloodstream in cases where normal nutrition is not possible.

It is used as part of a balanced intravenous diet, along with salts, trace elements and vitamins which together provide the complete nutritional need.

Contraindications When Periven should not be used

You should not be given Periven:

if you are allergic to any of the active substances or to 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 a content of lipid substances in your blood (such as cholesterol)
if you have severely reduced liver function
if you suffer from acute shock (resulting from heavy blood loss or an allergic reaction)
if you have a congenital defect of the blood clotting system (haemophagocytic syndrome) or if the blood does not clot properly
if you have a condition where your body has problems using proteins or amino acids
if you have severe kidney problems
if you have hyperglycaemia (too much blood sugar) in cases where more than 6 units of insulin per hour are required
if you have increased levels of electrolytes (salts) in your blood
if you have metabolic acidosis (the acid levels of the fluids in your body and tissues become too high)
if you have too much fluid in your body - overhydration
if you have fluid in your lungs (acute pulmonary edema)
if you are dehydrated with low levels of salts
if you have heart problems
if you are in a coma
if you have severe sepsis (a condition in which your body has a severe infection).

Precautions for use What you need to know before you take Periven

Talk to your doctor before taking Periven if you have:

impaired liver function
untreated diabetes
a condition in which your body has problems using lipids appropriately
kidney problems
any pancreatic problems
thyroid problems - hypothyroidism
sepsis (a condition in which your body is affected by an infection)
your body has trouble eliminating electrolytes
a condition where there is not enough oxygen in his cells
increased osmolarity of the serum

If during the infusion you get fever, rash, chills or have difficulty breathing tell the healthcare professionals immediately. These symptoms may be caused by an allergic reaction or indicate that you have been given too much medicine (see section 4).

This medicine can affect the results of other tests you may do. It is important to tell any doctor who is testing you that you are taking Periven.

Your doctor may want to have regular blood tests to make sure your Periven treatment is working properly.

Children

Periven should not be given to infants or children under 2 years of age.

Interactions Which drugs or foods can modify the effect of Periven

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 known as heparin which is used to prevent blood clots from forming and helping to disperse
warfarin, as Vitamin K1, which is contained in soybean oil, can impair the ability of blood to clot
insulin to treat diabetes

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of using Periven during pregnancy or breastfeeding has not been studied. If nutrition directly through the veins (parenteral nutrition) is deemed necessary during pregnancy or breastfeeding, your doctor will only give you Periven after careful consideration.

Driving and using machines

Periven is not expected to affect the ability to drive or use machines.

Dosage and method of use How to use Periven: Dosage

You will receive the medicine by infusion (intravenous drip infusion).

The dose of Periven and which pack is used depends on your body weight in kilograms and your body's ability to use lipids and sugar. Periven will be infused slowly over 12-24 hours. Your doctor will decide on the correct dose you or your child should receive.It must be monitored during treatment.

Children

Periven is not suitable for use in infants or children under two years of age.

Overdose What to do if you have taken too much Periven

It is very unlikely that you will receive more solution infused than you should as your doctor or nurse will monitor you during treatment. The effects of an overdose may include nausea, vomiting, sweating and fluid retention. Hyperglycaemia (too much sugar in the blood) has also been reported. blood) and disturbances in the electrolyte balance. In the event of an overdose there is a "risk of taking too many lipids. This is called" lipid overload syndrome ". See section 4" Possible side effects "for more information. If you notice any of the symptoms described above or believe if you have received too much Periven tell your doctor or nurse immediately. The infusion can either be stopped immediately or continued at a reduced dose. These symptoms usually disappear by decreasing the rate of infusion or by stopping the infusion.

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

Side Effects What are the side effects of Periven

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

Periven can cause an allergic reaction. Very rare (may affect up to 1 in 10,000 people).

Tell your doctor immediately if:

itchy, bumpy rash appears in your body
has too high a temperature
have difficulty breathing.

Other side effects include:

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

a slight increase in body temperature
inflammation of the vein where the infusion was given.

Uncommon side effects (may affect up to 1 in 100 people)

chills
tiredness
stomach ache
headache
nausea or vomiting
increased levels of enzymes. Your doctor will tell you if this happens.

Very rare side effects (may affect up to 1 in 10,000 people)

high or low blood pressure
difficulty in breathing
prolonged and painful erections in men
blood problems.

Lipid overload syndrome

This can happen if your body has problems using lipids, because you have taken too much Periven. It can also happen due to a sudden change in your condition (such as kidney problems or infection). Possible symptoms are fever, increased blood levels. lipids in the blood, its cells and tissues, disorders in various organs and coma. All these symptoms usually disappear if the infusion is stopped.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it. / responsible. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

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

The doctor and hospital pharmacist are responsible for the proper storage, use and disposal of Periven. Do not store above 25 ° C. Do not freeze and always keep the container in the package.

The emulsion must not be used after the expiry date indicated on the label.

Do not use if the bag is leaking.

Use for one administration only. Any unused residues must be discarded.

Other information

What Periven contains

Periven is available in a pouch with a three compartment system. Each bag contains the following different volumes in relation to the three packs:

2400 ml 1920 ml 1440 ml Glucose (Glucose 11%) 1475 ml 1180 ml 885 ml Amino acids and electrolytes (Vamin 18 Novum) 500 ml 400 ml 300 ml Lipid emulsion (Intralipid 20%) 425 ml 340 ml 255 ml

The active ingredients are

2400 ml 1920 ml 1440 ml Purified soybean oil 85 g 68 g 51 g Glucose monohydrate corresponding to Glucose (anhydrous) 178 g 162 g 143 g 130 g 107 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 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 corresponding to Lysine 5.6 g 4.5 g 4.5 g 3.6 g 3.4 g 2.7 g Methionine 2.8 g 2.2 g 1.7 g Phenylalanine 4.0 g 3.2 g 2.4 g Proline 3.4 g 2.7 g 2.0 g Serine 2.2 g 1.8 g 1.4 g Threonine 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 Valina 3.6 g 2.9 g 2.2 g Calcium chloride 2 H2O corresponding to Calcium chloride 0.49 g 0.37 g 0.39 g 0.30 g 0.29 g 0.22 g Sodium glycerophosphate (anhydrous) 2.5 g 2.0 g 1.5 g Magnesium sulphate 7 H2O corresponding to Magnesium sulphate 1.6 g 0.80 g 1.3 g 0.64 g 0.99 g 0.48 g Potassium chloride 3.0 g 2.4 g 1.8 g Sodium acetate 3 H2O corresponding to Sodium acetate 4.1 g 2.4 g 3.3 g 2.0 g 2.5 g 1.5 g

The other ingredients are:

purified egg phospholipids
glycerol
sodium hydroxide
glacial acetic acid
water for injections.

Description of what Periven looks like and contents of the pack

The glucose and amino acid solutions are clear and colorless or slightly yellow and the lipid emulsion is white. Periven consists of a bag with three compartments and an overpouch. An oxygen absorber is placed between the inner bag and the overpouch, which must be be discarded before use. The inner bag is divided into three compartments by openable partitions. The contents of the three compartments must be mixed before use, by opening the dividers that can be opened.

Packaging:

1 x 1440ml, 4 x 1440ml
1 x 1920 ml, 2 x 1920 ml, 4 x 1920 ml (Biofine)
1 x 2400 ml, 2 x 2400 ml, 3 x 2400 ml (Biofine)

Not all pack sizes may be marketed.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information about Periven can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

PERIVEN

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Periven is available in tripartite bags. Each compartment of the bag contains, depending on the various packs, the following different volumes:

2400 ml 1920 ml 1440 ml Glucose (Glucose 11%) 1475 ml 1180 ml 885 ml Amino acids and electrolytes (Vamin 18 Novum) 500 ml 400 ml 300 ml Lipid emulsion (Intralipid 20%) 425 ml 340 ml 255 ml

The corresponding total compositions are as follows:

Active principles: 2400 ml 1920 ml 1440 ml Purified soybean oil 85 g 68 g 51 g Glucose monohydrate corresponding to glucose (anhydrous) 178 g 162 g 143 g 130 g 107 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 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 corresponding to Lysine 5.6 g 4.5 g 4.5 g 3.6 g 3.4 g 2.7 g Methionine 2.8 g 2.2 g 1.7 g Phenylalanine 4.0 g 3.2 g 2.4 g Proline 3.4 g 2.7 g 2.0 g Serine 2.2 g 1.8 g 1.4 g Threonine 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 Valina 3.6 g 2.9 g 2.2 g Calcium chloride dihydrate corresponding to calcium chloride 0.49 g 0.37 g 0.39 g 0.30 g 0.29 g 0.22 g Sodium glycerophosphate (anhydrous) 2.5 g 2.0 g 1.5 g Magnesium sulfate heptahydrate corresponding to magnesium sulfate 1.6 g 0.80 g 1.3 g 0.64 g 0.99 g 0.48 g Potassium chloride 3.0 g 2.4 g 1.8 g Sodium acetate trhydrate corresponding to sodium acetate 4.1 g 2.4 g 3.3 g 2.0 g 2.5 g 1.5 g

Corresponding to

2400 ml 1920 ml 1440 Amino acids 57 g 45 g 34 Nitrogen 9.0 g 7.2 g 5,4 Lipids 85 g 68 g 51 Carbohydrates - Glucose (anhydrous) 162 g 130 g 97 g Caloric power - Total approx 1700 kcal 1400 kcal 1000 kcal - Not proteinaceous about 1500 kcal 1200 kcal 900 kcal Electrolytes sodium 53 mmol 43 mmol 32 mmol potassium 40 mmol 32 mmol 24 mmol magnesium 6.7 mmol 5.3 mmol 4.0 mmol football 3.3 mmol 2.7 mmol 2.0 mmol phosphate1 18 mmol 14 mmol 11 mmol sulphate 6.7 mmol 5.3 mmol 4.0 mmol chloride 78 mmol 62 mmol 47 mmol acetate 65 mmol 52 mmol 39 mmol

Osmolality about 830 mosm / kg H2O

Osmolarity about 750 mosm / l

pH about 5.6

For excipients see section 6.1.

(1 the contribution derives from both Intralipid® and Vamin®)

03.0 PHARMACEUTICAL FORM

Emulsion for infusion.

The bag containing Periven consists of three compartments. Each compartment contains glucose, amino acid solution and lipid emulsion, respectively. The glucose solution and the amino acid solution are clear and colorless or slightly yellow in color and the lipid emulsion is white and homogeneous.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Parenteral nutrition in patients and children over 2 years of age when oral or enteral nutrition is not possible, insufficient or contraindicated.

04.2 Posology and method of administration

The ability to eliminate lipids and metabolise glucose should guide the dosage and rate of infusion.

See section 4.4 "Special warnings and precautions for use".

The dose must be established individually and the use of packs of different volumes must be carried out in relation to the clinical condition of the patient, his body weight and nutritional needs.

Adult patients:

The nitrogen requirement for maintaining body protein mass depends on the patient's condition (e.g. nutritional status and degree of catabolic stress). The requirement is 0.10-0.15 g of nitrogen / kg / day under normal nutrition conditions. In patients with moderate to severe metabolic stress, with or without malnutrition, the requirement is in the order of 0.15-0.30 g of nitrogen / kg / day (1.0-2.0 g of amino acids / kg / day). The corresponding commonly accepted requirement is 2.0-6.0 g for glucose and 1.0-2.0 g for lipids.

The total energy requirement depends on the clinical condition of the patient and, very often, varies from 20 to 30 kcal / kg / day. In obese patients, the dose should be calibrated on the estimated ideal weight.

Periven is produced in three different volumes intended for patients with moderately high, basal or low nutritional needs.

The addition of additional trace elements, vitamins and electrolytes may be required to provide total parenteral nutrition.

The dose of 0.10-0.15 g nitrogen / kg / day (0.7-1.0 g amino acids / kg / day) and a total energy of 20-30 kcal / day corresponds to about 27-40 ml of Periven / kg / day.

Children:

The posology should be determined by the individual's ability to metabolise nutrients.

In general in young children (2-10 years of age) the infusion should be started with a low dose of 14 - 28 ml / kg / day (corresponding to 0.49-0.98 g lipids / kg / day, 0.34 -0.67 g amino acids / kg / day and 0.95 - 1.9 g glucose / kg / day) and be increased by 10 - 15 ml / kg / day up to a maximum dosage of 40 ml / kg / day.

For children over 10 years of age, the adult dosage can be used.

It is not recommended to use Periven in children under 2 years of age in whom the amino acid cysteine can be considered conditionally essential.

Infusion rate

The maximum infusion rate for glucose is 0.25 g / kg / h.

The dose of amino acids must not exceed 0.1 g / kg / h.

The lipid dose should not deliver more than 0.15 g / kg / h.

The infusion rate should not exceed 3.7 ml / kg / h (corresponding to 0.25 g of glucose, 0.09 g of amino acids and 0.13 g of lipids / kg). The recommended infusion period for single bags of Periven is 12-24 hours.

Maximum daily dose:

40 ml / kg / day. This is equivalent to the content of one bag (the largest in volume) for a 64 kg patient and provides 0.96 g of amino acids / kg / day (0.16 g of nitrogen / kg / day), 25 kcal / kg / day of non-protein energy (2.7 g glucose / kg / day and 1.4 g of lipids / kg / day).

The maximum daily dose varies according to the clinical condition of the patient and may also vary from day to day.

Method and duration of administration:

Intravenous infusion via peripheral or central vein only. The infusion can be continued for as long as required by the patient's clinical condition.

To minimize the risk of thrombophlebitis due to peripheral vein administration it is recommended to alternate the infusion site daily.

04.3 Contraindications

Hypersensitivity to egg, soy or peanut proteins or to any of the active substances or excipients.

Severe hyperlipidemia.

Severe hepatic insufficiency.

Severe coagulation disorders.

Congenital anomalies of amino acid metabolism.

Severe renal insufficiency without the possibility of recourse to haemofiltration or dialysis.

Acute shock.

Hyperglycemia requiring more than 6 units of insulin / hour.

Pathologically elevated serum levels of each of the electrolytes present.

General contraindications for any infusion therapy: acute pulmonary edema, overhydration, decompensated heart failure and hypotonic dehydration.

Hemophagocytotic syndrome.

Unstable conditions (e.g. severe post-traumatic conditions, decompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma).

Infants and children under 2 years of age.

04.4 Special warnings and appropriate precautions for use

The ability to eliminate lipids must be monitored.

It is recommended that such monitoring is done by checking serum triglycerides after a fat-free period of 5-6 hours.

The serum concentration of triglycerides during infusion should not exceed 3 mmol / l.

The packaging must be carefully chosen, especially the volume and quantitative composition. The volumes must be adapted according to the hydration and nutritional status of the children. A reconstituted bag is used for one administration only.

Disturbances in electrolyte and fluid balance (eg abnormally high or low serum electrolyte levels) must be corrected before starting the infusion.

Close clinical monitoring is required at the start of any intravenous infusion. If any abnormal symptoms occur, the infusion should be stopped. Since using a central vein increases the risk of infection, strict aseptic precautionary measures must be taken to avoid any contamination during catheter insertion and handling.

Periven should be administered with caution in conditions of impaired lipid metabolism due to renal insufficiency, in uncompensated diabetes mellitus, in pancreatitis, in case of impaired liver function, in hypothyroidism (with hypertriglyceridaemia) or in case of sepsis.

If Periven is administered to patients with these conditions, close monitoring of serum triglycerides is mandatory.

Blood glucose, serum electrolytes, osmolarity, as well as fluid balance, acid-base balance and liver enzymes should be checked regularly.

CBC and coagulation should be monitored when lipids are administered for an extended period.

In patients with renal insufficiency, the intake of phosphates and potassium should be carefully monitored to prevent "hyperphosphatemia and" hyperkalemia.

The amount of additional electrolytes should be determined by regular monitoring taking into account the patient's clinical condition.

This emulsion does not contain vitamins and trace elements.

The addition of trace elements and vitamins is always required.

Parenteral nutrition should be practiced with caution in cases of metabolic acidosis (eg in "lactic acidosis), increased serum osmolarity or in case of need for a recall of liquids.

Periven should be administered with caution in patients with a tendency to electrolyte retention.

Any signs or symptoms of anaphylactic reaction should lead to immediate discontinuation of the infusion.

The lipid content of Periven may interfere with some laboratory controls (e.g. bilirubin, lactate dehydrogenase, oxygen saturation, Hb) if blood is drawn before the lipids have been adequately removed from the bloodstream.

In most patients, lipids are cleared from the blood after a fat-free interval of 5-6 hours.

This medicine contains soybean oil and egg phospholipids, which in rare cases can cause allergic reactions. Cross-allergies have been observed between soybeans and peanuts.

Intravenous infusion of amino acids may be accompanied by increased urinary excretion of trace elements, especially zinc. In patients requiring long-term intravenous nutrition, additional trace elements may be required.

In malnourished patients, the initiation of parenteral nutrition can precipitate fluid transfer which can lead to pulmonary edema and congestive heart failure. In addition, a decrease in serum concentrations of potassium, phosphorus, magnesium and water-soluble vitamins may occur within 24-48 hours.

A careful and slow initiation of parenteral nutrition is recommended, accompanied by careful monitoring and adequate adjustment of the intake of fluids, electrolytes, minerals and vitamins.

Periven must not be administered simultaneously through the same infusion set with blood and blood derivatives.

In patients with hyperglycaemia, administration of exogenous insulin may be necessary.

Infusion via peripheral veins:

As with all hypertonic solutions, thrombophlebitis can occur if peripheral veins are used for the infusion. Multiple factors contribute to the incidence of thrombophlebitis. These include the type of cannula used and its diameter and length, the duration of infusion, the pH and the osmolality of the infused substances, infections and the number of manipulations. It is recommended that venous accesses for parenteral nutrition are not used for other intravenous additives or solutions.

04.5 Interactions with other medicinal products and other forms of interaction

Heparin administered at clinical doses causes a transient release of lipoprotein lipase into the circulation. This may lead to an initial increased plasma lipolysis followed by a transient decrease in the elimination of triglycerides.

Some drugs, such as insulin, can interfere with the lipase system but there is no evidence that this can have adverse effects on the therapeutic value.

Soybean oil has a natural content of vitamin K1 which can interfere with coagulation, especially in patients treated with coumarin derivatives. In practice, this is an uncommon occurrence, however careful monitoring of coagulation is suggested in patients receiving these drugs.

There are no clinical data demonstrating that any of the above mentioned interactions are of definite clinical relevance.

04.6 Pregnancy and breastfeeding

No specific studies have been performed to determine the safety of Periven in pregnancy and during lactation. The physician prescribing Periven must consider the benefit / risk ratio before administration to pregnant or breastfeeding women.

04.7 Effects on ability to drive and use machines

Not relevant.

04.8 Undesirable effects

The infusion may cause an increase in body temperature (incidence of chills and nausea / vomiting (intravenous incidence also transient increases in liver enzymes have been reported).

As with all hypertonic solutions for infusion, thrombophlebitis can occur if peripheral veins are used. Reports of other side effects in connection with the components are extremely rare.

Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (e.g. tachypnea) and hyper / hypotension have been reported.

Hemolysis, reticulocytosis, abdominal pain, headache, nausea, vomiting, fatigue and priapism have been reported.

Lipid overload syndrome:

An impaired ability to eliminate fat can lead to a lipid overload syndrome as a result of an overdose, but also with the recommended infusion rate in conjunction with a sudden change in the patient's clinical condition, such as worsening kidney function or infection.

Lipid overload syndrome is characterized by hyperlipidemia, fever, hepatomegaly, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorders and coma.

All symptoms are always reversible if the infusion is stopped.

04.9 Overdose

See section 4.8 "Lipid overload syndrome".

Nausea, vomiting, and sweating were observed during amino acid infusion at rates greater than the recommended maximum rate.

If symptoms of overdose appear, the infusion rate should be decreased or the administration stopped.

In addition, an overdose can cause fluid overload, electrolyte imbalances, hyperglycemia and hyperosmolality.

In some rare severe cases, hemodialysis, haemofiltration or haemodiafiltration may be required.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

ATC code: B05BA10

Lipid emulsion:

Intralipid, the lipid emulsion used in Periven, provides essential and non-essential long-chain fatty acids for energy metabolism and the structural integrity of cell membranes.

Intralipid at the recommended doses does not cause haemodynamic changes.

It has been found that, when Intralipid is used correctly, no clinically significant changes in lung function occur.

The transient increase in liver enzymes observed in some patients on parenteral nutrition is reversible and disappears with its discontinuation. Similar changes have also been observed during parenteral nutrition without lipid emulsions.

Amino acids and electrolytes:

Amino acids, constituents of normal diet proteins, are used for the synthesis of tissue proteins and any excess quantity is sent to glyconeogenesis

Amino acid infusions are associated with small increases in the rate of metabolism and thermogenesis.

Glucose:

Glucose has no pharmacodynamic effects other than contributing to normal homeostasis.

05.2 Pharmacokinetic properties

Lipid emulsion:

Intralipid has biological properties similar to those of endogenous chylomicrons.

Unlike the latter, Intralipid does not contain cholesterol esters or apolipoproteins, while its phospholipid content is significantly higher.

Intralipid is cleared from the circulation by a pathway similar to that of endogenous chylomicrons.

The exogenous fat particles are primarily hydrolyzed in the circulation and picked up by LDL receptors peripherally and in the liver.

The rate of elimination is determined by the composition of the lipid particles, the nutritional and clinical status and the rate of infusion.

In healthy volunteers, the maximum elimination rate of Intralipid after an overnight fast is equivalent to 3.8 ± 1.5 g of triglycerides / kg / 24 hours.

Both the elimination and oxidation rates are dependent on the patient's clinical condition; elimination is faster and the oxidation rate is increased in septic and traumatized patients, while patients with renal insufficiency and hypertriglyceridemia show a lower rate of elimination and oxidation of exogenous lipid emulsions.

Amino acids and electrolytes:

The primary pharmacokinetic properties of the infused amino acids and electrolytes are essentially the same as the elements supplied with normal foods.

However, the amino acids of dietary proteins first enter the portal vein and later into the systemic circulation, while those infused intravenously reach the systemic circulation directly.

Glucose:

The pharmacokinetic properties of glucose are essentially the same as glucose from normal foods.

05.3 Preclinical safety data

No preclinical safety studies have been conducted with Periven. However, preclinical safety studies with Intralipid, Vamin-type amino acid solutions and with glucose both used alone and in combination in various compositions and concentrations have confirmed satisfactory tolerability with minimal adverse reactions.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Purified egg phospholipids, glycerol, sodium hydroxide, glacial acetic acid, water for injections.

06.2 Incompatibility

Periven can only be mixed with other medicinal products for which compatibility has been documented. See section 6.6 "Special precautions for disposal and handling".

06.3 Period of validity

2 years in the overpouch.

Shelf life after mixing:

After rupture of the septa, the chemical and physical in-use stability of the three mixed compartments was demonstrated to be 24 hours at 25 ° C.

06.4 Special precautions for storage

Do not store above 25 ° C. Store in the overpouch. Do not freeze.

After mixing with additives:

After opening the septa and mixing the three solutions, additions can be made using the dressing system.

From a microbiological point of view, the product should be used immediately upon addition. 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. If immediate use is not possible and provided that the additions are made under controlled and validated aseptic conditions, the mixed emulsion can be stored for up to 6 days at a temperature between 2-8 ° C before use. When storage conditions between 2-8 ° C cease, the mixture must be administered within 24 hours.

06.5 Nature of the immediate packaging and contents of the package

The container consists of an internal multi-compartment bag and an overpouch. The inner bag is divided into three compartments by openable partitions. An oxygen absorber is placed between the inner bag and the overpouch.

The inner bag is composed of a multilayer polymeric film, alternatively of Excel or Biofine.

The inner pouch film in Excel consists of three layers. The inner layer consists of a poly (propylene / ethylene) copolymer and a thermoplastic elastomer styrene / ethylene / butylene / styrene (SEBS). The middle layer consists of SEBS and the outer layer of copolyester-ether. The infusion port is equipped with a polyolefin cap. The addition port is equipped with a synthetic polyisoprene closure (latex free).

The inner bag film in Biofine consists of poly (propylene-co-ethylene), poly [styrene-block- (butylene-co-ethylene)] synthetic rubber (SEBS) and poly (styrene-block-isoprene) synthetic rubber ( SIS). The infusion and addition ports are made of polypropylene and poly [styrene-block- (butylene-co-ethylene)] (SEBS) synthetic rubber and equipped with synthetic polyisoprene (latex-free) closures. The blind door, which is used only during production, is made of polypropylene and is equipped with a synthetic polyisoprene (latex-free) plug.

Bag volume: 1440 ml, 1920 ml, 2400 ml.

1 box of 4 bags of 1440 ml

1 box of 2 bags of 1920 ml

1 box of 2 bags of 2400 ml

1 box of 4 bags (Biofine) of 1920 ml

1 box of 3 bags (Biofine) of 2400 ml

06.6 Instructions for use and handling

Use for one administration only.

Do not use if package is damaged. The contents of the three separate compartments must be mixed before use.

After opening the separable baffles, to ensure homogeneous mixing, invert the bag several times.

Use only if the amino acid solution and glucose solution are clear and colorless or slightly yellow in color and the lipid emulsion is white and homogeneous.

Compatibility:

Additives:

Only drugs or nutritional solutions for which compatibility has been documented can be added to Periven.

Additions must be made under aseptic conditions.

Mixing data is provided upon request.

After infusion, any unused residues must be discarded.