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OLEUNOR N9E is a brand name for Glycine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: OLEUNOR N9E, emulsion for infusion is indicated for parenteral nutrition for adults and children older than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The appearance of the product after mixing the 3 compartments is a milk-like emulsion. 2). 8). The patient’s ability to eliminate fat and metabolise nitrogen and glucose, and the nutritional requirements should govern the dosage and infusion rate, see section
9). At the beginning of the infusion, any of the following abnormal signs (sweating, fever, shivering, headache, skin rashes, dyspnoea) should be cause for immediate discontinuation of the infusion: The adverse drug reactions (ADRs) reported with similar parenteral nutrition emulsions for infusion in a randomized, double-blind, active-controlled, efficacy and safety study, are listed in the table below.
e. postsurgical fasting, severe malnutrition, enteral intake insufficient or impossible) were included and treated; patients in the group receiving the medicinal product received up to 40 mL/kg/d of the medicinal product over 5 days.
The pooled data from clinical trials and the postmarketing experience indicate the following adverse drug reactions (ADRs) related to <Parenteral nutrition Peri-N4E>. System Organ Class MedDRA Preferred Term Frequencya Immune System Disorders Hypersensitivity reactions including hyperhidrosis, pyrexia, chills, headache, skin rash (erythematous, papular, pustular, macular, generalised rash), pruritus, hot flush, dyspnoea Not knownb Cardiac disorders Tachycardia Commona Decreased appetite Commona Hypertriglyceridaemia Commona Metabolism and nutrition disorders Hospital Acquired Hyponatraemia** Not known Abdominal pain Commona Diarrhoea Commona Nausea Commona Gastrointestinal disorders Vomiting Not knownb Vascular disorders Hypertension Commona General disorders and administration site conditions Extravasation which may result at infusion site level in: pain, irritation, swelling/oedema, erythema/warmth, skin necrosis, blisters/vesicles, inflammation, induration, skin tightness Not knownb Nervous system disorders Hyponatraemic encephalopathy** Not known a: Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); or not known (cannot be estimated from the available data).
4. The dose should be individualised with regard to the patient’s clinical condition and body weight (bw). The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. Dosage The recommended maximum daily dose of 40 mL/kg bw/day, mentioned below, should not be exceeded.
Due to the static composition of the multi-compartment bag, the ability to simultaneously meet all nutrient needs of the patient may not be possible. Clinical situations may exist where patients require amounts of nutrients varying from the composition of the static bag.
In this situation, any volume (dose) adjustments must take into consideration the resultant effect this will have on the dosing of all other nutrient components of OLEUNOR Peri-N4E. In adults The dosage depends on the patient’s energy expenditure, clinical status, body weight and the ability to metabolise the constituents of OLEUNOR Peri-N4E, as well as additional energy or proteins provided orally/enterally; therefore, the bag size shouldbe chosen accordingly.
9 g amino acids/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. 6 g amino acids/kg bw/day). g. burns or marked anabolism) the nitrogen need may be even higher. - 20 to 40 kcal / kg. 5 mL per expended kcal.
6 mmol/kg potassium. , 1680 non-protein kcal and 1960 total kcal). In obese patients the dose should be based on the estimated ideal weight. Infusion rate Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake and the duration of the infusion.
15 g/kg bw/h. 10 g/kg/hour lipids. In children greater than 2 years of age and adolescents. There have been no studies performed in the paediatric population. The dosage depends on the patient’s energy expenditure, clinical status, body weight and the ability to metabolise constituents of OLEUNOR Peri-N4E, as well as additional energy or proteins given orally/enterally; therefore, the bag size should be chosen accordingly.
The use of OLEUNOR Peri-N4E is contraindicated in the following situations: - In premature neonates, infants and children less than 2 years of age. 1. - Congenital abnormalities of amino acid metabolism. - Severe hyperlipidaemia or severe disorders of lipid metabolism characterized by hypertriglyceridaemia.
- Severe hyperglycaemia. - Severe hepatic insufficiency, hepatic coma. - Severe renal insufficiency without access to hemofiltration or dialysis. - Severe blood coagulation disorders. - Hemophagocytotic syndrome. - Acute shock. - General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency.
g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma) - Pathologically-elevated plasma concentrations of sodium, potassium, magnesium, calcium, and/or phosphorus.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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b: ADRs reported during post-marketing experience with a parenteral nutrition emulsion for infusion with an identical composition. 4). The following class-like adverse drug reactions (ADRs) have been described in other sources, in relation to similar parenteral nutrition products; the frequency of these reactions is not known.
4) Fat overload syndrome (very rare) Fat overload syndrome has been reported with similar products. 9); however, the signs and symptoms of this syndrome may also occur at the start of an infusion when the product is administered according to instructions.
The reduced or limited ability to metabolise the lipids contained in OLEUNOR Peri-N4E accompanied by prolonged plasma clearance may result in a “fat overload syndrome”. This syndrome is associated with a sudden deterioration in the patient’s clinical condition and is characterized by findings such as fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, liver fatty infiltration (hepatomegaly), deteriorating liver function and central nervous system manifestations (for example coma).
The syndrome is usually reversible when infusion of the lipid emulsion is stopped. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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In addition, daily fluid, nitrogen and energy requirements continuously decrease with age. Two groups, ages 2 to 11 years and 12 to 18 years, are considered. For OLEUNOR Peri-N4E, in both age groups, the magnesium concentration is the limiting factor for daily dose.
In the 2 to 11 year age group, the lipid concentration is the limiting factor for hourly rate. In the 12 to 18 year age group, the glucose concentration is the limiting factor for hourly rate. 10 a: Recommended values from 2018 ESPEN-ESPGHAN Guidelines Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake and the duration of the infusion.
In general, it is recommended to start the infusion for small children with low daily dose and gradually increase it up to the maximal dosage (see above). Method and duration of administration For single use only. Intravenous use, infusion into a peripheral or central vein.
It is recommended that, after opening the bag, the contents are used immediately and not stored for subsequent infusion. After reconstitution, the mixture is milk-like, homogenous liquid, showing no phase separation. 6. Due to its low osmolarity, OLEUNOR Peri-N4E can be administered through a peripheral or central vein.
The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours. Treatment with parenteral nutrition may be continued for as long as required by the patient’s clinical conditions. 3 Contraindications The use of OLEUNOR Peri-N4E is contraindicated in the following situations: - In premature neonates, infants and children less than 2 years of age.
1. - Congenital abnormalities of amino acid metabolism. - Severe hyperlipidaemia or severe disorders of lipid metabolism characterized by hypertriglyceridaemia. - Severe hyperglycaemia. - Severe hepatic insufficiency, hepatic coma. - Severe renal insufficiency without access to hemofiltration or dialysis.
- Severe blood coagulation disorders. - Hemophagocytotic syndrome. - Acute shock. - General contraindications to infusion therapy: […]