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LIPIDEM is a brand name for Medium Chain Triglycerides. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Supply of energy, including a readily utilisable lipid component (medium-chain triglycerides) and essential omega-6 fatty acids and omega-3 fatty acids, as part of parenteral nutrition when oral or enteral nutrition is impossible, insufficient or contraindicated. Lipidem 200mg/ml is indicated in adults, preterm and…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage has to be adapted to the patients’ individual requirements. Maximum daily doses should only be administered after stepwise increase with careful monitoring of the tolerance of the infusions. g. the severity of underlying disease, body weight, gestational and postnatal age and specific body functions.
) per day. g. /d. /d corresponds to a maximum daily dose of 700 ml Lipidem 200mg/ml. /d may be beneficial regarding the possibility to monitor the increase of the plasma triglyceride level and prevent hyperlipidaemia. /d of lipids. In preterm newborn infants, term newborn infants, infants and toddlers, the daily dose of lipids should be infused continuously over about 24 hours.
/d. Elderly patients Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.
Patients with diabetes mellitus, impaired cardiac or renal function See section
The following listing includes a number of systemic adverse reactions that may be associated with the use of Lipidem 200mg/ml. Under the conditions of correct use, in terms of dosing, monitoring, observation of safety restrictions and instructions, most of them are very rare (< 1/10,000).
g. anaphylactic reactions, dermal eruptions, laryngeal, oral and facial oedema) Metabolism and nutrition disorders Very rare: Hyperlipidaemia, metabolic acidosis The frequency of these adverse reactions is dose-dependent and may be higher under conditions of absolute or relative overdose.
Very rare:
Hyperglycaemia Nervous system disorders Very rare: Headache, drowsiness Vascular disorders Very rare: Hypertension or hypotension, flush Respiratory, thoracic and mediastinal disorders Very rare: Dyspnoea, cyanosis Gastrointestinal disorders Very rare: Nausea, vomiting, loss of appetite Skin and subcutaneous tissue disorders Very rare: Erythema, sweating Hepatobiliary disorders Not known: Cholestasis Musculoskeletal and connective tissue disorders Rare: Back, bones, chest and lumbar region pain General disorders and administration site conditions Very rare: Elevated body temperature, feeling cold, chills, fat overload syndrome (see below).
Should adverse reactions occur, the infusion must be stopped. 4 mmol/l (1000 mg/dl) during infusion, the infusion must be stopped. 4). If the infusion is restarted, the patient should be carefully monitored, especially at the beginning, and serum triglycerides should be determined at short intervals.
Information on particular undesirable effects Nausea, vomiting and lack of appetite are symptoms often related to conditions for which parenteral nutrition is indicated, and may be associated with parenteral nutrition at the same time.
Fat overload syndrome Impaired capacity to eliminate triglycerides can lead to “fat overload syndrome” which may be caused by overdose. Possible signs of metabolic overload must be observed. The cause may be genetic (individually different metabolism) or the fat metabolism may be affected by ongoing or previous diseases.
4. 4 (‘(‘Patients with impaired lipid metabolism’). Infusion rate The infusion should be administered at the lowest possible infusion rate. During the first 15 minutes the infusion rate should only be 50% of the maximum infusion rate to be used.
The patient should be monitored closely for the occurrence of adverse reactions. /h lipids. 5 ml per hour Lipidem 200mg/ml. 5 g per hour. /h lipids. /h lipids. Method of administration Intravenous use. Lipid emulsions are suitable for peripheral venous administration and can also be administered separately via peripheral veins as part of total parenteral nutrition.
The Y- or the bypass connector should be placed as close to the patient as possible if lipid emulsions are co-administered with amino acid and carbohydrate solutions. 6. 6). Duration of treatment As clinical experience with long-term use of Lipidem 200mg/ml is limited, it should normally not be administered for longer than one week.
If parenteral nutrition with lipid emulsions is further indicated, Lipidem 200mg/ml can be administered over longer periods provided appropriate monitoring is employed. g. 4 Special warnings and precautions for use The serum triglyceride concentration should be monitored when infusing Lipidem 200mg/ml.
In patients with suspected disorders of lipid metabolism, fasting hyperlipidaemia should be ruled out before the start of the infusion. Depending on the patient’s metabolic condition, occasional hypertriglyceridaemia may occur. 6 mmol/l (400 mg/dl) in adults during administration of lipids it is recommended to reduce the infusion rate.
4 mmol/l (1000 mg/dl), as these levels have been associated with an increased risk for acute pancreatitis. Disturbances of the fluid, electrolyte or acid-base balance must be corrected before the start of infusion. Refeeding or repletion of malnourished or depleted patients may cause hypokalaemia, hypophosphataemia and hypomagnesaemia.
g. decompensated diabetes mellitus, severe sepsis, coma of unknown origin) – Inadequate cellular oxygen supply – Disturbances of the electrolyte and fluid balance – Acute pulmonary oedema – Decompensated cardiac insufficiency
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This syndrome may also appear during severe hypertriglyceridaemia, even at the recommended infusion rate, and in association with a sudden change in the patient’s clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipidaemia, fever, fat infiltration, hepatomegaly with or without icterus, splenomegaly, anaemia, leucopenia, thrombocytopenia, coagulation disorder, haemolysis and reticulocytosis, abnormal liver function tests and coma.
The symptoms are usually reversible if the infusion of the fat emulsion is discontinued. Should signs of a fat overload syndrome occur, the infusion of Lipidem 200mg/ml must be discontinued immediately. 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. uk/yellowcard.
Adequate supplementation of electrolytes according to deviations from normal values is necessary. Controls of the serum electrolytes, the water balance, the acid-base balance, and of blood cell counts, coagulation status, hepatic and renal function are necessary.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion. Energy supply with lipid emulsions only could cause metabolic acidosis. It is therefore recommended to infuse an adequate quantity of intravenous carbohydrates or carbohydrate- containing amino acid solutions along with the fat emulsion.
For patients requiring complete parenteral nutrition, complementary carbohydrate, amino acid, electrolyte, vitamin, and trace element supplements are required. Also, an adequate total fluid intake has to be ensured. ). 6), both resulting in a high risk of embolism.
There is as yet only limited experience of the use of Lipidem 200mg/ml for periods longer than seven days. As with all intravenous solutions, especially for parenteral nutrition, strict aseptic precautions are necessary for the infusion of Lipidem 200mg/ml.
Patients with diabetes mellitus, impaired cardiac or renal function Like all large-volume infusion solutions, Lipidem 200mg/ml should be administered with caution to patients with impaired cardiac or renal function. There is only limited experience of its use in patients with diabetes mellitus or renal failure.
g. renal insufficiency, diabetes mellitus, pancreatitis, impaired hepatic function, hypothyroidism (with hypertriglyceridaemia), sepsis, and metabolic syndrome. 4 mmol/l (1000 mg/dl). In combined hyperlipidaemias and in metabolic syndrome, […]