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NUMETA G13%E PRETERM is a brand name for Cysteine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Numeta G13%E Preterm is indicated for parenteral nutrition in preterm newborn infants when oral or enteral nutrition is not possible, insufficient or contraindicated.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage depends on energy expenditure, the patient’s weight, age, clinical status, and on the ability to metabolize the constituents of Numeta, as well as on additional energy or proteins given orally/enterally. Total electrolyte and macronutrient composition is dependent on the number of activated chambers (See section 2).
The maximum daily dose should not be exceeded. Due to the static composition of the multi-chamber 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 static composition.
The maximal recommended hourly rate of infusion and volume per day depend on the constituent. The first of these limits to be reached sets the maximum daily dose. 2 a Limiting parameter according to ESPEN-ESPGHAN guidelines Numeta G13%E Preterm may not be appropriate for some preterm infants, as the clinical condition of the patient may require administration of individualized formulations to meet the specific needs of the patient as assessed by the clinician.
6. 6). 2 micron filter is recommended for administration of Numeta G13%E Preterm. Due to its high osmolarity, undiluted Numeta G13%E Preterm can only be administered through a central vein; however, sufficient dilution of Numeta G13%E Preterm with water for injection lowers the osmolarity and allows peripheral infusion.
The table below indicates the minimum volume of water for injection to be added to the activated bag in order to achieve the target osmolarity for peripheral administration. It should be noted that any other addition made to the activated bag will modify the final osmolarity.
Target Osmolarity (mOsm/L) Minimum addition of water for injection to achieve target osmolarity (mL) < 900 160 < 850 180 Numeta G13%E after 2- in-1 activation < 800 210 Numeta G13%E after 3- < 900 100 < 850 130in-1 activation < 800 160 The flow rate should be increased gradually during the first hour.
Upon discontinuation of Numeta G13%E Preterm, the flow rate should be decreased gradually during the last hour. 9. In preterm newborn infants, continuous parenteral administration over 24 hours is usually recommended; however, the same bag should not be activated, hung and infused longer than 24 hours.
1 Adverse Reactions from Clinical Trials and Post-marketing experience The safety and administration of Numeta was assessed in a single phase III study. One hundred and fifty nine (159) paediatric patients were included in the study and received Numeta.
The pooled data from clinical trials and the postmarketing experience indicate the following adverse drug reactions (ADRs) related to Numeta: Clinical Trial and Post-marketing experience Adverse Reactions System Organ Class (SOC) Preferred MedDRA Term Frequencyb Hypophosphataemia a Common Hyperglycaemia a Common Hypercalcaemia a Common Hypertriglyceridaemia a Common Hyperlipidaemia a Uncommon METABOLISM AND NUTRITION DISORDERS Hyponatraemia a Common HEPATOBILIARY DISORDERS Cholestasis Uncommon SKIN AND SUBCUTANEOUS Skin necrosis c Not known Clinical Trial and Post-marketing experience Adverse Reactions System Organ Class (SOC) Preferred MedDRA Term Frequencyb TISSUE DISORDERS Soft tissue injury c Not known GENERAL DISORDERS AND ADMINISTRATION SITE CONDITION Extravasation c Not known a Blood samples drawn during the infusion (without fasting conditions).
b Frequency is based upon the following categories: Very Common (≥1/10); Common (≥1/100 - <1/10), Uncommon (≥1/1,000 - <1/100), Rare (≥1/10,000 - <1/1,000), Very Rare (<1/10,000), Not known (cannot be estimated based on available data).
9); however the signs and symptoms of this syndrome may also occur when the product is administered according to instructions. The reduced or limited ability to metabolize the lipids contained in Numeta G13%E Preterm accompanied by prolonged plasma clearance may result in a “fat overload syndrome”.
g. coma). The syndrome is usually reversible when the infusion of the lipid emulsion is stopped. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as fever, sweating, shivering, headache, skin rashes, or dyspnea) develop. Numeta G13%E Preterm contains glucose produced from cornstarch.
Therefore, Numeta G13%E Preterm should be used with caution in patients with known allergy to corn or corn products. Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature newborns have been described.
3). Pulmonary vascular precipitates causing pulmonary vascular embolism and respiratory distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred. 2). Suspected precipitate formation in the blood stream have also been reported.
In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates. If signs of respiratory distress occur, the infusion should be stopped and medical evaluation initiated. 6.
Infection and sepsis may occur as a result of the use of intravenous catheters to administer parenteral formulations, or poor maintenance of catheters. Immunosuppressive effects of illness, or drugs, may promote infection and sepsis.
Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, technical complications with the access device, and hyperglycaemia can help recognize early infections. Patients who require parenteral nutrition are often predisposed to infectious complications due to malnutrition and/or their underlying disease state.
The occurrence of septic complications can be decreased with heightened emphasis on aseptic technique in catheter placement, maintenance, as well as aseptic technique in nutritional formula preparation. Fat overload syndrome has been reported with other parenteral nutrition products.
1, or components of the container. • Congenital abnormality of the amino acid metabolism • Pathologically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorus • Concomitant treatment with ceftriaxone, even if separate infusion lines are used.
2. • Severe hyperglycaemia The addition of lipids (administering Numeta G13E% Preterm as an activated 3 chamber bag for intravenous emulsion) is contraindicated in the following additional clinical situations: • Severe hyperlipidaemia, or severe disorders of lipid metabolism characterized by hypertriglyceridemia
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Cyclic infusions should be managed according to the patient’s metabolic tolerance. Treatment with parenteral nutrition may be continued for as long as is required by the patient’s clinical conditions. 6. 6.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
9). Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop.
Careful and slow initiation of parenteral nutrition is recommended, with close monitoring of fluids, electrolytes, trace elements and vitamins. 2). When making additions to the formulation, the final osmolarity of the mixture must be calculated before administration via peripheral vein to avoid vein irritation or tissue damage in the case of extravasation of the solution.
Peripheral administration of Numeta has resulted in extravasation leading to soft tissue injury and skin necrosis. Do not connect bags in series in order to avoid air embolism due to possible residual gas contained in the primary bag.
Lipids, vitamins, additional electrolytes and trace elements should be administered as required. 6). Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products.
6). Routinely monitor water and electrolyte balance, including magnesium, serum osmolarity, serum triglycerides, acid/base balance, blood glucose, liver and kidney function, blood count including platelets, and coagulation parameters throughout treatment.
In case of unstable conditions (for example, following severe post-traumatic conditions, uncompensated diabetes mellitus, acute phase of circulatory shock, acute myocardial infarction, severe metabolic acidosis, severe sepsis and hyperosmolar coma) delivery of Numeta G13%E Preterm should be monitored and adjusted to meet the clinical needs of the patient.
There are limited data on the administration of Numeta G13%E Preterm in preterm infants less than 28 weeks gestational age. Cardiovascular Use with caution in patients with pulmonary edema or heart failure. Fluid status should be closely monitored.
Renal Use with caution in patients with renal insufficiency. Fluid and electrolyte status, including magnesium, should be closely monitored in these patients. Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion.
Hepatic/Gastrointestinal Use with caution in patients with severe liver insufficiency, including cholestasis, or elevated liver enzymes. Liver function parameters should be closely monitored. Endocrine and Metabolism Metabolic complications may occur if the nutrient intake is not adapted to the patient's requirements, or the metabolic capacity of any given dietary component is not accurately assessed.
Adverse metabolic effects may arise from administration of inadequate or excessive nutrients or from inappropriate […]