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NUMETA G16%E is a brand name for Taurine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Numeta G16%E is indicated for parenteral nutrition in term newborn infants and children up to 2 years 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 composition of the static bag.
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. 6. 6). 2 micron filter is recommended for administration of Numeta G16%E.
Due to its high osmolarity, undiluted Numeta G16%E can only be administered through a central vein. However, sufficient dilution of Numeta G16%E 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) < 900 330 < 850 380 Numeta G16%E after 2- in-1 activation < 800 430 < 900 220 < 850 260 Numeta G16%E after 3- in-1 activation < 800 320 The flow rate should be increased gradually during the first hour.
Upon discontinuation of Numeta G16%E, the flow rate should be decreased gradually during the last hour. 9. The same bag should not be activated, hung, and infused longer than 24 hours. 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.
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 Frequency b METABOLISM AND NUTRITION DISORDERS Hypophosphataemiaa Hyperglycaemiaa Hypercalcaemiaa Hypertriglyceridaemiaa Hyperlipidaemia Hyponatraemiaa Common Common Common Common Uncommon Common HEPATOBILIARY DISORDERS Cholestasis Uncommon Skin necrosis c Not knownSKIN AND SUBCUTANEOUS 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).
g. 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 G16%E 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. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
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 G16%E contains glucose produced from cornstarch. Therefore, Numeta G16%E should be used with caution in patients with known allergy to corn or corn products.
Cases of fatal reactions with calcium-4ceftriaxone precipitates in lungs and kidneys in full- term newborns aged less than 1 month have been described. In patients of any age ceftriaxone must not be mixed or administered simultaneously with intravenous calcium-containing solutions, including Numeta), even via different infusion lines or at different infusion sites because of the risk of precipitation of ceftriaxone-calcium salt.
However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation.
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.
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 • As for other calcium-containing infusion solutions, concomitant treatment with ceftriaxone in newborn infants (≤28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone calcium salt precipitation in the neonate´s bloodstream).
2. • Severe hyperglycaemia The addition of lipids (administering Numeta G16%E 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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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.
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, 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 G16%E should be monitored and adjusted to meet the clinical needs of the patient.
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 (see Hypermagnesaemia) should be closely monitored in these patients.
3). Hepatic/Gastrointestinal Use with caution in patients with severe liver insufficiency, including cholestasis, or elevated liver enzymes. Liver function […]