Sign Out
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.
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. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates (see Incompatibilities under Cautions for Usage). 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.
No additions to the bag should be made without first checking the compatibility, as formation of precipitates or destabilization of the lipid emulsion could result in vascular occlusion, see Incompatibilities and Special precautions for disposal under Cautions for Usage.
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. The reduced or limited ability to metabolize the lipids contained in Numeta may result in a "fat overload syndrome".
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.
Numeta must only be administered through a central vein, except if appropriate dilution is performed (see Dosage & Administration). When making additions to the formulation, the final osmolarity of the mixture must be calculated before administration via peripheral vein to avoid vein irritation.
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.
Do not add other medicinal products or substances to one of the three chambers of the bag or to the reconstituted solution/emulsion without first confirming their compatibility and the stability of the resulting preparation (in particular, stability of the lipid emulsion) (see Incompatibilities and Special precautions for disposal under Cautions for Usage).
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 should be monitored and adjusted to meet the clinical needs of the patient.
There are limited data on the administration of Numeta G13%E 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 (see Hypermagnesaemia), 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 (see Contraindications).
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 composition of an admixture for a particular patient's needs.
Serum triglyceride concentrations and the ability of the body to metabolize lipids must be checked regularly. If a lipid metabolism abnormality is suspected, monitoring of serum triglycerides is recommended as clinically necessary.
In the event of hyperglycemia, the infusion rate of Numeta must be adjusted and/or insulin administered, see Overdosage.
Hematologic: Use with caution in patients with severe blood coagulation disorders. Blood count and coagulation parameters should be closely monitored.
Hypermagnesaemia: Numeta G16%E provides 0.3 mmol/kg/d of magnesium when administered at maximum dose (see Dosage & Administration). There is a possibility that this may lead to hypermagnesaemia. The signs of hypermagnesaemia include generalised weakness, hypo-reflexia, nausea, vomiting, hypocalcaemia, respiratory failure, hypotension and arrhythmias. As signs of hypermagnesaemia may not be detected, monitoring of magnesium levels is advised at baseline and at appropriate intervals thereafter, in accordance with routine clinical practice and the needs of the individual patient. This is especially important in those patients at increased risk of developing hypermagnesaemia including patients with impaired renal function, patients receiving other medicinal products which place them at risk of developing hypermagnesaemia or patients receiving magnesium from other sources, including neonates whose mother's recently received magnesium in the antepartum period.
If serum magnesium levels are elevated (above reference range normal values) the infusion of Numeta should be stopped or infusion rate reduced as deemed clinically appropriate and safe.
Effects on ability to drive and use machines: Not relevant.
Numeta G13%E: Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature newborns have been described.
In preterm newborn infants, concomitant treatment with ceftriaxone is contraindicated (see Contraindications).
Numeta G16%E: Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in full-term newborns aged less than 1 month have been described.
Numeta G16%E and Numeta G19%E: In patients of any age (including adults), ceftriaxone must not be mixed or administered simultaneously with any 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.
