Numeta G13%E/Numeta G16%E/Numeta G19%E

Numeta G13%E Per 300 mL Alanine 0.75 g, arginine 0.78 g, aspartic acid 0.56 g, cysteine 0.18 g, glutamic acid 0.93 g, glycine 0.37 g, histidine 0.35 g, isoleucine 0.62 g, leucine 0.93 g, lysine monohydrate 1.15 g, methionine 0.22 g, ornithine HCl 0.3 g, phenylalanine 0.39 g, proline 0.28 g, serine 0.37 g, taurine 0.06 g, threonine 0.35 g, tryptophan 0.19 g, tyrosine 0.07 g, valine 0.71 g, K acetate 0.61 g, Ca chloride dihydrate 0.55 g, Mg acetate tetrahydrate 0.1 g, Na glycerophosphate hydrated 0.98 g, glucose monohydrate 44 g, refined olive oil + refined soya bean oil 7.5 g Numeta G16%E Per 500 mL Alanine 1.03 g, arginine 1.08 g, aspartic acid 0.77 g, cysteine 0.24 g, glutamic acid 1.29 g, glycine 0.51 g, histidine 0.49 g, isoleucine 0.86 g, leucine 1.29 g, lysine monohydrate 1.59 g, methionine 0.31 g, ornithine HCl 0.41 g, phenylalanine 0.54 g, proline 0.39 g, serine 0.51 g, taurine 0.08 g, threonine 0.48 g, tryptophan 0.26 g, tyrosine 0.1 g, valine 0.98 g, NaCl 0.3 g, K acetate 1.12 g, Ca chloride dihydrate 0.46 g, Mg acetate tetrahydrate 0.33 g, Na glycerophosphate hydrated 0.98 g, glucose monohydrate 85.25 g, refined olive oil + refined soya bean oil 15.5 g Numeta G19%E Per 1,000 mL Alanine 1.83 g, arginine 1.92 g, aspartic acid 1.37 g, cysteine 0.43 g, glutamic acid 2.29 g, glycine 0.91 g, histidine 0.87 g, isoleucine 1.53 g, leucine 2.29 g, lysine monohydrate 2.82 g, methionine 0.55 g, ornithine HCl 0.73 g, phenylalanine 0.96 g, proline 0.69 g, serine 0.91 g, taurine 0.14 g, threonine 0.85 g, tryptophan 0.46 g, tyrosine 0.18 g, valine 1.74 g, NaCl 1.79 g, K acetate 3.14 g, Ca chloride dihydrate 0.56 g, Mg acetate tetrahydrate 0.55 g, Na glycerophosphate hydrated 2.21 g, glucose monohydrate 210.65 g, refined olive oil + refined soya bean oil 28.1 g

Numeta G13%E Parenteral nutrition in preterm newborn infants when oral or enteral nutrition is not possible, insufficient or contraindicated. Numeta G16%E Parenteral nutrition in term newborn infants & childn up to 2 yr when oral or enteral nutrition is not possible, insufficient or contraindicated. Numeta G19%E Parenteral nutrition in childn >2 yr & adolescents 16-18 yr when oral or enteral nutrition is not possible, insufficient or contraindicated.

Individualized dosage. Max recommended hrly rate of infusion & vol per day depend on the constituent. The 1st of these limits to be reached sets the max daily dose. Numeta G13%E Activated 2 chamber bag (240 mL): Max infusion rate 5.1 mL/kg/hr. Corresponding to amino acid 0.2 g/kg/hr, glucose 0.85 g/kg/hr. Max amount: 102.3 mL/kg/day. Corresponding to amino acid 4 g/kg/day, glucose 17.1 g/kg/day. Activated 3 chamber bag (300 mL): Max infusion rate 6.4 mL/kg/hr. Corresponding to amino acid 0.2 g/kg/hr, glucose 0.85 g/kg/hr, lipids 0.16 g/kg/hr. Max amount: 127.9 mL/kg/day. Corresponding to amino acid 4 g/kg/day, glucose 17.1 g/kg/day, lipids 3.2 g/kg/day. Numeta G16%E Activated 2 chamber bag (376 mL): Max infusion rate 5.8 mL/kg/hr. Corresponding to amino acid 0.2 g/kg/hr, glucose 1.2 g/kg/hr. Max amount: 72.3 mL/kg/day. Corresponding to amino acid 2.5 g/kg/day, glucose 14.9 g/kg/day. Activated 3 chamber bag (500 mL): Max infusion rate 5.5 mL/kg/hr. Corresponding to amino acid 0.14 g/kg/hr, glucose 0.85 g/kg/hr, lipids 0.17 g/kg/hr. Max amount: 96.2 mL/kg/day. Corresponding to amino acid 2.5 g/kg/day, glucose 14.9 g/kg/day, lipids 3 g/kg/day. Numeta G19%E Activated 2 chamber bag (775 mL): Max infusion rate 4.7 mL/kg/hr. Corresponding to amino acid 0.14 g/kg/hr, glucose 1.17 g/kg/hr. Max amount: 64.8 mL/kg/day. Corresponding to amino acid 1.9 g/kg/day, glucose 16 g/kg/day. Activated 3 chamber bag (1,000 mL): Max infusion rate 4.6 mL/kg/hr. Corresponding to amino acid 0.11 g/kg/hr, glucose 0.89 g/kg/hr, lipids 0.13 g/kg/hr. Max amount: 83.6 mL/kg/day. Corresponding to amino acid 1.9 g/kg/day, glucose 16 g/kg/day, lipids 2.3 g/kg/day.

Hypersensitivity to egg, soy or peanut proteins, or to any of the active substances, excipients or components of the container. Congenital abnormality of the amino acid metabolism. Pathologically elevated plasma conc of Na, K, Mg, Ca &/or P. Severe hyperglycaemia. Activated 3 chamber bag: Severe hyperlipidaemia, or severe disorders of lipid metabolism characterized by hypertriglyceridemia. Numeta G13%E Concomitant treatment w/ ceftriaxone, even if separate infusion lines are used. Numeta G16%E As for other Ca-containing infusion soln, concomitant treatment w/ ceftriaxone in newborn infants (≤28 days of age), even if separate infusion lines are used.

Stop infusion if any signs or symptoms of an allergic reaction develop. Risk of precipitation of ceftriaxone-Ca salt in patients of any age (including adults) if ceftriaxone is mixed or administered simultaneously w/ IV Ca-containing soln, even via different infusion lines or at different infusion sites. Ceftriaxone & Ca-containing soln may be administered sequentially 1 after another in patients older than 28 days if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions w/ physiological salt-soln to avoid precipitation. Risk of pulmonary vascular precipitates; infection & sepsis; fat overload syndrome; refeeding syndrome in refeeding severely undernourished patients; thiamine deficiency & fluid retention. Administer only through a central vein, except if appropriate dilution is performed. Routinely monitor water & electrolyte balance, including Mg (for Numeta G13%E & G16%E), serum osmolarity, serum triglycerides, acid/base balance, blood glucose, liver & kidney function, blood count including platelets, & coagulation parameters throughout treatment. In case of unstable conditions, delivery of Numeta should be monitored & adjusted to meet the clinical needs of the patient. Use w/ caution in patients w/ pulmonary edema or heart failure; renal insufficiency; severe liver insufficiency, including cholestasis or elevated liver enzymes; severe blood coagulation disorders. Metabolic complications may occur if nutrient intake is not adapted to patient's requirements, or metabolic capacity of any given dietary component is not accurately assessed. Numeta G13%E Cases of Ca-ceftriaxone precipitates in lungs & kidneys in premature newborns. Preterm infants <28 wk gestational age. Numeta G16%E Cases of Ca-ceftriaxone precipitates in lungs & kidneys in full-term newborns <1 mth. Risk of hypermagnesaemia.

Hypophosphataemia, hyperglycaemia, hypercalcaemia, hypertriglyceridaemia, hyponatraemia.

Risk of pseudoagglutination when administered simultaneously w/ blood through same infusion tubing. Risk of precipitation of ceftriaxone-Ca salt in patients of any age (including adults) if ceftriaxone is mixed or administered simultaneously w/ IV Ca-containing soln, even via different infusion lines or at different infusion sites. Olive & soybean oil may counteract anticoagulant activity of coumarin (or coumarin derivatives including warfarin). Risk of hyperkalemia w/ K sparing diuretics, ACE inhibitors, AIIA or tacrolimus & cyclosporine. Lipids may interfere w/ results of certain lab tests (eg, bilirubin, LDH, O₂ saturate, blood Hb) if blood sample is taken before the lipids are eliminated.

Parenteral Nutritional Products

B05BA10 - combinations ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.

P₁S₁S₃