Download Clinimix N14G30E solution for infusion. Dual compartment

CLINIMIX N14G30E PRESCRIBING INFORMATION
Name and composition: Clinimix N14G30E solution for infusion. Dual compartment bag
containing 8.5% amino acid solution with electrolytes and 30% glucose solution with calcium.
Active ingredients: 8.5% amino acid solution with electrolytes compartment – L-Leucine
6.20g/l, L-Phenylalanine 4.76g/l, L-Methionine 3.40g/l, L-Lysine (as L-Lysine hydrochloride)
4.93g/l, L-Isoleucine 5.10g/l, L-Valine 4.93g/l, L-Histidine 4.08g/l, L-Threonine 3.57g/l, LTryptophan 1.53g/l, L-Alanine 17.6g/l, L-Arginine 9.78g/l, Glycine 8.76g/l, L-Proline 5.78g/l,
L-Serine 4.25g/l, L-Tyrosine 0.34g/l, Sodium acetate, 3H2O 5.94g/l, Dibasic potassium
phosphate 5.22g/l, Sodium chloride 1.54g/l, Magnesium chloride, 6H2O 1.02g/l. 30% glucose
solution with calcium compartment – Glucose (as monohydrate glucose) 300g/l, Calcium
chloride 2H2O 0.66g/l. Indications: Parenteral nutrition when oral or enteral alimentation
impossible, insufficient or contraindicated. Possible to add lipid emulsion. Dosage and Route:
Dosage according to metabolic needs, energy expenditure and clinical status. See Summary of
Product Characteristics for details. Infusion via central vein. Side effects: Potential
undesirable effect may occur as result of inappropriate use, e.g. overdose or excessively fast
infusion rate. Adverse reactions reported with Clinimix formulations – hypersensitivity
including the following manifestations: hypotension, hypertension, peripheral cyanosis,
tachycardia, dyspnea, vomiting, nausea, urticarial, rash, pruritus, erythema, hyperhidrosis,
pyrexia, chills. Adverse reactions reported with parenteral nutrition include anaphylaxis,
pulmonary vascular precipitates, hyperglycaemia, hyperammonemia, azotemia, hepatic failure,
hepatic cirrhosis, hepatic fibrosis, cholestasis, hepatic steatosis, blood bilirubin increase, hepatic
enzyme increased, cholecystitis, cholelithiasis, infusion site thrombophlebitis, venous irritation
(infusion site phlebitis, pain, erythema, warmth, swelling, induration), glucose intolerance
common metabolic complication in severely stressed patients. Glycosuria, hyperosmolar
syndrome may occur. Precautions: Reports of anaphylaxis have been reported with other
parenteral nutrition products. Special clinical monitoring at beginning of infusion –
immediately stop if any abnormal signs or symptoms occur. Caution in patient with known
allergy to corn or corn products. Pulmonary vascular precipitates have been reported, some
fatal outcomes. Excessive addition of calcium and phosphate increases risk of formation of
calcium phosphate precipitates. If signs of pulmonary distress, stop infusion, initiate medical
evaluation. Periodically inspect solution, infusion set and catheter for precipitates. Infection
and sepsis may occur as result of use of intravenous catheters to administer parenteral
formulations, poor catheter maintenance or contaminated solutions. Immunosuppression and
other factors, e.g. hyperglycaemia, malnutrition and/or their underlying disease state may
predispose to infectious complications. Symptomatic and laboratory monitoring for fever/chills,
leukocytosis, access device complications, hyperglycaemia can help recognize early infections.
Septic complications can be decreased with heightened emphasis on aseptic technique with
catheter placement, maintenance and nutritional formula preparation. Care in monitoring and
slowly increasing nutrient intakes to prevent refeeding syndrome complications. Consideration
of final osmolarity of mixture, age and condition of patient in suitability for peripheral or central
administration. Do not connect bags in series in order to avoid air embolism. Correct water and
electrolyte equilibration disorders and metabolic disorders before starting infusion. Frequent
clinical evaluation and laboratory determinations, electrolytes (should include ionogram, kidney
and liver function tests) during administration. Clinimix without electrolytes should not be used
in hypokalaemia and hyponatremia. Hyperglycaemia, glycosuria and hyperosmolar syndrome
may occur, monitor blood and urine glucose, adapt diabetics insulin usage. Caution in patients
with renal insufficiency, closely monitor fluid and electrolyte status. In severe kidney failure,
specially formulated amino acid solutions should be preferred. Caution in patients with adrenal
insufficiency. Care in patients with pulmonary oedema, cardiac insufficiency and/or failure,
closely monitor fluid status. Control hyperammonaemia in patients with pre-existing liver
disease or hepatic insufficiency. Hepatobiliary disorders (cholestasis, hepatic steatosis, fibrosis,
cirrhosis, hepatic failure, cholecystitis, cholelithiasis) known to develop. Early assessment of
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abnormal laboratory parameters or other signs of hepatobiliary disorders by clinician for
therapeutic and prophylactic interventions. Frequent measure of blood ammonia in newborns
and infants to detect hyperammonemia which requires immediate intervention. Too rapid
infusion of amino acids may result in nausea, vomiting and chills – immediately stop infusion.
Caution in elderly patients due to greater frequency of decreased hepatic, renal or cardiac
function, concomitant disease or drug therapy. No studies performed in paediatric population.
Contraindications: Known hypersensitivity to any of active substances, excipients,
components of container. Amino acid metabolism disorders, severe hyperglycaemia, metabolic
acidosis, hyperlactataemia. Should not be used in patients with hyperkalaemia, hypernatraemia,
pathologically elevated plasma concentrations of magnesium, calcium and/or phosphorus.
Concomitant treatment with ceftriaxone contraindicated in newborns (≤28 days of age) – risk of
fatal ceftriaxone calcium salt precipitation in neonate’s bloodstream.
Interactions: See
contraindications section regarding ceftriaxone in newborns. Patient older than 28 days
(including adults) – do not administer ceftriaxone simultaneously with intravenous calciumcontaining solutions through same infusion line. Caution in patients treated with agents or
products that can cause hyperkalemia or increase risk of hyperkalemia, e.g. potassium-sparing
diuretics (amiloride, spironolactone, triamterene), ACE inhibitors, angiotensin II receptor
antagonists, or immunosuppressants tacrolimus and cyclosporine. Overdose: Inappropriate
administration (overdose, and/or higher infusion rate than recommended), hypervolemia,
electrolyte disturbances or acidosis may occur and result in severe or fatal consequences,
immediately stop infusion. Hyperglycaemia, glycosuria, hyperosmolar syndrome with
excessive glucose infusion. Nausea, vomiting, chills with too rapid infusion of amino acid –
stop infusion immediately. In serious cases, haemodialysis, haemofiltration or haemo-diafiltration may be necessary. No specific antidote for overdose, emergency procedures for
appropriate corrective measures with particular attention to respiratory and cardiovascular
systems.
Legal category: POM Marketing Authorisation Number and Holder:
PA167/098/004 Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE Date of
preparation: April 2014
Baxter Healthcare encourages healthcare professionals to continue to be vigilant and to report
suspected adverse reactions to the HPRA (online at http://www.hpra.ie/homepage/aboutus/report-an-issue, telephone 01-6764971 or using the yellow card system). Any adverse events
relating to Baxter products can also be reported direct to Baxter Pharmacovigilance on +44
(0) 1635 206360, or by email to [email protected]
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