Loading…
PRIMENE is a brand name for Glycine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Primene 10% is indicated in 1) children and infants 2) neonates, at term or premature, of normal or low birth weight when oral or enteral nutrition is impossible, insufficient or contraindicated.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Parenteral nutrition initiation and duration as well as dosage (dose and rate of administration) depends on a patient’s • age, weight, clinical condition, • nitrogen requirements, • ability to metabolize the constituents of Primene, • additional nutrition that may be provided parenterally and/or enterally.
05ml/kg/min.
Recommended flow rates:
Neonates and Infants: continuous infusion (over 24 hours). Children: continuous infusion (over 24 hours) or cyclic infusion (over about 12 hours in 24). The flow rate should be adjusted according to the dosage, the characteristics of the infusion solution, the total volume intake per 24 hours and the infusion duration.
The flow rate should be increased gradually during the first hour. Method of administration Primene is intended for intravenous use. Primene is not intended for fluid or volume replacement. 6). Primene 10% is usually administered with a source of energy appropriate for the needs of the child, either by co-administration or as a mixture.
2). Primene 10% alone should be administered in a central vein. Primene 10% in co-administration or as a mixture should be administered according to the final osmolarity of the solution infused, in a peripheral or central vein. The osmolarity of a specific infusion solution must be taken into account when peripheral administration is considered.
Strongly hypertonic parenteral nutrition solutions (>900 mOsm/L) should be administered through a central venous catheter with the tip located in a large central vein. If deemed appropriate by the healthcare professional, parenteral nutrition solution may be administered peripherally in patients of all ages if the osmolarity of the formulation is ≤ 900 mOsm/L.
8. Patients should be monitored accordingly. • Severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion. • Use with caution in patients with pulmonary oedema or heart failure.
Fluid status should be closely monitored. 5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed. The compatibility and stability of nutritive mixtures should be confirmed before administration.
6 Fertility, pregnancy and lactation There are no adequate data from the use of Primene in pregnant or lactating women. Healthcare Professionals should carefully consider the potential risks and benefits for each specific patient before administering Primene.
7 Effects on ability to drive and use machines There is no information of the effects of Primene on the ability to drive or operate other heavy machinery. 8 Undesirable effects The adverse reactions listed below have been identified from post-marketing reports of Primene administered as a component of parenteral nutrition.
The frequency of the adverse drug reactions listed in this section cannot be estimated from the available data. Tabulated summary of adverse reactions System Organ Class (SOC) Preferred MedDRA Term frequency IMMUNE SYSTEM DISORDERS Hypersensitivity reaction manifested by: • Face oedema, • Eyelid oedema, • Rash Not known Adverse reactions reported with parenteral amino acid products include: • Azotaemia, Hyperammonaemia.
Adverse reactions reported with parenteral nutrition to which the amino acid component may play a causal or contributory role include: • Anaphylactic/anaphylactoid reactions, including skin, gastrointestinal, and severe circulatory (shock) and respiratory manifestations as well as other hypersensitivity/infusion reactions, including pyrexia, chills, hypotension, hypertension, arthralgia, myalgia, urticaria, pruritus, erythema, and headache.
8). The infusion must be stopped immediately if any signs or symptoms of a reaction develop. Precipitates in Patients Receiving Parenteral Nutrition Pulmonary vascular precipitates 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. Precipitates have been reported even in the absence of phosphate salt in the solution.
Precipitation distal to the in line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated. In addition to inspection of the solution, the infusion set and catheter should also periodically be checked for precipitates.
Infectious complications Infection and sepsis may occur as a result of intravenous catheters used to administer parenteral formulations, poor maintenance of catheters or contaminated solutions. Immunosuppression and other factors such as hyperglycaemia, malnutrition and/or their underlying disease state may predispose patients to infectious complications.
Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, technical complications with the access device, and hyperglycaemia can help recognize early infections. 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.
Refeeding Syndrome in Patients Receiving Parenteral Nutrition 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 monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. 8). In view of its osmolality, Primene 10% should not be infused alone into a peripheral vein.
1. • congenital abnormality of amino acid metabolism.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Glycine in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
• Hepatic failure, Hepatic cirrhosis, Hepatic fibrosis, Cholestasis, Hepatic steatosis, Blood bilirubin increased, Hepatic enzyme increased; Cholecystitis, Cholelithiasis. • Raised blood urea nitrogen in children with renal insufficiency.
• Metabolic acidosis. • Pulmonary vascular precipitates. 4). • Infusion site thrombophlebitis; Venous irritation (infusion site phlebitis, pain, erythema, warmth, swelling, induration). Amino acid solutions may precipitate acute folic acid deficiency which should be corrected by supplements.
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
General Monitoring Monitoring should be appropriate to the patient’s clinical situation and condition, and should include determinations of water and electrolyte balance, serum osmolarity, acid/base balance, blood glucose levels, blood ammonia levels, and liver and kidney function.
Metabolic Effects 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.
Hepatic function Patients on parenteral nutrition may experience hepatic complications (including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as cholecystitis and cholelithiasis) and should be monitored accordingly.
The etiology of these disorders is thought to be multifactorial and may differ between patients. Patients developing abnormal laboratory parameters or other signs of hepatobiliary disorders should be assessed by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.
Amino acid solutions should be used with caution in patients with pre-existing liver disease or liver insufficiency. Liver function parameters should be closely monitored in these patients, and they should be monitored for possible symptoms of hyperammonaemia.
Increase in blood ammonia levels and hyperammonaemia may occur in patients receiving amino acid solutions. 3) or hepatic insufficiency. Blood ammonia should be measured frequently in newborns and infants to detect hyperammonaemia. Depending on extent and etiology, hyperammonaemia may require immediate intervention.
Renal effects Azotaemia has been reported with parenteral administration of solutions containing amino acids, and may occur in particular in the presence of renal impairment. , uraemia). Nitrogen tolerance may be altered and dosage may have to be adjusted.
Fluid and electrolyte status should be closely monitored in these patients. Additional precautions • Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcomes in neonates, due to the generation of peroxides and other degradation products.
6). • Infusion site reactions have occurred with the use of parenteral nutrition. , necrosis and blistering) when associated with extravasation. 8. Patients should be monitored accordingly. • Severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion.
• Use with caution in patients with pulmonary oedema or heart failure. Fluid status should be closely monitored.