Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Primene 10% solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Glycine, Threonine, Tryptophan, Methionine, Lysine, Taurine, Alanine, Arginine, Aspartic acid, Cysteine, Glutamic acid, Histidine, Isoleucine, Leucine, Ornithine, Phenylalanine, Proline, Serine, Tyrosine, Valine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Primene is a sterile solution which contains:
- amino acids – these are the building blocks which your body uses to make proteins Primene is used in Children, infants and the newborn at term or born prematurely to give your child food (nutrition) straight into the blood, when your child cannot take enough food by his or her mouth. The doctor will check your body has all the nutrition that it needs for good health. If necessary, your child may also have a vitamins (such as folic Acid), minerals, fatty acids (the building blocks of fats), electrolytes (salts) and sugar solutions (such as glucose) at the same time as Primene.
2 What you need to know before your child is given Primene Primene must not be given to your child if:
- your child is allergic (hypersensitive) to any of the ingredients of Primene (see section 6)
- Your child's body has problems using the building blocks of proteins. 1
GR-30-01-883
BAXTER CONFIDENTIAL – INTERNAL USE ONLY Part Number:
GR-30-01-883
Date: 07NOV19
Designer:
G.V.
Page: 2 of 4
Colour Reference:
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Symptoms may include nausea, vomiting, shivering, confusion and rapid heart rate. In such situations, the infusion must be stopped immediately.
- Amino acid solutions can increase the level of ammonia or nitrogen-containing compounds in your child's blood. The doctor will check your child's blood tests for this.
- The doctor should also be aware of severe conditions affecting how your child's body handles fluid, sugars, fats, proteins or salt (metabolic disorders). These conditions will be corrected before your child is given Primene.
- your child will not have Primene through the same tubes and equipment used for any blood tranfusion.
The doctor will decide if additional actions are required. To prevent these events from occurring, the doctor will regularly monitor your child's condition and test your child's blood levels during treatment.
How to take it
The doctor will decide how much Primene your child should be given. It will depend on:
- age and weight
- what his or her body needs
- why he or she is being given it.
- the usual daily dose is 15 to 35 ml of Primene per kilogram of body weight.
- these are the recommended amounts to have each day, but your child may be given more or less
- Primene is given as an infusion into a large vein in your child's chest (called the vena cava). When mixed with other solutions it may be given into a vein in your child's arm. The solution is slowly given to your child at a rate which will not be more than 0.05 ml per kg per minute.
- When used in neonates and children below 2 years of age, the solution (in bottles and administration sets) should be protected from light exposure until administration is completed (see section 2).
The following side effects have been reported with similar products:
- High blood level of ammonia and nitrogen-containing compounds
- Anaphylactic reactions, a serious allergic shock reaction that is rapid in onset and if not treated can be life-threatening.
- Impairment of liver functions, abnormal blood test for the liver function
- Inflammation of the gall bladder, the presence of gallstones in the gallbladder
- Increase in the acidity of the blood
- Formation of small particles blocking lung blood vessels
- Vein inflammation at infusion site, venous irritation, pain, warmth, swelling and induration
- Severe local reactions can occur in case of leakage of the infusion fluid in the tissues surrounding the infusion site: death of skin tissue, blistering, swelling, scarring, skin discoloration.
If your child is given too much The doctor will give your child Primene so it is unlikely that your child will be given too much. If you are worried that your child has had too much, tell the doctor or nurse.
If your child gets any side effects, talk to the doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.
If the dose given is too high or the infusion too fast, your child may have an increased volume of circulating blood, your child's blood may become too acidic or the nitrogen content in your child's blood and urine may increase.
Turn over leaflet for further information. 2
GR-30-01-883
BAXTER CONFIDENTIAL – INTERNAL USE ONLY Part Number:
GR-30-01-883
Date: 07NOV19
Designer:
G.V.
Page: 3 of 4
Colour Reference:
Proofread No.:
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P 287 U
You can also report side effects directly to the Medicines and Healthcare products Regulatory Agency via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more
Caxton Way Thetford Norfolk IP24 3SE United Kingdom
information on the safety of this medicine.
Send all enquiries to this address. Primene is made at the following place: Bieffe Medital S.p.A. Via Nuova Provinciale I-23034 Grosotto Italy
5 How Primene is stored Keep the medicine out of the sight and reach of children when not being administered.
This leaflet was last revised 11/2019
When used in neonates and children below 2 years, the solution (in bottles and administration sets) should be protected from light exposure until administration is completed.
For information about Primene or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder: Tel: 01635 206345.
Primene should be stored as follows: Do not store above 25oC and protect it from light. Do not use Primene after the expiry date which is stated on the label after Exp. The expiry date means the last day of that month.
Baxter and Primene are trademarks of Baxter International Inc.
Partly used containers should not be used again. Any left over solution should be thrown away safely by a healthcare professional. All equipment will be thrown away safely by a healthcare professional after use.
Possible side effects
Like all medicines, Primene can cause side effects, although not every child gets them. If you notice any changes in the way your child feels during or after the treatment, tell the doctor or nurse right away. The tests the doctor will perform while your child is taking the medicine minimise the risk of side effects.
Use with other medicines There are no known problems when Primene is used with other medicines. Pregnancy and breast-feeding If your child is pregnant, think she might be pregnant or is breast-feeding, tell the doctor. They will decide if she can be given Primene.
If any abnormal signs or symptoms of an allergic reaction develop, such as abnormally low or high blood pressure, appearance of a blue or purple coloration of the skin, abnormally high heart rate, breathing difficulties, joint pain, muscle pain, vomiting, nausea, skin rashes, raised body temperature, excessive sweating chills, and shivering, the infusion will be stopped immediately.
Contents of the pack and other information
What Primene contains
- The active substances are L-Isoleucine 6.70 g, L-Leucine 10.00 g, L-Valine 7.60 g, L-Lysine 11.00 g, L-Methionine 2.40 g, L-Phenylalanine 4.20 g, L-Threonine 3.70 g, L-Tryptophan 2.00 g, L-Arginine 8.40 g, L-Histidine 3.80 g, L-Alanine 8.00 g, L-Aspartic Acid 6.00 g, L-Cysteine 1.89 g, L-Glutamic Acid 10.00 g, Glycine 4.00 g, L-Proline 3.00 g, L-Serine 4.00 g, L-Tyrosine 0.45 g, L-Ornithine Hydrochloride 3.18 g, Taurine 0.6 g in 1000 ml of solution.
- The other ingredients are sterile water (called 'water for injections') and L-Malic acid. What Primene looks like and the contents of the pack Primene is a solution for infusion. It is a clear sterile solution. It is available in glass bottles containing 100 ml, 125 ml, 200 ml, 250 ml, 500 ml, 1,000 ml or 2,000 ml of solution. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation holder is: Baxter Healthcare Ltd 3
GR-30-01-883
BAXTER CONFIDENTIAL – INTERNAL USE ONLY Part Number:
GR-30-01-883
Date: 07NOV19
Designer:
G.V.
Page: 4 of 4
Colour Reference:
Proofread No.:
01
P 287 U
4
GR-30-01-883
Frequently asked questions about Primene 10% solution for infusion
How do I take Primene 10% solution for infusion?
Primene 10% solution for infusion comes as infusion. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Primene 10% solution for infusion?
The active substance in Primene 10% solution for infusion is glycine, threonine, tryptophan, methionine, lysine, taurine, alanine, arginine, aspartic acid, cysteine, glutamic acid, histidine, isoleucine, leucine, ornithine, phenylalanine, proline, serine, tyrosine, valine.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Primene 10% solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Primene 10% solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: glycine, threonine, tryptophan, methionine, lysine, taurine, alanine, arginine, aspartic acid, cysteine, glutamic acid, histidine, isoleucine, leucine, ornithine, phenylalanine, proline, serine, tyrosine, valine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
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.
4.2. Posology and method of administration
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.
The usual range is
1.5 – 3.5g amino-acids/kg/24 hours0.230 – 0.53g nitrogen/kg/24 hours15 – 35ml of Primene 10%/kg/24 hours
The infusion rate should not exceed 0.05ml/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.
When used in neonates and children below 2 years of age, the solution (in bottles and administration sets) should be protected from light exposure until administration is completed (see sections 4.4, 6.3 and 6.6).
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.
Primene 10% may be included in the composition of nutritive mixtures combining carbohydrates, lipids, electrolytes, trace elements and vitamins to meet nutrient needs and prevent deficiencies and complications from developing, when compatibility and stability are known (see section 6.2).
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.
4.3. Contraindications
Primene is contraindicated in patients with:
• hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1.
• congenital abnormality of amino acid metabolism.
4.4. Special warnings and precautions for use
Allergic Reactions / Hypersensitivity Reactions
Anaphylactic/anaphylactoid reactions and other hypersensitivity/infusion reactions have been reported with amino acid solutions administered as a component of parenteral nutrition (see section 4.8). 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.
Hypertonic solutions
Hypertonic infusion solutions may cause irritation of the vein, vein damage, and thrombosis when administered into a peripheral vein (see section 4.8).
In view of its osmolality, Primene 10% should not be infused alone into a peripheral vein.
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. In some patients this may indicate the presence of a congenital disorder of amino acid metabolism (see section 4.3) 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.
Use with caution in patients with renal insufficiency (with e.g., 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. When used in neonates and children below 2 years of age, Primene should be protected from ambient light until administration is completed (see sections 4.2, 6.3, and 6.6).
• Infusion site reactions have occurred with the use of parenteral nutrition. They include infusion site thrombophlebitis and venous irritation, as well as severe reactions (with, e.g., necrosis and blistering) when associated with extravasation. See section 4.8. 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.
4.5. 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.
4.6. 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.
4.7. 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.
4.8. 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.
• 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.
• Necrosis, blistering, swelling, scarring, skin discoloration at the infusion site associated with extravasation (See also infusion site reaction statement in section 4.4).
• 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:Website: www.mhra.gov.uk/yellowcard
4.9. Overdose
In the event of inappropriate administration (overdose, and/or infusion rate higher than recommended), hypervolaemia, electrolyte disturbances, acidosis and/or azotaemia may occur. In such situations, the infusion must be stopped immediately. If medically appropriate, further intervention may be indicated to prevent clinical complications.
There is no specific antidote for overdose. Emergency procedures should include appropriate corrective measures.
💬 Ask about this leaflet
Ask anything about Primene 10% solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.