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.

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Nutriflex plus 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 Isoleucine, Leucine, Lysine hydrochloride, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Arginine, Glutamic acid, Histidine hydrochloride monohydrate, Alanine, Aspartic acid, Glycine, Proline, Serine, Magnesium acetate tetrahydrate, Sodium acetate trihydrate, Sodium dihydrogen phosphate dihydrate, Potassium hydroxide, Sodium hydroxide, Calcium chloride dihydrate, Glucose monohydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Isoleucine, Leucine, Lysine hydrochloride, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Arginine, Glutamic acid, Histidine hydrochloride monohydrate, Alanine, Aspartic acid, Glycine, Proline, Serine, Magnesium acetate tetrahydrate, Sodium acetate trihydrate, Sodium dihydrogen phosphate dihydrate, Potassium hydroxide, Sodium hydroxide, Calcium chloride dihydrate, Glucose monohydrate

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

The product contains substances (nutrients) called amino acids, salts (electrolytes) and carbohydrates (glucose) which are essential for the body to grow or to recover and calories in the form of carbohydrates. You are given this product by a vein drip (infusion) because you are unable to eat adequately or cannot be fed via a tube. Nutriflex plus is specifically indicated for adults and children aged 2-17 years with moderately severe catabolism, a condition where patients are burning up their stores of energy, protein, etc. faster than they can be replaced. 2.

What you need to know before you take it

e Nutriflex plus

Do not use Nutriflex plus ● if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6) ● if you have an inborn error of amino acid metabolism, where you need a special protein diet ● if you have abnormally high blood sugar levels that need more than 6 units of insulin per hour to be controlled ● if you have abnormally high levels of acidic substances in the blood (acidosis) ● if you have bleeding within the skull or the spinal cord ● if you have severe liver failure (severe hepatic insufficiency) ● if you have severe kidney failure (severe renal insufficiency) without access to treatment with an artificial kidney (haemofiltration or dialysis)

As with other medicines of this type Nutriflex plus should not be given if you have: ● acute phase of heart attack (myocardial infarction) or stroke ● any kind of poorly controlled metabolic disorder, for example state of unconsciousness (coma), the cause of which is not known or insufficient supply of oxygen to tissues or decompensated diabetes mellitus ● life-threatening blood circulation problems such as those that can occur for example if you are in a state of collapse or shock, have accumulation of fluid in your lungs (pulmonary oedema) or your water balance is disturbed Nutriflex plus must not be given to newborn infants, infants and toddlers that are under two years old. Warnings and precautions Talk to your healthcare professional before using Nutriflex plus ● if you have impaired heart or kidney function ● if you have disturbances in fluid, salt or acid-base balance, for example low body fluid and salt content (hypotonic dehydration) or low sodium or potassium levels in your blood ● if you have abnormally high blood sugar levels. Special care will be taken to adjust and control your daily dose if you have impairment of kidneys, liver, adrenal glands, heart or lungs. Your doctor will also take special care for you if your blood-brain barrier is damaged, because then this medicine may cause an increase of the pressure within your skull or the spinal cord. If you are in a state of severe underfeeding, special care will be taken to build up your intravenous feeding gradually, accompanied by adequate controls and necessary supplies of electrolytes, in particular potassium, magnesium and phosphate. This medicine contains glucose (a sugar) so this may affect your blood sugar level. Blood samples may have to be taken to check this. If your infusion has accidentally been stopped suddenly, your blood sugar level may also drop suddenly. Your doctor will take this into consideration especially when your ability to metabolise glucose is impaired (e.g. if you have diabetes) or when children below the age of 3 receive this solution. Therefore especially after stopping the infusion your blood sugar level will be carefully monitored. Moreover controls of your blood salt levels, the water balance, the acid-base balance and of blood cell counts, blood clotting, kidney and liver function are necessary. Adequate supply of vitamins (in particular vitamin B1) will be ensured. The doctor will also take measures to ensure that your body's fluid and electrolyte requirements are met. In addition to Nutriflex plus you will receive further nutrients (foodstuffs) in order to fully cover your requirements. As with all intravenous solutions strict aseptic precautions are necessary for the infusion of Nutriflex plus. Children and adolescents Concerning sudden drop of the blood sugar level of your child after accidental stop of the infusion, please refer also to section 'Warnings and precautions' above. Your doctor will not give Nutriflex plus to children under two years old. Other medicines and Nutriflex plus

Tell your doctor if you are taking, have recently taken or might take any other medicines. Nutriflex plus can interact with some other medicines. Please tell your doctor if you are taking or receiving any of the following: ● medicines to treat inflammation (corticosteroids) ● hormone preparations that affect your fluid balance (adrenocorticotropic hormone [ACTH]) ● medicines to promote urine flow (diuretics) such as spironolactone, triamterene or amiloride ● medicines to treat high blood pressure (ACE inhibitors) such as captopril and enalapril ● medicines to treat high blood pressure or heart problems (angiotensin-II-receptor antagonists) such as losartan and valsartan ● medicines used in organ transplants such as cyclosporine and tacrolimus. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy If you are pregnant, you will receive this medicine only if the doctor considers it absolutely necessary for your recovery. Breast-feeding Breast-feeding is not recommended if women need intravenous feeding in that time. Fertility No data available. Driving and using machines This medicine is normally given to immobile patients, e.g. in a hospital or clinic which would exclude driving and using machines. However, the medicine itself has no effect on the ability to drive or use machines. 3.

How to take it

Nutriflex plus

This medicine will be administered to you by intravenous infusion (drip), that is, through a small tube directly into a large vein. Before infusion the solution must always be brought to room temperature. Your doctor will decide how much of this medicine you need and for how long you will require treatment with this medicine. The recommended daily dose for adults is up to 40 ml solution for infusion per kg body weight. Your doctor will determine the exact dose. Use in children and adolescents There are special dosage guidelines for children and adolescents between 2 and 17 years old. Your doctor knows this guidelines and will determine the dose accordingly. If you received more Nutriflex plus than you should It is unlikely that you would receive an overdose of this medicine on proper administration. However, if you are given too much of this medicine this may lead to: ● abnormally high body fluid levels (hyperhydration) ● abnormally high amounts of urine (polyuria) ● disorders of your body salt composition (electrolyte imbalance)

● ● ● ● ● ● ● ● ● ●

water on your lungs (pulmonary oedema) loss of amino acids through the urine and disturbed amino acid balance accumulation of acidic substances in your blood (metabolic acidosis) feeling sick, vomiting, shivering, headache high levels of nitrogen in the blood (hyperammonaemia) abnormally high blood sugar levels (hyperglycaemia) glucose in the urine (glucosuria) fluid deficit (dehydration) blood much more concentrated than normal (hyperosmolality) unconsciousness caused by extremely high blood sugar levels (hyperglycaemic-hyperosmolar coma).

If any of these symptoms occur, the infusion will be stopped immediately. Your doctor will decide on any additional treatment to be given. The infusion will not be started again until you have recovered. If you have any further questions on the use of this medicine, ask your healthcare professional. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

are mainly caused by overdose or too rapid infusion. They will usually disappear when the infusion is stopped. Rare (may affect up to 1 in 1,000 people) ● Feeling sick (nausea), vomiting and decreased appetite If these side effects occur, your treatment should be stopped, or if the doctor decides, it may be continued but at a lower dose level. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.

How to store it

Nutriflex plus

Keep this medicine out of the sight and reach of children. Do not store above 25 °C. Keep the bag in the outer carton in order to protect from light. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. 6.

Contents of the pack and other information

What Nutriflex plus contains –

The active substances are amino acids, glucose and electrolytes.

Each bag contains after mixing: Isoleucine Leucine Lysine hydrochloride equivalent to lysine Methionine Phenylalanine Threonine Tryptophan Valine Arginine monoglutamate equivalent to arginine equivalent to glutamic acid Histidine hydrochloride monohydrate equivalent to histidine Alanine Aspartic acid Glutamic acid Glycine Proline Serine Magnesium acetate tetrahydrate Sodium acetate trihydrate Sodium dihydrogen phosphate dihydrate Potassium hydroxide Sodium hydroxide Glucose monohydrate equivalent to glucose Calcium chloride dihydrate –

1000 ml 2.82 g 3.76 g 3.41 g 2.73 g 2.35 g 4.21 g 2.18 g 0.68 g 3.12 g 5.98 g 3.24 g 2.74 g 2.03 g 1.50 g 5.82 g 1.80 g 1.47 g 1.98 g 4.08 g 3.60 g 1.23 g 1.56 g 3.12 g 1.40 g 0.23 g 165.0 g 150.0 g 0.53 g

2000 ml 5.64 g 7.52 g 6.82 g 5.46 g 4.70 g 8.42 g 4.36 g 1.36 g 6.24 g 11.96 g 6.48 g 5.48 g 4.06 g 3.00 g 11.64 g 3.60 g 2.94 g 3.96 g 8.16 g 7.20 g 2.46 g 3.12 g 6.24 g 2.80 g 0.46 g 330.0 g 300.0 g 1.06 g

The other ingredients are citric acid monohydrate and water for injections. Electrolytes: Sodium Potassium Calcium Magnesium Chloride Phosphate Acetate

1000 ml 37.2 mmol 25.0 mmol 3.6 mmol 5.7 mmol 35.5 mmol 20.0 mmol 22.9 mmol

2000 ml 74.4 mmol 50.0 mmol 7.2 mmol 11.4 mmol 71.0 mmol 40.0 mmol 45.8 mmol

Amino acid content Nitrogen content Carbohydrate content

1000 ml 48 g 6.8 g 150 g

2000 ml

Energy in the form of amino acids [kJ (kcal)] Energy in the form of carbohydrates [kJ (kcal)] Total energy [kJ (kcal)]

1000 ml 804 (192)

96 g 13.6 g 300 g

2000 ml 1607 (384)

2512 (600)

5023 (1200)

3315 (792)

6631 (1584)

Theoretical osmolarity [mOsm/l] pH

1400 4.8 – 6.0

1400 4.8 – 6.0

What Nutriflex plus looks like and contents of the pack This medicine is a solution for infusion, i.e. it is administered through a small tube into a vein. Nutriflex plus is presented in an infusion bag with two compartments. The lower compartment contains glucose while the upper compartment contains the amino acid solution. The glucose and the amino acid solutions are clear and colourless or slightly yellowish. The product is supplied in two-chamber plastic bags containing: ● 1000 ml (400 ml of amino acids solution + 600 ml of glucose solution) ● 2000 ml (800 ml of amino acids solution + 1200 ml of glucose solution) Pack sizes: 5 × 1000 ml, 5 × 2000 ml Not all pack sizes may be marketed. Marketing Authorisation Holder B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen, Germany Postal address 34209 Melsungen Germany Phone: +49-5661-71-0 Fax: +49-5661-71-4567 Manufacturer B. Braun Medical AG Route de Sorge 9 1023 Crissier, Switzerland

Manufacturer responsible for batch release B.Braun Melsungen AG Street address: Carl-Braun-Straße 1 34212 Melsungen Germany B. Braun Medical Limited Brookdale Road Thorncliffe Park Estate Chapeltown Sheffield S35 2PW United Kingdom This leaflet was last revised in 06/2026. —————————————————————————————————————————–

The following information is intended for healthcare professionals only: The solution should always be brought to room temperature prior to infusion. Only use Nutriflex plus if the solution is clear and the bag undamaged. After infusion, any remaining solution should never be stored for later use. Preparation of the mixed solution Immediately before use the internal peel seam between the two compartments must be opened allowing the respective contents to be aseptically mixed. Remove the bag from its protective bag and proceed as follows:

  • Open out the bag and lay on a solid surface
  • Open the peel seam by using pressure with both hands
  • Briefly mix the contents of the bag together An additive port is provided for admixing of supplements to Nutriflex plus. The medicinal product must be administered via a filter with a pore size of 0.2 μm. When admixing other solutions or fat emulsions to Nutriflex plus, aseptic precautions must be strictly observed. Fat emulsions can be easily admixed by means of a special transfer set. Maximum infusion rates: The maximum infusion rate for adults, children and adolescents from 2 to 17 years is 1.6 ml per kg body weight per hour. Storage after mixing of the contents Ideally after mixing the two solutions, Nutriflex plus should be administered immediately but if immediate administration is not possible in special circumstances it can be stored for up to 7 days at room temperature and up to 14 days if stored in a refrigerator at 2 – 8°C (including administration time). Partially used containers must not be stored for later use.

Frequently asked questions about Nutriflex plus Solution for Infusion

How do I take Nutriflex plus Solution for Infusion?

Nutriflex plus 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 Nutriflex plus Solution for Infusion?

The active substance in Nutriflex plus Solution for Infusion is isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, threonine, tryptophan, valine, arginine, glutamic acid, histidine hydrochloride monohydrate, alanine, aspartic acid, glycine, proline, serine, magnesium acetate tetrahydrate, sodium acetate trihydrate, sodium dihydrogen phosphate dihydrate, potassium hydroxide, sodium hydroxide, calcium chloride dihydrate, glucose monohydrate.

Are there equivalent medicines to Nutriflex plus Solution for Infusion?

Medicines with the same active substance, strength and form include: Nutriflex basal Solution for Infusion, Nutriflex peri Solution for Infusion, Nutriflex special Solution for Infusion. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Nutriflex plus 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 Nutriflex plus 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: isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, threonine, tryptophan, valine, arginine, glutamic acid, histidine hydrochloride monohydrate, alanine, aspartic acid, glycine, proline, serine, magnesium acetate tetrahydrate, sodium acetate trihydrate, sodium dihydrogen phosphate dihydrate, potassium hydroxide, sodium hydroxide, calcium chloride dihydrate, glucose monohydrate
  • Official document: view the original leaflet on emc →
Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Supply of amino acids, glucose, electrolytes and fluid in the parenteral nutrition of patients in states of moderately severe catabolism when oral or enteral nutrition is impossible, insufficient or contraindicated.

Nutriflex plus is indicated in adults and children aged 2 to 17 years.

4.2. Posology and method of administration

Posology

Nutriflex plus is suitable for patients with normal tolerance for both glucose and fluid.

Adults

The dosage and infusion rate have to be adjusted individually according to the clinical status of the patients and their requirements of amino acids, glucose, energy, electrolytes and fluid. If necessary, additional fluid, amino acid, glucose or lipid infusions may be given. In special clinical settings, e.g. parenteral nutrition during haemodialysis to compensate for dialysis related nutrients losses, higher infusion rates may have to be used.

It is recommended that Nutriflex plus be administered continuously. A stepwise increase of the infusion rate over the first 30 minutes up to the desired infusion rate prevents possible complications.

The daily dose is:

max up to 40 ml per kg body weight per day, corresponding to

up to 1.9 g amino acids per kg body weight per day

up to 6.0 g glucose per kg body weight per day

up to 2800 ml for a 70 kg patient per day

The maximum infusion rate is:

1.6 ml per kg body weight per hour, corresponding to

0.077 g amino acids per kg body weight per hour

0.24 g glucose per kg body weight per hour.

112 ml/hour for a 70 kg patient, corresponding to

5.4 g amino acids per hour and 16.8 g glucose per hour.

Paediatric population

Nutriflex plus is contraindicated in newborn infants, infants and toddlers < 2 years of age (see section 4.3).

The dosage ranges stated below are values for guidance. The exact dosage and infusion rate should be adjusted individually according to clinical status, age, developmental stage and underlying disease. In critically ill and metabolically unstable children, it is advisable to start with lower daily dosages or infusion rates and to increase them according to the patient's condition. If necessary, additional fluid, amino acid, glucose or lipid infusions may be given.

Daily dose ( 2-17 years of age)

max up to 42 ml per kg body weight per day, corresponding to

up to2.0 g amino acids per kg body weight per day

up to 6.3 g glucose per kg body weight per day

Maximum infusion rate (2 to 17 years of age)

1.6 ml per kg body weight per hour, corresponding to

0.077 g amino acids per kg body weight per hour

0.27 g glucose per kg body weight per hour

Patients with impaired glucose metabolism

If the oxidative metabolism of glucose is impaired (e.g. in the early post-operative or posttraumatic period or in the presence of hypoxia or organ failure), the dosage should be adjusted to keep the blood glucose level close to normal values. Close monitoring of blood glucose levels is recommended in order to prevent hyperglycaemia.

Patients with renal/hepatic impairment

The doses should be adjusted individually in patients with hepatic or renal insufficiency (see also section 4.4). Nutriflex plus is contraindicated in severe hepatic insufficiency and in severe renal insufficiency without renal replacement therapy (see section 4.3).

Duration of treatment

The duration of treatment for the indications stated is not limited. During administration appropriate supply of additional energy (preferably in the form of lipids), essential fatty acids, trace elements and vitamins is necessary.

Method of administration

Intravenous use. For infusion into central veins only.

Precautions to be taken before handling or administering the medicinal product

The solution should always be brought to room temperature prior to infusion.

For instructions on aseptic mixing of the chamber contents before administration, see section 6.6.

4.3. Contraindications

● Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1

● Inborn errors of amino acid metabolism

● Hyperglycaemia not responding to insulin doses of up to 6 units insulin/hour

● Intracranial or intraspinal haemorrhage

● Acidosis

● Severe hepatic insufficiency

● Severe renal insufficiency in absence of renal replacement therapy

On account of its composition, Nutriflex plus must not be used in newborn infants, infants and toddlers < 2 years of age.

General contraindications to parenteral nutrition include:

● Unstable circulatory status with vital threat (e.g. states of collapse,shock, fluid overload, pulmonary oedema etc.)

● Acute myocardial infarction and stroke

● Unstable metabolic condition (e.g. coma of unknown origin, hypoxia, decompensated diabetes mellitus etc)

4.4. Special warnings and precautions for use

Caution should be exercised in cases of increased serum osmolarity.

Like all solutions containing carbohydrates the administration of Nutriflex plus can lead to hyperglycaemia. The blood glucose level should be monitored. If there is hyperglycaemia, the rate of infusion should be reduced or insulin should be administered. If the patient is receiving other intravenous glucose solutions concurrently, the amount of additionally administered glucose has to be taken into account.

Abrupt discontinuation of high glucose infusion rates during parenteral nutrition may lead to hypoglycaemia, especially in children less than 3 years of age and in patients with disturbed glucose metabolism. In these patient groups, tapering off of glucose administration is recommended. As a precaution it is recommended that patients should be monitored for hypoglycaemia for at least 30 minutes on the first day of abrupt discontinuation of parenteral nutrition.

Refeeding or repletion of malnourished or depleted patients may cause hypokalaemia, hypophosphataemia and hypomagnesaemia. Close monitoring of serum electrolytes is mandatory. Adequate supplementation of electrolytes according to deviations from normal values is necessary.

Due to the risk of developing a severe lactic acidosis and/or a Wernicke encephalopathy a preexisting thiamin (Vitamin B1) deficiency must be corrected before infusion of glucose containing solutions.

Substitution of additional energy in form of lipids may be necessary, as well an adequate supply of essential fatty acids, electrolytes, vitamins and trace elements. As Nutriflex plus contains magnesium, calcium, and phosphate, care should be taken when it is co-administered with solutions containing these substances.

Patients with organ impairments

Like all large-volume infusion solutions, Nutriflex plus should be administered with caution to patients with impaired cardiac or renal function.

In patients with renal insufficiency, the dose must be carefully adjusted according to individual needs, severity of organ insufficiency and the kind of instituted renal replacement therapy (haemodialysis, haemofiltration etc.).

Likewise in patients with insufficiencies of liver, adrenal glands, heart and lungs the dose must be carefully adjusted according to individual needs and the severity of organ insufficiency.

Application of hyperosmolar glucose solutions in patients with damaged haematoencephalic barrier may lead to increase of intracranial/intraspinal pressure.

There is only limited experience of its use in patients with diabetes mellitus or renal failure.

Patients with metabolic disturbances

Disturbances of the fluid, electrolyte or acid-base balance must be corrected before the start of infusion.

Solutions containing sodium salts should be used with caution in patients with sodium retention (see section 4.5).

Monitoring of clinical parameters

Controls of the serum electrolytes, the water balance, the acid-base balance, and of blood cell counts, coagulation status, hepatic and renal function are necessary.

An interruption of administration of the emulsion may be indicated if the blood glucose concentration rises to above 14 mmol/l (250 mg/dl) during administration.

During long-term administration also blood cell counts and blood coagulation should be monitored carefully.

Warnings and precautions concerning intravenous administration

Too rapid infusion can lead to fluid overload with pathological serum electrolyte concentrations, hyperhydration pulmonary oedema and polyuria.

Nutriflex plus should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.

As with all intravenous solutions, especially for parenteral nutrition, strict aseptic precautions are necessary for the infusion of Nutriflex plus.

Nutriflex plus is a preparation of complex composition. It is, therefore, strongly advisable not to add other solutions or emulsions (as long as compatibility is not proven – see section 6.2).

Elderly patients

Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.

4.5. Interaction with other medicinal products and other forms of interaction

Corticosteroids and ACTH are associated with sodium and fluid retention.

Potassium containing solutions should be used with caution in patients receiving medicinal products that increase the serum potassium concentration, such as potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride), ACE inhibitors (e.g. captopril, enalapril), angiotensin-II-receptor antagonists (e.g. losartan, valsartan), cyclosporine and tacrolimus.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of Nutriflex plus in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

Nutriflex plus should not be used during pregnancy unless the clinical condition of the woman requires treatment with parenteral nutrition.

Breast-feeding

Components/metabolites of Nutriflex plus are excreted in human milk, but at therapeutic doses no effects on the breastfed newborns/infants are anticipated. Nevertheless, breast-feeding is not recommended for mothers on parenteral nutrition.

Fertility

No data available.

4.7. Effects on ability to drive and use machines

Nutriflex plus has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile

Undesirable systemic effects with the components of Nutriflex plus are rare (≥ 1/10,000 to < 1/1,000) and usually related to inadequate dosage and/or infusion rate. Those that do occur are usually reversible and regress when therapy is discontinued.

Listing of undesirable effects Undesirable effects are listed according to their frequencies as follows:

Very common

(≥ 1/10)

Common

(≥ 1/100 to < 1/10)

Uncommon

(≥ 1/1,000 to < 1/100)

Rare

(≥ 1/10,000 to < 1/1,000)

Very rare

(< 1/10,000)

Not known

(frequency cannot be estimated from the available data)

Gastrointestinal disorders

Rare:

Nausea, vomiting, decreased appetite

Information on particular undesirable effects

If nausea, vomiting or decreased appetite occur, the infusion should be discontinued or, if appropriate, the infusion should be continued at a lower dose level.

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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Overdose of Nutriflex plus is not to be expected on proper administration.

Symptoms of fluid and electrolyte overdose

Hyperhydration, polyuria, electrolyte imbalance and pulmonary oedema.

Symptoms of amino acid overdose

Renal amino acid losses with consecutive amino acid imbalances, sickness, vomiting, shivering, headache, metabolic acidosis, and hyperammonaemia.

Symptoms of glucose overdose

Hyperglycaemia, glucosuria, dehydration, hyperosmolality, hyperglycaemic-hyperosmolar coma.

Treatment

Immediate cessation of infusion is indicated for overdose.

Further therapeutic measures depend on the particular symptoms and their severity. Disorders of the carbohydrate and electrolyte metabolism are treated by insulin administration and appropriate electrolyte substitution, respectively. When infusion is recommenced after the symptoms have declined it is recommended that the infusion rate be raised gradually with monitoring at frequent intervals.

💬 Ask about this leaflet

Ask anything about Nutriflex plus 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.

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