Patient leaflet - CRESNI WITH ELECTROLYTES 6.3% SOLUTION FOR INFUSION
1. what cresni is and what it is used for
Cresni is a solution for infusion presented in a single chamber bag.
Cresni with electrolytes contains amino acids and electrolytes.
Cresni is used to provide nutrition to adults and children greater than 2 years of age by a tube into a vein when normal feeding by mouth is not suitable. This nutrition is known as parenteral nutrition.
Cresni must only be used under medical supervision.
2. what you need to know before cresni is administered
Cresni must not be used:
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– if you are allergic to any of the ingredients of this medicine (listed in section 6),
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– If your body has problems using amino acids.
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– If you have an abnormally high amount of any of the electrolytes contained in Cresni with electrolytes (sodium, potassium, magnesium, and/or phosphorus) in your blood.
In all cases, your doctor will base his/her decision on whether you should receive this medicine on factors such as your age, weight, and medical condition, together with the results of any test performed.
Warnings and precautions
Talk to your doctor or nurse before Cresni is administered to you.
If you are given parenteral nutrition solutions too fast this may result in harmful effects.
The infusion must be stopped immediately if any abnormal signs or symptoms of an allergic reaction develop. These can include sweating, fever, chills, headache, skin rashes or difficulty breathing.
Difficulty breathing could also be a sign that small particles have formed, blocking blood vessels in the lungs (pulmonary vascular precipitates). If you experience any difficulty breathing, tell your doctor or nurse. They will decide a course of action to be taken.
Certain medications and illnesses can increase the risk of developing infection or sepsis (bacteria in the blood). There is a particular risk of infection or sepsis when a tube is placed in your vein (intravenous catheter). Your doctor will carefully watch you for any signs of infection. Patients who require parenteral nutrition (giving nutrition through a tube in your vein) may be more likely to develop infections from their medical conditions. Using “germ-free” (aseptic) techniques when placing and caring for the catheter and when making the parenteral nutrition can reduce the risk of infection.
If you are severely malnourished and you need to receive feedings by vein, your doctor should start the treatment slowly. Also, your doctor should monitor you closely to prevent sudden changes in your fluid, vitamin, electrolyte and mineral levels.
The balance of water and salt in your body and metabolic disorders may be corrected before starting the infusion. Your doctor will monitor your condition while you receive this medicine and may change the dosage or give you additional nutrients, such as vitamins, electrolytes, and trace elements, if he/she feels they are appropriate.
Children and adolescents
If your child is under 18 years old, special care will be taken to give him/her the correct dosage. Increased precautions will also be taken because of the greater sensitivity of children to the risk of infection.
Vitamin and trace element supplementation is always required. Paediatric formulations must be used for supplementation when available.
Geriatric population
Dose selection for elderly patient will be cautiously adapted based on the conditions of the hepatic, renal, or cardiac function, taking into account concomitant disease or another drug therapy.
Other medicines and Cresni
Tell your doctor if you are taking or using, have recently taken or used or might take or use any other medicines.
If you take other medicinal products, with or without medical prescription, you should inform your doctor in advance to check compatibility.
Cresni must not be administered simultaneously with blood through the same infusion tubing.
Cresni contains potassium. Special care should be taken in patients taking diuretics, ACE inhibitors, angiotensin II receptor antagonists (drugs for high blood pressure), or immunosuppressants. These types of drugs may increase potassium levels in your blood.
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 you are given this medicine.
There are no adequate experiences from the use of Cresni in pregnant or breast-feeding women. Cresni may be considered during pregnancy and breastfeeding, if necessary. Cresni should only be given to pregnant or breast-feeding women after careful consideration from your doctor.
Driving and using machines
Not relevant
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3. How Cresni will be used
Dosage
Cresni should only be given in adults and children greater than 2 years of age.
It is a solution for infusion, to be administered via a tube (catheter) into a vein in your chest.
Cresni should be at room temperature before use.
Cresni is for single use only.
The infusion of 1 bag usually lasts between 12 and 24 hours.
Dosage -Adults
Your doctor will specify a flow rate corresponding to your needs and clinical condition.
The prescription may be continued for as long as it is needed, depending upon your clinical condition.
Dosage – Children greater than two years of age and adolescents
The doctor will decide the dose and for how long the medication will be given. This will depend on age, weight, height, medical condition and the ability of the body to break down and use the ingredients in Cresni.
If you have been administered more Cresni than you should
If the dose given is too high or the infusion is too fast, the amino acid content may make your blood too acidic, and signs of hypervolaemia (increase of circulating blood volume) may occur. Receiving a volume of Cresni that is too large may cause nausea, vomiting, chills, headache, hot flush, excessive sweating (hyperhidrosis) and electrolyte disturbances. In such situations, the infusion must be stopped immediately and your doctor notified.
In some severe cases, your doctor may have to give you temporary renal dialysis to help your kidneys eliminate the excess product.
To prevent these events occurring, your doctor will regularly monitor your condition and test your blood parameters.
If you have any further questions on the use of this product, ask your doctor.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any changes in the way you feel during or after the treatment, tell your doctor or nurse right away.
The tests your doctor will perform while you are taking the medicine should help minimise the risk of side effects.
If any abnormal signs or symptoms of an allergic reaction develop, such as sweating, fever, chills, headache, skin rashes, or breathing difficulties, the infusion should be stopped immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom (Northern Ireland)
Yellow Card Scheme
Website: or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
HPRA Pharmacovigilance
Website:
5. how to store cresni
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container and the outer packaging after EXP. The expiry date refers to the last day of that month.
Do not freeze.
Store in the overpouch to protect Cresni from oxidation.
Do not use this medicine if the container is damaged or if the solution is not clear and colourless or slightly yellow.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Cresni contains
The active substances are amino acids with electrolytes :
| Composition [g/L] | |
| Amino Acid | 6.3% |
| Alanine | 9.16 |
| Arginine | 6.20 |
| Aspartic Acid | 1.83 |
| Glutamic acid | 3.16 |
| Glycine | 4.39 |
| Histidine | 3.77 |
| Isoleucine | 3.16 |
| Leucine | 4.39 |
| Lysine (as Lysine acetate) | 4.98 (7.02) |
| Methionine | 3.16 |
| Phenylalanine | 4.39 |
| Proline | 3.77 |
| Serine | 2.50 |
| Threonine | 3.16 |
| Tryptophan | 1.06 |
| Tyrosine | 0.16 |
| Valine | 4.05 |
| Electrolytes | |
| Sodium acetate trihydrate | 2.89 |
| Potassium chloride | 2.98 |
| Magnesium chloride hexahydrate | 1.12 |
| Sodium glycerophosphate, hydrated | 4.78 |
– The excipients are glacial acetic acid (for pH adjustment) and water for injections.
What Cresni looks like and contents of the pack
Cresni is a clear and colourless or slightly yellow solution for infusion presented in a single chamber bag.
To prevent contact with oxygen contained in the air, the bag is packaged in an oxygen barrier overpouch.
Pack size:
1 carton with 12 bags of 500 mL
Marketing Authorisation Holder and Manufacturer
UK (NI)
Baxter Healthcare Ltd
Caxton Way, Thetford,
Norfolk, IP24 3SE
United Kingdom
Ireland
Baxter Holding B.V.
Kobaltweg 49,
3542CE Utrecht,
Netherlands
Manufacturer
BAXTER S.A.
Boulevard Rene Branquart, 80
7860 Lessines
Belgium
This medicinal product is authorised in the Member States of the EEA under the following names:
| Austria, , France, Germany, Greece, Ireland, Italy, Portugal, Spain, United Kingdom, | Cresnisol with electrolytes 6.3% |
| Belgium, Denmark, Finland, Luxembourg, Netherlands, Norway, Sweden | Cresnisol N10E |
| Czech Republic, Poland, Slovakia, | Cresnimene |
This leaflet was last revised in Jan 2021
The following information is intended for healthcare professionals only:
The percentage (%w/v) of strength in the product name refers to the total amino acid content of the solution*
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* applicable when the strength in the product name is expressed in % (w/v)
A. QUALITATIVE AND QUANTITATIVE COMPOSITION
The Cresni with electrolytes 6.3% – is an amino acids solution with electrolytes presented in a 500 mL single chamber bag containing 17 amino acids and electrolytes: ____________________________
| Composition [g/L] | |
| Amino Acid | 6.3% |
| Alanine | 9.16 |
| Arginine | 6.20 |
| Aspartic Acid | 1.83 |
| Glutamic acid | 3.16 |
| Glycine | 4.39 |
| Histidine* | 3.77 |
| Isoleucine* | 3.16 |
| Leucine* | 4.39 |
| Lysine* (as Lysine acetate) | 4.98 (7.02) |
| Methionine* | 3.16 |
| Phenylalanine* | 4.39 |
| Proline | 3.77 |
| Serine | 2.50 |
| Threonine* | 3.16 |
| Tryptophan* | 1.06 |
| Tyrosine | 0.16 |
| Valine* | 4.05 |
| Electrolytes | |
| Sodium acetate trihydrate | 2.89 |
| Potassium chloride | 2.98 |
| Magnesium chloride hexahydrate | 1.12 |
| Sodium glycerophosphate, hydrated | 4.78 |
| Amino Acid Content | 63.29 |
| Nitrogen Content | 10.0 |
* Essential amino acids
The amino acid and electrolytes solution is clear and colourless or slightly yellow.
Energy [kJ/L (kcal/L)]: 1054 (252)
Theoretical osmolarity [mOsm/L]: approx. 755
pH: 6.0–7.0
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B. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Cresni is not recommended for use in children less than 2 years of age due to inadequate composition (see sections 4.4; 5.1 and 5.2 of the SmPC).
The maximum daily dose mentioned below should not be exceeded.
The flow rate must be increased gradually during the first hour and then be adjusted to take into account the dose being administered, the daily volume intake, and the duration of the infusion.
In adults
The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolize the constituents of Cresni, as well as additional energy or proteins provided orally/enterally.
The average daily nitrogen/amino acid requirements are:
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– 0.16 to 0.32 g nitrogen /kg body weight (1 to 2 g of amino acids/kg), depending on the patient's nutritional status and degree of catabolic stress. Special populations may require up to 0.4 g nitrogen/kg body weight (2.5 g of amino acids/kg).
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– 20 to 40 kcal/kg,
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– 20 to 40 mL fluid /kg, or 1 to 1.5 mL per expended kcal.
Daily Dose of amino acids per body weight (g/kg)
Volume of Cresni with electrolytes 6.3%
mL/kg
For a 70 kg patient (mL)
1
15.8
1106
2
31.6
2212
2.5
39.5
2765
Maximum infusion rate (mL/kg/hr)
Maximum infusion rate (g of amino acids/kg/hr)
mL/kg/hr
For a 70 kg patient (mL/hr)
0.1
1.58
111
In children, greater than 2 years of age
There have been no studies performed in the paediatric population.
The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability to metabolize constituents of Cresni, as well as additional energy or proteins given orally/enterally.
In addition, daily fluid, nitrogen, and energy requirements continuously decrease with age. Two groups, ages 2 to 11 years and 12 to 18 years, are considered.
| Constituent | 2 to 11 years | 12 to 18 years |
| Maximum Daily Dosea | ||
| Amino acids (g/kg/d) | 1–2.5 | 1–2 |
| Maximum Hourly Ratea | ||
| Amino acids (g/kg/h) | 0.2 | 0.12 |
a Recommended values from 2018 ESPGHAN/ESPEN/ESPR Guidelines
| Daily dose of amino acids per body weight (g/kg) | Volume of Cresni with electrolytes 6.3% (mL/kg) |
| 1 | 15.8 |
| 2 | 31.6 |
| 2.5 | 39.5 |
| Maximum infusion rate (g of amino acids/kg/hr) | Maximum infusion rate (mL/kg//hr) |
| 0.2 | 3.16 |
| 0.12 | 1.9 |
In general, it is recommended to start the infusion for small children with a low daily dose and gradually increase it up to the maximal dosage (see above).
Method of administration
For single use only.
The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 850 mOsm/L or greater must be infused through a central catheter.
It is recommended that, after opening the bag, the content is used immediately. Any unused portion of Cresni should be discarded and should not be used for subsequent admixing.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours.
Treatment with parenteral nutrition may be continued for as long as required by the patient’s clinical conditions.
As indicated on an individual basis, vitamins and trace elements and other components (including glucose and lipids) can be added to the parenteral nutrition regimen to meet nutrient needs and prevent deficiencies and complications from developing (see Section 6.2 of the SmPC).
Fat emulsion coadministration should be considered when prolonged parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD).
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C. INCOMPATIBILITIES
Do not add other medicinal products or substances without first confirming their compatibility and the stability of the resulting preparation.
As with any parenteral nutrition admixture, calcium and phosphate ratios must be considered, especially in the form of mineral salts, as excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates.
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D. SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Confirm the integrity of the container. Use only if the container is not damaged and if the solution is clear and colourless or slightly yellow.
To open:
- Do not remove from overpouch until ready to use.
- Remove the protective overpouch. Discard the overpouch.
- Check container for leaks.
Cresni should only be mixed with other intravenous solutions for administration, if compatibility has been proven in advance.
Cresni can be mixed with the following additives:
- Multivitamin preparations
- Multi-trace element preparations
- Sodium salt
- Potassium salt
- Magnesium salt
- Calcium salt
- Phosphate salt
The compatibility indicative table below shows possible additions of a multi-trace element product such as Nutryelt and a multivitamin product such as Cernevit and generics of electrolytes and trace elements in defined quantities. The addition of clinically needed electrolytes and trace elements should take into account the amounts already included in the initial bag formulation.
| Macronutrient | Compatibility range for admixture with lipids | Compatibility range for admixture without lipids | ||
| Glucose (kcal/L) | 150–955 | 120–1167 | ||
| Cresni with electrolytes 6.3% (gN/L) | 3.2–10.3 | 3.2–12.9 | ||
| ClinOleic 20% (kcal/L) | 154–667 | – | ||
| Sodium (mmol/L) b | 0–150 | 0–150 | ||
| Potassium (mmol/L)b | 0–150 | 0–150 | ||
| Calcium (mmol/L) | 0–5 | 0–5 | ||
| Magnesium (mmol/L)c | 0–6 | 0–6 | ||
| Phosphate (mmol/L) | 0–22 (organic) a | 0–9.2 (inorganic) | 0–22 (organic) d | 0–9.2 (inorganic) |
| Cernevit (vials/L) (Composition per vial: Vit. A (as Retinol palmitate) 3500 IU, Vit. D3 (Cholecalciferol) 220 IU, Vit. E (Alphatocopherol) 11.2 IU, Vit. C (Ascorbic acid) 125 mg, Vit. B1 (Thiamine) 3.51 mg, Vit. B2 (Riboflavin) 4.14 mg, Vit. B6 (Pyridoxine) 4.53 mg, Vit. B12 (Cyanocobalamin) 6 pg, Vit. B9 (Folic acid) 414 pg, Vit. B5 (Pantothenic acid) 17.25 mg, Vit. B8 (Biotin) 69 pg, Vit. PP (Nicotinamide) 46mg) | 0–1 | 0–1 | ||
| Nutryelt (vials/L) (Composition per vial: Zinc 153 pmol; Copper 4.7 pmol; Manganese 1.0 pmol; Fluorine 50 pmol; Iodine 1.0 pmol; Selenium 0.9 pmol; Molybdenum 0.21 pmol; Chromium 0.19 pmol; Iron 18 pmol) | 0–2 | 0.1 | 0.2 | 0.1 |
| a Including organic phosphate coming from ClinOleic 20% and Cresni with electrolytes 6.3%
| ||||
Compatibility may vary between products from different sources and healthcare professionals are advised to carry out appropriate checks when mixing Cresni with other parenteral solutions.
If additions to the container are made:
- Observe strict aseptic conditions.
- Ensure stability and compatibility of additives.
- Prepare the injection site of the container.
- Puncture the injection site and inject the additives using an injection needle or a reconstitution
device.
- Mix contents of the container and the additives thoroughly.
- Inspect final solution for particulate matter.
- After completion of admixture, check container for leaks.
- Ensure proper storage requirements of additives are followed.
Preparation of the infusion:
- Observe strict aseptic conditions.
- Suspend the bag.
- Remove the plastic protector from the administration outlet.
- Firmly insert the infusion set spike into the administration outlet.
Administration of the infusion:
- For single use only.
- Do not reconnect any partially used container.
- Use immediately after opening the bag; do not store the opened bag for a subsequent infusion.
- Do not connect containers in series in order to avoid air embolism due to possible residual air contained in the primary container.