Clinimix n12g20e solucion para perfusion
Introduction
Package Insert: Information for the Patient
Clinimix N12G20E Infusion Solution
Read this package insert carefully before starting administration of this medication, as it contains important information for you.
- Keep this package insert, as you may need to refer to it again.
- If you have any questions, consult your doctor or nurse.
- If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this package insert. See section 4.
1. What is Clinimix and how is it used
Clinimix is a solution for infusion. It is supplied in a bag with 2 chambers. One chamber contains an amino acid solution with electrolytes and the second contains a glucose solution with calcium chloride. The chambers are separated by a non-permanent seal. The contents of the chambers must be mixed immediately before administration by rolling the top of the bag to open the seals.
Clinimix is administered to feed adults and children through a tube connected to a vein when normal oral feeding is not suitable.
Clinimix should only be administered under medical supervision.
2. What you need to know before starting Clinimix administration
CLINIMIX should not be administered if:
- You are allergic to the active ingredients or any of the other components of this medication (listed in section 6),
- Your body has problems using certain amino acids,
- You have severe high blood sugar (severe hyperglycemia),
- Your blood is excessively acidic (metabolic acidosis due to excessive lactate),
- You have high levels of sodium, potassium, magnesium, calcium, and/or phosphate in your blood (hypernatremia, hyperkalemia, hypermagnesemia, hypercalcemia, and/or hyperphosphatemia),
- Children under 28 days should not be co-administered ceftriaxona with intravenous solutions containing calcium, as particles may form.
Your doctor will decide whether to administer this medication based on factors such as age, weight, and clinical condition, along with the results of all tests performed.
Warnings and precautions
Consult your doctor or nurse before CLINIMIX is administered to you.
If any abnormal signs or symptoms of an allergic reaction develop, such as fever, chills, skin rash, or difficulty breathing, sweating, nausea, and headache, inform your doctor or nurse: the infusion will be stopped immediately. Your doctor will monitor your condition while you are receiving this medication and may change the dose or add other nutrients, such as lipids, vitamins, electrolytes, and oligoelements if deemed necessary.
Certain medications and conditions may increase the risk of developing an infection or sepsis (bacteria in the blood). There is a special risk of infection or sepsis when a tube (intravenous catheter) is placed in your vein. Your doctor will closely monitor you for any signs of infection. The use of aseptic techniques (germ-free) when placing and maintaining the catheter and preparing the nutritional formula can reduce the risk of infection.
CLINIMIX with electrolytes contains calcium. It should not be administered with the antibiotic Ceftriaxona because particles may form.
If you are severely malnourished to the point where you need to receive nutrition through a vein, it is recommended that parenteral nutrition be initiated slowly and carefully.
Your doctor will monitor your condition at the start of the infusion, especially if you currently have liver, kidney, adrenal, heart, or circulation problems. Your doctor should also be aware of severe conditions that affect how the body handles sugars, fats, proteins, or salts (metabolic disorders). If any abnormal signs occur, including venous irritation, the infusion should be stopped.
To check the effectiveness and safety of administration, your doctor will perform laboratory and clinical tests while you are receiving this medication. If you are receiving this medication for several weeks, your blood will be analyzed regularly. In particular, in cases of glucose intolerance, blood glucose and urine glucose will be regularly monitored, and if you are a diabetic patient, your insulin dose may need to be adjusted.
Children and adolescents
When used in newborns and children under 2 years, the solution (in bags and administration equipment) must be protected from exposure to light until administration is complete. Exposure of Clinimix to ambient light, especially after mixing with oligoelements and/or vitamins, generates peroxides and other degradation products that can be reduced by protecting exposure to light.
Interaction of CLINIMIX with other medications
Inform your doctor or nurse if you are taking or have recently taken or may need to take any other medication.
CLINIMIX with electrolytes contains calcium. It should not be administered with the antibiotic Ceftriaxona because particles may form.
Due to the potassium content of CLINIMIX, special attention should be paid to patients treated with potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene), angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor antagonists, or immunosuppressants tacrolimus or cyclosporine due to the risk of hyperkalemia.
Pregnancy, lactation, and fertility
If you are pregnant or breastfeeding, or believe you may be pregnant or intend to become pregnant, consult your doctor before using this medication.
3. How Clinimix is Administered
Before administering the product, the non-permanent seal between the two compartments must be broken and the contents of both mixed.
CLINIMIX can be administered to adults and children.
When used in newborns and children under 2 years, the solution (in bags and administration equipment) must be protected from exposure to light until the end of administration (see section 2).
It is a perfusion solution that is administered through a plastic tube connected to a vein in your arm or a large vein in your chest.
Dose – Adults and children
Your doctor will decide on the dose you need and the time for which it will be administered, based on age, weight, height, clinical condition, daily fluid volume, and energy and nitrogen needs.
Follow exactly the CLINIMIX administration instructions given by your doctor. Consult your doctor if you have any doubts.
Administration may continue for as long as necessary, based on your clinical condition.
A bag perfusion usually lasts between 8 and 24 hours.
If you are administered more CLINIMIX than you should
If the administered dose is too high or the perfusion too rapid, it may cause an increase in your blood circulation volume or make your blood too acidic. The glucose content may increase your blood glucose and urine levels. An excessive volume administration may cause nausea, vomiting, tremors, and electrolyte imbalances. In these situations, the perfusion must be stopped immediately.
In some severe cases, your doctor may need to perform temporary renal dialysis to help your kidneys eliminate the excess product.
To prevent these cases, your doctor will regularly monitor your condition and analyze your blood parameters.
If you have any other doubts about the use of this product, ask your doctor.
4. Possible Adverse Effects
Like all medications, this medication may produce adverse effects, although not everyone will experience them. If you notice any change in how you feel during treatment or after it, inform your doctor or nurse immediately.
The tests your doctor will perform while administering this medication should minimize the risk of adverse effects.
Infusion will be stopped immediately if any abnormal sign or symptoms of an allergic reaction develop, such as abnormally high or low blood pressure, appearance of blue or purple skin discoloration, abnormally high heart rate, difficulty breathing, vomiting, nausea, skin eruptions, increased body temperature, excessive sweating, and chills.
Other adverse effects have been observed, which occur with more or less frequency:
- Anaphylaxis (a severe allergic reaction that starts quickly and can cause death).
- High levels of glucose, ammonia, and nitrogen-containing compounds in the blood.
- Liver function deterioration, abnormal liver function blood tests.
- Bile duct inflammation, presence of gallstones in the bile duct.
- Vein inflammation at the infusion site, venous irritation, pain, irritation, burning, swelling.
- Presence of glucose in the urine.
- Diabetic coma
- Formation of small particles that block pulmonary blood vessels.
Reporting Adverse Effects:
If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.
5. Conservation of Clinimix
Keep this medication out of the sight and reach of children.
When used in newborns and children under 2 years, the solution (in the bags and administration equipment) must be protected from exposure to light until the administration is completed (see section 2).
Do not use this medication after the expiration date appearing on the packaging and outer packaging (MM/YYYY). The expiration date is the last day of the month indicated.
Do not freeze.
Store the packaging in the outer packaging.
Do not dispose of the medication through the drains or trash. In case of doubt, ask your pharmacist how to dispose of the packaging and medication that you do not need. This way, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Clinimix
The active principles of each bag of the reconstituted solution are:
| Active Principles | 1 l | 1.5 l | 2 l |
| L-alanine | 7.25 g | 10.87 g | 14.49 g |
| L-arginine | 4.03 g | 6.04 g | 8.05 g |
| Glycine | 3.61 g | 5.41 g | 7.21 g |
| L-histidine | 1.68 g | 2.52 g | 3.36 g |
| L-isoleucine | 2.10 g | 3.15 g | 4.20 g |
| L-leucine | 2.56 g | 3.83 g | 5.11 g |
| L-lysine (as hydrochloride) | 2.03 g (2.54 g) | 3.05 g (3.80 g) | 4.06 g (5.07 g) |
| L-methionine | 1.40 g | 2.10 g | 2.80 g |
| L-phenylalanine | 1.96 g | 2.94 g | 3.92 g |
| L-proline | 2.38 g | 3.57 g | 4.76 g |
| L-serine | 1.75 g | 2.63 g | 3.50 g |
| L-threonine | 1.47 g | 2.21 g | 2.94 g |
| L-tryptophan | 0.63 g | 0.95 g | 1.26 g |
| L-tyrosine | 0.14 g | 0.21 g | 0.28 g |
| L-valine | 2.03 g | 3.05 g | 4.06 g |
| Sodium acetate 3H2O | 2.58 g | 3.86 g | 5.15 g |
| Potassium phosphate dibasic | 2.61 g | 3.92 g | 5.22 g |
| Sodium chloride | 0.94 g | 1.41 g | 1.88 g |
| Magnesium chloride 6H2O | 0.52 g | 0.77 g | 1.02 g |
| Glucose anhydrous (as glucose monohydrate) | 100 g (110 g) | 150 g (165 g) | 200 g (220 g) |
| Calcium chloride 2H2O | 0.33 g | 0.50 g | 0.66 g |
The other components are:
- acetic acid, hydrochloric acid (to adjust the pH of the solution),
- water for injection.
Appearance of CLINIMIX and contents of the container
CLINIMIX is a solution for infusion that is presented in a multi-layered plastic bag with two chambers. The inner layer (contact layer) of the bag is made of polymers (a mixture of polyolefin copolymers) to be compatible with the components and authorized additives. Other layers are made of EVA (polyethylene-vinyl-acetate) and a copolyester.
Before reconstitution, the glucose and amino acid solutions are transparent, colorless, or slightly yellowish. After reconstitution, the solution is also transparent, colorless, or slightly yellowish.
To prevent contact with air oxygen, the bag is packaged inside an outer bag that acts as an oxygen barrier, containing an oxygen absorbent.
Container sizes
1000 ml bag: carton box with 8 bags
1 bag of 1000 ml
1500 ml bag: carton box with 6 bags
1 bag of 1500 ml
2000 ml bag: carton box with 4 bags
1 bag of 2000 ml
Only some container sizes may be marketed.
Marketing Authorization Holder
Baxter S.L.
Pouet de Camilo 2,
46394 Ribarroja del Turia (Valencia) Spain
Responsible for manufacturing
Baxter SA, Boulevard René Branquart, 80, 7860 Lessines, Belgium
This medicinal product is authorized in the member states of the European Economic Area with the following names:
Clinimix N12G20E, solution for infusion
In some countries, it is registered under another name, as indicated below
Germany: Clinimix 3.5% G-E
Last review of this leaflet was in September 2021
More detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
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This information is intended solely for healthcare professionals:
1. Quantitative composition
After mixing the contents of the two compartments, the composition of the binary mixture for all available bag sizes provides the following:
| 1 l | 1.5 l | 2 l | |
| Nitrogen (g) Amino acids (g) Glucose (g) | 5.8 35 100 | 8.7 53 150 | 11.6 70 200 |
| Total calories (kcal) Calories from glucose (kcal) | 540 400 | 810 600 | 1080 800 |
| Sodium (mmol) Potassium (mmol) Magnesium (mmol) Calcium (mmol) | 35 30 2.5 2.3 | 53 45 3.8 3.4 | 70 60 5.0 4.5 |
| Acetate (mmol) Chloride (mmol) Phosphate as HPO42- (mmol) | 60 40 15 | 90 60 23 | 120 80 30 |
| pH Osmolarity (mOsm/l) | 6 1060 |
2. Dosage and administration
Before administering the product, the non-permanent seal between the two compartments must be broken and the contents of both mixed.
Dose and infusion rate
The dose must be individualized according to the patient's nutritional needs, energy expenditure, clinical status, body weight, and ability to metabolize the components of Clinimix, as well as the additional energy or protein administered orally/enterally.
In adults, the needs range from 0.16 g of nitrogen/kg/day (approximately 1 g of amino acid/kg/day) to 0.32 g of nitrogen/kg/day (approximately 2 g of amino acid/kg/day).
In neonates, the needs range from 0.16 g of nitrogen/kg/day (approximately 1 g of amino acid/kg/day) to 0.40 g of nitrogen/kg/day (approximately 2.5 g of amino acid/kg/day).
In adults and patients 12 to 18 years the needs of calories range from 25 kcal/kg/day to 40 kcal/kg/day, depending on the patient's nutritional status and the level of catabolism. Patients under 12 years may have higher requirements.
There may be clinical situations where patients require amounts of nutrients that differ from the composition of Clinimix. In this situation, any adjustment of volume (dose) must take into account the resulting effect on the dosing of all other nutritional components of Clinimix.
The infusion rate and volume must be established by a prescribing physician with experience in pediatric intravenous fluid therapy.
This medicinal product does not contain the amino acids cysteine and taurine, considered conditionally essential for neonates and infants.
This medicinal product is not recommended for premature newborns, full-term newborns, and children under 2 years.
The infusion time must be greater than 8 hours. Normally, the infusion rate is gradually increased during the first hour without exceeding 2.5 ml/kg body weight per hour, and the maximum dose is 40 ml/kg body weight per day.
Administration
When used in newborns and children under 2 years, the solution (in bags and administration equipment) must be protected from exposure to light until the end of administration.
Route of administration
It will be administered by intravenous peripheral or central route depending on the final osmolarity of the mixture. In general, the accepted limit for peripheral infusion is around 800 mOsm/l, but it varies greatly with age and the patient's general condition and peripheral vein characteristics.
3. Warnings and precautions for use
WARNING
With Clinimix formulations, hypersensitivity reactions/infusion reactions have been reported, including hypotension, hypertension, peripheral cyanosis, tachycardia, dyspnea, vomiting, nausea, urticaria, skin rash, pruritus, erythema, hyperhidrosis, fever, and chills. With other parenteral nutrition products, anaphylaxis has been reported.
When starting any intravenous infusion, special clinical monitoring is required. If any abnormal sign or symptom occurs, such as a hypersensitivity reaction or infusion reaction, the infusion must be stopped immediately.
Solutions containing glucose should be used with caution, in any case, in patients with known allergy to corn or corn-derived products.
Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition.
In some cases, fatal results have been reported. Excessive addition of calcium and phosphate increases the risk of phosphate calcium precipitate formation. Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation has also been reported in the in-line filter and is suspected to occur in vivo.
If pulmonary distress symptoms occur, the infusion must be stopped and a medical evaluation initiated.
In addition to inspecting the solution, the infusion equipment, and the catheter, they must be checked periodically for precipitates.
In patients over 28 days (including adults), ceftriaxone should not be administered intravenously at the same time as solutions containing calcium, including Clinimix N12G20E, through the same infusion route. If the same infusion line is used for sequential administration, it must be carefully cleaned with a compatible liquid between infusions.
The use of intravenous catheters for administering parenteral formulations, poor maintenance of catheters, or contaminated solutions can lead to infection and sepsis.
Immunosuppression and other factors, such as hyperglycemia, malnutrition, and/or underlying disease, can predispose patients to infectious complications.
Clinical and laboratory monitoring, including fever/chills, catheter-related complications, and hyperglycemia, can help identify early infections.
Reducing the risk of septic complications can be achieved by emphasizing the use of aseptic technique in catheter placement, maintenance, and parenteral formula preparation.
Refeeding syndrome can occur in severely malnourished patients, characterized by changes in intracellular potassium, phosphate, and magnesium. It can also be associated with thiamine deficiency and fluid retention. Strict monitoring and gradual nutrient intake, avoiding overfeeding, can prevent these complications.
Hypertonic solutions can cause venous irritation if infused through a peripheral vein. The choice of peripheral or central vein depends on the final osmolarity of the mixture.
The generally accepted limit for peripheral infusion is around 800 mOsm/l, but it varies greatly with age and the patient's general condition and peripheral vein characteristics.
To avoid gas embolism due to possible residual air in the primary container, do not connect plastic containers in series.
PRECAUTIONS
Before starting the infusion, severe water and electrolyte imbalances, severe fluid overload, and severe metabolic disorders must be corrected.
Metabolic complications can occur if nutrient intake is not adapted to the patient's needs, or if the metabolic capacity of any nutritional component is not evaluated accurately. Adverse metabolic effects can occur due to inadequate or excessive administration of nutrients, or due to the composition of a mixture not suitable for the patient's specific needs.
Frequent clinical and laboratory monitoring, including ionogram and renal and liver function tests, is essential for proper control during administration.
Electrolyte needs must be carefully determined and controlled in patients receiving these solutions, especially in solutions without electrolytes.
Glucose intolerance is a common metabolic complication in severely stressed patients. Infusion of this solution can cause hyperglycemia, glycosuria, and hyperosmolar syndrome. Blood glucose and urine glucose must be monitored regularly, and if necessary, insulin dosage must be adjusted for diabetic patients.
Use with caution in patients with renal insufficiency, especially if hyperkalemia is present, due to the risk of developing or worsening metabolic acidosis and hyperazotemia if not performing extra-renal waste removal. Fluid and electrolyte status must be carefully controlled in these patients.
Severe renal insufficiency requires the use of specially formulated amino acid solutions.
Care must be taken when administering Clinimix to patients with adrenal insufficiency.
Fluid overload must be avoided, especially in patients with pulmonary edema, heart failure, or cardiac failure. Fluid status must be carefully monitored.
Apart from routine liver function tests, patients with pre-existing liver disease or liver insufficiency must be monitored for possible symptoms of hyperammonemia.
It is known that in some patients receiving parenteral nutrition, hepatobiliary disorders, including cholestasis, hepatic steatosis, fibrosis, and cirrhosis, can occur, leading to liver insufficiency, as well as cholecystitis and cholelithiasis. The etiology of these disorders is multifactorial and may differ between patients. Those who develop abnormal laboratory parameters or other signs of hepatobiliary disorders must be rapidly evaluated by a clinical expert in liver diseases to identify possible causal and contributing factors and possible therapeutic and preventive interventions.
In patients receiving amino acid solutions, an increase in blood ammonia levels and hyperammonemia can occur. In some patients, this may indicate the presence of a congenital disorder of amino acid metabolism (see Section 4.3 of the SmPC) or liver insufficiency.
Blood ammonia levels must be measured regularly in newborns and infants to detect hyperammonemia, which may indicate the presence of a congenital disorder of amino acid metabolism.
Depending on the degree and etiology, hyperammonemia may require immediate intervention.
Too rapid infusion of amino acids can cause nausea, vomiting, and chills. In these cases, infusion must be stopped immediately.
In general, the dose for elderly patients must be cautious, taking into account the higher frequency of liver, kidney, or heart insufficiency and concomitant diseases or pharmacotherapy.
Pediatric population
- No studies have been conducted in the pediatric population.
- See above regarding the monitoring of hyperammonemia in pediatric patients.
Exposure to light of parenteral nutrition solutions for intravenous administration, especially after mixing with oligoelements or vitamins, can have adverse effects on the clinical outcome of newborns due to the generation of peroxides and other degradation products. When used in newborns and children under 2 years, Clinimix must be protected from ambient light until the end of administration.
4. Practical information on preparation and handling
Caution: Administer the product only after breaking the seal and mixing the contents of the two compartments
| 1. | 2. | 3. | |||
| Break from the top to open the outer bag. | Remove the front part of the outer bag to access the Clinimix bag. Dispose of the outer bag and the sachet with the oxygen absorbent. | Place the bag on a horizontal and clean surface with the spigot in front of you. | |||
| 4. | 5. | 6. | |||
