Plusflex

Package leaflet: Information for the user

Plusflex, infusion solution

Amino acids/glucose/electrolytes
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Plusflex is and what it is used for
2. What you need to know before using Plusflex
3. How to use Plusflex
4. Possible side effects
5. How to store Plusflex
6. Contents of the pack and other information

1. What Plusflex is and what it is used for

The product contains nutritive substances called amino acids, salts (electrolytes), and glucose, which are essential for the body to grow or heal, as well as calories in the form of carbohydrates.
This product is administered to you intravenously (by infusion) because you are unable to eat sufficiently or cannot be fed via a feeding tube. Plusflex is specifically indicated for patients in a moderately severe catabolic state, a condition in which patients burn their own energy and protein reserves faster than they can replenish them.

2. What you need to know before using Plusflex Do not use Plusflex

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a congenital amino acid metabolism disorder and need to follow a special protein diet
• if you have excessively high blood glucose levels requiring more than 6 units of insulin per hour to keep them under control
• if you have excessively high levels of acidic substances in the blood (acidosis)
• if you have bleeding in the brain or spinal cord
• if you suffer from severe liver failure (severe hepatic insufficiency)
• if you suffer from severe kidney failure (severe renal insufficiency) without recourse to artificial kidney treatment (hemofiltration or dialysis)
• Like other medicines of the same type, Plusflex must not be administered in cases of: acute heart attack (myocardial infarction) or stroke
• any poorly controlled metabolic disorder, for example unconsciousness (coma) of unknown origin, insufficient oxygen supply to tissues, or decompensated diabetes mellitus
• potentially life-threatening circulatory disorders, such as those that may occur, for example, in case of collapse or shock, fluid accumulation in the lungs (pulmonary edema), or disturbances in fluid balance

Plusflex must not be administered to neonates, infants, or children under two years of age.
Warnings and precautions

• if you have impaired heart or kidney function;
• if you have disturbances in fluid and electrolyte balance or acid-base balance, for example low levels of fluids and salts in the body (hypotonic dehydration) or low levels of sodium or potassium in the blood;
• if you have excessively high blood sugar levels. Your daily dose will be determined and monitored with particular caution if you have impaired kidney, liver, adrenal gland, heart, or lung function. The doctor will also exercise particular caution in case of damage to the blood-brain barrier, as this medicine could cause an increase in pressure inside the skull or spinal cord.

If you are in a state of severe malnutrition, intravenous nutrition will be administered gradually and with particular caution, with adequate monitoring and necessary supplementation of electrolytes, especially potassium, magnesium, and phosphate.
This medicine contains glucose (a sugar) and may therefore affect blood glucose levels. Blood samples may need to be taken to monitor this.
If the infusion is accidentally interrupted suddenly, blood glucose levels may drop sharply. The doctor will take this into account especially if your ability to metabolize glucose is reduced (for example, if you have diabetes) or when the solution is administered to children under 3 years of age.
Therefore, blood glucose levels must be closely monitored, especially after stopping the infusion.
In addition, monitoring of blood electrolyte levels, fluid balance, acid-base balance, blood cell count, coagulation, and kidney and liver function is necessary.
The doctor will ensure that your requirements for fluids and electrolytes are met. In addition to Plusflex, you will receive other nutritional substances (nutrients) to fully meet your needs.
As with all intravenous solutions, strict aseptic precautions must be observed when administering Plusflex.
Children and adolescents
In case of a sudden drop in your child's blood glucose following an unexpected interruption of the infusion, refer also to the previous section "Warnings and precautions".
The doctor will not administer Plusflex to children under two years of age.
Other medicines and Plusflex
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Plusflex may interact with other medicines. Inform your doctor if you are taking any of the following medicines:

• medicines used to treat inflammation (corticosteroids);
• hormonal preparations affecting fluid balance (adrenocorticotropic hormone [ACTH]);
• medicines that increase urine flow (diuretics), such as spironolactone, triamterene, or amiloride;
• medicines for treating high blood pressure (ACE inhibitors), such as captopril and enalapril;
• medicines used to treat high blood pressure or heart problems (angiotensin II receptor antagonists), such as losartan and valsartan;
• medicines used in organ transplantation, such as cyclosporine and tacrolimus.
  Pregnancy, breastfeeding, and fertility
  If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You will be given this medicine during pregnancy only if your doctor considers it absolutely necessary for your recovery.
Breastfeeding
Breastfeeding is not recommended if the woman requires intravenous nutrition.
Fertility
No data are available.
Driving and use of machines
This medicine is normally administered to immobilized patients, for example in hospital or clinic settings.
This condition excludes the ability to drive vehicles or operate machinery. The medicine itself does not impair the ability to drive or operate machinery.

3. How to use Plusflex

This medicine will be administered to you by intravenous infusion (drip), that is, through a small cannula inserted directly into a large vein.
The solution must always be brought to room temperature before infusion.
Your doctor will determine the amount of medicine you need and the duration of treatment.
The recommended daily dose for adults is up to 40 mL of infusion solution per kg of body weight. Your doctor will determine the exact dose.

Use in children and adolescents
There are specific dosing criteria for children and adolescents aged 2 to 17 years. Your doctor will determine the dose based on these criteria.

If you have been given more Plusflex than you should have received
With correct administration, it is unlikely that you will receive an excessive dose of this medicine.
However, if you do receive too much, the following effects may occur:

• excessive levels of body fluids (overhydration)
• abnormally high urine output (polyuria)
• disturbances in the body's electrolyte balance (electrolyte imbalances)
• fluid in the lungs (pulmonary edema)
• loss of amino acids in the urine and disturbances in amino acid balance
• accumulation of acidic substances in the blood (metabolic acidosis)
• malaise, vomiting, chills, headache
• elevated levels of nitrogen in the blood (hyperammonemia)
• blood glucose levels too high (hyperglycemia)
• glucose in the urine (glycosuria)
• fluid loss (dehydration)
• blood concentration significantly higher than normal (hyperosmolality)
• unconscious state due to extremely high blood glucose (hyperglycemic-hyperosmolar coma).

If any of these symptoms occur, the infusion will be stopped immediately. Your doctor will determine any additional treatment you may require. The infusion will not be resumed until your condition has improved.
If you have any doubts about the use of this medicine, consult your healthcare provider.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects are mainly due to overdose or too rapid infusion, and usually disappear at the end of the infusion.
Rare (may affect up to 1 in 1,000 people):

• Malaise (nausea), vomiting, and decreased appetite.

If these side effects occur, treatment should be discontinued, or the doctor may decide to continue at lower doses.
Reporting of side effects
If any of the side effects worsen, or if you experience any side effect not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Plusflex

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

6. Contents of the pack and other information

What Plusflex contains

• The active substances are amino acids, glucose and electrolytes. After mixing, each bag contains:

• The other components are citric acid monohydrate and water for injections.

Description of the appearance of Plusflex and contents of the pack
This medicinal product is an infusion solution for direct intravenous administration through a small cannula.
Plusflex is supplied in a two-compartment infusion bag. The lower compartment contains glucose, while the upper compartment contains the amino acid solution. The glucose and amino acid solutions are clear, colourless or slightly yellowish.
The product is supplied in plastic two-compartment bags containing:

• 1,000 ml (400 ml of amino acid solution + 600 ml of glucose solution)
• 2,000 ml (800 ml of amino acid solution + 1,200 ml of glucose solution)
  Pack sizes: 5×1,000 ml, 5×2,000 ml
  Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
Postal address: 34212 Melsungen, Germany
34209 Melsungen, Germany
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567

The following information is intended for healthcare professionals only:
The solution must always be brought to room temperature before infusion.
Use Plusflex only if the solution is clear and the bag is undamaged. After infusion, any remaining solution must never be retained for future use.

Preparation of the mixture
Immediately before use, the internal seal separating the two compartments must be opened to allow aseptic mixing of the components.
Remove the bag from the protective overwrap and proceed as follows:

• Lay the bag flat on a rigid surface.
• Open the seal by pressing with both hands.
• Mix the contents of the bag briefly.
  An additional port allows supplementation of Plusflex with additives. When adding other solutions or lipid emulsions to Plusflex, strict aseptic precautions must be observed. Lipid emulsions can be easily added using a specific transfer set.

Maximum infusion rate
The maximum infusion rate for adults, children and adolescents aged 2 to 17 years is 1.6 mL per kg of body weight per hour.

Storage after mixing the contents
Plusflex should preferably be administered immediately after mixing the two solutions. However, if immediate administration is not possible, it may be stored under certain conditions for up to 7 days at room temperature or up to 14 days refrigerated at 2–8 °C (including administration time). Partially used containers must not be stored for future use.