Periflex

Package leaflet: Information for the user

Periflex, infusion solution

Amino acids/glucose/electrolytes
Please read all of this leaflet carefully before you start using this medicine because 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
  Contents of this leaflet:
  1. What Periflex is and what it is used for
  2. What you need to know before using Periflex
  3. How to use Periflex
  4. Possible side effects
  5. How to store Periflex
  6. Contents of the pack and other information

1. What Periflex 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 for growth or healing, as well as calories in the form of carbohydrates.
This product is administered to you through a vein (infusion) because you are unable to eat sufficiently or cannot be fed through a feeding tube.
Periflex is specifically indicated for patients in a mild to moderate 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 Periflex

Do not use Periflex

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6)
• if you have a congenital amino acid metabolism disorder and need to follow a special protein-restricted diet
• if you have blood glucose levels so high that they require more than 6 units of insulin per hour to be controlled
• 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, Periflex must not be administered in the following cases:

• acute myocardial infarction (heart attack) 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 occurring, for example, in shock or collapse, fluid accumulation in the lungs (pulmonary edema), or disturbances in fluid balance

Periflex must not be administered to neonates, infants, or children under two years of age.

Warnings and precautions

• Consult a healthcare professional before using Periflex if you have impaired heart or kidney function;
• if you have disturbances in fluid or electrolyte balance or acid-base equilibrium, for example low body fluid and salt levels (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 function of the kidneys, liver, adrenal glands, heart, or lungs.

The doctor will exercise particular caution also 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 initiated gradually and with special caution, with adequate monitoring and appropriate 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 also drop sharply. The doctor will pay particular attention to this, 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 counts, coagulation, and kidney and liver function is necessary.
The doctor will ensure that your requirements for fluids and electrolytes are met. In addition to Periflex, you will receive other nutrients to fully meet your needs.
Infusion into peripheral veins may cause inflammation of the vein due to a blood clot (thrombophlebitis). The doctor will check the infusion site daily.
As with all intravenous solutions, strict aseptic precautions must be observed when administering Periflex.

Children and adolescents
In case of sudden drop in your child's blood glucose following sudden interruption of the infusion, refer also to the previous section "Warnings and precautions".
The doctor will not administer Periflex to children under two years of age.

Other medicines and Periflex
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Periflex may interact with other medicines. Inform your doctor if you are taking or receiving 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 used to treat 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, suspect you may be pregnant, planning to become pregnant, or 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 parenteral (intravenous) nutrition.

Fertility
No data are available.

Driving and using machines
This medicine is normally administered to immobilized patients, for example in hospital or clinic settings.
This condition excludes driving vehicles or operating machinery. However, the medicine itself does not impair the ability to drive or operate machinery.

3. How to use Periflex

This medicine will be administered to you by intravenous infusion (drip), that is, through a
small cannula inserted directly into a vein. It can be administered into small (peripheral) or
large (central) veins.
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 between 2 and 17 years. Your doctor
will determine the dose based on these criteria.
If you have been given more Periflex than you should have
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 salt composition (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, nausea, vomiting, chills, headache
• elevated levels of nitrogen in the blood (hyperammonaemia)
• blood sugar levels too high (hyperglycaemia)
• glucose in the urine (glycosuria)
• fluid loss (dehydration)
• blood concentration significantly higher than normal (hyperosmolality)
• unconsciousness due to extremely high blood sugar (hyperglycaemic-hyperosmolar coma).

If any of these symptoms occur, the infusion must be stopped immediately. Your doctor will decide on any additional treatment you may need. The infusion will not be restarted until your condition has improved.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects are mainly due to overdose or too rapid infusion, and usually disappear at the end of the infusion.

Common (may affect up to 1 in 10 people)

• Irritation of the vein, inflammation of the wall of a vein at the infusion site (phlebitis, thrombophlebitis)

Rare (may affect up to 1 in 1,000 people)

• Feeling unwell (nausea), vomiting, and decreased appetite

If any of these side effects occur, treatment must be stopped, or the doctor may decide to continue at lower doses.
If signs of vein irritation or inflammation of the vein walls occur, the doctor may change the infusion site.

Reporting of side effects
If any of the side effects worsens, 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 Periflex

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 bag and label. The expiry date refers to the last day of the month.

6. Contents of the pack and other information

What Periflex 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 Periflex and contents of the pack
This medicinal product is an infusion solution intended for direct intravenous administration through a small cannula.
Periflex 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 exclusively for physicians or healthcare professionals:
The solution must always be brought to room temperature before infusion.
Use Periflex only if the solution is clear and the bag is intact. 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 its protective overwrap and proceed as follows:

• Lay the bag flat on a rigid surface.
• Open the seal by pressing with both hands.
• Gently mix the contents of the bag.

An additional port allows supplementation of Periflex with additives. When adding other solutions or lipid emulsions to Periflex, 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 2.5 mL per kg of body weight per hour.

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