Specialflex

Package leaflet: Information for the user

Specialflex infusion solution

Amino acids/glucose/electrolytes
Please read this leaflet carefully before you start taking 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, because it could be dangerous.
• 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 Specialflex is and what it is used for
  2. What you need to know before using Specialflex
  3. How to use Specialflex
  4. Possible side effects
  5. How to store Specialflex
  6. Contents of the pack and other information

1. What Specialflex 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.

2. This product is administered into a vein (infusion) because you are unable to eat sufficiently or cannot be fed via a feeding tube. Specialflex is specifically indicated for adults and children aged between 2 and 17 years with moderate to severe catabolic state, a condition in which patients burn their own energy and protein reserves faster than they can replenish them.

What you need to know before using Specialflex

Do not use Specialflex

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6)
• if you suffer from a congenital error of amino acid metabolism and require a specific protein-restricted diet
• if you have excessively high blood glucose levels requiring 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, Specialflex must not be administered in the following cases:

• acute myocardial infarction (heart attack) or stroke
• any poorly controlled metabolic disorder, such as 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, pulmonary fluid accumulation (pulmonary edema), or disturbances in water balance

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

Warnings and precautions

Consult a healthcare professional before using Specialflex

• if you have impaired heart or kidney function
• if you have disturbances in fluid or salt 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 physician will exercise particular caution also in case of damage to the blood-brain barrier, as this medicine could cause increased pressure within the brain or spinal cord.
If you are in a state of severe malnutrition, intravenous nutrition will be initiated gradually and cautiously, with appropriate monitoring and adequate supply 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 physician will pay particular attention to this, especially if your ability to metabolize glucose is reduced (e.g., 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 interruption of the infusion.
In addition, monitoring of blood electrolyte levels, fluid balance, acid-base balance, and, in case of long-term administration, blood cell counts, coagulation, and kidney and liver function is necessary.
The physician will ensure that your requirements for fluids and electrolytes are met. In addition to Specialflex, you will receive other nutritive substances (nutrients) to fully meet your needs.
As with all intravenous solutions, strict aseptic precautions must be observed during the infusion of Specialflex.

Children and adolescents
In case of a sudden drop in your child's blood glucose following an abrupt interruption of the infusion, refer also to the previous section “Warnings and precautions”.
The physician will not administer Specialflex to children under two years of age.

Other medicines and Specialflex
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Specialflex 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 promote 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 a pregnancy, or breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You will receive this medicine 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 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. The medicine itself does not impair the ability to drive or operate machinery.

3. How to use Specialflex

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 25 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 receive more Specialflex than you should
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:

• excessively high levels of body fluids (overhydration)
• abnormally large amount of urine (polyuria)
• disturbances in the body's electrolyte 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, vomiting, chills, headache

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• elevated levels of nitrogen in the blood (hyperammonaemia)
• blood sugar levels too high (hyperglycaemia)
• glucose in the urine (glucosuria)
• lack of fluids (dehydration)
• blood concentration significantly higher than normal (hyperosmolality)
• unconscious state due to extremely high blood sugar (hyperglycaemic-hyperosmolar coma).

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

4. Possible adverse reactions

Like all medicines, Specialflex may cause adverse reactions, although not everyone experiences them.
Adverse reactions 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.
• Excessive urine production (polyuria).

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

5. How to store Specialflex

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 Specialflex after the expiry date stated on the bag and on the carton label. The expiry date refers to the last day of the month.

6. Contents of the pack and other information

What Specialflex contains

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

• The excipients are citric acid monohydrate and water for injections.

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Description of the appearance of Specialflex and contents of the pack
This medicinal product is an infusion solution to be administered directly into a vein through a small cannula.
Specialflex 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 (500 ml amino acid solution + 500 ml glucose solution)
• 1.500 ml (750 ml amino acid solution + 750 ml glucose solution)
  Pack sizes: 5×1.000 ml, 5×1.500 ml. Not all pack sizes may be marketed. Marketing Authorization Holder and Manufacturer B. Braun Melsungen AG Carl-Braun-Straße 1 Mailing 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 Specialflex only if the solution is clear and the bag is intact. After infusion, any remaining solution must never be stored 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.
• Briefly mix the contents of the bag. An additional port allows supplementation of Specialflex. Strict aseptic precautions must be observed when adding other solutions or lipid emulsions to Specialflex. 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 1.0 mL per kg of body weight per hour.

Storage after mixing the contents
Specialflex should preferably be administered immediately after mixing the two solutions; however, if immediate administration is not possible, 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 stored for future use.
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