Basalflex

Package leaflet: Information for the user

Basalflex, solution for infusion

Amino acids/glucose/electrolytes
Please read this leaflet carefully before 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 could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Basalflex is and what it is used for

2. Before you use Basalflex

3. How to use Basalflex

4. Possible side effects

5. How to store Basalflex

6. Contents of the pack and other information

7. What Basalflex 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's growth and healing processes, as well as calories in the form of carbohydrates.

This product is administered to you intravenously (by infusion) because you are unable to eat adequately or cannot be fed via a feeding tube.
Basalflex 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 Basalflex

Do not use Basalflex

• 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 diet
• if you have very high blood sugar 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 undergoing artificial kidney treatment (hemofiltration or dialysis)

Like other medicines of the same type, Basalflex must not be administered in case of:

• 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, during collapse or shock, fluid accumulation in the lungs (pulmonary edema), or disturbances in water balance

Basalflex must not be administered to neonates, infants, or children under two years of age.
Warnings and precautions
Consult a healthcare professional before using Basalflex

• if you have impaired heart or kidney function
• if you have disturbances in fluid or 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 exercise particular caution also in case of damage to the blood-brain barrier, as
this medicine could cause increased pressure within the skull or spinal cord.
If you are in a state of severe malnutrition, intravenous nutrition will be initiated gradually and with
particular 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 sugar levels. Blood samples
may need to be taken to monitor this.
If the infusion is accidentally interrupted suddenly, blood sugar 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 sugar levels will be closely monitored, especially after stopping the infusion.
Thus, blood sugar levels must be closely monitored, especially after discontinuation 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 required.
The doctor will ensure that your requirements for fluids and electrolytes are met. In addition to Basalflex,
you will receive other nutritional substances (nutrients) to fully meet your needs.
As with all intravenous solutions, strict aseptic precautions must be observed during the infusion of Basalflex.
Children and adolescents
In case of a sudden drop in your child's blood sugar following sudden interruption
of the infusion, refer also to the previous section “Warnings and precautions”.
The doctor will not administer Basalflex to children under two years of age.
Other medicines and Basalflex
Inform your doctor if you are taking, have recently taken, or might take any other
medicines.
Basalflex 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 water balance (adrenocorticotropic hormone [ACTH])
• medicines that promote urine flow, 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, 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 intravenous nutrition is required.
Fertility
No data are available.
Driving and use of machinery
This medicine is normally administered to immobilized patients, for example in hospital or clinic.
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 Basalflex

This medicine will be administered to you by intravenous infusion (drip), that is, through a small catheter 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 between 2 and 17 years. Your doctor will determine the dose based on these criteria.

If you receive more Basalflex 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)
• excessive urine production (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
• elevated levels of nitrogen in the blood (hyperammonaemia)
• excessively high blood glucose levels (hyperglycaemia)
• glucose in the urine (glycosuria)
• lack of fluids (dehydration)
• blood concentration much higher than normal (hyperosmolality)
• loss of consciousness due to extremely high blood glucose (hyperglycaemic-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 restarted until your condition has improved.

If you have any questions about how to use this medicine, consult your healthcare provider.

4. Possible side effects

Like all medicines, Basalflex may cause side effects, although not everybody gets 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 loss of appetite.

If these side effects occur, treatment must be discontinued, or the doctor may decide to continue treatment 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 may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Basalflex

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 that month.

6. Package contents and other information

What Basalflex 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 Basalflex and contents of the pack
This medicinal product is an infusion solution to be administered directly into a vein through a small cannula.
Basalflex 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 and colourless or slightly yellowish.
The product is supplied in plastic two-compartment bags containing:

• 1,000 ml (400 ml amino acid solution + 600 ml glucose solution)
• 2,000 ml (800 ml amino acid solution + 1,200 ml 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 Basalflex 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 its protective pouch 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 the addition of supplements to Basalflex. When adding other solutions or lipid emulsions to Basalflex, 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 2.0 mL per kg of body weight per hour.

Storage after mixing the contents
Basalflex 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 in a refrigerator at 2–8 °C (including administration time). Partially used containers must not be stored for future use.