Package leaflet: Information for the patient

TPH

6% Solution for infusion
Please read this leaflet carefully before this medicine is given to your child, 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 nurse.
If any adverse reaction occurs, including any not listed in this leaflet, please inform your doctor or nurse. See section 4.

Contents of this leaflet:

What TPH is and what it is used for
What you need to know before TPH is given to your child
How TPH will be given to your child
Possible side effects
How to store TPH
Contents of the pack and other information

1. What TPH is and what it is used for

TPH is a solution for parenteral nutrition, meaning it is administered through a vein,
together with sugar- and fat-rich solutions, supplemented with salts, vitamins and trace elements, to
meet your child's nutritional needs.
TPH is a solution containing amino acids (substances used by the body for protein synthesis).
TPH is indicated to provide energy to neonates (including those with low birth weight) and young children.
TPH is indicated in neonates and young children in whom:

oral feeding is not possible;
poor absorption of orally administered proteins occurs;
nutritional requirements are substantially increased, as in the case of extensive burns.
Speak to the doctor if your child does not feel better or feels worse.

2. What you should know before your child is given TPH

TPH must not be given to your child

if he/she is allergic to one or more of the amino acids or to any of the other ingredients of this medicine (listed in section 6),
if he/she does not produce urine (anuria),
if he/she has a severe liver disease (hepatic coma),
if he/she has an inherited disease that makes amino acid metabolism difficult (such as maple syrup urine disease or isovaleric acidemia).

Warnings and precautions
Talk to the doctor or nurse before your child is given TPH:

if he/she has or has had asthma, as he/she may experience an allergic reaction to TPH (see section 4. Possible side effects);
if vascular precipitates form. In case of pulmonary insufficiency, the infusion must be stopped;
if he/she is taking medicines that reduce the body's defences (immunosuppressants), if he/she has high blood sugar levels (hyperglycaemia), or if he/she is malnourished, infections and sepsis may occur more easily;
if there are abnormalities in blood test results;
if he/she has a kidney or liver disease;
if he/she has fluid accumulation in the lungs (pulmonary edema);
if he/she has a weak heart (heart failure);
if he/she has imbalances in blood substances (electrolytes) or in metabolism;
if he/she has excess fluid in the body.

Patients with kidney disease
The doctor will carry out blood tests on your child during treatment with TPH:

if he/she has a kidney disease (uraemia).

Patients with liver disease
The doctor will carry out blood tests on your newborn during treatment with TPH to monitor whether he/she has high levels of ammonia in the blood. If this is the case, treatment will be suspended.
If necessary, the doctor will carry out blood tests on your child to monitor his/her health status.

Other medicines and TPH
Inform the doctor if your child is taking, has recently taken, or might take any other medicines.

Driving and using machines
Not applicable

TPH contains sodium bisulphite
Rarely, this may cause severe hypersensitivity reactions and bronchospasm.

3. How TPH will be administered to your child

This medicine will be administered to your child strictly according to the doctor's instructions.
If you have any doubts, consult the doctor.
The dose will be determined by the doctor based on your child's weight and health status.
Your child will receive this medicine through a vein (intravenous infusion).

If your child receives more TPH than they should
It is very unlikely that your child will be given more infusion solution than required, as your doctor or nurse will monitor them during treatment.
In case of fluid overload (hypervolemia) or substance imbalances (electrolyte imbalances, acidosis and/or azotemia) during therapy, the infusion must be stopped. The doctor will reassess your child's condition and initiate appropriate therapy.

If your child stops treatment with TPH
When solutions such as TPH are stopped abruptly, to prevent low blood sugar levels (hypoglycemia), the doctor will administer a sugar-containing solution (5% glucose).

If you have any questions about the use of this medicine, consult the doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects of TPH are listed below:

elevated levels of nitrogen and ammonia in the blood
a disease characterized by low levels of hemoglobin, a protein that carries oxygen in the blood (acute hemolytic anemia)
low levels of calcium in the blood (hypocalcemia)
gastrointestinal reactions
nausea
reduced blood supply to the body (circulatory and respiratory shock)
low/high blood pressure (hypo- and hypertension)
inflammation and blood clots in the veins (thrombophlebitis) at the infusion site; vein irritation (infusion site phlebitis, pain, erythema, warmth, swelling, induration)
fever, chills
high levels of acid in the blood (metabolic acidosis)
fluid weight gain, swelling due to fluid retention (edema)
mild acidosis (when, in the absence of sugars, the body's cells begin to use fatty acids rather than sugars as an energy source)
joint and muscle pain (arthralgia, myalgia)
cramps, uncontrolled body movements (tetany and convulsions), and increased response to stimuli (muscular hyperexcitability)
urticaria, itching
skin death (necrosis), blisters, swelling of scars
skin discoloration at the infusion site associated with leakage of the solution from blood vessels (extravasation)
skin rash
erythema
headache
liver diseases (hepatic failure, hepatic cirrhosis, hepatic fibrosis, cholestasis, hepatic steatosis)
increased bilirubin and liver enzymes detectable by blood tests
inflammation of the gallbladder, an organ involved in food digestion (cholecystitis)
gallstones (cholelithiasis)
blood clots in the lung (pulmonary vascular precipitates)

If any reaction occurs, inform the doctor, who will STOP the infusion and reassess your child's condition, initiate appropriate treatments, and, if necessary, retain the remaining solution for testing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TPH

Do not store at temperatures above 40°C. Protect from freezing.
Protect the medicine from light until time of use.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bag after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What TPH contains

The active substances per 1000 ml of solution are: Essential amino acids Non-essential amino acids

L-Phenylalanine g 2.9 L-Alanine g 3.2
L-Isoleucine g 4.9 L-Arginine g 7.3
L-Leucine g 8.4 L-Proline g 4.1
L-Lysine (*) g 4.9 L-Serine g 2.3
L-Methionine g 2.0 Glycine g 2.2
L-Threonine g 2.5 L-Aspartic acid g 1.9
L-Tryptophan g 1.2 Glutamic acid g 3.0
L-Valine g 4.7
L-Histidine g 2.9
L-Cysteine.HCl.H₂O g 0.2
Taurine g 0.15
L-Tyrosine (**) g 1.4

(*) Added as lysine acetate 6.9 g/l. There is no definitive evidence that, under conditions of parenteral nutrition, acetate derived from lysine acetate and acetic acid acts as a precursor of bicarbonate.
(**) As L-Tyrosine g 0.4 and N-acetyl-tyrosine g 1.2

The other components are sodium metabisulfite (see section 2. TPH contains sodium metabisulfite), water for injections, acetic acid.

Description of the appearance of TPH and contents of the pack
TPH is an infusion solution containing amino acids at a total concentration of 6%.
It is available in glass bottles of 100, 250 and 500 ml.
The following pack sizes are available:
25 bottles of 100 ml
30 bottles of 250 ml
20 bottles of 500 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BAXTER S.p.A.
Piazzale dell’Industria 20
00144 Rome, Italy

Manufacturer
Bieffe Medital S.p.A.
Via Nuova Provinciale s.n.c.
Grosotto (So), Italy

The following information is intended for healthcare professionals only:
Central venous nutrition
Central venous infusion should be considered when amino acid solutions are mixed with hypertonic glucose solutions to promote protein synthesis in hypercatabolic neonates or those with severe depletion, or in those requiring long-term parenteral nutrition.

Peripheral parenteral nutrition
In moderately catabolic or moderately depleted patients in whom central venous administration is not indicated, diluted amino acid solutions mixed with 5-10% glucose solutions may be infused into peripheral veins, together with possible additional lipid emulsions.

Allergic reactions/Hypersensitivity reactions
Anaphylactic/anaphylactoid reactions and other hypersensitivity infusion reactions have been reported with amino acid solutions administered as components of parenteral nutrition (see section 4.8). Infusion must be immediately stopped if any sign or symptom of a reaction occurs.
The solution may cause allergic-type reactions in susceptible individuals, particularly in those with a history of asthma.

Precipitates in patients receiving parenteral nutrition
Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred. Excessive addition of calcium and phosphate increases the risk of calcium phosphate precipitate formation. Precipitates have also been reported in the absence of phosphate salts in solution. Cases of precipitation at the distal filter level and suspected in vivo precipitate formation have also been reported.
In case of pulmonary insufficiency, infusion must be stopped and a medical evaluation initiated.
In addition to inspecting the solution, the infusion set and catheter should be periodically checked for precipitate formation.

Infectious complications
Infection and sepsis are complications that may occur with the use of venous catheters in patients receiving parenteral nutrition, especially with poor catheter maintenance or contaminated solutions.
Immunosuppression and other factors such as hyperglycaemia, malnutrition, and/or pre-existing diseases may predispose patients to infectious complications.
Close monitoring of symptoms and laboratory test results in cases of fever/chills, leucocytosis, technical complications with the access device, and hyperglycaemia may help in early recognition of infections.
The occurrence of septic complications can be reduced by careful attention to catheter placement and maintenance, and to the preparation of the nutritional formulation using aseptic techniques.

Refeeding syndrome in patients on parenteral nutrition
Refeeding severely malnourished patients may lead to refeeding syndrome, characterized by intracellular shifts of potassium, phosphate, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. Careful monitoring and gradual increase in nutrient intake can prevent overfeeding and these complications.

Hypertonic solutions
Infusion of hypertonic solutions may cause venous irritation, vein damage, and thrombosis when administered into peripheral veins (see section 4.8 of the Summary of Product Characteristics).

General monitoring
Monitoring should be adapted to the patient's individual situation and clinical condition and should include assessment of fluid and electrolyte balance, serum osmolarity, acid/base balance, blood glucose levels, blood ammonia levels, and liver and kidney function.

Metabolic effects
Metabolic complications may occur if nutrient intake does not match the patient's needs or if the metabolic capacity for a given dietary component has not been adequately assessed. Adverse metabolic effects may result from inadequate or excessive administration of nutrients or from administration of a solution with inappropriate composition for a patient with specific requirements.

Liver function
Patients receiving parenteral nutrition may develop hepatic complications (including cholestasis, hepatic steatosis, fibrosis, and cirrhosis, which may lead to liver failure, as well as cholecystitis and cholelithiasis), and should therefore be monitored accordingly. The aetiology of these disorders is thought to be multifactorial and may vary between patients.
Patients who develop abnormal laboratory parameters or other symptoms suggestive of hepatobiliary dysfunction should be evaluated by a hepatologist to identify potential causative or contributing factors and, if necessary, to initiate appropriate therapy or prophylaxis.
Amino acid solutions should be used with caution in patients with pre-existing liver disease or renal insufficiency.
Liver function parameters should be closely monitored in these patients, who should also be monitored for possible signs of hyperammonaemia.
Elevated blood ammonia levels and hyperammonaemia may develop in patients receiving amino acid solutions. In some patients, this may indicate the presence of a congenital amino acid metabolism disorder (see section 4.3 of the Summary of Product Characteristics) or liver failure.
Blood ammonia levels should be frequently measured in neonates and children up to 2 years of age to detect hyperammonaemia.
Potential symptoms (e.g., lethargy, irritability, poor feeding, hyperventilation, chills, and seizures) that may lead to complications including developmental delay and mental disability may be difficult to identify in this age group. Depending on severity and aetiology, hyperammonaemia may require immediate intervention.

Renal effects
Elevated blood urea nitrogen (BUN) has been reported in patients receiving amino acid-containing solutions, particularly in those with renal insufficiency.
Use with caution in patients with renal failure (e.g., uraemia). Nitrogen tolerance may be altered, and dosage adjustments may be required. Fluid and electrolyte status must be closely monitored in these patients.

Additional precautions

Injection site reactions have been reported with parenteral nutrition. These include thrombophlebitis at the infusion site, venous irritation, and severe reactions (e.g., necrosis and blistering) when extravasation occurs (see section 4.8 of the Summary of Product Characteristics). Patients should be monitored accordingly.
Severe fluid and electrolyte imbalances, severe fluid overload, and severe metabolic disturbances should be corrected before starting infusion.
Use with caution in patients with pulmonary oedema or heart failure. Fluid status must be closely monitored.
Do not connect containers in series, to avoid gas embolism due to possible residual air in the primary container.

Safe and effective use of parenteral nutrition requires thorough knowledge of nutritional issues, as well as clinical experience with potential complications.
Frequent clinical assessments and laboratory tests are necessary for proper management of parenteral nutrition.
These laboratory tests should include blood glucose, serum proteins, liver and kidney function tests, haemogram, CO₂ content, serum osmolarity, blood ammonia, and, when indicated, blood cultures.

Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may increase already elevated blood urea nitrogen. Patients with azotaemia of any origin should not receive amino acids without careful monitoring of total nitrogen intake.

Intravenous administration of these solutions may cause fluid and/or solute overload, leading to dilution of serum electrolyte concentrations, overhydration, congestive states, and pulmonary oedema. The risk of dilutional states is inversely proportional to the solute concentration of the infused solution. The risk of solute overload leading to congestive states with peripheral and pulmonary oedema is directly proportional to the solution concentration.

Administration of amino acids to patients with liver failure may result in imbalances of plasma amino acids, hyperammonaemia, pre-renal azotaemia, lethargy, and coma. Hyperammonaemia is of particular importance in neonates, as its occurrence due to genetic metabolic defects is sometimes associated—although not necessarily causally—with mental retardation.

This reaction appears to be dose-dependent and is more likely during prolonged therapy. It is essential that blood ammonia levels be frequently measured in neonates. The mechanisms involved in this reaction are not fully understood but may be related to genetic defects, immature liver function, or subclinical liver damage. Amino acid dosages should be determined based on the patient's nutritional status. If symptoms of hyperammonaemia occur, administration should be suspended and the patient's clinical condition reassessed.

The product contains sodium metabisulfite, which may cause allergic-type reactions and severe asthma attacks in sensitive individuals, particularly in asthmatics.

Caution: Parenteral nutrition should be administered only by personnel experienced in this therapeutic technique and aware of the possible complications.

Additions
TPH may be mixed with solutions containing phosphates or supplemented with phosphates. The presence of calcium and magnesium ions in an additive solution should be considered when phosphate is also present, to avoid precipitation.
Care must be taken to avoid incompatible mixtures. Consult a pharmacist.
Significant deviations from normal concentrations may require additional electrolyte supplementation.
Highly hypertonic nutrient solutions should be administered through a central venous catheter, preferably into the superior vena cava.
Circulatory overload should be avoided, especially in patients with heart failure.
Particular care is required when administering hypertonic glucose to diabetic or pre-diabetic patients. Insulin may be necessary in such patients to prevent severe hyperglycaemia.
Administration of glucose in amounts exceeding the patient's ability to utilize it may lead to hyperglycaemia, coma, and death.
Administration of amino acids without carbohydrates may cause accumulation of ketone bodies in the blood; ketonaemia can be corrected by administering carbohydrates.

If, after appropriate dilution, TPH is to be administered via peripheral venous route, ensure that the needle and catheter are correctly placed in the vein. The venipuncture site should be frequently checked for signs of infiltration. If thrombosis or phlebitis occurs, administration should be suspended or the infusion site changed, and appropriate treatment initiated. Excessive electrolyte losses, as may occur with prolonged nasogastric suction, vomiting, diarrhoea, or gastrointestinal fistula, may require additional electrolyte supplementation.

Metabolic acidosis can be prevented and rapidly controlled by including part of the cations in the electrolyte mixture as acetates or lactates. In cases of hyperchloraemic acidosis, maintaining the total chloride concentration at minimal levels is sufficient.

TPH contains less than 3 mEq/l of chloride and does not contain phosphates. Some patients, especially those with hypophosphataemia, may require phosphate supplementation. To prevent hypocalcaemia, phosphate administration should always be accompanied by calcium supplementation. To ensure adequate electrolyte intake, serum concentrations should be frequently monitored.

To minimize the risk of possible incompatibilities arising from mixing the amino acid solution with other additives prescribed by the physician, the final mixture should be immediately inspected for turbidity or precipitation, and rechecked both before administration and periodically during infusion.

Special precautions for central venous nutrition
Parenteral nutrition should be administered only by personnel experienced in this therapeutic technique and aware of the possible complications.
Central venous nutrition may lead to complications that can be reduced or prevented by careful attention to all aspects of the procedure, including solution preparation, administration, and patient monitoring.
It is essential to follow a precisely prepared programme based on up-to-date medical practice, preferably managed by physicians experienced in parenteral nutrition.

1. Technical Information

The placement of a central venous catheter should be considered a true surgical procedure.
One should have thorough knowledge of the various techniques for catheter insertion, as well as the measures to identify and manage potential complications.
For technical information and guidance regarding the most suitable insertion sites, consult the medical literature dealing with these topics.
Radiological examination allows verification of correct catheter placement.
Incorrect insertion may result in: pneumothorax, hemothorax, hydrothorax, arterial puncture and its transverse section, brachial plexus injury, catheter malposition, arteriovenous fistula formation, phlebitis, thrombosis, or entry of air or embolus into the catheter.

2. Sepsis

During total parenteral nutrition, the risk of sepsis is always present. Since contaminated solutions and catheters are potential sources of infection, it is essential that the preparation of solution mixtures, as well as catheter insertion and care, be carried out under the strictest aseptic conditions. It is preferable that solution mixtures are prepared in the Hospital Pharmacy under a laminar flow hood. The "key" factor in the preparation of mixtures is strict aseptic technique, which prevents inadvertent contamination by contact, both during and after preparation. After preparation, parenteral hyperalimentation solutions should be used as soon as possible. Refrigerated storage should last no longer than absolutely necessary.
Administration of a single bottle should never exceed 12 hours. Consult the literature to fully understand and be able to discuss knowledgeably the measures to be taken in the event of sepsis occurring during parenteral hyperalimentation. Briefly, the "classical" therapy for sepsis consists of replacing the infused bottle with a freshly prepared one and using a new administration set, and culturing the discarded solution to investigate possible bacterial or fungal contamination. If sepsis persists and no other source of infection can be identified, remove the catheter and culture the proximal tip. When fever subsides, insert a new catheter. The administration of antibiotics for non-specific, prophylactic treatment is contraindicated.
Clinical experience has shown that the catheter is the main source of infections, whereas solutions prepared using strict aseptic technique are rarely the cause of sepsis.

3. Metabolic Complications

The following metabolic complications have been observed: metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria, osmotic diuresis and dehydration, rebound hypoglycemia, increased liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, hyperammonemia in children.

To prevent or minimize the risk of these complications, frequent clinical evaluations and laboratory tests should be performed, especially during the first days of treatment.

Central Venous Nutrition

Mixtures of amino acids and hypertonic glucose can be safely administered only by continuous infusion via a central venous catheter placed in the vena cava.
The initial infusion rate must be slow and gradually increased to the recommended 60–125 mL per kg of body weight per day. If the administration rate is lower than the prescribed doses, do not attempt to recover the lost time. In addition to meeting protein requirements, especially during the first days of therapy, administration must also be adjusted according to the patient's glucose tolerance.

The daily intake of amino acids and glucose should be gradually increased until the maximum dose is reached; frequent determinations of blood and urine glucose levels will indicate the necessary rate of increase.

Peripheral Parenteral Nutrition

In patients for whom central venous access is not indicated and who can receive part or all of their required calories enterally, TPH may be administered through a peripheral vein with or without carbohydrate calories. Mixtures of TPH with 5% or 10% glucose solutions may also be used to prepare slightly hypertonic solutions for peripheral infusion; peripheral caloric intake may also be provided via lipid emulsions. It is essential that peripheral amino acid infusion be accompanied by adequate caloric intake.

Parenteral solutions, particularly when extemporaneously compounded, should be visually inspected for particulate matter or discoloration prior to use, whenever the solution and container permit.

Dosage and Method of Administration

Dosage

The initiation, duration, and dosage (dose and rate of administration) of parenteral nutrition depend on the following patient characteristics:

age, weight, and clinical condition,
nitrogen requirements,
ability to metabolize the components of TPH,
additional nutritional support that may be provided parenterally or enterally.

The infusion rate must be adjusted according to dosage, characteristics of the solution to be infused, total volume over 24 hours, and duration of infusion.
The flow rate should be gradually increased during the first hour.

The goal of nutritional therapy in neonates and young children is to provide sufficient amino acid and caloric support for protein synthesis and growth.

The total daily dose of TPH depends on the daily protein requirement and the patient's clinical and metabolic response.

Nitrogen balance determination and careful daily monitoring of body weight and fluid balance are the methods of choice for determining individual protein requirements.

Total daily fluid intake must be appropriate for the patient's age and body size.

Additives may be incompatible.

Excessive addition of calcium and phosphate increases the risk of calcium phosphate precipitate formation (see section "Precautions for Use").

Neonates and Children up to 10 kg

In the literature, a daily protein intake of 2 to 4 g per kg of body weight (2.0–4.0 g/kg/day) is recommended for neonates and children up to 10 kg. Daily doses of approximately 125 mL/kg body weight are appropriate for most neonates receiving parenteral nutrition.

Children over 10 kg

For children weighing more than 10 kg, the amino acid dose includes 20–25 g/day for the first 10 kg of body weight, plus 1.0–1.25 g/day for each additional kg above 10 kg.

Normally, TPH is mixed with hypertonic glucose solutions, supplemented with electrolytes and vitamins, and administered continuously over 24 hours.

Although nitrogen requirements may be higher in severely hypercatabolic or depleted patients, providing additional nitrogen may not be feasible due to limitations in fluid or nitrogen intake, or glucose intolerance.

Cysteine is considered an essential amino acid in neonates and young children. Therefore, it is recommended to add cysteine hydrochloride to the TPN solution: 1.0 mmol of L-cysteine hydrochloride monohydrate/kg/day.

In some patients, providing adequate calories in the form of hypertonic glucose may require administration of exogenous insulin to prevent hyperglycemia and glycosuria.

For optimal utilization of amino acids, sufficient intracellular electrolytes—primarily potassium, magnesium, and phosphate—must be provided.

Adequate amounts of major extracellular electrolytes—sodium, calcium, and chloride—must also be administered.

Patients with Hyperchloremia

In patients with hyperchloremia or other types of metabolic acidosis, sodium and potassium should be added as acetates or lactates to provide bicarbonate precursors.

The electrolyte content of TPH must be taken into account when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphate, should be monitored frequently.

Patients receiving predominantly parenteral nutrition must also receive vitamins, particularly water-soluble vitamins, as well as trace elements.

Route of Administration

TPH is intended for intravenous use only.
TPH is not indicated for fluid or volume replacement. Solution for intravenous infusion via peripheral or central vein.

Highly hypertonic parenteral nutrition solutions (>900 mOsm/L) must be administered through a central venous catheter with the tip positioned in a large central vein.

If deemed appropriate by healthcare personnel, parenteral nutrition solutions may be administered via peripheral vein in patients of all ages if the osmolarity of the formulation is ≤ 900 mOsm/L.

General Warnings

Visually inspect the container for cracks or damage.

Use the vial only if the solution is completely clear, free of visible suspended particles, not discolored, and if vacuum is present.

Use aseptic techniques. Discard any unused portion of TPH and do not use for subsequent administrations.

When additives are added to the container:

ensure compatibility and stability of the added substances (contact the Marketing Authorization Holder).
use aseptic techniques. Properly prepare the injection site on the container.
puncture the stopper and inject the additives using a syringe or a transfer/reconstitution set as described.
thoroughly mix the container contents and added substances.
inspect the container for possible discoloration and presence of particles.

Confirm container integrity. Use only if the container is undamaged and the solution is clear.
Ensure that proper storage requirements for added substances are observed.

Administration of infusion solution:
Before use, the solution should be at room temperature.
Use aseptic techniques.
For single use only.
Confirm container integrity. Use only if the container is undamaged and the solution is clear.
Do not reconnect partially used containers.
The use of an in-line filter is recommended during administration of all parenteral nutrition solutions.
Inspect the container for discoloration and presence of particles.
Do not connect used containers in series to avoid potential gas embolism due to residual air in the primary container.
TPH must not be infused through the same tubing used for blood or blood components.

Interactions

Adding drugs that may cause irritation directly into the amino acid solution should be avoided; such drugs may be administered by injection at a different site.
When adding other medicinal products, their compatibility must be verified and the stability of the final mixtures checked.

Overdose

In case of inappropriate administration (overdose and/or infusion rate higher than recommended), hypervolemia, electrolyte imbalances, acidosis, and/or azotemia may occur. In such situations, the infusion must be immediately stopped. If medically appropriate, further interventions may be indicated to prevent clinical complications.

There is no specific antidote for overdose. Emergency procedures should include appropriate corrective measures.

How to Store TPH

Expiry date: see the date printed on the packaging.
The expiry date refers to the product stored in its original, intact packaging under recommended storage conditions.
Warning: Do not use the medicinal product after the expiry date stated on the packaging.
Exposure of TPH to heat should be minimized; avoid temperatures above 40°C and protect from freezing.
Store protected from light until use.

For further information, consult the Summary of Product Characteristics.