TPH 100 ML Инфузионный раствор

Содержание инструкции

1. TPH
   1. What is TPH and what is it for
   2. What you need to know before TPH is given to your child
   3. How TPH will be administered to your child
   4. Possible side effects
   5. How to store TPH
   6. Content of the pack and other information
   7. Technical information
   8. Sepsis
   9. Metabolic Complications

TPH

6% Solution for infusion

Read this leaflet carefully before this medicine is administered 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 side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What TPH is and what it is used for
• 2. What you need to know before TPH is administered to your child
• 3. How TPH will be administered to your child
• 4. Possible side effects
• 5. How to store TPH
• 6. Contents of the pack and other information

1. What is TPH and what is it for

TPH is a parenteral nutrition solution, meaning it is administered through a vein,
together with solutions rich in sugars and fats, in addition to salts, vitamins and trace elements, to
meet the nutritional needs of your child.
TPH is a solution containing amino acids (substances used by your body for the production
of proteins).
TPH is indicated to provide energy to newborns (including those with low birth weight) and to
small children. TPH is indicated in newborns and small children in whom:

• 1) oral feeding is not possible;
• 2) there is poor absorption of proteins taken orally;
• 3) the nutritional requirement is substantially increased as in the case of extensive burns.

Contact your doctor if your child does not feel better or if they feel worse.

2. What you need to know before TPH is given to your child

TPH must not be given to your child

• if they are allergic to one or more of the amino acids or to any of the other ingredients of this medicine (listed in section 6),
• if they do not produce urine (anuria),
• if they suffer from a severe liver disease (hepatic coma),
• if they suffer from an inherited disease that makes amino acid metabolism difficult (such as maple syrup urine disease and isovaleric acidemia).

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

• if they suffer or have suffered from asthma, because they 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 they are taking medicines that decrease the body's defenses (immunosuppressants), if they suffer from high blood sugar levels (hyperglycemia) or if they suffer from malnutrition, infections and sepsis may occur more easily;
• if they have abnormalities in blood test results;
• if they suffer from a kidney or liver disease;
• if they suffer from fluid accumulation in the lungs (pulmonary edema);
• if they have a weak heart (heart failure);
• if they suffer from imbalances of substances contained in the blood (electrolytes) or metabolism;
• if they have a lot of fluid in the body

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

• if they suffer from a kidney disease (uremia).

Patients with a liver disease
The doctor will perform blood tests on your newborn during treatment with TPH to
check if they have high levels of ammonia in the blood. In such a case, the administration will be
suspended.
If necessary, the doctor will perform blood tests on your child to check their health status.

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

Driving and using machines
Not applicable

TPH contains sodium bisulfite
Rarely it can cause severe hypersensitivity reactions and bronchospasm.

3. How TPH will be administered to your child

This medicine will be administered to your child always following the instructions exactly
given by the doctor. If you have any doubts, consult your doctor.
The dose will be established by the doctor based on the weight and health condition of your child.
Your child will receive this medicine through a vein.

If your child is given more TPH than they should
It is very unlikely that your child will be given more infusion solution than necessary
because your doctor or nurse will monitor them during the treatment.
In the event of fluid overload (hypervolemia) or substances (electrolyte imbalances, acidosis and/or
azotemia) during therapy, the infusion must be stopped, the doctor will re-evaluate the conditions
of your child and will establish appropriate therapy.

If your child stops the treatment with TPH
When solutions like TPH are stopped suddenly, to prevent a lowering
of blood sugar levels (hypoglycemia), the doctor will administer a solution containing
sugar (glucose) 5%.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The possible side effects of TPH are listed below:

• elevated levels of nitrogen and ammonia in the blood
• 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)
• reactions to the stomach and intestines
• nausea
• decreased blood supply to the body (circulatory and respiratory shock)
• low/high blood pressure (hypo- and hypertension)
• inflammation and formation of blood clots in the veins (thrombophlebitis) at the infusion site; irritation of the veins (phlebitis at the infusion site, pain, erythema, heat, swelling, hardening)
• fever, chills
• elevated levels of acids in the blood (metabolic acidosis)
• weight gain due to fluid, swelling due to fluid retention (edema)
• mild acidosis (when, in the absence of sugars, the body's cells begin to use fatty acids instead of sugars as an energy source)
• joint and muscle pain (arthralgia, myalgia)
• cramps, uncontrolled body movements (tetany and convulsions) and accentuated reactions to stimuli (muscle hyperexcitability)
• urticaria, itching
• skin death (necrosis), blisters, swelling of scars
• discoloration of the skin at the infusion site associated with leakage of the solution from blood vessels (extravasation)
• skin rash
• erythema
• headache
• liver diseases (liver failure, cirrhosis, liver fibrosis, cholestasis, steatosis)
• increased bilirubin and liver enzymes detectable by blood tests
• inflammation of the gallbladder, an organ involved in the digestion of food (cholecystitis)
• gallstones (cholelithiasis)
• blood clots in the lung (vascular pulmonary precipitates)

If any reaction occurs, inform the doctor who will SUSPENDthe administration of the
solution and re-evaluate your child's condition, institute appropriate therapies and, if deemed
necessary, preserve the remaining solution for checks.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor. You can also report
side effects directly through 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 a temperature above 40°C. Protect from frost.
Protect the medicine from light until the time of use.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the bag after SCAD. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Content of the pack and other information

What TPH contains

• The active ingredients 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.HCI H O g 0.2
Taurine g 0.15
L-Tyrosine (**) g 1.4
(*) Added as Lysine acetate 6.9 g/l. There is no certain evidence that, in the conditions of
parenteral nutrition, the acetate from lysine acetate and acetic acid is a precursor
of bicarbonate.
(**) As L-Tyrosine g 0.4 and N-acetyl-Tyrosine g 1.2

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

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

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

Manufacturer
Bieffe Medital S.p.A.
Via Nuova Provinciale s.n.c.-
Grosotto (So)
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The following information is intended only for doctors or healthcare professionals:
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 or severely depleted neonates, or in those who require parenteral nutrition for
prolonged periods.

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 should be infused into peripheral veins, together with any supplementary administrations
of lipid emulsions.
Allergic Reactions/Hypersensitivity Reactions
Anaphylactic/anaphylactoid reactions and other infusion reactions of
hypersensitivity have been reported with amino acid solutions administered as components of parenteral nutrition (See paragraph 4.8). Infusion must be stopped immediately in case of
appearance of any sign or symptom of reaction.
The solution may cause allergic-type reactions in susceptible subjects, particularly in
those with a history of asthma.
Precipitates in patients on parenteral nutrition
Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition. In some cases
there have been fatal outcomes. Excessive addition of calcium and phosphate increases the risk of formation
of calcium phosphate precipitates. Precipitates have also been reported in the absence of phosphate salts in
solution. Cases of precipitation at the distal filtration and suspected formation of precipitate in vivo have also been reported.
In case of pulmonary insufficiency, infusion must be stopped and medical evaluation must be started.
In addition to inspecting the solution, the infusion set and catheter must also be checked periodically for precipitate formation.
Infectious Complications
Infection and sepsis are complications that can occur with the use of venous catheters
in patients receiving parenteral nutrition, especially in case of poor catheter maintenance or contaminated solutions.
Immunosuppression and other factors such as hyperglycemia, malnutrition and/or pre-existing diseases
can predispose patients to infectious complications.
Careful monitoring of symptoms and laboratory tests in case of fever/chills,
leukocytosis, technical complications with the access device and hyperglycemia can help to
early recognize infections.
The occurrence of septic complications can be reduced by paying more attention to
catheter placement and maintenance and in the preparation of the nutritional formulation
using aseptic techniques.
Refeeding syndrome in patients on parenteral nutrition
Refeeding severely malnourished patients can lead to refeeding syndrome, which is
characterized by the intracellular shift of potassium, phosphorus and magnesium as the patient
becomes anabolic. Thiamine deficiency and fluid retention can develop. Careful
monitoring and slow increase of nutrients avoid overfeeding and can prevent
these complications.
Hypertonic Solutions
Infusion of hypertonic solutions can cause vein irritation, vein damage and thrombosis
when administered in peripheral veins (see paragraph 4.8 of the Summary of Product Characteristics).
General Controls
Control should be adapted to the situation and the patient's clinical condition and must
include the dosage of water-electrolyte balance, serum osmolarity, acid/base balance, blood glucose levels, blood ammonia levels and liver and kidney function.
Metabolic Effects
Metabolic complications can occur if the nutrient intake is not appropriate for the patient's needs
or if the metabolic capacity of a dietary component administered has not been carefully assessed. Adverse metabolic effects can occur from inadequate or excessive administration of nutrients or from the administration of a solution with an inappropriate composition for a patient with specific needs.
Liver Function
Patients on parenteral nutrition may develop liver complications (including cholestasis,
hepatic steatosis, fibrosis and cirrhosis, which can lead to liver failure, as well as cholecystitis
and cholelithiasis) and must therefore be monitored accordingly. The etiology of these disorders is
thought to be due to multiple factors and may differ depending on the patients.
Patients who develop abnormal laboratory parameters or other symptoms of hepatobiliary dysfunction
should be evaluated by a hepatologist so that he can identify the possible factors that cause or contribute to them and, if necessary, prescribe appropriate therapy or prophylaxis.
Amino acid solutions should be used with caution in patients with pre-existing liver disease or with renal insufficiency.
Liver function parameters must be carefully monitored in these patients who must also be monitored for possible symptoms of hyperammonemia.
Increased blood ammonia levels and hyperammonemia can develop in patients
receiving amino acid solutions. In some patients this may indicate the presence of a
congenital amino acid metabolism disorder (see paragraph 4.3 of the Summary of
Product Characteristics) or liver failure.
Blood ammonia must be measured frequently in neonates and children up to 2 years of age to identify
hyperammonemia. Potential symptoms (e.g., lethargy, irritability, poor feeding, hyperventilation, chills and
convulsions) that can lead to complications including developmental delay and mental disability can be difficult to identify in this age group. Depending on the extent and
etiology, hyperammonemia may require immediate intervention.
Renal Effects
An elevated blood urea value has been reported in patients undergoing therapy with
solutions containing amino acids, in particular it can occur in patients with renal insufficiency.
Use with caution in patients with renal insufficiency (e.g., uremia). Nitrogen tolerance
may be altered and dosage may need to be modified. Fluid and electrolyte status must be carefully monitored in these patients.
Additional Precautions

• Reactions at the injection site have been reported with the use of parenteral nutrition. These include thrombophlebitis at the infusion site and vein irritation as well as severe reactions (e.g., necrosis and blisters) when associated with extravasation. (See paragraph 4.8 of the Summary of Product Characteristics). Patients should be monitored accordingly.
• Severe water and electrolyte imbalances, severe states of fluid overload and severe metabolic imbalances must be corrected before starting the infusion.
• Use with caution in patients with pulmonary edema or heart failure. Fluid status must be carefully monitored.
• Do not connect containers in series to avoid gaseous embolism due to possible residual air in the primary container.

The safe and effective use of parenteral nutrition requires a thorough understanding of
nutritional problems, as well as clinical experience of the complications that can occur.
For proper control of parenteral nutrition, frequent clinical assessments and laboratory determinations are necessary.
These laboratory investigations should include blood glucose, proteinemia, tests on
liver and kidney function, blood count, CO2 content, serum osmolarity, ammonemia,
any blood cultures.
The administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may increase an already elevated blood urea nitrogen. Patients with azotemia of
any nature should not be infused with amino acids without controlling total nitrogen intake.
Intravenous administration of these solutions can cause fluid and/or solute overload
resulting in dilution of serum electrolyte concentrations, hyperhydration, congested states and pulmonary edema. The risk of dilutional states is inversely proportional to
the concentration of solute in the infused solution. The risk of solute overload with resulting
congested state with peripheral and pulmonary edema is directly proportional to
the concentration of the solution. The administration of amino acids to a patient with liver insufficiency may result in imbalances of plasma amino acids, hyperammonemia, prerenal azotemia,
torpor and coma. Hyperammonemia is of particular importance in neonates as its occurrence for genetic metabolic defects is sometimes associated, although not necessarily in a causal relationship, with mental retardation.
This reaction appears to be dose-dependent and occurs more easily during prolonged therapy. It is essential that blood ammonia be measured frequently in neonates. The mechanisms involved in this reaction are not clearly defined but may be linked to genetic defects, immature or subclinically damaged liver function. The doses of amino acids to
be infused should be established based on the patient's nutritional status. If symptoms of
hyperammonemia occur, administration should be stopped and the patient's clinical status should be re-evaluated.
The product contains sodium bisulfite, which can cause allergic-type reactions and severe asthma attacks in susceptible subjects and particularly in
asthmatics.

Warning: parenteral nutrition should only be performed by personnel experienced in this therapeutic method and aware of the possible complications.
Supplements
TPH can be mixed with solutions containing phosphates or that have been 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 the pharmacist.
Significant deviations from normal concentrations may require additional electrolyte supplementation.
Highly hypertonic nutrient solutions should be administered through a central venous catheter, preferably the superior vena cava.
Circulatory overload should be avoided, especially in patients with heart failure.
Particular attention is required when administering hypertonic glucose to diabetic or pre-diabetic patients. In such patients, it may be necessary to administer insulin to prevent severe hyperglycemia.
The administration of glucose in quantities exceeding those utilisable by the patient can cause hyperglycemia, coma and death.
The administration of amino acids without carbohydrates can cause an accumulation of ketone bodies in the blood; ketonemia can be corrected by administering carbohydrates.
If, after adequate dilution, TPH is to be administered via peripheral vein, ensure that the needle and catheter are correctly placed in the vein. Frequently check the venipuncture site for signs of infiltration. If thrombosis or phlebitis occurs, discontinue administration or change the infusion site and initiate appropriate treatment. Excessive electrolyte losses, found for example in cases of prolonged nasogastric aspiration, vomiting, diarrhea or gastrointestinal fistula, may require additional electrolyte supplements.
Metabolic acidosis can be prevented and rapidly controlled by adding a portion of cations such as acetates or lactates to the electrolyte mixture, while in cases of hyperchloremic acidosis it is sufficient to maintain the total chloride concentration at minimal levels.
TPH contains less than 3 mEq/l of chloride, does not contain phosphates. Some patients, especially in cases of hypophosphatemia, may require phosphate supplements. To prevent hypocalcemia, the administration of phosphates should always be supplemented with a calcium supplement. To ensure adequate electrolyte intake, serum concentrations should be frequently monitored.
To minimise the risk of possible incompatibilities due to mixing the amino acid solution with other additives possibly prescribed by the doctor, the final mixture should be inspected immediately for turbidity or precipitation and rechecked both before administration and periodically during administration.

Special precautions in central vein nutrition
Parenteral nutrition should only be performed by personnel experienced in this therapeutic method and aware of the possible complications.
Central venous nutrition can lead to complications that can be reduced or prevented by taking into account all aspects of the procedure, including solution preparation, administration and patient monitoring.
It is essential to follow a program prepared with the utmost precision and based on the most up-to-date medical practice; it is appropriate that it be handled by doctors experienced in parenteral nutrition.

1. Technical information

The placement of a central venous catheter should be considered a true surgical procedure.
The various techniques for catheter insertion, as well as the measures to be taken for the identification and treatment of any complications, should be thoroughly known.
For technical information and guidance on the most suitable areas for catheter insertion, consult medical literature that addresses these topics.
Radiological examination allows verification of correct catheter placement.
Following incorrect insertion, the following may occur: pneumothorax, hemothorax, hydrothorax, puncture of the artery and its transverse section, brachial plexus injury, catheter malposition, formation of an arteriovenous fistula, phlebitis, thrombosis, penetration 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 the solution mixtures, as well as the insertion and care of the catheter, occur with the most rigorous asepsis. It is preferable that the solution mixtures are prepared in the Hospital Pharmacy under a laminar flow hood. The “key” factor in the preparation of the mixtures is constituted by a strictly aseptic technique, which prevents inadvertent contamination from contact, both during preparation and afterwards. After preparation, hyperalimentation solutions should be used as soon as possible. Storage in the refrigerator should be kept to a minimum. The administration of a single container should never exceed 12 hours. Consult the literature to fully understand and be able to discuss knowledgeably the measures to be taken in case of sepsis occurring during hyperalimentation. In short, the “classic” therapy for sepsis consists of replacing the administered container with a freshly prepared one and adopting a new connection, and culturing the discarded solution for the search of any bacterial or fungal contaminations. If sepsis persists and another source of infection cannot be identified, remove the catheter and culture the proximal end. When the fever decreases, insert a new catheter. The administration of antibiotics for nonspecific prophylactic treatment is contraindicated. Clinical experience has shown that the catheter is the main source of infections, while solutions prepared with a strictly aseptic technique rarely cause 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, it is advisable to subject the patient to
frequent clinical evaluations and laboratory tests, especially during the first few days of treatment.

Central Venous Nutrition
Amino acid and hypertonic glucose mixtures can only be administered safely via continuous infusion
through a central venous catheter inserted into the vena cava.
The initial infusion rate should 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 programmed doses, do not
attempt to make up for lost time. In addition to meeting protein requirements, especially during the
first few days of therapy, administration should also be adjusted based on the patient's glucose tolerance.
The daily intake of amino acids and glucose should be gradually increased to reach the maximum dose;
frequent determinations of sugar levels in urine and blood will indicate the necessary gradualness.

Peripheral Parenteral Nutrition
In patients for whom central venous access is not indicated and who can consume some or all of the
required calories enterally, TPH can be administered into a peripheral vein with or without
carbohydrate calories. Mixtures of TPH or with 5% or 10% glucose solution can also be used to prepare
slightly hypertonic solutions for peripheral infusion; calories can also be administered peripherally via
lipid emulsions. It is essential that peripheral amino acid infusion be accompanied by adequate caloric
intake.
Parenteral solutions, especially in the case of extemporaneous mixtures, should be inspected before use
to visually detect particles or color changes, when the solution and container allow.

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

• age, weight and clinical condition,
• nitrogen requirements,
• ability to metabolize TPH components,
• nutritional support that can be provided parenterally/enterally.

The flow rate must be adjusted according to the dosage, characteristics of the solution to be infused,
total volume over 24 hours and duration of the infusion.
The flow rate should be gradually increased during the first hour.
The goal of nutritional treatment of 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.
Determination of nitrogen balance and accurate daily monitoring of body weight and fluid balance are
the preferred methods for establishing individual protein requirements.
Total daily fluid intake should be appropriate for the patient's age and body size.
Additives may be incompatible.
Excessive addition of calcium and phosphate increases the risk of formation of calcium phosphate
precipitates (see section “Precautions for Use”).

Neonates and Children up to 10 Kg
The literature recommends 2 to 4 g of protein per kg of body weight per day (2.0-4.0 g/Kg/day) for
neonates and children up to 10 Kg. Daily doses of approximately 125 ml/Kg of body weight are
appropriate for most neonates undergoing NPT.

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 Kg of body weight over 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 possible due to limits on fluid intake, nitrogen, or glucose intolerance.
Cysteine is considered an essential amino acid in neonates and young children. It is therefore
advisable to add cysteine hydrochloride to the NTP solution: 1.0 mmole of L-cysteine hydrochloride
monohydrate/Kg/day.
In some patients, providing adequate calories in the form of hypertonic glucose may require the
administration of exogenous insulin to prevent hyperglycemia and glycosuria.
For optimal amino acid utilization, sufficient intracellular electrolytes, primarily potassium, magnesium and
phosphate, must be provided.
Sufficient amounts of the major extracellular electrolytes, sodium, calcium and chloride, must also be
administered.

Hyperchloremic Patients
In hyperchloremic patients or those affected by other types of metabolic acidosis, sodium and potassium
should be added as acetates or lactates, to provide bicarbonate precursors.
The electrolyte content of TPH should be taken into account when calculating daily electrolyte intake.
Serum electrolytes, including magnesium and phosphorus, should be checked frequently.
If the patient is predominantly fed parenterally, they should also receive vitamins, especially water-soluble
vitamins and trace elements.

Route of Administration
TPH is for intravenous use only.
TPH is not indicated for fluid or volume restoration. Solution for use for fleboclisis in peripheral or
central vein.
Highly hypertonic parenteral nutrition solutions (>900 mOsm/L) must be administered through a central
venous catheter with the tip located in a large central vein.
If deemed appropriate by healthcare professionals, parenteral nutrition solution may be administered in a
peripheral vein in patients of all ages if the osmolarity of the formulation is ≤ 900 mOsm/L.

General Warnings
Visually inspect the container for breakage.
Use the vial only if the solution is perfectly clear, free of visible particles in suspension, not discolored and
if a vacuum is present.
Use aseptic conditions. Discard any unused TPH and do not use it for subsequent administrations.
In case of additions to the container:

• ensure the compatibility and stability of the additions (contact the marketing authorization holder).
• use aseptic conditions. Prepare the injection site of the container appropriately.
• pierce the stopper and inject the substances to be added with a syringe or transfer/reconstitution set as
  described.
• thoroughly mix the contents of the container and the added substances.
• inspect the container for any discoloration and the presence of particles.

Confirm the integrity of the container. Use only if the container is not damaged and the solution is clear.
Ensure that the correct storage requirements of the added substances are respected.
Administration of the infusion solution:
Before use, the solution must be at room temperature.
Use aseptic conditions.
For single use only.
Confirm the integrity of the container. Use only if the container is not damaged and the solution is clear.
Do not reconnect partially used containers.
The use of a final filter is recommended during the administration of all parenteral nutrition solutions.
Inspect the container for discoloration and the presence of particles.
Do not connect containers in series to avoid possible gas embolism phenomena due to residual air in the
primary container.
TPH should not be infused through the same tubes containing blood or blood components.

Interactions
The addition of drugs that may cause irritation directly into the amino acid solution should be avoided;
these drugs can be administered to the patient by injecting them into a different area.
If other medications are added, their compatibility and the stability of the final mixtures must be verified.

Overdosage
In case of inappropriate administration (overdose, and/or infusion rate too high compared to that
recommended), hypervolemia, electrolyte imbalances, acidosis and/or azotemia may occur. In such
situations, the infusion must be immediately stopped. If medically appropriate, further intervention 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 expiry date reported on the packaging.
The expiry date indicated refers to the product in intact packaging, stored correctly.
Caution: Do not use the medicine after the expiry date reported on the packaging.
Exposure of the medicinal product TPH to heat should be minimized; avoid temperatures above 40°C,
protect from frost.
Store protected from light until the time of use.
For further information, see the Summary of Product Characteristics.