Nutrinil PD 4 with 1.1% amino acid content - instructions for use, doses, side effects, contraindications

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Dosage form: & nbspperitoneal dialysis solution

Composition:

1000 ml of solution contain:

Active substances:

Alanine 0.951 g

Arginine - 1.071 g

Glycine 0.510 g

Histidine - 0.714 g

Isoleucine - 0.850g

Leucine 1.020 g

Lysine hydrochloride - 0,955 g.

Methionine - 0.850 g

Phenylalanine 0.570 g

Proline 0.595 g

Serine 0.510 g

Threonine - 0.664 g

Tryptophan 0.270 g

Tyrosine 0.300 g

Valine 1.393 g

Sodium chloride 5.380 g

Calcium chloride dihydrate - 0.184 g

Magnesium chloride hexahydrate - 0.051 g

Sodium lactate - 4,480g

Excipients:

Acid chlorinericetoddlernative q.s.

Water for injections- up to 1000 ml

Ionic composition per 1000 ml of solution:

	’ '' - mmol / l
Amino acids	87
Sodium	132
Calcium	1,25
Magnesium	0,25
Chloride	105
Lactate	40

Theoretical osmolarity of the solution Nutrinil PD4 with 1.1% amino acid content: 365 mOsm / l.

The pH of the solution at 25 ° C approximately 6,6.

Description:Transparent light yellow liquid

Pharmacotherapeutic group:Solution for peritoneal dialysis.

ATX: & nbsp

B.05.D Solutions for peritoneal dialysis

Pharmacodynamics:

A sterile, pyrogen-free solution for peritoneal dialysis allows the removal of toxic substances; formed in the process of metabolism of nitrogen-containing compounds-and normally excreted by the kidneys, a also maintain adequate regulation of water, electrolyte and acid-base balances.

This procedure is carried out by introducing a solution for peritoneal dialysis into the abdominal cavity through a catheter. As a result of osmosis and diffusion through the peritoneum there is an exchange of substances between the peritoneal capillaries and the dialysis fluidth. After expiredand abouttime limitthe exposure solution is saturated toxic substances, after which it must be replaced. With the exception of lactate, which is a precursor of bicarbonate, the concentration ^- Electrolytes in the solution are selected in such a way as to normalize the concentrations of electrolytes in the plasma of the patient. Nitric exchange products present in high concentrations in the blood passingt hThrough the peritoneum into the dialysis solution.

:Concentration Electrolytes in a liquid are equivalent to electrolyte composition.

Pharmacokinetics:

Amino acids, electrolytes, a buffer solution and water, the entered abdominal cavity; Absorbed into the blood and metabolized by the usual route.

Electrolytes are metabolized by the way characteristic for each ion.

From 70 to 80% of the injected amino acids are absorbed from the solution injected into the blood for 4-6 hours of finding the solution in the abdominal cavity.

Indications:

The use of a solution for peritoneal dialysis Nutrinil PD4 with a 1.1% amino acid content is contraindicated in patients with:

hypersensitivity to the components of the drug;
the level of urea in the blood serum, exceeding 38 mmol / l; symptoms of uremia; . ,
metabolic acidosis;
congenital defects of amino acid metabolism; .
hepatic insufficiency; "
_ severe hypokalemia. '

Carefully:

In patients with uncompensated metabolic acidosis, severe hepatic insufficiency or hyperammonemia. It is necessary to control metabolic acidosis before prescribing Nutrinil PD4 from 1,1 ' % the content of amino acids and during treatment.

In patients with pathology of the abdominal organs and peritoneum, including rupture of the peritoneum and diaphragm associated with surgery,

incomplete healing of lesions resulting from, developmental or trauma abnormalities, abdominal swelling, inflammatory diseases of the abdominal wall, hernia, fistula of the rectum or colostomy,massive polycystic kidney lesions, or other conditions associated with abnormality of the abdominal wall, abdominal surface, or abdominal cavity.

Patients. with other pathological conditions, including correction

aortic defect with graft or severe lung disease.

In patients taking cardiac glycosides. It is necessary to carefully monitor the concentration of potassium, calcium and magnesium in the blood plasma.

Have patients with diabetes should monitor blood glucose concentrations and adjust the dose of insulin or other drugs used in hyperglycemia appropriately.

If hypersensitivity symptoms are suspected, the use of Nutrinil PD4 with 1.1% amino acid content should be discontinued immediately. Must be prescribed appropriate therapy.

The effectiveness and safety of the drug in pediatric patients is not established.

Pregnancy and lactation:

Data on the safety of the use of Nutrinil PD4 with 1.1% amino acid content during pregnancy and during breastfeeding are not available.Administration of the drug Nutrinil PD4 with a 1.1% amino acid content during pregnancy and during breastfeeding is possible only if PredolphinBeneficial use mand thoseexceeds sweatesocialth risk for theYes or child.

Dosing and Administration:

Only for intraperitoneal administration. Not for intravenous administration.

This method of administration requires use. fromnesocial katheta and correspondenceseasingShe has a system that connects the container with the patient's catheter. Nutrinyl PD4-1,1% _ the content of amino acids should be introduced at a rate,

comfortable for the patient. The volume of the injected solution is determinedis attending physicianth. Dosage regimen, frequency of application, volume of the solution to be replaced, duration of delay of the solution in the abdominal cavity and duration of lecheappointmentteaand controlled by the attending physician.

If after 3 months of application. there is no positive-dynamics from the clinical state of the patient and such indicators as the concentration of creatinine, urea, potassium in the serum, the level of hemoglobin and erythrocytes, the tactics of treatment should be reviewed.

Before use, the solution is advisable to heat in the outer bag to 37 ° C in order to increase the comfort of peritoneal dialysis in the patient.

'Only use dry heat (for example, heating pad, heating tile). Do not heat the solution in water or a microwave oven, which can cause discomfort or damage to the patient.

During the peritoneal dialysis procedure, you must follow the rules asepsis.

The outer protective package should be removed immediately before use. Before use, it is necessary to check the solution for transparency and, absence, foreign particles.

The drained fluid should be checked for fibrin or turbidity, which may indicate the presence of peritonitis. The unused solution should be discarded.

Patients who are on permanent outpatient peritoneal dialysis at home should undergo training in specialized centers.

Only for single use.

Adults and elderly patients:

For patients with a body weight of 70 kg, one peritoneal solution per day is recommended at 2.0 or 2.5 liters ..For of patients with a lower body weight, the volume of the injected solution can be reduced in accordance with body weight: In exceptional cases, another administration regimen may be prescribed, but the dose should not exceed two cycles, administration per day.

It should be noted that the recommended daily intake of protein is approximately 1,2 g / kg for an adult patient., 2-litrovy container of the preparation Nutrinil PD4 s 1,1% contentsandnokisThe lot contains 22 gramsno acids, hthen it is equivalentabout 0,30 g /kg/ day PApproximately 25% of the dayth rate of sweatchildren squirrel) -dFor a patient with a body weight of 70 kg.

Children and adolescents:^:

Efficacy and safety of the drug: Nutrinil PD4 with a 1.1% content amino acids in clinical studiesx-y pediatric patients have not yet been studied.

In this regard, in this category of patients it is necessary to compare the expected clinical benefit of the drug and the risk of developing unwanted reactions.

We recommend one cycle of solution administration per day. For children older than 2 years, the recommended volume of solution is from 800 to 1400 ml / m^{2 ,}per cycle maximum volume with good tolerability of the drug - 2000 ml / m2.Children over 2 years of age are recommended a volume of 200 - 1000 ml / m2.

Side effects:

It is assumed that the adverse events presented in this section have a connection with the drug Nutrinil PD4 with 1.1% amino acid content, or with peritoneal dialysis.

Adverse events observed in clinical trials

The following adverse events were observed in clinical studies in> 5%. patients receiving Nutrinil.

Adverse events are included in this table if the incidence rate was higher than in the control group by 2% or more.

System-Organ Class	Preferred term	Frequency
Infections	Infections at the site of administration Infections	Often
Violations of the blood and lymphatic system	Anemia	Often
Disorders from the metabolism and nutrition	Acidosis Hypervolaemia Hypokalemia Hypovolemia.	Often Often Often Often
Disorders of the psyche	Depression	Often
Disturbances from the respiratory system	Dyspnea	Often
Disorders from the digestive tract	Nausea, vomiting* Anorexia Nausea Gastritis	Often Often Very often Often
General disorders and disorders inplace of introduction	Asthenia	Often
Laboratory and instrumental data	Increased serum urea levels	Often

The frequency of adverse reactions with the use of the drug was evaluated using the following scale: very frequent (≥1/10), frequent (≥1 / 100 - <1/10), infrequent (≥ 1/1000 - <1/100), rare ≥ 1/10 000 - <1/1000) and very rare (<1/10 000).

* The term "nausea or vomiting" does not correspond to the terminology of MedDRA 11.0 Medical Dictionary of Regulatory Activities. This term was retained to reflect the information provided in the source.

Adverse events observed in the postmarketing period

In the postmarketing period, the following adverse events were reported.

Infectious and parasitic diseases: bacterial peritonitis.

Immune system disorders: hypersensitivity reactions, angioedema.

Disorders from the metabolism and nutrition: anorexia.

Disorders from the digestive tract: abdominal pain, peritonitis, turbidity of peritoneal fluid discomfort in the abdomen.

Disturbances from the skin and subcutaneous tissues: itching.

General disorders and disorders at the site of administration: violations associated with the introduction of a catheter, fever and malaise.

Laboratory and instrumental data: data of peritoneal fluid analysis beyond the norm.

Overdose:

Consequences. a possible overdose may be hypervolaemia, and disorderselectrolyte exchange. .

Treatment of overdose -

Treatment of hypervolemia can consist in the appointment of hypertonic solutions for peritoneal dialysis and the restriction of fluid intake. - - "

Disorders of electrolyte metabolism require specific treatment for each individual case, confirmed by blood analysis. Hypokalemia, which is the most likely disorder, can be treated by administration to potassium or by adding potassium chloride to a solution for peritoneal dialysis in accordance with beforewritersandI'm a lechGeneralcha.

Interaction:

Studies on the interaction of the drug Nutrinil PD4 with a 1.1% content amino acids with other drugs / were not performed: Concentrations of other drugs in the blood can decrease during dialysis. *

Incompatibility

If possible, consult with.a specialist competent in the field of peritoneal dialysis. It is necessary to follow the rules of asepsis, if, in the presence of a written recommendation of a specialist, the introduction of additional substances into the solution is expedient.

When using additives it is necessary to check compatibility, mixed solution with additives should be used immediately.

Special instructions:

Encapsulating peritoneal sclerosis (IPS) is a rare complication of dialysis therapy. IPS was observed in5 patients using solutions for peritoneal dialysis, incl. Nutrinil PD4 with 1,1 % the content of amino acids.

In the case of development of peritonitis, the choice and dose of antibiotics should, if possible,seizeultras aboutand andZučesensitivefinenessand isolatedRfrail microorganism (s). Before determination of the microorganism (s), antibiotics of a wide spectrum of action can be prescribed.

Nutrinil PD4 - with a 1.1% content of amino acids is intended only for intraperitoneal administration. Not intended for intravenous administration.

Do not use if the solution has changed color, clouded, contains foreign inclusions, shows signs of leakage or if the integrity of the package is impaired. , ..

The drained fluid should be checked for fibrin or turbidity, which may indicate the presence of peritonitis.

The effectiveness and safety of the drug, in pediatric patients is not established.

Protein, amino acids, water-soluble vitamins and substances can be excreted during the procedure for peritoneal dialysis, which may require a substitution therapy.

Patients taking cardiac glycosides should carefully monitor the concentration of potassium, calcium and magnesium in the blood plasma.

The introduction of an excess amount of peritoneal dialysis solution into the abdominal cavity may be accompanied by bloating, abdominal pain and / or dyspnea. Measures in the case of the introduction of excessive volume of the solution for peritoneal dialysis consist in removing the solution from the abdominal cavity by means of drainage.

To avoid hyperhydration and dehydration, it is necessary to carefully monitor the patient's condition. It is necessary to control the balance of injected and withdrawn liquid; a also withto be patienta.

Potassium is not included in the solution of Nutrinil PD4 with a 1.1% amino acid content because of the risk of developing hyperkalemia. If the patient has a normal potassium concentration in the serum or hypokalemia, additional potassium chloride (up to 4 meq / L) is possible to prevent the development of severe hypokalemia.azbeginningit is necessary to determine theandtoaliya in the sowRochatka shelterand. The appointment of treatment is carried out only under the supervision of the attending physician.

Periodically, it is necessary to monitor the concentration of electrolytes in the blood serum (in particular potassium bicarbonate, magnesium, calcium and phosphate), conduct a biochemical blood test (including the concentration of parathyroid hormone) and hematological parameters in diabetic patients, monitor the blood glucose concentration and adjust accordingly dose of insulin or other drugs used in hyperglycemia.

A part of the amino acids from the solution -Nutrinil PD4- with 1,1~% content - amino acids is metabolized to nitrogen-containing exchange products, such as urea. With incomplete conduct of peritoneal dialysis, nitrogen-containing, , the solution exchange products can accumulate, leading to the appearance of uremia symptoms such as anorexia or vomiting. Symptoms stop, by stopping the administration of the solution or increasing the proportion of the amino acid-free solution.

Effect on the ability to drive transp. cf. and fur:

When performing peritoneal dialysis in patients with terminal stage of renal failure, adverse effects may occur that can affect which may influence the ability to drive vehicles and other mechanisms.

Form release / dosage:Solution for peritoneal dialysis in plastic containers "Vifaflex", made of PVC PL-146-3 (Hebrew Pharm.) 500, 1000, 1500, 2000, 2500, 3000 ml. The container is provided with a port for connection to a suitable drainage system and an injection port from a re-sealing latex. The container is packed in a protective plastic bag.

RAster for peritoneal dialysis in plastic containers "Vifaflex", made of polyvinyl chloride PL-146-3 (Eurol Pharm.) With a volume of 500, 1000, 1500, 2000, 2500, 3000 ml. The container is factory-connected with Y-shaped connecting tube and an empty - drainage-container into the "Twin Bag" system.

The system is packed in a protective plastic bag.

Cardboard boxes of 3,4, 5 or 6 containers together with instructions for use (for hospitals)

Packaging:

Plastic bags "Vifaflex", made of PVC (3) / 1) Plastic containers "Vifaflex", made of polyvinyl chloride PL-146-3 (Eur. Pharm.) With the volume of 3000 ml. The container is provided with a port for connecting with a suitable drainage system and an injection port from a re-sealing latex. The container is packed in a protective plastic bag. 2) Plastic containers "Vifaflex", made of polyvinyl chloride PL-146-3 (Eur. Pharm.) In volume of 3000 ml. The container is factory-bonded with a Y-shaped connecting tube and empty drainage containers / a cardboard box
Plastic bags "Vifaflex", made of PVC (4) / 1) Plastic containers "Vifaflex", made of PVC PL-146-3 (Hev. Pharm.) With a capacity of 2500 ml. The container is provided with a port for connecting with a suitable drainage system and an injection port from a re-sealing latex. The container is packed in a protective plastic bag.2) Plastic containers "Vifaflex", made of PVC PL-146-3 (Hev. Pharm.) With a volume of 2500 ml. The container is factory-bonded with a Y-shaped connecting tube and empty drainage containers / a cardboard box
Plastic bags "Vifaflex", made of PVC (5) / 1) Plastic containers "Vifaflex", made of PVC PL-146-3 (Eur. Pharm.), 2000 ml. The container is provided with a port for connecting with a suitable drainage system and an injection port from a re-sealing latex. The container is packed in a protective plastic bag. 2) Plastic containers "Vifaflex", made of polyvinyl chloride PL-146-3 (Eur. Pharm.) With a volume of 2000 ml. The container is factory-bonded with a Y-shaped connecting tube and empty drainage containers / a cardboard box
Plastic bags "Vifaflex", made of PVC (6) / 1) Plastic containers "Vifaflex", made of PVC PL-146-3 (Eur.Pharm.) With a volume of 1000 ml. The container is provided with a port for connecting with a suitable drainage system and an injection port from a re-sealing latex. The container is packed in a protective plastic bag.2) Plastic containers "Vifaflex", made of polyvinyl chloride PL-146-3 (Eur.Pharm.) With a volume of 1000 ml. The container is factory-bonded with a Y-shaped connecting tube and empty drainage containers / a cardboard box
Plastic bags "Vifaflex", made of PVC (6) / 1) Plastic containers "Vifaflex", made of PVC PL-146-3 (Eur. Pharm.) With a volume of 1500 ml. The container is provided with a port for connecting with a suitable drainage system and an injection port from a re-sealing latex. The container is packed in a protective plastic bag. 2) Plastic containers "Vifaflex", made of PVC PL-146-3 (Eur. Pharm.) With a volume of 1500 ml. The container is factory-bonded with a Y-shaped connecting tube and empty drainage containers / a cardboard box
Plastic bags "Vifaflex", made of PVC (6) / 1) Plastic containers "Vifaflex", made of PVC PL-146-3 (Eur. Pharm.) With a capacity of 500 ml. The container is provided with a port for connecting with a suitable drainage system and an injection port from a re-sealing latex. The container is packed in a protective plastic bag.2) Plastic containers "Vifaflex", made of polyvinyl chloride PL-146-3 (Eur. Pharm.) With a volume of 500 ml. The container is factory-bonded with a Y-shaped connecting tube and an empty drainage container / cardboard box

Storage conditions:

At temperatures from 0 to 30 ° C in the dark place. Do not freeze

Shelf life:

Shelf life 2 of the year.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015323 / 01

Date of registration:15.12.2008

The owner of the registration certificate:Baxter Khelskea SABaxter Khelskea SA Ireland

Manufacturer: & nbsp

BAXTER HEALTHCARE, S.A. Ireland

Representation: & nbspBaxter Baxter USA

Information update date: & nbsp11.09.2012

Illustrated instructions

Instructions

Nutrinil PD 4 with 1.1% amino acid content (Nutrineal PD 4 with 1.1% amino acids)