SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nutrineal PD4 with 1.1% amino acids.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
L-Tyrosine Ph. Eur.
L-Tryptophan Ph. Eur.
L-Phenylalanine Ph. Eur.
L-Threonine Ph. Eur.
L-Serine Ph. Eur.
L-Proline Ph. Eur.
Glycine Ph. Eur.
L-Alanine Ph. Eur.
L-Valine Ph. Eur.
L-Methionine Ph. Eur.
L-Isoleucine Ph. Eur.
L-Leucine Ph. Eur.
L-Lysine (chlorhydrate) Ph. Eur.
L-Histidine Ph. Eur.
L-Arginine Ph. Eur.
Calcium chloride dihydrate Ph. Eur.
Magnesium chloride hexahydrate Ph. Eur.
Sodium Lactate Ph. Eur.
Sodium Chloride Ph. Eur.
兴高采烈什么意思L-Tyrosine 0.300 g/l
L-Tryptophan 0.270 g/l
L-Phenylalanine 0.570 g/l
L-Threonine 0.646 g/l
L-Serine 0.510 g/l
L-Proline 0.595 g/l
Glycine 0.510 g/l
L-Alanine 0.951 g/l
L-Valine 1.393 g/l
L-Methionine 0.850 g/l
L-Isoleucine 0.850 g/l
L-Leucine 1.020 g/l
L-Lysine (chlorhydrate) 0.955 g/l
L-Histidine 0.714 g/l
L-Arginine 1.071 g/l
Calcium chloride dihydrate 0.184 g/l
Magnesium chloride hexahydrate 0.051 g/l
Sodium S-Lactate 4.48 g/l
Sodium Chloride 5.38 g/l
3. PHARMACEUTICAL FORM
Peritoneal dialysis solution contained in bags.
PARTICULARS
4. CLINICAL
indications
4.1 Therapeutic
Nutrineal is recommended as a non-gluco bad peritoneal dialysis solution as part of a peritoneal dialysis regimen for the treatment of chronic renal failure patients. In particular, it is recommended fo
r the malnourished peritoneal dialysis patients.
4.2Posology and method of administration
Administration
NUTRINEAL is intended for intraperitoneal administration only.Not for intravenous administration.
Peritoneal dialysis solutions may be warmed in the overpouch to 37°C to enhance patient comfort. However, only dry heat (for example, heating pad, warming plate) should be ud.
Solutions should not be heated in water or in a microwave oven due to the potential for patient injury or discomfort.
Aptic technique should be employed throughout the peritoneal dialysis procedure.
我们的运动会Do not administer if the solution is discoloured, cloudy, contains particulate matter or shows evidence of leakage, or if als are not intact.
The drained fluid should be inspected for the prence of fibrin or cloudiness, which may indicate the prence of peritonitis.
For single u only.
Posology
The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be initiated and supervid by the prescribing physician
Treatment should be re-evaluated after 3 months if there is no clinical or biochemical improvement in the status of the patient.
Adults: one peritoneal dialysis exchange per day of one 2.0 l or one 2.5 l bag is the recommended do for a 70 kg body weight patient. In smaller patients the fill volume may need to be reduced depending on body size. In exceptional cas, a different posology may be indicated but the do should not exceed two exchanges per day. Note that the recommended daily total intake of proteins is over or equal to 1.2 g/kg body weight for adult dialysis patients. A 2.0 l bag of Nutrineal contains 22 g of amino acids which corresponds to 0.30 g/kg body weight/24 h (approximately 25% of the daily protein requirements) for an adult dialysis patient of 70 kg body weight.
Elderly: as for adults.
Children and adolescents: The recommended posology is one peritoneal dialysis exchange per day. The risk/benefit ratio should be assd and individual dialysis prescription is necessary which includes appropriate adaptation of fill volumes.
4.3 Contraindications
Nutrineal is contraindicated in patients with:
-known hypernsitivity to any amino acids in the product or to any of the excipients.
-rum urea level above 38 mmol/L,设备更新
-uraemic symptoms,
-metabolic acidosis,
-
inborn errors of amino acid metabolism,
-liver insufficiency
-vere hypokalaemia.
4.4 Special warnings and precautions for u
-Encapsulating peritoneal sclerosis (EPS) is considered to be a known, rare complication of peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis
solutions including NUTRINEAL
-If peritonitis occurs, the choice and dosage of antibiotics should be bad upon the results of identification and nsitivity studies of the isolated organism(s) when possible. Prior to
identification of the involved organism(s), broad-spectrum antibiotics may be indicated.
-Metabolic acidosis should be corrected before and during Nutrineal treatment.
-Safety and effectiveness in paediatric patients has not been established.
-Significant loss of medicinal products (including water soluble vitamins) may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.
-Dietary protein intake should be monitored
-Peritoneal dialysis should be done with caution in patients with: 1) abdominal conditions, including disruption of the peritoneal membrane and diaphragm by surgery, from
congenital anomalies or trauma until healing is complete, abdominal tumors, abdominal
wall infection, hernias, fecal fistula or colostomy, large polycystic kidneys, or other
conditions that compromi the integrity of the abdominal wall, abdominal surface, or
intra-abdominal cavity; and 2) other conditions including aortic graft placement and vere
pulmonary dia.
-Overinfusion of a peritoneal dialysis solution into the peritoneal cavity may be characterized by abdominal distension/abdominal pain and/or shortness of breath.
-
Treatment of peritoneal dialysis solution overinfusion is to drain the solution from the peritoneal cavity.
-Patients should be carefully monitored to avoid over- and underhydration. An accurate fluid balance record should be kept and the patient’s body weight monitored.
-Potassium is omitted from NUTRINEAL solutions due to the risk of hyperkalemia.
In situations in which there is a normal rum potassium level or hypokalemia, the addition
of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent
vere hypokalemia and should be made after careful evaluation of rum and total body
potassium, only under the direction of a physician .
-
Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium and phosphate), blood chemistry (including parathyroid hormone) and haematological
parameters should be monitored periodically.
-In diabetic patients, blood gluco levels should be regularly monitored and the dosage of insulin or other treatment for hyperglycaemia should be adjusted.
- A portion of the amino acids in Nutrineal is converted to metabolic nitrogenous waste, such as urea. If dialysis is insufficient, the additional metabolic waste generated by the u of
Nutrineal may lead to the appearance of uremic symptoms such as anorexia or vomiting.
Symptoms can be managed by reduction of the number of Nutrineal exchanges, or
discontinuation of Nutrineal or an incread dialysis do with a non amino acid bad
solution.
-In patients with condary hyperparathyroidism, the benefits and risks of the u of dialysis solution with a low calcium content should be carefully considered as it might worn
hyperparathyroidism.
4.5 Interaction with other medicinal products and other forms of interaction
-No interaction studies have been conducted with NUTRINEAL. Blood concentration of other dialyzable medicinal products may be reduced during dialysis.佳句欣赏
-Plasma levels of potassium, calcium and magnesium in patients using cardiac glucosides must be carefully monitored, as there is a risk of digitalis intoxication. Potassium
supplements may be necessary.
4.6 Pregnancy and lactation
There are no clinical data on expod pregnancies and lactation, and no animal studies are available. Nutrineal should not be ud during pregnancy or lactation unless clearly necessary.
See ction 4.
4.7Effects on ability to drive and u machines
End stage renal dia (ESRD) patients undergoing peritoneal dialysis may experience undesirable effects, which could affect the ability to drive or u machines.
4.8Undesirable effects
The adver reactions within this ction reprent tho that are thought to have an
association with NUTRINEAL or in conjunction with performing the peritoneal dialysis procedure.
Undesirables effects which occurred in patients treated with Nutrineal from clinical trials and post marketing are listed below.
Frequency is bad upon the following scale: Very Common (≥1/10); Common (≥1/100 - <1/10), Uncommon (≥1/1,000 - <1/100), Rare (≥1/10,000 - <1/1,000), Very Rare (<1/10,000)
娱乐的近义词
SYSTEM ORGAN CLASS (SOC) Preferred MedDRA Term Frequency INFECTIONS AND INFESTATIONS
Infection Common BLOOD AND LYMPHATIC SYSTEM DISORDERS
Anemia Common METABOLISM AND NUTRITION DISORDERS Acidosis
Hypervolemia Hypokalemia Hypovolemia
Anorexia
Very Common Very Common Common Common Very common PSYCHIATRIC DISORDERS Depression Common
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Dyspnea Common
GASTROINTESTINAL DISORDERS Vomiting* Naua Gastritis Abdominal pain Abdominal discomfort Peritonitis Peritoneal Cloudy effluent Very Common
进行英文Very Common
Very Common
Common
Not known
Not known
Not known
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Asthenia Pyrexia Malai Very Common
Not known
Not known
INVESTIGATIONS Blood urea incread Peritoneal fluid analysis abnormal Very Common
Not known
SKIN AND SUBCUTANEOUS
DISORDERS Pruritis
Not known *The term naua and vomiting is not available in MedDRA 11.0. The term has been retained to reflect the available source data.
养阴清肺膏Other undesirable effects of peritoneal dialysis related to the procedure: catheter site infection, Catheter related complication and peritonitis bacterial.
4.9 Overdo
河南大旱There is potential for overdo resulting in hypervolemia and electrolyte disturbances.
Management of Overdo:
- Hypervolemia may be managed by using hypertonic peritoneal dialysis solutions and fluid restriction.
- Electrolyte disturbances may be managed according to the specific electrolyte disturbance verified by blood testing. The most probable disturbance, hypokalemia, may be managed
by the oral ingestion of potassium or by the addition of potassium chloride in the peritoneal dialysis solution prescribed by the treating physician (e ction 6.2).
