Section 3 – change of position

Section 4.2 addition of paragraph - To avoid the risk of severe dehydration, hypovolaemia and to minimise the loss of proteins, it is advisable to select the peritoneal dialysis solution with the lowest osmolarity consistent with fluid removal requirements for each exchange.   And changes to existing paragraphs –

Adults:

patients Patients on continuous ambulatory peritoneal dialysis (CAPD) typically perform 4 cycles per day (24 hours). Patients on automated peritoneal dialysis (APD) typically perform 4-5 cycles at night and up to 2 cycles during the day. The fill volume depends on body size, usually from 2.0 to 2.5 litres.

Elderly

As for adults.

• Older people: as for adults.

Paediatric population (patients from pre-term newborn infants to adolescents):

The safety and efficacy of PHYSIONEAL 40 in paediatric patients have not been established.Paediatric patients have not been evaluated in clinical studies with PHYSIONEAL 40. Therefore the clinical benefits of PHYSIONEAL 40 have to be balanced versus the risks of side effects in this patient category.

For pediatricpaediatric patients >2 years old, 800 to 1400 mL/m2 per cycle up to a maximum amount of 2000 mL, as tolerated, has been recommended. Fill volumes of 200 to 1000 mL/m2 are recommended in children less than 2 years of age.

To avoid the risk of severe dehydration, hypovolaemia and to minimise the loss of proteins, it is advisable to select the peritoneal dialysis solution with the lowest osmolarity consistent with fluid removal requirements for each exchange.

Method of administrationAdministration

For instructions on the use of the medicinal product see section 6.6 Special precautions for disposal and other handling.For further information on the use of the medicinal product see section 6.6 Instructions for use and handling.

Section 4.4 Below headings entered:

Patient conditions requiring caution of use

Encapsulating Peritoneal Sclerosis (EPS)

Peritonitis

Hypersensitivity

Use in patients with elevated lactate levels

General monitoring

Overinfusion

Use of higher glucose concentrations

Addition of potassium

Use in diabetic patients

Improper administration

Changes under sections – Peritonitis - broad-spectrum broadspectrum    General monitoring – deletion of paragraphs In patients with secondary hyperparathyroidism, the benefits and risks of the use of a solution with 1.25 mmol/l calcium, such as PHYSIONEAL 40, should be carefully considered as it might worsen hyperparathyroidism. And In patients with plasma bicarbonate level above 30 mmol/l, the risk of possible metabolic alkalosis should be weighed against the benefits of treatment with this product  Addition of paragraphs - Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium and phosphate), blood chemistry (including parathyroid hormone and lipid parameters) and haematological parameters should be monitored periodically.

Secondary hyperparathyroidism

In patients with secondary hyperparathyroidism, the benefits and risks of the use of a solution with 1.25 mmol/l calcium, such as PHYSIONEAL 40, should be carefully considered as it might worsen hyperparathyroidism.

Metabolic alkalosis

In patients with plasma bicarbonate level above 30 mmol/l, the risk of possible metabolic alkalosis should be weighed against the benefits of treatment with this product.  Use of higher glucose concentrations – addition of See section 4.9 Addition of potassium - Potassium is omitted from PHYSIONEAL 40 solutions due to the risk of hyperkalemiahyperkaelemia.

In situations in which there is a normal serum potassium level or hypokalaemiahypokaelemia, the addition of potassium chloride (up to a concentration of 4 mEq/l) may be indicated to prevent severe hypokalaemiahypokaelemia and should be made after careful evaluation of serum 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 lipid parameters) and haematological parameters should be monitored periodically.

Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis.    Use in Diabetic patients – addition of Improper administration.

Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis.

In case of infusion of unmixed solution, the patient should immediately drain the solution and use a newly mixed bag.  Section Paediatric population addition and deletion Safety and efficacy in paediatric patients have not been established.Safety and effectiveness in paediatric patients has not been established.

Section 4.5 – addition of No interaction studies have been performed.

Section 4.8 small changes in table to sections GASTROINTESTINAL DISORDERS and GENERAL DISORDERS

Section 4.9 – Delete Refer to and add See

Section 5.1 addition of Hypertonic solutions to first line of text and added paragraph headings - Mechanism of action, Pharmacodynamic effects, Clinical efficacy and safety

Section 5.3 - No non-clinical studies have been performed with PHYSIONEAL 40.There are no preclinical data considered relevant to clinical safety beyond data included in other sections of the SPC.

Section 6.6 change - Refer to to See  

Add point Aminoglycosides should not be administered with penicillins in the same bag due to chemical incompatibility.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

In the case of damage, the container should be discarded.  

Discard any unused remaining solution.

Section 10 - change of date

Section 3 – change of position

Section 4.2 addition of paragraph - To avoid the risk of severe dehydration, hypovolaemia and to minimise the loss of proteins, it is advisable to select the peritoneal dialysis solution with the lowest osmolarity consistent with fluid removal requirements for each exchange.   And changes to existing paragraphs –

Adults:

patients Patients on continuous ambulatory peritoneal dialysis (CAPD) typically perform 4 cycles per day (24 hours). Patients on automated peritoneal dialysis (APD) typically perform 4-5 cycles at night and up to 2 cycles during the day. The fill volume depends on body size, usually from 2.0 to 2.5 litres.

Elderly

As for adults.

• Older people: as for adults.

Paediatric population (patients from pre-term newborn infants to adolescents):

The safety and efficacy of PHYSIONEAL 40 in paediatric patients have not been established.Paediatric patients have not been evaluated in clinical studies with PHYSIONEAL 40. Therefore the clinical benefits of PHYSIONEAL 40 have to be balanced versus the risks of side effects in this patient category.

For pediatricpaediatric patients >2 years old, 800 to 1400 mL/m2 per cycle up to a maximum amount of 2000 mL, as tolerated, has been recommended. Fill volumes of 200 to 1000 mL/m2 are recommended in children less than 2 years of age.

To avoid the risk of severe dehydration, hypovolaemia and to minimise the loss of proteins, it is advisable to select the peritoneal dialysis solution with the lowest osmolarity consistent with fluid removal requirements for each exchange.

Method of administrationAdministration

For instructions on the use of the medicinal product see section 6.6 Special precautions for disposal and other handling.For further information on the use of the medicinal product see section 6.6 Instructions for use and handling.

Section 4.4 Below headings entered:

Patient conditions requiring caution of use

Encapsulating Peritoneal Sclerosis (EPS)

Peritonitis

Hypersensitivity

Use in patients with elevated lactate levels

General monitoring

Overinfusion

Use of higher glucose concentrations

Addition of potassium

Use in diabetic patients

Improper administration

Changes under sections – Peritonitis - broad-spectrum broadspectrum    General monitoring – deletion of paragraphs In patients with secondary hyperparathyroidism, the benefits and risks of the use of a solution with 1.25 mmol/l calcium, such as PHYSIONEAL 40, should be carefully considered as it might worsen hyperparathyroidism. And In patients with plasma bicarbonate level above 30 mmol/l, the risk of possible metabolic alkalosis should be weighed against the benefits of treatment with this product  Addition of paragraphs - Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium and phosphate), blood chemistry (including parathyroid hormone and lipid parameters) and haematological parameters should be monitored periodically.

Secondary hyperparathyroidism

In patients with secondary hyperparathyroidism, the benefits and risks of the use of a solution with 1.25 mmol/l calcium, such as PHYSIONEAL 40, should be carefully considered as it might worsen hyperparathyroidism.

Metabolic alkalosis

In patients with plasma bicarbonate level above 30 mmol/l, the risk of possible metabolic alkalosis should be weighed against the benefits of treatment with this product.  Use of higher glucose concentrations – addition of See section 4.9 Addition of potassium - Potassium is omitted from PHYSIONEAL 40 solutions due to the risk of hyperkalemiahyperkaelemia.

In situations in which there is a normal serum potassium level or hypokalaemiahypokaelemia, the addition of potassium chloride (up to a concentration of 4 mEq/l) may be indicated to prevent severe hypokalaemiahypokaelemia and should be made after careful evaluation of serum 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 lipid parameters) and haematological parameters should be monitored periodically.

Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis.    Use in Diabetic patients – addition of Improper administration.

Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis.

In case of infusion of unmixed solution, the patient should immediately drain the solution and use a newly mixed bag.  Section Paediatric population addition and deletion Safety and efficacy in paediatric patients have not been established.Safety and effectiveness in paediatric patients has not been established.

Section 4.5 – addition of No interaction studies have been performed.

Section 4.8 small changes in table to sections GASTROINTESTINAL DISORDERS and GENERAL DISORDERS

Section 4.9 – Delete Refer to and add See

Section 5.1 addition of Hypertonic solutions to first line of text and added paragraph headings - Mechanism of action, Pharmacodynamic effects, Clinical efficacy and safety

Section 5.3 - No non-clinical studies have been performed with PHYSIONEAL 40.There are no preclinical data considered relevant to clinical safety beyond data included in other sections of the SPC.

Section 6.6 change - Refer to to See  

Add point Aminoglycosides should not be administered with penicillins in the same bag due to chemical incompatibility.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

In the case of damage, the container should be discarded.  

Discard any unused remaining solution.

Section 10 - change of date