NUTRINEAL PD4 1.1% AMINO ACIDS CLEAR-FLEX SOLUTION FOR PERITONEAL DIALYSIS
Active substance: SODIUM S-LACTATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
NUTRINEAL PD4 1.1% Amino Acids CLEAR-FLEX, Solution for Peritoneal Dialysis
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. Since, during peritoneal dialysis your body may lose protein, amino acids, vitamins. Your doctor will know if these need to be replaced. If you have problems affecting your abdominal wall or cavity. For example if you have a hernia or a chronic infectious or inflammatory condition affecting your intestines. If you had aortic graft placement. If you have severe lung disease, e.g. emphysema. If you have breathing difficulties. If you use insulin or any other treatments for correcting hyperglycaemia. Your doctor may need to adjust their dose. If you are undergoing treatment for secondary hyperparathyroidism, your doctor will decide if you can use a dialysis solution with a low calcium content. You should also take into account that a disorder called encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy. You possibly together with your doctor should be aware of this possible complication. EPS causes: inflammation in your abdomen (belly) the growth of sheets of fibrous tissue that cover and bind your organs and affect their normal movement. Rarely this has been fatal. Your doctor will check your potassium levels regularly. If they fall too low he may give you some potassium chloride to compensate. Your doctor will advise you about particular precautions as it applies to you. He will monitor your blood parameters at regular intervals. He will ensure that they are adequate during your treatment. You possibly together with your doctor should keep a record of your dietary protein intake, your fluid balance and your body weight. Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you use other medicines, your doctor may need to increase their dose. This is because peritoneal dialysis treatment increases the elimination of certain medicines. Take care if you use heart medicines known as cardiac glycosides (e.g.digoxin). Your heart medicine may not be so effective or its toxicity may be increased. You may: need potassium and calcium supplements develop an irregular heartbeat (an arrhythmia) Your doctor will monitor you closely during treatment, especially your potassium levels.
In this leaflet: 1. What NUTRINEAL is and what it is used for 2. Before you use NUTRINEAL 3. How to use NUTRINEAL 4. Possible side effects 5. How to store NUTRINEAL 6. Further information
1. WHAT NUTRINEAL IS AND WHAT IT IS USED FOR
NUTRINEAL is a solution for peritoneal dialysis which does not contain glucose. It removes water and waste products from the blood and corrects abnormal different components of blood. NUTRINEAL may be prescribed for you: if you have kidney failure which needs peritoneal dialysis in particular if you are malnourished.
2. BEFORE YOU USE NUTRINEAL
Your doctor will assess whether NUTRINEAL is a suitable solution for your peritoneal dialysis treatment. He will have taken into account any factors in your medical history which might exclude the use of peritoneal dialysis solutions.
Using other medicines
Do NOT use NUTRINEAL
You must NOT use NUTRINEAL If you have hypersensitivity to any amino acids or any other ingredients. If your blood urea level is above 38 mmol/l. If you suffer from a disorder affecting amino acid metabolism. If your blood potassium level is too low. If you show uraemic symptoms such as loss of appetite, nausea or vomiting. If your blood bicarbonate levels are too low. If you suffer from liver insufficiency. If you already have severe lactic acidosis (too much acid in the blood). If you have a surgically uncorrectable problem affecting your abdominal wall or cavity or uncorrectable problem that increases risk of abdominal infections.
Pregnancy and breast-feeding
NUTRINEAL is not recommended during pregnancy or while breast-feeding unless your doctor advises differently.
Driving and using machines
This treatment may cause weakness, malaise or reduction in body fluid volume (hypovolaemia). Do not drive or operate machines if you are affected.
Take special care with NUTRINEAL
If you experience loss of appetite, nausea or vomiting. Your doctor may need to reduce the number of NUTRINEAL exchanges or stop NUTRINEAL treatment. If you experience abdominal pain or notice cloudiness, haziness or particles in the drained fluid. This may be a sign of peritonitis (inflamed peritoneum) or infection. You should contact your medical team urgently. Note the batch number and bring it along with the drained fluid bag to your medical team. They will decide if the treatment should be stopped or any corrective treatment started. For example if you have an infection your doctor may perform some tests to find out which antibiotic will be best for you. Until your doctor knows which infection you have, he may give you an antibiotic that is effective against a wide number of different bacteria. This is called a broadspectrum antibiotic.
3. HOW TO USE NUTRINEAL
NUTRINEAL is to be administered into your peritoneal cavity. This is the cavity in your abdomen (belly) between your skin and the peritoneum. The peritoneum is the membrane surrounding your internal organs such as your intestines and liver. NUTRINEAL is not for intravenous use. Always use NUTRINEAL exactly as instructed by the medical team specialised in peritoneal dialysis. Check with them if you are not sure. In case of damage, you should discard the bag.
1
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How much and how often
Your doctor will prescribe you the appropriate number of bags you must use. Usually, it varies from one bag of 2.0 litres to one bag of 2.5 litres every day. If you are below 18 years, your doctor will assess carefully the prescription of NUTRINEAL. Your doctor will re-evaluate your treatment after 3 months if there is no improvement in your nutritional status.
6. FURTHER INFORMATION
This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor.
What NUTRINEAL PD4 1.1% Amino Acids contains
The formula is NUTRINEAL PD4 1.1% Amino Acids Formula in mg/l Blend of Amino Acids: Alanine Arginine Glycine Histidine Isoleucine Leucine Lysine, HCl Methionine Phenylalanine Proline Serine Threonine Tryptophan Tyrosine Valine Sodium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium lactate Composition in mmol/l Amino Acids Sodium Calcium Magnesium Lactate Chlorides The other ingredients are: Water for Injections Hydrochloric acid, concentrated. 87.16 132 1.25 0.25 40 105 951 1071 510 714 850 1020 955 850 570 595 510 646 270 300 1393 5380 184 51 4480
Method of administration
Before use, Warm the bag to 37C. Use the warming plate specially designed for this purpose. Never immerse in water to warm the bag. Never use a microwave oven to warm the bag. Remove the overpouch and administer immediately. Use only if the solution is clear and the container undamaged. Use each bag only once. Discard any unused remaining solution. Use aseptic technique throughout the administration of the solution as you have been trained.
Compatibility with other drugs
Your doctor may prescribe you other injectable drugs to be added directly into the NUTRINEAL bag. In that situation, add the drug through the medication site. Use the product immediately after addition of the drug. Check with your doctor if you are not sure.
If you use more than one bag of NUTRINEAL in 24 hours
If you infuse too much NUTRINEAL you may get: abdominal distension a feeling of fullness Contact your doctor immediately. He will advise what to do.
If you stop taking NUTRINEAL
Do not stop peritoneal dialysis without the agreement of your doctor. If you stop the treatment it may have life-threatening consequences.
4. POSSIBLE SIDE EFFECTS
Like all medicines, NUTRINEAL can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. If any of the following happen, tell your doctor or your peritoneal dialysis center immediately: Abdominal pain Bleeding disorder
Side effects commonly observed in patients using NUTRINEAL:
Nausea, vomiting Anaemia Anorexia (prolonged disorder of eating due to loss of appetite) Gastritis (inflamed stomach) Depression Shortness of breath Feeling of weakness, headache Reduction (hypovolaemia) or increase (hypervolaemia) in body fluid volume Decrease in potassium salt blood level (hypokalaemia). Peritonitis (inflammation of the peritoneum) which may be followed by cloudy effluent or fever Infection around the exit site of your catheter, catheter blockage Decrease in calcium blood level (hypocalcaemia).
Other side effects related to the peritoneal procedure:
What NUTRINEAL looks like and contents of the pack
NUTRINEAL is packed in a non-PVC plastic bag of 2.0 litres or 2.5 litres capacity. Each bag is over-wrapped in an overpouch and supplied in carton boxes. Number of units per box 4 5 4 5 3 4 3 4 Product configuration Single bag Single bag Twin bag Twin bag Single bag Single bag Twin bag Twin bag CB-30-01-499
Volume 2.0 L 2.0 L 2.0 L 2.0 L 2.5 L 2.5 L 2.5 L 2.5 L
5. HOW TO STORE NUTRINEAL
Keep out of the reach and sight of children. Store in the original package. Do not store below 4C. Do not use NUTRINEAL after the expiry date. The date is stated on the carton and on the bag after the abbreviation Exp. and the symbol E. The expiry date refers to the last day of that month. Dispose NUTRINEAL as you have been trained.
Not all configurations may be marketed.
2
23/7/10 14:18:49
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Marketing Authorisation Holder
Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
Manufacturers
Baxter Healthcare S.A. Moneen Road Castlebar County Mayo Ireland
Bieffe Medital SpA Via Nuova Provinciale 23034 Grosotto Italy
This leaflet was last approved in April 2010
For information about NUTRINEAL or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder: Tel: +44 (0) 1635 206345.
Baxter, Nutrineal and Clear-Flex are trademarks of Baxter International Inc.
3
CB-30-01-499.indd 3
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23/7/10 14:18:49
NUTRINEAL PD4 1.1% Amino Acids CLEAR-FLEX, Solution for Peritoneal Dialysis
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. Since, during peritoneal dialysis your body may lose protein, amino acids, vitamins. Your doctor will know if these need to be replaced. If you have problems affecting your abdominal wall or cavity. For example if you have a hernia or a chronic infectious or inflammatory condition affecting your intestines. If you had aortic graft placement. If you have severe lung disease, e.g. emphysema. If you have breathing difficulties. If you use insulin or any other treatments for correcting hyperglycaemia. Your doctor may need to adjust their dose. If you are undergoing treatment for secondary hyperparathyroidism, your doctor will decide if you can use a dialysis solution with a low calcium content. You should also take into account that a disorder called encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy. You possibly together with your doctor should be aware of this possible complication. EPS causes: inflammation in your abdomen (belly) the growth of sheets of fibrous tissue that cover and bind your organs and affect their normal movement. Rarely this has been fatal. Your doctor will check your potassium levels regularly. If they fall too low he may give you some potassium chloride to compensate. Your doctor will advise you about particular precautions as it applies to you. He will monitor your blood parameters at regular intervals. He will ensure that they are adequate during your treatment. You possibly together with your doctor should keep a record of your dietary protein intake, your fluid balance and your body weight. Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you use other medicines, your doctor may need to increase their dose. This is because peritoneal dialysis treatment increases the elimination of certain medicines. Take care if you use heart medicines known as cardiac glycosides (e.g.digoxin). Your heart medicine may not be so effective or its toxicity may be increased. You may: need potassium and calcium supplements develop an irregular heartbeat (an arrhythmia) Your doctor will monitor you closely during treatment, especially your potassium levels.
In this leaflet: 1. What NUTRINEAL is and what it is used for 2. Before you use NUTRINEAL 3. How to use NUTRINEAL 4. Possible side effects 5. How to store NUTRINEAL 6. Further information
1. WHAT NUTRINEAL IS AND WHAT IT IS USED FOR
NUTRINEAL is a solution for peritoneal dialysis which does not contain glucose. It removes water and waste products from the blood and corrects abnormal different components of blood. NUTRINEAL may be prescribed for you: if you have kidney failure which needs peritoneal dialysis in particular if you are malnourished.
2. BEFORE YOU USE NUTRINEAL
Your doctor will assess whether NUTRINEAL is a suitable solution for your peritoneal dialysis treatment. He will have taken into account any factors in your medical history which might exclude the use of peritoneal dialysis solutions.
Using other medicines
Do NOT use NUTRINEAL
You must NOT use NUTRINEAL If you have hypersensitivity to any amino acids or any other ingredients. If your blood urea level is above 38 mmol/l. If you suffer from a disorder affecting amino acid metabolism. If your blood potassium level is too low. If you show uraemic symptoms such as loss of appetite, nausea or vomiting. If your blood bicarbonate levels are too low. If you suffer from liver insufficiency. If you already have severe lactic acidosis (too much acid in the blood). If you have a surgically uncorrectable problem affecting your abdominal wall or cavity or uncorrectable problem that increases risk of abdominal infections.
Pregnancy and breast-feeding
NUTRINEAL is not recommended during pregnancy or while breast-feeding unless your doctor advises differently.
Driving and using machines
This treatment may cause weakness, malaise or reduction in body fluid volume (hypovolaemia). Do not drive or operate machines if you are affected.
Take special care with NUTRINEAL
If you experience loss of appetite, nausea or vomiting. Your doctor may need to reduce the number of NUTRINEAL exchanges or stop NUTRINEAL treatment. If you experience abdominal pain or notice cloudiness, haziness or particles in the drained fluid. This may be a sign of peritonitis (inflamed peritoneum) or infection. You should contact your medical team urgently. Note the batch number and bring it along with the drained fluid bag to your medical team. They will decide if the treatment should be stopped or any corrective treatment started. For example if you have an infection your doctor may perform some tests to find out which antibiotic will be best for you. Until your doctor knows which infection you have, he may give you an antibiotic that is effective against a wide number of different bacteria. This is called a broadspectrum antibiotic.
3. HOW TO USE NUTRINEAL
NUTRINEAL is to be administered into your peritoneal cavity. This is the cavity in your abdomen (belly) between your skin and the peritoneum. The peritoneum is the membrane surrounding your internal organs such as your intestines and liver. NUTRINEAL is not for intravenous use. Always use NUTRINEAL exactly as instructed by the medical team specialised in peritoneal dialysis. Check with them if you are not sure. In case of damage, you should discard the bag.
1
CB-30-01-499.indd 1
CB-30-01-499
23/7/10 14:18:49
How much and how often
Your doctor will prescribe you the appropriate number of bags you must use. Usually, it varies from one bag of 2.0 litres to one bag of 2.5 litres every day. If you are below 18 years, your doctor will assess carefully the prescription of NUTRINEAL. Your doctor will re-evaluate your treatment after 3 months if there is no improvement in your nutritional status.
6. FURTHER INFORMATION
This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor.
What NUTRINEAL PD4 1.1% Amino Acids contains
The formula is NUTRINEAL PD4 1.1% Amino Acids Formula in mg/l Blend of Amino Acids: Alanine Arginine Glycine Histidine Isoleucine Leucine Lysine, HCl Methionine Phenylalanine Proline Serine Threonine Tryptophan Tyrosine Valine Sodium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium lactate Composition in mmol/l Amino Acids Sodium Calcium Magnesium Lactate Chlorides The other ingredients are: Water for Injections Hydrochloric acid, concentrated. 87.16 132 1.25 0.25 40 105 951 1071 510 714 850 1020 955 850 570 595 510 646 270 300 1393 5380 184 51 4480
Method of administration
Before use, Warm the bag to 37C. Use the warming plate specially designed for this purpose. Never immerse in water to warm the bag. Never use a microwave oven to warm the bag. Remove the overpouch and administer immediately. Use only if the solution is clear and the container undamaged. Use each bag only once. Discard any unused remaining solution. Use aseptic technique throughout the administration of the solution as you have been trained.
Compatibility with other drugs
Your doctor may prescribe you other injectable drugs to be added directly into the NUTRINEAL bag. In that situation, add the drug through the medication site. Use the product immediately after addition of the drug. Check with your doctor if you are not sure.
If you use more than one bag of NUTRINEAL in 24 hours
If you infuse too much NUTRINEAL you may get: abdominal distension a feeling of fullness Contact your doctor immediately. He will advise what to do.
If you stop taking NUTRINEAL
Do not stop peritoneal dialysis without the agreement of your doctor. If you stop the treatment it may have life-threatening consequences.
4. POSSIBLE SIDE EFFECTS
Like all medicines, NUTRINEAL can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. If any of the following happen, tell your doctor or your peritoneal dialysis center immediately: Abdominal pain Bleeding disorder
Side effects commonly observed in patients using NUTRINEAL:
Nausea, vomiting Anaemia Anorexia (prolonged disorder of eating due to loss of appetite) Gastritis (inflamed stomach) Depression Shortness of breath Feeling of weakness, headache Reduction (hypovolaemia) or increase (hypervolaemia) in body fluid volume Decrease in potassium salt blood level (hypokalaemia). Peritonitis (inflammation of the peritoneum) which may be followed by cloudy effluent or fever Infection around the exit site of your catheter, catheter blockage Decrease in calcium blood level (hypocalcaemia).
Other side effects related to the peritoneal procedure:
What NUTRINEAL looks like and contents of the pack
NUTRINEAL is packed in a non-PVC plastic bag of 2.0 litres or 2.5 litres capacity. Each bag is over-wrapped in an overpouch and supplied in carton boxes. Number of units per box 4 5 4 5 3 4 3 4 Product configuration Single bag Single bag Twin bag Twin bag Single bag Single bag Twin bag Twin bag CB-30-01-499
Volume 2.0 L 2.0 L 2.0 L 2.0 L 2.5 L 2.5 L 2.5 L 2.5 L
5. HOW TO STORE NUTRINEAL
Keep out of the reach and sight of children. Store in the original package. Do not store below 4C. Do not use NUTRINEAL after the expiry date. The date is stated on the carton and on the bag after the abbreviation Exp. and the symbol E. The expiry date refers to the last day of that month. Dispose NUTRINEAL as you have been trained.
Not all configurations may be marketed.
2
23/7/10 14:18:49
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Marketing Authorisation Holder
Baxter Healthcare Limited Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
Manufacturers
Baxter Healthcare S.A. Moneen Road Castlebar County Mayo Ireland
Bieffe Medital SpA Via Nuova Provinciale 23034 Grosotto Italy
This leaflet was last approved in April 2010
For information about NUTRINEAL or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder: Tel: +44 (0) 1635 206345.
Baxter, Nutrineal and Clear-Flex are trademarks of Baxter International Inc.
3
CB-30-01-499.indd 3
CB-30-01-499
23/7/10 14:18:49
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
