PD4 1.1% Amino acids, peritoneal dialysis fluid
What Nutrineal is and what it is used for
Nutrineal is a peritoneal dialysis fluid that is glucose-free. The solution removes water and waste products from the blood and corrects imbalances in the blood components.
Nutrineal can be prescribed to you:
- if you have kidney failure that requires treatment with peritoneal dialysis
- especially if you are malnourished.
What you need to know before you use Nutrineal
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Your doctor will decide if Nutrineal is a suitable liquid for your peritoneal dialysis treatment. Your doctor will take into account many factors in your medical history that may preclude the possibility of using peritoneal dialysis fluids.
Do not use Nutrineal:
You should NOT use Nutrineal
- If you are allergic to any amino acid or any of the other ingredients of this medicine (listed in section 6).
- If your urea level in the blood exceeds 38 mmol / l.
- If you have a disease that affects the metabolism of amino acids .
- If you have lowered your blood potassium level.
- If you have uremic symptoms, e.g. decreased appetite, nausea or vomiting.
- If you have too little bicarbonate in your blood.
- If you have impaired liver function.
- If you have problems that affect the abdominal wall or abdominal cavity and that cannot be operated on or if you have non-correctable problems that increase the risk of abdominal infections.
Warnings and cautions
Stop taking Nutrineal and contact a doctor immediately if you get any of the following symptoms ( angioedema )
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing.
Talk to your doctor:
- if you suffer from loss of appetite, nausea or vomiting. Your doctor may need to reduce the number of changes of Nutrineal or discontinue treatment with Nutrineal.
- if you experience stomach pain or find that the dialysate is cloudy, cloudy or contains particles. This may be a sign of peritonitis or infection . You should then contact your care team immediately. Make a note of the batch number and take it with you to the dialysate bag for your healthcare team. They will decide if the treatment should be stopped and if any other treatment is necessary. For example, if you have an infection , your doctor may perform tests to find out which antibiotic is best for you. Until your doctor knows what infection you have, you can get an antibioticwhich is effective against a large number of different bacteria. This is called a broad-spectrum antibiotic.
- if you get a hypersensitivity reaction (an allergic reaction ) – see also section 4. Doctors may need to stop taking Nutrineal.
- During peritoneal dialysis , the body can lose protein , amino acids and vitamins . Your doctor knows if replacement therapy is needed.
- if you have problems affecting the abdominal wall or abdominal cavity. For example, if you have a hernia or an infection or an inflammatory disease that affects your intestines.
- if you have had an aortic graft.
- if you have severe lung disease, e.g. emphysema .
- if you have difficulty breathing.
- if you are taking insulin or other medicines for hyperglycaemia (high blood sugar). Your doctor may need to adjust the dose of one of these medicines.
- If you are being treated for secondary hyperparathyroidism , your doctor will decide if you can use a low-calcium dialysis fluid.
You should also note that:
- The disease sclerosing peritonitis (EPS) is a known, rare complication of treatment with peritoneal dialysis . You should, possibly in consultation with your doctor, be aware of this possible complication. EPS causes:
- inflammation of the abdomen (stomach)
- growth of layers of fibrous tissue that cover and bind the organs and affect their normal movement. It is rarely fatal
Your doctor will check your potassium levels regularly. If the potassium content is too low, your doctor may give you potassium chloride to compensate.
- Your doctor will tell you if you need to take special precautions. Your doctor will check your blood parameters regularly and ensure that the values are adequate during treatment.
- You should, possibly in consultation with your doctor, keep a record of protein intake via diet, fluid balance and body weight.
Other medicines and Nutrineal
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- If you are taking other medicines, your doctor may need to increase the dose of one of these. This is because treatment with peritoneal dialysis increases the secretion of certain drugs.
- Be careful if you use cardiac glycosides (eg digoxin ). Cardiac drugs may be less effective and their toxicity may increase. You can:
- need potassium and calcium supplements.
- develop irregular heartbeats (an arrhythmia ).
Your doctor will monitor you closely during treatment, especially your potassium , calcium and magnesium levels.
Pregnancy and breastfeeding
Nutrineal is not recommended during pregnancy or breastfeeding unless your doctor considers it necessary.
Driving and using machines
This treatment may cause weakness, malaise, or decreased body fluid volume ( hypovolemia ). Do not drive or use machines if you are affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Nutrineal
Nutrineal should be administered intraperitoneally, ie in the abdomen (stomach) between the skin and the peritoneum. The peritoneum is the membrane that surrounds the internal organs, e.g. the intestines and liver.
Nutrineal should not be given intravenously.
Always use this medicine exactly according to the instructions of the care team that specializes in peritoneal dialysis. Consult them if you are unsure.
Discard the bag if it has been damaged.
How much and how often
Your doctor will prescribe the appropriate number of bags for you. It usually varies between a 2.0-liter bag and a 2.5-liter bag daily.
Use for children and adolescents
If you are under 18 years of age, your doctor will, after careful evaluation, determine the dosage of Nutrineal.
After 3 months, your doctor will re-evaluate your treatment if your nutritional status has not improved.
Method of use
Before use:
- Heat the bag to 37 ° C. Use a hot plate designed for this purpose. The bag must not be heated in a water bath. The bag must not be heated in the microwave.
- Remove the outer bag and use immediately.
- Use the bag only if the solution is ready and if the container is undamaged.
- Each bag may only be used once.
- Discard any remaining solution.
Aseptic technique should be applied throughout the use of the solution as you have learned.
Miscibility with other drugs
Your doctor may prescribe other medicines for injection to be added directly to the Nutrineal bag. In such cases, the drug should be added via the injection port. Use the product immediately after the drug has been added. Ask your doctor if you are unsure.
If you use more than one bag of Nutrineal for 24 hours
If you infuse too much Nutrineal, you may get:
- stretched abdomen
- a feeling of satiety
Contact your doctor immediately. The doctor decides on any measures.
If you stop using Nutrineal
Do not end treatment with peritoneal dialysis without your doctor’s consent. Discontinuation of treatment may have life-threatening consequences.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following symptoms, tell your doctor or peritoneal dialysis clinic immediately.
- Swelling of the face, tongue or throat; difficulty swallowing; hives and difficulty breathing ( angioedema , has been reported – occurs in an unknown number of patients treated with Nutrineal ).
- Abdominal pain ( common side effect – occurs in more than 1 in 100 patients treated with Nutrineal ).
Other side effects ar
Very common side effects (affects more than 1 user in 10 patients treated with Nutrineal):
- Nausea, vomiting
- Loss of appetite
- Gastritis (gastritis)
- Increased fluid volume in the body ( hypervolemia )
- Feeling weak
- High content of acidic substances in the body ( acidosis )
Common side effects (affects more than 1 user in 100 patients treated with Nutrineal):
- Anemia
- Depression
- Shortness of breath
- Decreased fluid volume in the body ( hypovolemia )
- Decreased level of potassium salt in the blood ( hypokalaemia )
- Infection
Adverse reactions that have been reported (occurs in an unknown number of patients treated with Nutrineal):
- Peritonitis
- Cloudy dialysate from the abdominal cavity
- Discomfort from the abdomen
- Fever
- Feeling sick
- Itching
- Hypersensitivity reaction (an allergic reaction )
Other side effects are related to peritoneal dialysis:
- Infection at the catheter starting point
- Complications due to the catheter
- Decreased calcium content in the blood ( hypocalcaemia )
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Nutrineal
Keep this medicine out of the sight and reach of children.
Store at a maximum of 30 ° C in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the label after “EXP”.
The expiration date is the last day of the specified month.
The product should be used immediately after opening the outer bag.
Only use the solution if it is ready and the bag is undamaged.
Contents of the pack and other information
Content declaration
The active substances are:
| mg / l | |
| Mixture of amino acids:AlanineArginineGlycineHistidineIsoleucineLeucineLysine hydrochlorideMethioninePhenylalanineProlinSerineTreoninTryptophanTyrosineValin | 951107151071485010209558505705955106462703001393 |
| Sodium chloride | 5380 |
| Calcium chloride dihydrate | 184 |
| Magnesium chloride hexahydrate | 51 |
| Sodium lactate | 4480 |
Composition in mmol / l | |
| mmol / l | |
| Amino acids | 87.16 |
| Sodium | 132 |
| Calcium | 1.25 |
| Magnesium | 0.25 |
| Lactate | 40 |
| Chloride | 105 |
The other ingredients are: Water for injections, concentrated hydrochloric acid
What the medicine looks like and contents of the pack
Nutrineal is a sterile, clear, colorless to slightly yellow solution.
Pack size:
- 5 x 2000 ml Duo bag with screw coupling
- 5 x 2000 ml Duo bag with Lineo coupling
- 6 x 2000 ml Duo bag with screw coupling
- 8 x 2000 ml Duo bag with screw coupling
- 4 x 2500 ml single bag with screw coupling
- 4 x 2500 ml Duo bag with screw coupling
- 4 x 2500 ml Duo bag with Lineo coupling
Duo bag can be delivered with Lineo coupling, which contains an ointment with 10.5% povidone-iodine.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Baxter Medical AB
Box 63
SE-164 94 Chest
Manufacturer
Baxter Healthcare SA
Moneen Road
Castlebar
County Mayo- Ireland.