peritoneal dialysis fluid
1. What Extraneal is and what it is used for
Extraneal is a peritoneal dialysis fluid. The peritoneal cavity is the space in the abdomen (stomach) between the skin and the peritoneum. The peritoneum is the membrane that surrounds the internal organs such as the intestines and liver. The extraneal solution is introduced into the peritoneal cavity where it removes water and residues from the blood. It also corrects abnormal levels of various components in the blood.
Extraneal can be prescribed to you:
- If you are an adult and have chronic kidney failure that needs to be treated with peritoneal dialysis.
- If regular glucose-containing peritoneal dialysis fluids alone cannot remove enough water
2. What you need to know before you use Extraneal
Do not use Extraneal
The first time you use the product, a doctor should monitor the procedure.
- If you are allergic to icodextrin or starch products (eg corn starch) or any of the other ingredients of Extraneal.
- If you are allergic (hypersensitive) to maltose or isomaltose ( starch sugar ).
- If you have glycogen storage disorders.
- If you already have severe lactic acidosis (too much acid in your blood).
- If you have problems affecting the abdominal wall or abdominal cavity and cannot be operated on or if you have non-curable problems that increase the risk of abdominal infections.
- If you have documented peritoneal dysfunction due to severe scarring of the peritoneum.
Warnings and cautions
Talk to your doctor before using Extraneal
- If you are older. There is a risk of dehydration.
- If you have diabetes and are using this liquid for the first time. You may need to adjust your insulin dose.
- If you need to check your blood sugar level (eg if you have diabetes ). Your doctor will advise you on what measurement you want to use (see Other interaction s ).
- if you have a high risk of severe lactic acidosis (too much acid in the blood). You have an increased risk of lactic acidosis if:
- you have very low blood pressure.
- you have an infection in the blood.
- you have acute severe kidney failure.
- you have a hereditary metabolic disease.
- you are using metformin (a medicine used to treat diabetes ).
- you use medicines to treat HIV, especially medicines called NRTIs.
- if you experience stomach pain or the dialysate is cloudy, cloudy, or contains particles. It may be a sign of peritonitis (inflamed peritoneum) or infection. Contact your medical care team immediately. Make a note of the batch number and take it with the dialysate bag to your healthcare team. They will decide if the treatment should be stopped or if any other treatment needs to be started. For example, if you have an infection, your doctor may take certain samples to find out which antibiotic is best for you. Until the doctor knows what kind of infection you have, you can get an antibiotic that is effective against a large number of different bacteria. This is called a broad-spectrum antibiotic.
- During peritoneal dialysis, your body can lose protein, amino acids, vitamins. Your doctor knows if they need to be replaced.
- if you have problems affecting the abdominal wall or abdominal cavity. For example, if you have a hernia or a chronic infectious or chronic inflammatory condition that affects your intestines.
- if you have a (graft) prosthesis in the large carotid artery.
- if you have severe lung disease, such as emphysema.
- if you have difficulty breathing.
- if you have any disorder that prevents normal nutrition.
- if you have a potassium deficiency.
You should also take into account that:
- A condition called encapsulating peritoneal sclerosis is a known, rare complication of peritoneal dialysis treatment. You should, possibly in consultation with your doctor, be aware of this possible complication. Encapsulating peritoneal sclerosis causes:
- inflammation of the abdomen (stomach).
- growth of layers of fibrous tissue that cover and bind the organs and affect their normal movements. In rare cases, this has been fatal.
- you should, possibly in consultation with your doctor, keep a record of your fluid balance and body weight. Your doctor will check your blood parameters regularly.
- Your doctor will measure your potassium levels regularly. If they get too low, you can get potassium chloride to compensate.
Sometimes treatment with this medicine is not appropriate, such as:
- if you have acute kidney disease.
Children
Safety and efficacy in children under 18 years of age have not been established.
Other medicines and Extraneal
Tell your doctor 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 elimination of one of the certain drugs.
- Be careful if you are taking heart medicines called cardiac glycosides (eg digoxin ). Your heart medicine may be less effective or its toxicity may increase. You can:
- need the addition of potassium and calcium.
- get irregular heart rhythm (an arrhythmia ).
Your doctor will monitor you closely during treatment, especially your potassium levels.
Other interaction s
| Extraneal affects blood glucose levels for certain test methods. If you need to check your blood sugar, make sure you use a glucose-specific test method. Your doctor will advise you on which glucose meter to use. Using the wrong test method can result in falsely high blood sugar levels. This can cause you to take more insulin than you need. This can cause hypoglycemia (low blood sugar) which can lead to unconsciousness, coma, neurological damage, or death. Besides, a falsely high blood sugar level can hide real hypoglycemia so that it is not treated, which has similar consequences. False blood sugar levels may occur up to two weeks after stopping your treatment with Extraneal. If you are admitted to the hospital, you should warn your doctors about this possible interaction and they should carefully study the test method’s product information to ensure that it is glucose specific. |
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Extraneal is not recommended during pregnancy or breastfeeding except on the advice of a doctor.
Driving and using machines
This treatment can cause fatigue, weakness, blurred vision, and dizziness. Do not drive or use any tools or 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.
3. How to use Extraneal
Extraneal should be administered to the peritoneal cavity. It is the space in the abdomen (stomach) between the skin and the peritoneum. The peritoneum is the membrane that surrounds the internal organs such as the intestines and liver.
Always use this medicine exactly according to the instructions of the care team that specializes in peritoneal dialysis. Consult a doctor if you are unsure.
The recommended dose is
- One bag per day during the longest dialysis period, ie:
- Overnight in CAPD ( continuous outpatient peritoneal dialysis ).
- During the day at APD (automatic peritoneal dialysis ).
- Give the liquid for 10-20 minutes.
- The dialysis time with Extraneal is 6–12 hours for CAPD and 14–16 hours for APD.
Method of use
Before use:
- Heat the bag to 37 ° C. Use a hotplate designed for this purpose. The bag must not be heated in a water bath.
- Use aseptic technique throughout the administration of one of the solutions, as you have been taught.
- Before starting a solution change, wash your hands and the surface where the change is to be made.
- Before opening the outer bag, check that it is the correct solution, expiry date, and quantity (volume). Lift the dialysis bag to check for leaks (excess fluid in the outer bag). Do not use the bag if leakage is detected. After the outer bag has been removed, check the container for signs of leakage by pressing the bag firmly. Do not use the bag if leakage is detected.
- Check that the solution is ready. Do not use the bag if the solution is cloudy or contains particles.
- Make sure that all connections are secure before starting the change.
- Ask your doctor if you have any questions or concerns about this product or its use.
Each bag may only be used once. Discard the unused, leftover solutions. After use, make sure that the drained liquid is not cloudy.
Compatibility with other drugs
Your doctor may prescribe other injectable medicines to be added directly to the bag of Extraneal. In such cases, the drug should be added via the injection port at the bottom of the bag. 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 Extraneal for 24 hours
If you infuse too much Extraneal, you may get:
- stretched abdomen
- feeling full and/or
- shortness of breath
Contact your doctor immediately. The doctor decides on any measures.
If you stop using Extraneal
Do not stop treatment with peritoneal dialysis without your doctor’s consent. Discontinuation of treatment may have life-threatening consequences.
4. Possible side effects
Like all medicines, Extraneal can cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
If you develop any of the following, tell your doctor or dialysis department immediately:
• high blood pressure ( blood pressure higher than normal)
• swollen ankles or legs, swollen eyes, shortness of breath or chest pain ( hypervolemia )
• hypersensitivity ( allergic reaction ) which may include a swollen face, swollen throat, and swelling around the eyes ( angioedema )
• abdominal pain
• chills (chills / flu-like symptoms)
These symptoms may be signs of serious side effects. You may need urgent medical attention.
Common side effects (may affect up to 1 in 10 people treated with Extraneal):
- reddening and scaly skin, rash, itching ( pruritus )
- feeling intoxicated or dizzy, thirsty (dehydration)
- decreased blood volume ( hypovolemia )
- abnormal laboratory values
- weakness, headache, fatigue
- swollen ankles and legs
- drop in blood pressure
- earring
Other side effects associated with peritoneal dialysis treatment or common to all peritoneal dialysis fluids:
• cloudy dialysate from the abdominal cavity, abdominal pain
• abdominal bleeding, wart formation, swelling, pain or infection at the catheter starting point, catheter blockage, injury, or another impact on the catheter
• low blood sugar (hypoglycemia)
• shock or coma due to low blood sugar
• high blood sugar (hyperglycemia)
• nausea, vomiting, decreased appetite, dry mouth, constipation, diarrhea, flatulence (flatulence), upset stomach and intestines such as intestinal obstruction, gastric ulcer, gastritis (inflamed stomach), indigestion.
• stretched abdomen, hernia in the abdominal cavity (it causes a lump in the groin)
• change in your blood tests
• abnormal results when checking liver function
• increased or decreased weight
• pain, fever, general malaise
• heart disease, faster heart rate, shortness of breath or chest pain
• anemia (decreased number of red blood cells which can lead to pale skin and cause weakness or shortness of breath). Increased or decreased white blood cell count. Reduced platelet count, which increases the risk of bleeding and bruising
Numbness, tingling, burning sensation
• hyperkinesia (increased movement and inability to stand still)
• dimsyn
• loss of sense of taste
• fluid retention ( pulmonary edema ), shortness of breath, difficulty breathing or wheezing, cough, hiccups
• kidney pain
• nail problem
• skin conditions such as hives ( urticaria ), psoriasis, skin ulcers, eczema, dry skin, discolored skin, blisters on the skin, allergic or contact dermatitis, rash, and itching.
• skin rash may be itchy with lumpy red spots, or with eruptions and flaky skin. The following three serious skin reactions may occur:
- toxic epidermal necrolysis (TEN). It causes:
- a red rash over large parts of the body
- flaking of the outer skin layer
- erythema multiformat. An allergic skin reaction that causes blemishes, red raised areas, purple areas, or areas with blisters. It can also affect the mouth, eyes, or other moist areas of the body.
- vasculitis. Inflammation of certain blood vessels in the body. The symptoms depend on which part of the body is involved, but can appear on the skin in the form of red or purple spots or streaks, or show symptoms similar to those of an allergic reaction and include rash, joint pain, and fever.
• muscle cramps, skeletal pain, pain in joints, muscles, back, neck
• drop in blood pressure when you get up ( orthostatic hypotension )
• peritonitis (inflamed peritoneum) including peritonitis caused by fungi or bacteria
• infection includes flu syndrome, abscess
• abnormal thoughts, anxiety, nervousness
5. How to store Extraneal
- Keep out of sight and reach of children.
- Store in the original package.
- Do not store below 4 ° C.
- Do not use Extraneal after the expiry date which is stated on the carton and the bag after the abbreviation EXP. and the symbol. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
This leaflet does not contain all the information about the medicine. Ask your doctor if you have any questions or are unsure.
Content declaration
The active substances are:
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| Icodextrin | 75 g / l |
| Sodium chloride | 5.4 g / l |
| Sodium (s) -lactate | 4.5 g / l |
| Calcium chloride | 0.257 g / l |
| Magnesium chloride | 0.051 g / l |
| Sodium | 133 mmol / l |
| Calcium | 1.75 mmol / l |
| Magnesium | 0.25 mmol / l |
| Chloride | 96 mmol / l |
| Lactate | 40 mmol / l |
Other ingredients are:
Water for injections
Sodium hydroxide or hydrochloric acid
What the medicine looks like and the contents of the pack
- Extraneal is packaged in flexible plastic bags that contain 1.5, 2.0, or 2.5 liters.
- The liquid in the bags is clear and colorless.
- Each bag is packed in a separate outer bag and delivered in cartons.
| Volume | Number in each box | Pack size | Type of coupling |
|---|---|---|---|
| 1.5 l | 8 | Single bag (APD) | Luer / Lace |
| 1.5 l | 8 | DUO bag ( CAPD ) | Luer / Lace |
| 1.5 l | 6 | Single bag (APD) | Luer / Lace |
| 1.5 l | 6 | DUO bag ( CAPD ) | Luer / Spets / Lineo |
| 2.0 l | 8 | Single bag (APD) | Luer / Lace |
| 2.0 l | 8 | DUO bag ( CAPD ) | Luer / Lace |
| 2.0 l | 6 | Single bag (APD) | Luer / Lace |
| 2.0 l | 6 | DUO bag ( CAPD ) | Luer / Lace |
| 2.0 l | 5 | Single bag (APD) | Luer / Lace |
| 2.0 l | 5 | DUO bag ( CAPD ) | Luer / Spets / Lineo |
| 2.5 l | 5 | Single bag (APD) | Luer / Lace |
| 2.5 l | 5 | DUO bag ( CAPD ) | Luer / Lace |
| 2.5 l | 4 | Single bag (APD) | Luer / Lace |
| 2.5 l | 4 | DUO bag ( CAPD ) | Luer / Spets / Lineo |
The line coupling contains iodine.
Not all pack sizes may be marketed.
Further information on this medicinal product can be obtained from the Marketing Authorization Holder:
Marketing Authorization Holder
Baxter Medical AB
Box 63
164 94 Kista
Tel: 08-632 64 00
Email: info@baxter.se
Manufacturer
Baxter Healthcare SA
Moneen Road
Castlebar, County Mayo
Ireland
Baxter Healthcare Ltd.
Caxton Way
Thetford, Norfolk
IP24 3SE
UK