Glucose 13.6 mg / ml (1.36% w / v), 22.7 mg / ml (2.27% w / v), 38.6 mg / ml (3.86% w / v), Clear -Flex peritoneal dialysis fluid
What Physioneal 35 is and what it is used for
Physioneal 35 is a peritoneal dialysis fluid. It removes water and waste products from the blood. It also corrects abnormal levels of components in the blood. Physioneal 35 is available with different glucose contents (1.36%, 2.27%, and 3.86%). The stronger the glucose content of the solution, the more water it will draw from the blood.
Physioneal 35 can be prescribed to you if you suffer from:
- either temporary or permanent renal failure
- heavy accumulation of water in the body
- severe disturbances in acidity or alkalinity ( pH ) and salt levels in the blood
- certain types of drug poisoning where no other treatment is available
Physioneal 35 has an acidity ( pH ) that is close to the blood. Therefore, it can be especially useful if you experience pain or discomfort when ingesting other peritoneal dialysis fluids that are more acidic.
What you need to know before you use Physioneal 35
Do not use Physioneal 35
The first time you use the product, a doctor should monitor the procedure.
– if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
– if you have problems that affect the abdominal wall or abdominal cavity and that can not be operated on or if you have non-correctable problems that lead to an increased risk of abdominal infections
– if you have documented impaired peritoneal function due to severe scarring of the peritoneum.
In some cases the use of Physioneal 35 in a CLEAR-FLEX bag is not recommended:
– for children who need a filling volume of fewer than 1600 ml.
Warnings and cautions
Before use you need:
- Start by mixing the contents of the two chambers by first opening the long closure.
- Then open the shorter SafetyMoon closure.
- If you infuse reconstituted solution (if the long closure between the chambers is not open) you may experience abdominal pain. Drain immediately, replace with a freshly mixed bag and inform your doctor immediately.
- If you do not drain the reconstituted solution, blood levels of salt and other chemicals may rise. This leads to side effects such as confusion, fatigue, and irregular heartbeat.
Talk to your doctor before using Physioneal 35.
Be especially careful:
– 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 breathing problems.
– if you experience stomach pain, fever, or notice that 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 you to the dialysate bag for 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.
– If you have a high level of lactic acid in your blood. You have a greater risk of lactic acidosis if:
- You have very low blood pressure
- You have a blood infection
- You have severe kidney failure
- You have a congenital metabolic disorder
- You are using metformin (a medicine used to treat diabetes )
- You are taking medicines for HIV, especially medicines called NRTIs ( nucleoside analog reverse transcriptase inhibitors)
– if you have diabetes and use this liquid, the dose of one of the medicines used to adjust your blood sugar level (eg insulin ) should be evaluated regularly. Especially when peritoneal dialysis treatment is started or changed, the dose of one of your diabetes medicines may need to be adjusted.
– If you are allergic to maize, which may cause a hypersensitivity reaction, including a severe allergic reaction, called anaphylaxis. Discontinue the infusion immediately and remove the solution from the abdominal cavity.
– You should, possibly in consultation with your doctor, keep a record of fluid balance and body weight. Your doctor will monitor your blood levels at regular intervals. Especially for salts (eg bicarbonate, potassium, magnesium, calcium, and phosphate ), parathyroid hormone, and fats.
– If you have high levels of bicarbonate in your blood.
– Do not use more solutions than your doctor prescribed. Symptoms of over-infusion are a feeling of tension in the abdomen, a feeling of satiety, and shortness of breath.
– Your doctor will measure your potassium levels regularly. If they get too low, you can get potassium chloride to compensate.
– If flushing or opening and closing of clamps occur in the wrong order, it can result in air entering the abdominal cavity, which can cause abdominal pain and/or inflammation of the peritoneum ( peritonitis ).
A condition called encapsulating peritoneal sclerosis (EPS) 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)
• thickening of the intestines that can lead to abdominal pain, distended abdomen, or vomiting. EPS can be fatal.
Children
Your doctor will assess the risk against the benefits of using this medicine if you are younger than 18 years old.
Other medicines and Physioneal 35
- 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
- If you are taking heart medication called cardiac glycosides (eg digoxin ) you can:
- Need potassium and calcium supplements.
- Develop an irregular heartbeat (arrhythmia).
- Your doctor will monitor you closely during treatment, especially your potassium levels.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Physioneal 35 is not recommended during pregnancy or breastfeeding unless your doctor tells you otherwise.
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.
How to use Physioneal 35
Physioneal 35 should be inserted into the abdominal 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. It is not for intravenous use.
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.
If the bag is damaged, it must be discarded.
How much and how often
Your doctor will prescribe the appropriate glucose strength and the appropriate number of bags for you to use each day.
Use for children and adolescents
If you are under 18 years of age, your doctor will carefully assess the prescription of this medicine.
If you stop using Physioneal 35
Do not stop treatment with peritoneal dialysis without your doctor’s consent. Discontinuation of treatment may have life-threatening consequences.
Method of use
Before use:
- Heat the bag to 37 ° C. Use a hot plate designed for this purpose. Never immerse in water. The bag must not be heated in the microwave.
- Use the aseptic technique while administering one of the solutions, as you have learned.
- 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. Make sure that neither the long nor the short seal is open anywhere. If one of the seals is opened, even if only partially, the bag should be discarded. 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.
- Mix the contents of the two chambers thoroughly by first opening the long seal and then the short SafetyMoon seal.
- Ask your doctor if you have any questions or concerns about this product or its use.
- Each bag may only be used once. Discard any remaining solution.
- The solution must be used within 24 hours after mixing.
After use, check that the drained liquid is not cloudy.
Compatibility with other drugs
Your doctor may prescribe other injectable medicines to be added directly to the Physioneal 35 bag. In this case, the medicine should be added through the injection port on the large chamber before opening the long seal. Use the product immediately after the drug has been added. Ask your doctor if you are unsure.
If you use more Physioneal 35 bags than you should in 24 hours
If you infuse too much Physioneal 35 you can get:
– stretched abdomen
feeling full and/or
– shortness of breath
Contact your doctor immediately. He informs you about what to do.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or dialysis department immediately if you get any of the following:
- Hypertension ( blood pressure is higher than usual)
- Swollen ankles or legs, swollen eyes, shortness of breath, or chest pain ( hypervolemia ).
- Abdominal pain
- Chills (chills / flu-like symptoms), fever.
- Inflamed peritoneum ( peritonitis )
These are serious side effects. You may need immediate medical attention.
If you get any side effects, talk to your doctor or doctor. This also applies to side effects that are not mentioned in this information
Common (may affect up to 1 in 10 people):
- Changing your blood tests:
- increase in calcium ( hypercalcemia )
- decrease in potassium ( hypokalemia ), which can cause muscle weakness, twitching, and abnormal heart rhythm.
- Weakness, fatigue
- Fluid retention ( edema )
- Weight gain
Uncommon (may affect up to 1 in 100 people)
- Reduced fluid secretion during dialysis.
- Fainting, tiredness, or headache.
- Turbid dialysis from the abdominal cavity, abdominal pain.
- Bleeding in the abdominal cavity, scarring, swelling, or pain at the catheter starting point, stop in the catheter.
- Nausea, decreased appetite, flatulence (thirst), thirst, dry mouth.
- Stretched abdomen or inflammation in the abdomen, pain in the shoulders, and hernia in the abdominal cavity (bulging in the groin).
- Changing your blood tests:
- lactic acidosis
- increased content of carbon dioxide
- increased sugar content (hyperglycemia)
- increased white blood cell count ( eosinophilia )
- Difficulty sleeping
- Low blood pressure ( hypotension )
- Cough
- Pain in muscles or legs
- Swelling of the face or neck
- Rash
Other side effects are associated with peritoneal dialysis treatment
- infection at the catheter starting point, stop in the catheter.
How to store Physioneal 35
- Keep this medicine out of the sight and reach of children.
- Do not store below 4 ° C.
- Do not use this medicine after the expiry date which is stated on the carton and the carton after the abbreviation EXP. and the symbol. The expiration date is the last day of the specified month.
Dispose of Physioneal 35 according to the instructions given to you.
Contents of the package and other information
Content declaration
This leaflet does not contain all the information about the medicine. Ask your doctor if you have any questions or are unsure.
| 1.36% | 2.27% | 3.86% | |
|---|---|---|---|
| Glucose monohydrate (g / l) | 15.0 | 25.0 | 42.5 |
| corresponds to anhydrous glucose (g / l) | 13.6 | 22.7 | 38.6 |
| Sodium chloride (g / l) | 5.67 | ||
| Calcium chloride dihydrate (g / l) | 0.257 | ||
| Magnesium chloride hexahydrate (g / l) | 0.051 | ||
| Sodium bicarbonate (g / l) | 2.10 | ||
| Sodium (S) -lactate solution,equivalent to sodium (S) -lactate(g / l) | 1.12 |
The other ingredients are: water for injection, sodium hydroxide, hydrochloric acid
| 1.36% | 2.27% | 3.86% | |
|---|---|---|---|
| Anhydrous glucose (mmol / l) | 75.5 | 126 | 214 |
| Sodium (mmol / l) | 132 | ||
| Calcium (mmol / l) | 1.75 | ||
| Magnesium (mmol / l) | 0.25 | ||
| Chlorides (mmol / l) | 101 | ||
| Bicarbonate (mmol / l) | 25 | ||
| Lactate (mmol / l) | 10 |
What the medicine looks like and the contents of the pack
- Physioneal 35 is a clear, colorless, sterile liquid for peritoneal dialysis.
- Physioneal 35 is packaged in PVC-free bags with two chambers. The two chambers are separated by an openable closure. Physioneal 35 must not be given until the solutions in the two chambers have been mixed properly. Only then may the short SafetyMoon closure be opened.
- Each bag is packed in an outer bag and the bags are delivered in a carton.
| Volume | Number of each box | Packaging | Type of coupling |
|---|---|---|---|
| 1.5 l | 5/6 | Single two-chamber bag (APD) | Screw |
| 1.5 l | 5/6 | Duo two-chamber bag ( CAPD ) | Screw |
| 2.0 l | 4/5 | Single two-chamber bag (APD) | Screw |
| 2.0 l | 4/5 | Duo two-chamber bag ( CAPD ) | Screw |
| 2.5 l | 3/4 | Single two-chamber bag (APD) | Screw |
| 2.5 l | 3/4 | Duo two-chamber bag ( CAPD ) | Screw |
| 3.0 l | 3 | Single two-chamber bag (APD) | Screw |
| 3.0 l | 3 | Duo two-chamber bag ( CAPD ) | Screw |
| 4.5 l | 2 | Single two-chamber bag (APD) | Screw |
| 5.0 l | 2 | Single two-chamber bag (APD) | Screw / Screw and HomeChoice APD set with screw coupling |
Not all pack sizes may be marketed.
Further information on this medicinal product can be obtained from the marketing authorization holder:
Marketing Authorization Holder and Manufacturer
Baxter Medical AB
Box 63
164 94 Kista
Tel: 08-632 64 00
Manufacturer
Baxter Healthcare SA
Moneen Road
Castlebar
County Mayo – Ireland
Bieffe Medical SpA
Via Nuova Provinciale
23034 Grotto
Italy
This medicinal product is authorized under the European Economic Area under the names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, UK: PHYSIONEAL 35 CLEAR-FLEX
Italy: FIXIONEAL 35
Baxter, Physioneal, and Clear-Flex are trademarks of Baxter International Inc.