Informations for option: Physioneal 40 Glucose 1.36% W/V 13.6mg/Ml Clear-Flex Soln, show other option

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1. Physioneal 40 Glucose 1.36% W/V 13.6mg/Ml Clear-Flex Soln
2. Physioneal 40 Glucose 1.36% W/V 13.6mg/Ml Clear-Flex Soln

PHYSIONEAL 40 may be prescribed to you if you have:

•    either temporary or permanent kidney failure;

•    severe water retention;

•    severe disturbances in the acidity or alkalinity (pH) and the level of salts in your blood;

•    certain types of drug intoxication where no other treatments are available.

PHYSIONEAL 40 solution has an acidity (pH) close to that of your blood. Therefore it may be particularly useful if you experience inflow pain or discomfort with other more acidic Peritoneal Dialysis solutions.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE PHYSIONEAL 40

Your doctor must supervise you the first time you use this product.

Do NOT use PHYSIONEAL 40

•    If you have a surgically uncorrectable problem affecting your abdominal wall or cavity or uncorrectable problem that increases risk of abdominal infections.

•    If you have documented loss of peritoneal function due to severe peritoneal scarring.

Sometimes treatment with PHYSIONEAL 40 in the CLEAR-FLEX container is not

recommended:

•    Children requiring fill volumes less than 1600 ml.

Warnings and precautions

Before use, you must:

•    Firstly mix the content of the two chambers by opening the long seal;

•    Secondly open the short SafetyMoon seal.

•    If you infuse unmixed solution (the long-seal between the two chambers is not opened), you may experience abdominal pain. Drain the solution immediately, use a newly mixed bag and inform your doctor straight away.

-    you have an inherited metabolic disease

-    you are taking metformin (a medicine used to treat diabetes)

-    you are taking medicines to treat HIV, especially medicines called NRTIs.

If you have diabetes and use this solution, the dose of your drugs which regulate the blood sugar level (e.g. insulin) should be evaluated on a regular basis. Especially when the peritoneal dialysis treatment is started, or changed, the dose of your diabetes drugs may need to be adjusted.

If you are under 18 years old. Your doctor will assess the risk against the benefit of using this product.

If you have a high level of parathyroid hormone in your blood due to your kidney disease. The low level of calcium in PHYSIONEAL 40 could worsen hyperparathyroidism. Your doctor will monitor levels of parathyroid hormone in your blood.

You - possibly together with your doctor - should keep a record of your fluid balance and of your body weight. Your doctor will monitor your blood parameters at regular intervals. Particularly salts (e.g. bicarbonate, potassium, magnesium, calcium and phosphate), parathyroid hormone and lipids.

If you have a high level of bicarbonate in your blood.

Not to use more solution than your doctor has prescribed. Symptoms of overinfusion include abdominal distension, feeling of fullness and shortness of breath.

Your doctor will check your potassium level regularly. If it falls too low they may give you some potassium chloride to compensate.

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

Because 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)

-    Thickening of intestines that may be associated with abdominal pain, abdominal distension or vomiting. EPS can be fatal.

Other medicines and PHYSIONEAL 40

•    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 (eg. digoxin) you may:

-    need potassium and calcium supplements

-    develop an irregular heartbeat (an arrhythmia)

-    Your doctor will monitor you closely during treatment, especially your potassium level.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, please inform your doctor. They will advise if this treatment is suitable or not for you.

Driving and using machines

This treatment may cause weakness, blurred vision or dizziness. Do not drive or operate machines if you are affected.

3. HOW TO USE PHYSIONEAL 40

PHYSIONEAL 40 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.

It is not for intravenous use.

Always use PHYSIONEAL 40 exactly as instructed by the medical team specialised in peritoneal dialysis. Check with them if you are not sure.

If the bag is damaged, you must discard it.

How much and how often

Your doctor will prescribe the appropriate glucose strength and the number of bags you must use every day.

Use in children and adolescents

If you are below 18 years, your doctor will assess carefully the prescription of this medicine.

If you stop using PHYSIONEAL 40

Do not stop peritoneal dialysis without the agreement of your doctor. If you stop the treatment it may have life-threatening consequences.

Method of administration

Before use,

•    Warm the bag to 37°C. Use the warming plate specially designed for this purpose. Never immerse in water. Never use a microwave oven to warm the bag.

•    Use aseptic technique throughout the administration of the solution as you have been trained.

•    Prior to beginning an exchange, ensure you clean your hands and the area where your exchange will be performed.

•    Prior to opening the overpouch, check for the correct solution type, expiration date, and amount (volume). Lift the dialysate bag to check for any leaks (excess fluid in the overpouch). Do not use the bag if leaks are discovered.

•    After removing the overpouch, inspect the container for signs of leakage by pressing firmly on the bag. Check that the long and short seals are not opened at any point. If one of the seals is opened, even partially, discard the bag. Do not use the bag if any leak is detected.

•    Check that the solution is clear. Do not use the bag if the solution is cloudy or contains particles.

Ensure all connections are secure before beginning the exchange.

•    Mix the two chambers thoroughly, by opening the long seal first and then the short SafetyMoon seal.

•    Ask your doctor if you have questions or concerns about this product or how to use it.

•    Use each bag only once. Discard any unused remaining solution.

•    The solution must be infused within 24 hours after mixing.

After use, check that the drained fluid is not cloudy.

Compatibility with other drugs

Your doctor may prescribe you other injectable drugs to be added directly into the PHYSIONEAL 40 bag. In that situation, add the drug through the medication site located on the large chamber before opening the long-seal. Use the product immediately after addition of the drug. Check with your doctor if you are not sure.

If you use more bags of PHYSIONEAL 40 than you should in 24 hours

If you infuse too much PHYSIONEAL 40 you may get:

•    abdominal distension

•    a feeling of fullness and/or

•    a shortness of breath.

Contact your doctor immediately. They will advise you what to do.

If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, PHYSIONEAL 40 can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor or your peritoneal dialysis centre immediately:

•    Hypertension (blood pressure that is higher than usual),

•    Swollen ankles or legs, puffy eyes, shortness of breath or chest pain (hypervolaemia),

•    Abdominal pain,

•    Chills (shivering/flu-like symptoms), fever,

•    Inflamed peritoneum (peritonitis).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor or your peritoneal dialysis centre as soon as possible if you notice any of the following:

Side effects commonly observed (between 1% and 10%) in patients using PHYSIONEAL 40:

•    Modification of your blood tests:

-    increase of calcium (hypercalcaemia)

-    decrease of potassium (hypokalaemia) which can cause muscle weakness, twitching or abnormal heart rhythm

-    increase of bicarbonate (alkalosis)

•    Weakness, fatigue

•    Fluid retention (oedema)

•    Weight increase.

Other side effects uncommonly observed (between 0.1% and 1%) in patients using PHYSIONEAL 40:

•    Decrease in fluid removal on dialysis

•    Fainting, dizziness or headache

•    Cloudy solution drained from the peritoneum, stomach-ache

•    Peritoneal bleeding, puss, swelling or pain around the exit site of your catheter, catheter blockage.

•    Nausea, loss of appetite, indigestion, flatulence (passing wind), thirst, dry mouth

•    Distension or inflammation of your abdomen, shoulder pain, hernia of the abdominal cavity (groin lump).

•    Modification of your blood tests:

-    lactic acidosis

-    increased level of carbon dioxide

-    increase in sugar (hyperglycaemia)

-    increase in white blood cells (eosinophilia)

•    Difficulty in sleeping

•    Low blood pressure (hypotension)

•    Cough

•    Aching in muscles or bones

•    Swelling of the face or throat

•    Rash.

Other side effects related to the peritoneal procedure:

• Infection around the exit site of your catheter, catheter blockage.

If you experience any of the side effects mentioned above, or if you notice any side effects not listed in this leaflet, contact your doctor or your peritoneal dialysis center immediately.

5. HOW TO STORE PHYSIONEAL 40

•    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. The date is stated on the carton label and on the bag after the abbreviation Exp. and the symbol E. The expiry date refers to the last day of that month.

Dispose of PHYSIONEAL 40 as you have been trained.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

The Lineo connector contains iodine.

Not all configurations may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Marketing Authorisation Holder

Baxter Healthcare Ltd Caxton Way, Thetford,

Norfolk, IP24 3SE,

United Kingdom

Manufacturers

Baxter Healthcare S.A

Moneen Road Castlebar

County Mayo - Ireland

This leaflet was last approved in January 2013

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.

Baxter, Physioneal and Clear-Flex are trademarks of Baxter International Inc.

For information about PHYSIONEAL 40 or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder: Tel: +44 (0)1635 206345.

The other ingredients are Water for Injections, sodium hydroxide, hydrochloric acid.

The composition in mmol/l in the mixed solution is:

	1.36%	2.27%	3.86%
Glucose anhydrous (mmol/l)	75.5	126	214
Sodium (mmol/l)	132
Calcium (mmol/l)	1.25
Magnesium (mmol/l)	0.25
Chlorides (mmol/l)	95
Bicarbonate (mmol/l)	25
Lactate (mmol/l)	15

What PHYSIONEAL 40 CLEAR-FLEX looks like and contents of the pack

•    PHYSIONEAL 40 is a clear, colourless, sterile solution for peritoneal dialysis.

•    PHYSIONEAL 40 is packed in a non-PVC bag with two chambers. The two chambers are separated by non-permanent seals.

You must only infuse PHYSIONEAL 40 once the solutions of the two chambers are fully mixed. Only then should you open the short SafetyMoon seal.

• Each bag is over-wrapped in an overpouch and supplied in a carton box.

Volume	Number of units per box	Product configuration	Type of connector(s)
1.5 L	5/6	Single bag (APD)	luer
1.5 L	5/6	Twin bag (CAPD)	luer/lineo
2.0 L	4/5	Single bag (APD)	luer
2.0 L	4/5	Twin bag (CAPD)	luer/lineo
2.5 L	3/4	Single bag (APD)	luer
2.5 L	3/4	Twin bag (CAPD)	luer/lineo
3.0 L	3	Single bag (APD)	luer
3.0 L	3	Twin bag (CAPD)	luer/lineo
4.5 L	2	Single bag (APD)	luer
5.0 L	2	Single bag (APD)	luer/luer and Homechoice APD set luer or lineo

CB-30-01-834

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