PHYSIONEAL 40 Glucose 3.86% w/v / 38.6 mg/ml Clear-Flex, Solution for peritoneal dialysis

Summary of Product Characteristics last updated on medicines.ie: 2/4/2019

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Baxter Holding B.V.

Company Products

Medicine NameActive Ingredients
Medicine Name 0.18% w/v Sodium Chloride and 4.0% w/v Glucose Intravenous Infusion BP, (Viaflo Container) Active Ingredients Glucose Monohydrate, Sodium Chloride
Medicine Name Aciclovir 25 mg/ml Concentrate for solution for infusion Active Ingredients Aciclovir sodium
Medicine Name ARTISS Solutions for Sealant Active Ingredients Aprotinin, Calcium Chloride, Human Fibrinogen, Human Thrombin
Medicine Name Brevibloc Premixed 10 mg/ml Solution for Infusion Active Ingredients Esmolol hydrochloride
Medicine Name Brevibloc Premixed 10 mg/ml Solution for Injection Active Ingredients Esmolol hydrochloride
Medicine Name Bupivacaine 2.5 mg/ml Solution for Injection Active Ingredients Bupivacaine Hydrochloride
Medicine Name Bupivacaine 5 mg/ml Solution for Injection Active Ingredients Bupivacaine Hydrochloride
Medicine Name Cernevit, Powder for Solution for Injection or Infusion Active Ingredients Ascorbic Acid (Vitamin C), Colecalciferol (Vitamin D3), Cyanocobalamin (Vitamin B12), d-Biotin (Vitamin H), Dexpanthenol, Folic Acid, Nicotinamide, Pyridoxine Hydrochloride (Vitamin B6), Riboflavine (Vitamin B2), Vitamin A (Palmitate), Vitamin B1, Vitamin E (tocopherol)
Medicine Name Chlorhexidine Acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation Solution Active Ingredients Cetrimide, Chlorhexidine Acetate
Medicine Name Chlorhexidine Acetate BP 0.05% w/v Irrigation Solution Active Ingredients Chlorhexidine Acetate
Medicine Name CLINIMIX N14G30E, solution for infusion Active Ingredients Alanine, Arginine, Calcium Chloride, Glucose Monohydrate, Glycine, Histidine, Isoleucine, Leucine, Lysine, Magnesium chloride, Methionine, Phenylalanine, Potassium phosphate dibasic, Proline, Serine, Sodium acetate, trihydrate, Sodium Chloride, Threonine, Tryptophan, Tyrosine, Valine
Medicine Name Compound Sodium Lactate Solution for Infusion BP Active Ingredients Calcium Chloride Dihydrate, Potassium Chloride, Sodium Chloride, Sodium Lactate
Medicine Name Dianeal PD4 Glucose 1.36% w/v (13.6 mg/ml), Solution for peritoneal dialysis Active Ingredients Calcium Chloride Dihydrate, Glucose Monohydrate, Magnesium chloride, hexahydrate, Sodium Chloride, Sodium Lactate
Medicine Name Dianeal PD4 Glucose 2.27% w/v (22.7 mg/ml), Solution for peritoneal dialysis Active Ingredients Calcium Chloride Dihydrate, Glucose Monohydrate, Magnesium chloride, hexahydrate, Sodium Chloride, Sodium Lactate
Medicine Name Dianeal PD4 Glucose 3.86% w/v (38.6 mg/ml), Solution for peritoneal dialysis Active Ingredients Calcium Chloride Dihydrate, Glucose Monohydrate, Magnesium chloride, hexahydrate, Sodium Chloride, Sodium Lactate
Medicine Name Dobutamine 12.5 mg/ml Concentrate for solution for infusion Active Ingredients Dobutamine
Medicine Name Endoxana Coated Tablets 50 mg Active Ingredients Cyclophosphamide monohydrate
Medicine Name EXTRANEAL (Icodextrin 7.5%) Solution for peritoneal dialysis Active Ingredients Calcium Chloride, Icodextrin, Magnesium chloride, Sodium Chloride, Sodium Lactate
Medicine Name Finomel emulsion for infusion Active Ingredients Alanine, Arginine, Calcium Chloride Dihydrate, Glucose Monohydrate, Glycine, Histidine, Isoleucine, Leucine, Lysine hydrochloride, Methionine, Phenylalanine, Potassium Chloride, Proline, Refined olive oil, Refined soybean oil, Serine, Sodium acetate, trihydrate, Sodium glycerophosphate, hydrated, Threonine, Tryptophan, Tyrosine, Valine, Zinc sulfate heptahydrate, Magnesium sulfate heptahydrate, Fish oil, rich in omega-3-acids, Medium-chain triglycerides
Medicine Name Finomel Peri emulsion for infusion Active Ingredients Alanine, Arginine, Calcium Chloride Dihydrate, Glucose Monohydrate, Glycine, Histidine, Isoleucine, Leucine, Lysine hydrochloride, Methionine, Phenylalanine, Potassium Chloride, Proline, Refined olive oil, Refined soybean oil, Serine, Sodium acetate, trihydrate, Sodium glycerophosphate, hydrated, Threonine, Tryptophan, Tyrosine, Valine, Zinc sulfate heptahydrate, Magnesium sulfate heptahydrate, Fish oil, rich in omega-3-acids, Medium-chain triglycerides
Medicine Name Fluconazole 2 mg/ml solution for infusion Active Ingredients Fluconazole
Medicine Name Furosemide 10 mg/ml Solution for Injection Active Ingredients Furosemide
Medicine Name Glucose 10% w/v Solution for Infusion Active Ingredients Glucose Monohydrate
Medicine Name Glucose 5% Intravenous Infusion BP Active Ingredients Glucose Monohydrate
Medicine Name Heparin Sodium BP 1000 IU/l in 0.9% w/v Sodium Chloride IV Infusion Active Ingredients Citric Acid Monohydrate, Disodium Phosphate Dodecahydrate, Heparin Sodium, Sodium Chloride
1 - 0 of 79 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 2 April 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 July 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 February 2017 PIL

Reasons for updating

  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

6.2 - text added  - Aminoglycosides (eg. netilmycin, gentamycin, tobramycin) should not be mixed with penicillins due to chemical incompatibility.

6.3 text added "After opening / dilution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C for: cefazolin (750 mg/l), heparin (2500 IU/L), low molecular weight heparin (Innohep 2500 IU/L), netilmycin (60 mg/l) and vancomycin (1000 mg/l).

Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C for insulin (Actrapid 4 IU/L, 10 IU/L, 20 IU/L and 40 IU/L).

Gentamicin (60 mg/l) and tobramycin (60 mg/l) can be added if the solution is used immediately after drug addition.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the  responsibility of the user and would normally not be longer than 24 hours, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions

6.4 Text added - For storage conditions of the reconstituted medicinal product, see section 6.3.

6.6 Text added - In the case of damage, the container should be discarded.

Updated on 22 February 2017 SmPC

Reasons for updating

  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.2 - text added  - Aminoglycosides (eg. netilmycin, gentamycin, tobramycin) should not be mixed with penicillins due to chemical incompatibility.

6.3 text added "After opening / dilution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C for: cefazolin (750 mg/l), heparin (2500 IU/L), low molecular weight heparin (Innohep 2500 IU/L), netilmycin (60 mg/l) and vancomycin (1000 mg/l).

Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C for insulin (Actrapid 4 IU/L, 10 IU/L, 20 IU/L and 40 IU/L).

Gentamicin (60 mg/l) and tobramycin (60 mg/l) can be added if the solution is used immediately after drug addition.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the  responsibility of the user and would normally not be longer than 24 hours, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions

6.4 Text added - For storage conditions of the reconstituted medicinal product, see section 6.3.

6.6 Text added - In the case of damage, the container should be discarded.

Updated on 22 February 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 September 2016 PIL

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 1 September 2016 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided