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Hemosol B0 solution for haemodialysis/haemofiltration

Summary of Product Characteristics last updated on medicines.ie: 16/12/2020

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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 Hemosol B0 solution for haemodialysis/haemofiltration Active Ingredients Calcium Chloride, Lactic Acid, Magnesium chloride, Sodium Chloride, Sodium Hydrogen Carbonate
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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 16 December 2020 SPC

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 27 March 2019 SPC

Reasons for updating

  • 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)

Updated on 17 October 2017 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Modification of the SmPC sections 2, 3, 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 6.5, 6.6, 7 and 10

Section 2 - removal of text - Theoretical Osmolarity   287 mOsm/1
Section 3 - removal of text - Theoretical Osmolarity   287 mOsm/1
Section 4.2 major change in text
Section 4.4 major change in text
Section 4.5 major change in text
Section 4.6 addition of text - Pregnancy and breastfeeding and Fertility - There are no clinical data on fertility.  However no effects on fertility are anticipated
Section 4.8 major changes in text and addition of a table
Section 4.9 major text changes
Section 5.1 addition of two headings - Pharmacodynamic effects and Mechanism of action - deletion of the work Bicarbonate under heading Mechanism of action
Section 6.5 deletion of text frangible pin (PC) or
Section 6.6 major text changes
Section 7 - address change
Section 10 date change

Updated on 17 October 2017 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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

Modification of the SmPC sections 2, 3, 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 6.5, 6.6, 7 and 10

Section 2 - removal of text - Theoretical Osmolarity   287 mOsm/1
Section 3 - removal of text - Theoretical Osmolarity   287 mOsm/1
Section 4.2 major change in text
Section 4.4 major change in text
Section 4.5 major change in text
Section 4.6 addition of text - Pregnancy and breastfeeding and Fertility - There are no clinical data on fertility.  However no effects on fertility are anticipated
Section 4.8 major changes in text and addition of a table
Section 4.9 major text changes
Section 5.1 addition of two headings - Pharmacodynamic effects and Mechanism of action - deletion of the work Bicarbonate under heading Mechanism of action
Section 6.5 deletion of text frangible pin (PC) or
Section 6.6 major text changes
Section 7 - address change
Section 10 date change

Updated on 17 October 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 10 January 2017 PIL

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 10 January 2017 SPC

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