Chlorhexidine Acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation Solution

  • Name:

    Chlorhexidine Acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation Solution

  • Company:
    info
  • Active Ingredients:

    Cetrimide, Chlorhexidine Acetate

  • Legal Category:

    Supply through pharmacy only

Summary of Product Characteristics last updated on medicines.ie: 24/12/2018

Click on this link to Download PDF directly

Baxter Holding B.V.

Company Products

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Medicine Name Brevibloc Premixed 10 mg/ml Solution for Injection Active Ingredients Esmolol 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 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 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
Medicine Name Heparin Sodium BP 2000 IU/l in 0.9% w/v Sodium Chloride IV Infusion Active Ingredients Citric Acid Monohydrate, Disodium Phosphate Dodecahydrate, Heparin Sodium, Sodium Chloride
Medicine Name Maintelyte solution for infusion Active Ingredients Glucose anhydrous, Magnesium chloride, hexahydrate, Potassium Chloride, Sodium acetate, trihydrate, Sodium Chloride
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1 - 0 of 68 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 24 December 2018 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: Supply through pharmacy only

Updated on 28 December 2016 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.4 - items in red added

Anaphylactic/anaphylactoid reactions to chlorhexidine have been reported. Manifestations of such reactions have included hypotension, bronchospasm, rash, erythema, tachycardia, and shock. Fatal anaphylactic reaction has been     reported.

Hypersensitivity reactions have been reported on contact with Chlorhexidine acetate or Cetrimide

If any signs or symptoms of a suspected hypersensitivity reaction develop, immediately stop use. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates. Based on available case reports and the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.

Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to Chlorhexidine Acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation Solution, care must be taken to ensure no excess product is present prior to application of the dressing.

Caution should be exercised when chlorhexidine is used in preoperative skin preparations for face or head. (See section 4.3 Contraindications).            This product should only be used in specialist units familiar with the appropriate selection of patients.

            Section 4.8 items in red added/ changed


Immune system disorders:

Hypersensitivity reactions including anaphylactic/anaphylactoid reactions (which might be fatal) manifested by cardiac arrest, shock, circulatory collapse, hypotension, bronchospasm, tachycardia, rash, erythema and urticaria

Skin and subcutaneous tissue disorders:

Rash

Other Adverse Reactions:

The adverse events reported and/or observed with other chlorhexidine products include:

.  Chemical burns in neonates (See Section 4.4 Special Warnings and Precaustions for Use)

The following reactions have been noted when Chlorhexidine containing irrigation solutions have been used intravesically, intravaginally or topically on traumatised skin: Hypotension, paraesthesia, dyspnea, tachycardia, cold sweat, generalised erythema, urticaria and loss of consciousness.

Chemical burns in neonates (frequency unknown).


Updated on 28 December 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.4 - items in red added

Anaphylactic/anaphylactoid reactions to chlorhexidine have been reported. Manifestations of such reactions have included hypotension, bronchospasm, rash, erythema, tachycardia, and shock. Fatal anaphylactic reaction has been     reported.

Hypersensitivity reactions have been reported on contact with Chlorhexidine acetate or Cetrimide

If any signs or symptoms of a suspected hypersensitivity reaction develop, immediately stop use. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates. Based on available case reports and the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.

Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to Chlorhexidine Acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation Solution, care must be taken to ensure no excess product is present prior to application of the dressing.

Caution should be exercised when chlorhexidine is used in preoperative skin preparations for face or head. (See section 4.3 Contraindications).            This product should only be used in specialist units familiar with the appropriate selection of patients.

            Section 4.8 items in red added/ changed


Immune system disorders:

Hypersensitivity reactions including anaphylactic/anaphylactoid reactions (which might be fatal) manifested by cardiac arrest, shock, circulatory collapse, hypotension, bronchospasm, tachycardia, rash, erythema and urticaria

Skin and subcutaneous tissue disorders:

Rash

Other Adverse Reactions:

The adverse events reported and/or observed with other chlorhexidine products include:

.  Chemical burns in neonates (See Section 4.4 Special Warnings and Precaustions for Use)

The following reactions have been noted when Chlorhexidine containing irrigation solutions have been used intravesically, intravaginally or topically on traumatised skin: Hypotension, paraesthesia, dyspnea, tachycardia, cold sweat, generalised erythema, urticaria and loss of consciousness.

Chemical burns in neonates (frequency unknown).


Updated on 28 December 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

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: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided