Updated on 05/04/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In Section 2, Qualitative and quantitative composition, excipient has changed from benzalkonium chloride to poyquaternium-1 and propylene glycol.
In Section 4.4, Special warnings and precautions for use, warnings related to benzalkonium chloride are replaced by warnings related to polyquaternuim-1 and propylene glycol.
In Section 4.8, Undesirable effects, side effects related to polyquaternuim-1 and propylene glycol are added.
In Section 5.1, Pharmacodynamic properties, the following statement is added – ‘In a 6-week, controlled clinical study in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 24 to 26 mmHg, the mean IOP-lowering effect of DuoTrav (polyquaternium-1-preserved) dosed once-daily in the morning was 8 mmHg and equivalent to that of DuoTrav (benzalkonium chloride-preserved).’
In Section 5.2, Pharmacokinetic properties, information related to polyquaternuim-1 and propylene glycol is added.
In Section 5.3, Pre-clinical safety data, the following statement is added – ‘DuoTrav preserved with polyquaternium-1 induced minimal ocular surface toxicity, compared to eye drops preserved with benzalkonium chloride, on cultured human corneal cells and following topical ocular administration in rabbits.’
In Section 6.1, List of excipients, the list has been updated.
In Section 10, Date of revision of the text, the date of revision is updated.
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Updated on 22/10/2010 and displayed until 05/04/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 07-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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• In Section 2 (Qualitative and quantitative composition), ‘1 ml’ is changed to ‘Each ml’, ‘benzalkonium chloride 0.15mg, polyoxyethylene hydrogenated castor oil 40 (HC0 40) 5 mg (see section 4.4)’ changed to ‘Each ml of solution contains 0.15ml of benzalkonium chloride and 5mg polyoxyethylene hydrogenated castor oil 40’
• In Section 3 (Pharmaceutical form), ‘drops’ is replaced with ‘drop’
• In Section 4.1 (Therapeutic indications), ‘in patients’ is replaced with ‘in adult patients’
• In Section 4.2 (Posology and method of administration)-
-Sub-section ‘Posology’ is added, ‘elderly’ is replaced with ‘elderly population’.
-Information on nasolacrimal occlusion and usage of more than on topical ophthalmic product is moved to the sub-section ‘method of administration’. Also, information on contact lenses and substitution of a different antiglaucoma medicinal product with DuoTrav has been included in this sub-section.
-Information on hepatic and renal impairment has been moved to the sub-section ‘special populations’
• In Section 4.3 (Contraindications), ‘travoprost, timolol’ are replaced with ‘the active substances’
• In Section 4.4 (Special warnings and precautions for use),
-‘ophthalmic agents’ replaced with ‘ophthalmic medicinal products’
-‘beta adrenergic component’ replaced with ‘beta adrenergic active substance’
-‘beta adrenergic blocking agents’ replaced with ‘beta adrenergic blocking medicinal products’
-‘biologically active materials’ replaced with ‘biologically active substances’
-‘beta blocking agent’ replaced with ‘beta blocking medicinal product’
-‘irritation’ replaced with ‘eye irritation’
-‘ Patients must be instructed to remove contact lenses prior to application of DuoTrav and wait 15 minutes after instillation of the dose before reinsertion’ is removed
• In Section 4.5 (Interaction with other medicinal products and other forms of interaction),
-‘beta blocking agent’ replaced with ‘beta blocking medicinal product’
-‘ antidiabetic agents’ replaced with ‘antidiabetic medicinal products’
• Section 4.6 (Pregnancy and lactation) is changed to ‘Fertility, pregnancy and lactation’; and information on fertility is included.
• In Section 4.7 (Effects on ability to drive and use machines), ‘machinery’ replaced with ‘machines’
• In Section 4.8 (Undesirable Effects), ‘undesirable effects’ replaced with ‘adverse reactions’; new system organ classes ‘Psychiatric disorders, hepatobiliary disorders’ are included, and the tabnle structure is reorganized.
• In section 4.9 (Overdose), ‘A topical overdose with travoprost is not likely to occur or to be associated with toxicity. The most common symptoms of a systemic timolol overdose are bradycardia, hypotension, bronchospasm and heart failure’ is added.
• In Section 5.1(Pharmacodynamic properties), ‘beta blocking agents timolol, combinations’ is removed
• In Section 5.2 (Pharmacokinetic properties), ‘Metabolism’ replaced with ‘Biotransformation’ and ‘Excretion’ replaced with ‘Elimination’
• In Section 6.1 (List of Excipients), ‘Mannitol’ replaced with ‘Mannitol (E421)’
• In Section 6.5 (Nature and contents of container), ‘Cartons containing’ replaced with ‘Pack sizes of’.
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Updated on 05/03/2009 and displayed until 22/10/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 02-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 - Under heading cardiac disorders - 'Uncommon - arrhythmia' added
Under heading Eye disorders in Uncommon - 'corneal erosion, keratitis' added
Under heading Skin and tissue disorders - 'Uncommon - dermatitis contact' added and 'Not known - rash, alopecia' added
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Updated on 04/09/2008 and displayed until 05/03/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 31-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 (Special warnings and precautions) has been updated to include information on absorption through the skin, including caution for pregnant women or women attempting to become pregnant coming into contact with the bottle contents. Additionally, information has been included in this section on known problems associated with prolonged use of BAC.
Section 4.6 (Pregnancy and lactation) has been updated to state that travoprost has harmful effects on pregnancy and/or foetus/new-born children.
Section 4.8 (Undesirable effects) Included is the adverse reactions listed were observed in clinical studies and post marketing experience. The adverse reactions have been put into a table.
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Updated on 11/05/2006 and displayed until 04/09/2008
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Reasons for adding or updating:
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