| Actilyse SPC Changes
Section 1 Name of the Medicinal Product
The text in this section’s header i.e. Name of the Medicinal Product has been put into upper case letters.
The words solvent, solution, injection and infusion in each of the 10 mg, 20 mg and 50 mg paragraphs now all begin with lower case letters.
Section 2 Qualitative and Quantitative Composition
The text in this section’s header i.e. Qualitative and Quantitative Composition has been put into upper case letters.
Section 3 Pharmaceutical Form
The text in this section’s header i.e. Pharmaceutical Form has been put into upper case letters.
Section 4 Clinical Particulars
The text in this section’s header i.e. Clinical Particulars has been put into upper case letters.
Section 4.2 Posology and Method of Administration
The text between paragraphs 2 and 3 has been put into a table.
Section 4.3 Contraindications
The hyphen between contra and indications has been deleted from this section’s header.
The spelling mistake in the first paragraph of this section has been corrected i.e. from exipients to excipients.
The word acute has been added to the last bullet point of the Additional contraindications in acute myocardial infarction section.
The spelling mistake in the second to last bullet point of the Additional contraindications in acute ischaemic stroke section has been corrected i.e. from pharacotherapy to pharmacotherapy.
Section 4.4 Special Warnings and Special Precautions for Use
The second occurrence of the word special in the text of this section’s header has been added.
The words Posology and Method of Administration have been deleted from the end of the second paragraph of the Additional special warnings and precautions in acute myocardial infarction section.
The word special has been deleted from the section header Additional special warnings and precautions in acute ischaemic stroke.
The use of a hyphen as a bullet point for the text Special precautions for use under the Additional special warnings and precautions in acute ischaemic stroke section has been deleted and the text left aligned.
The use of a hyphen as a bullet point for the text Special warnings / conditions with a decreased benefit/risk ration under the Additional special warnings and precautions in acute ischaemic stroke section has been deleted and the text left aligned.
The word Contra-indications has been deleted from the paragraph beginning Patients with very severe stroke are at higher risk have been deleted and the word section has been added between the text see and 4.3.
The use of a hyphen as a bullet point for the header text Other special warnings under the Additional special warnings and precautions in acute ischaemic stroke section has been deleted and the text left aligned.
Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
The letter s has been deleted from the word Interactions in the header of this section.
The word Contraindications has been deleted from the second paragraph of this section and the word section added between the text see and 4.3.
The text GPIIp has been replaced with GPIIb in the last paragraph of this section.
Section 4.6 Pregnancy and Lactation
The text in this section’s header has been amended from Use During Pregnancy to Pregnancy and Lactation.
Section 4.8 Undesirable Effects
The spelling mistake in the uncommon section of the Immune system disorders paragraph has been corrected i.e. from anapylactoid to anaphylactoid.
The word embolism has been replaced by the word embolisation in the rare section of the Injury and poisoning and procedural complications paragraph.
Section 5 Pharmacological Properties
The text in this section’s header i.e. Pharmacological Properties has been put into upper case letters.
Section 5.1 Pharmacodynamic Properties
On two occasions, the word intravenous has been replaced with the text iv. in the third paragraph of this section.
The word subcutaneous has been replaced with the text s.c. in the third paragraph of this section.
Section 5.3 Preclinical Safety Data
The word side has been replaced with the word undesirable in the first paragraph of this section.
The spelling mistake in the second paragraph of this section has been corrected i.e. from wea to was.
Section 6 Pharmaceutical Particulars
The text in this section’s header i.e. Pharmaceutical Particulars has been put into upper case letters.
Section 6.1 List of Excipients
The word excipients in this section’s header now begins with a lower case letter.
The text +/- has been replaced with ± in the last sentence of this section.
Section 6.2 Incompatabilities
The word neither has been added to the last paragraph of this section.
Section 6.6 Special Precautions for Disposal
The words and handling have been deleted from this section’s header.
Section 7 Marketing Authorisation Holder
The text in this section’s header i.e. Marketing Authorisation Holder has been put into upper case letters.
The text Berkshire and RG12 8YS are now on the same line.
Section 8 Marketing Authorisation Number
The text in this section’s header i.e. Marketing Authorisation Number has been put into upper case letters.
Section 9 Date of First Authorisation/Renewal of the Authorisation
The text in this section’s header i.e. Date of First Authorisation/Renewal of the Authorisation has been put into upper case letters.
Section 10 Date of Revision of the Text
The text in this section’s header i.e. Date of Revision of the Text has been put into upper case letters.
The text March 2007 has been replaced with the text 16/05/2007.
Legal Category
The text in this section’s header i.e. Legal Category has been put into upper case letters.
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