Gyno-Pevaryl Once 150mg vaginal pessary *
Company:
Janssen Sciences IrelandStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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 08 April 2019
File name
Gyno-pev Once-PIL-C14-29Mar19_clean_1554734129.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 08 April 2019
File name
Gyno-pev Once 150mg SPC-C11-29Mar19_clean_1554734175.pdf
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 23 December 2016
File name
PIL_10771_259.pdf
Reasons for updating
- New PIL for new product
Updated on 23 December 2016
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 June 2015
Reasons for updating
- Change of contraindications
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
Updated on 03 November 2014
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.3 - Preclinical safety data
- 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
4.6: Deletion of wording re effects of the cream on pregnancy and addition of;
'Animal studies have shown reproductive toxicity (see section 5.3).'
'Fertility
Results of econazole animal reproduction studies showed no effects on fertility'
4.8: Reporting of suspected adverse reactions: IMB changed to HPRA and email address updated
5.3 Addition of 'Low neonatal survival and fetal toxicity was associated only with maternal toxicity. In animal studies, econazole nitrate has shown no teratogenic effects but was fetotoxic in rodents at maternal subcutaneous doses of 20 mg/kg/day and at maternal oral doses of 10 mg/kg/day. The significance of this in humans is unknown.'
10: 31 October 2014
Updated on 03 November 2014
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 31 October 2014
Reasons for updating
- Change to side-effects
Updated on 13 May 2014
Reasons for updating
- 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 4.8 – Undesirable effects - how to report a side effect
- 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
In pregnant women, it is recommended that administration takes place without the use of the applicator, or is performed by a physician. Pregnant women should thoroughly wash their hands before self-administering Gyno-Pevaryl Once 150mg vaginal pessaries.
4.4:
Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by this preparation.
Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive (see section 4.5).
4.5: Contact between latex products such as contraceptive diaphragms or condoms and this product must be avoided since the constituents of the product may damage the latex. Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive (see section 4.4).
4.8: Addition of wording re how to report adverse reactions
10: 08 May 2014
Updated on 12 May 2014
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 12 May 2014
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 04 November 2013
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 12 July 2012
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
Change to section 4.5: Reworded. No new interactions.
Change to section 4.8: Revised table of ADRs and information on clinical trials.
Change to section 4.9: Cross reference to section 4.8 added.
Change to section 10: July 2012
Updated on 06 July 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
- Correction of spelling/typing errors
Updated on 24 February 2011
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 23 February 2011
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.3 Contraindications
Hypersensitivity to any imidazole preparation, or other vaginal antifungal products or to any ingredients of Gyno- Pevaryl Once150mg vaginal pessary.
4.4 Special warnings and precautions
addtion of:
Gyno-Pevaryl vaginal pessary should not be used in conjunction with other internal or external treatment of the genitalia.Hypersensitivity has rarely been recorded; if it should occur, administration should be discontinued
4.5. Interaction with other Medicaments and other forms of Interactions
Addition of :
Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive.
Adjustment of the oral anticoagulant dosage may be necessary during and after the treatment with econazole
4.6-Pregnancy and Lactation
addtion of 'because there is vaginal absorption'
and
Lactation
Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. It is not known whether econazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Pevaryl 1 vaginal pessary if the patient is breast-feeding
section 4.8 undesirable efects , side effect now in category (frequency not know.
#
4.9 Overdose This product is intended for vaginal use and by that route overdose is extremely unlikely. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered desirable. Overdose with econazole nitrate has not been reported to date. In the event of accidental ingestion, nausea, vomiting and diarrhoea may occur. If necessary treat symptomatically
Updated on 25 June 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 17 November 2009
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
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3. |
PHARMACEUTICAL FORM |
Change of description from bullet to torpedo shaped. Removal of fat like odour |
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10. |
DATE OF REVISION OF THE TEXT |
Changed to 05 November 2009
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Updated on 13 November 2009
Reasons for updating
- Change to date of revision
- Change to appearance of the medicine
Updated on 16 October 2008
Reasons for updating
- Change of trade or active ingredient name
- Change to storage instructions
- Change to date of revision
Updated on 16 October 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 6.3 - Shelf life
- Change to section 6 - Pharmaceutical particulars
- Change to section 6.4 - Special precautions for storage
- 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
Updated on 09 April 2008
Reasons for updating
- Change of licence holder
- Change to marketing authorisation holder address
Updated on 07 April 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- 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
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Change to section 7 – Marketing Authorisation Holder |
50 100 Holmers Farm Way High Wycombe Bucks HP12 4EG UK |
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Change to section 8 – Marketing Authorisation Numbers |
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Change to section 9 – Date of Renewal of Authorisation |
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Change to section 10 – Date of revision of the text |
27th March 2006 |
Updated on 20 March 2006
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Supply through pharmacy only
Updated on 20 March 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 05 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only