Periodo de validez (después de abrir el envase)

English translation: Shelf-life (after opening the packaging)

12:13 Nov 22, 2006

Spanish to English translations [PRO]
Law/Patents - Medical (general)

Spanish term or phrase: Periodo de validez (después de abrir el envase)

Características especialidad farmacéutica

Contenido de los envases (formato y código nacional)
Periodo de validez: 5 años
Periodo de validez después de haber abierto el envase: uso inmediato

Validity period after opening of the bottle???? Gracias!

Bernadette Mora KudoZ activity Questions: 2080 (2 open) (2 without valid answers) (49 closed without grading) Answers: 263 Spain
Local time: 13:33

English translation:Shelf-life (after opening the packaging)

Explanation:
This is it. Two solid references of many below:

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Note added at 8 mins (2006-11-22 12:21:42 GMT)
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Or, in this case, after opening the bottle!

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Note added at 7 hrs (2006-11-22 20:02:40 GMT)
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If anyone doubts that shelf-life can refer to a product after opening, note the following examples:

Shelf Life after Opening:
The vaccine should be administered shortly after withdrawal from the vial.

From: http://www.cdc.gov/nip/publications/vac_mgt_book.htm

Or:

Blister packed for easy use and sustained shelf life after opening of box; High quality ingredients and manufacturing

from: www.boehringer-ingelheim.com/corporate/products/animal_heal...

Note also that this does not seem to be from the patient information leaflet, but more technical information, and the prescribed term is "shelf-life".

And that, I think, is quite enough on the matter.

Selected response from:

David Russell
Spain
Local time: 13:33

Grading comment

Thanks a lot!
4 KudoZ points were awarded for this answer

Summary of answers provided

4 +4

Use within (of opening)

Edward Tully

5 +3

Shelf-life (after opening the packaging)

David Russell

4 +2

Shelf-life after first opening the immediate packaging

Lia Fail (X)

3 +2

options below

Rachel Fell

period of validity / valid time (after opening the packaging)

Dolores Vázquez

4 -1

period after opening/period of use after opening

Barbara Duffus

Discussion entries: 1

Answers

7 mins confidence:

period of validity / valid time (after opening the packaging)

Explanation:
Una sugerencia.

Reference: http://ec.europa.eu/eurodicautom/Controller

Dolores Vázquez
Native speaker of:

Galician,

Spanish
PRO pts in category: 57

7 mins confidence:

peer agreement (net): +4

Use within (of opening)

Explanation:
if followed by a period - if it's followed by a date then it's "use before" or "expiry date"

Edward Tully
Local time: 13:33
Native speaker of:

English
PRO pts in category: 126

Peer comments on this answer (and responses from the answerer)

disagree

Barbara Duffus: like shelf life - this period may run out with the package never having been opened

8 mins

-> difficult to use medicine without opening the package!

agree

Barbara Thomas: I agree with Barbara Duffus, but the Scadplus document cited indicates that a symbol used. Otherwise, I think this is a good alternative until official wording becomes available.

20 mins

-> thank you :-)

agree

cmwilliams (X)

55 mins

-> thank you!

agree

Silvia Brandon-Pérez: This is not shelf life; it has to do with the immediate use of the contents.

1 hr

-> thank you :-)

agree

sarahjeanne (X): this is what i find on my american medications; use within 3 months after opening. i think that shelf life may be a bit ambiguous and would avoid using it.

2 hrs

-> thank you Sarah!

agree

Carol Gullidge: use within xxx of opening. There may also be an overall expiry date, after which the product becomes ineffective/dangerous

9 hrs

-> thank you Carol!

11 mins confidence:

peer agreement (net): -1

period after opening/period of use after opening

Explanation:
En los productos cosméticos (y supongo que será el mismo caso en los farmaceúticos) ahora el PAO es obligatorio en todos los productos que no sea monodosis, etc. Se utiliza PAO como abreviación bastante

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Note added at 17 mins (2006-11-22 12:30:34 GMT)
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En el caso de los cosméticos - se considera que un producto puede tener un "shelf life" de 30 meses pero una vez abierta, si se puede contaminar rapidamente, puede que un PAO de un solo mes - aunque este dentro de los 30 mese originales

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Note added at 23 mins (2006-11-22 12:37:13 GMT)
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http://pharmacos.eudra.org/F3/home.html

Reference: http://europa.eu/scadplus/leg/en/lvb/l21191.htm

Barbara Duffus
Canada
Specializes in field
Native speaker of: English
PRO pts in category: 4

28 mins confidence:

peer agreement (net): +2

options below

Explanation:
frequently on containers as: Once open use within X hours/days/months

also: Expiry date once opened

Solian Solution has an expiry of two. months once opened. Any solution ... medicines. There will be an expiry date. (month, year) on your Solian. container. ...
www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/swcsolia...$File/swcsolia.pdf

and: Discard [period of time] after opening

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Note added at 43 mins (2006-11-22 12:57:21 GMT)
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This is from the regs. for Australia and New Zealand
2. Batch Number and Expiry Date
The batch number and expiry date should be positioned together and situated preferably the
end or side panel of the package.
The batch number and expiry date should be easily legible; for example ink is preferred over
embossing. For eye preparations, and other topicals, the words “after opening use within [xx]
days” should be on the label. See TGO for mandatory requirements.

http://www.anztpa.org/label/pmbestpracticedr.pdf

Rachel Fell
United Kingdom
Local time: 12:33
Specializes in field
Native speaker of:

English
PRO pts in category: 206

28 mins confidence:

peer agreement (net): +2

Shelf-life after first opening the immediate packaging

Explanation:
From teh EMEA, which prescribes the language of SPCs etc:

6.3 Shelf life

<Shelf-life of the veterinary medicinal product as packaged for sale>

<Shelf-life after first opening the immediate packaging >

<Shelf-life after dilution or reconstitution according to directions >

<Shelf life after incorporation into meal or pelleted feed>

http://www.emea.eu.int/htms/vet/qrd/qrdplt/V01a EN SPC-II-la...

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Note added at 29 mins (2006-11-22 12:42:43 GMT)
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Read more about the templates in http://www.emea.europa.eu/htms/human/qrd/qrdplt/24530905en.p...

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Note added at 2 hrs (2006-11-22 14:43:28 GMT)
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Sorry, I mistakenly referred to the VET rather than the HUMAN meds, but the language is the same. See, for example, http://www.emea.eu.int/pdfs/human/qwp/015996en.pdf

See also No 42 in http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-...

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Note added at 2 hrs (2006-11-22 14:44:33 GMT)
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Lots more hits liDOC]
REPUBLIC OF SINGAPORE
File Format: Microsoft Word - View as HTML
(i) Shelf Life (after first opening): _________ (hours/days/months). (i) Shelf Life (after reconstitution): _________ (hours/days/months) ...
www.hsa.gov.sg/docs/DRform_checklist_effective_1Nov04.doc - Similar pages
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[DOC]
[Version 7, 06/2005] QRD TEMPLATE ANNEX I SUMMARY OF PRODUCT ...
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<Shelf life after first opening the container (where relevant)>. <Shelf life after dilution or reconstitution according to directions (where relevant)> ...
www.emea.eu.int/htms/vet/qrd/qrdplt/QRD template.doc - Similar pages
[DOC]
angliski
File Format: Microsoft Word - View as HTML
<Shelf-life after first opening the immediate packaging >. <Shelf-life after dilution or reconstitution according to directions > ...
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[PDF]
PART 1B1
File Format: PDF/Adobe Acrobat
shelf-life after first opening the container. 6.4. Special precautions for storage. The maximum (or minimum) storage temperatures should be stated in ...
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[DOC]
Note: The following sections should be completed where appropriate.
File Format: Microsoft Word - View as HTML
2.2.3.3 Proposed shelf life (after first opening container):. 2.2.3.4 Proposed shelf life (after reconstitution or dilution): ...
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shelf life after first opening the container. A clear statement of the shelf life should be given, in an appropriate unit of time. ...
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Data Sheet
Shelf-life (after first opening of container): If the container is left open, contents will evaporate. If securely reclosed, shelf-life is unaffected. ...
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www.pharma-center.kiev.ua/n220pord7_a.html - 57k - Cached - Similar pageske this:

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Note added at 2 hrs (2006-11-22 14:49:12 GMT)
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SHELF-LIFE AFTER FIRST OPENING: USE IMMEDIATELY

DF]
Nobilis OR inac, INN-Ornithobacterium rhinotracheale
File Format: PDF/Adobe Acrobat - View as HTML
Shelf life after first opening: Use immediately after opening. 6.3 Special precautions for storage. Store and transport at 2 - 8°C. Do not freeze. ...
www.emea.eu.int/vetdocs/PDFs/EPAR/NobilisorInac/V-062-PI-en... - Similar pages
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SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE VETERINARY ...
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FENTANYL 50 MICROGRAM/ML INJECTION PL 01502/0062 UKPAR TABLE OF ...
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Public Assessment Report
File Format: PDF/Adobe Acrobat - View as HTML
Shelf-life after first opening:. Use Immediately. Shelf-life after dilution: Chemical and physical in-use stability has been demonstrated for up to 48 ...
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Lia Fail (X)
Spain
Local time: 13:33
Specializes in field
Native speaker of:

English
PRO pts in category: 100

7 mins confidence:

peer agreement (net): +3

Shelf-life (after opening the packaging)

David Russell
Spain
Local time: 13:33
Specializes in field
Native speaker of:

English
PRO pts in category: 52

Grading comment

Thanks a lot!

Peer comments on this answer (and responses from the answerer)

agree

David Brown

0 min

-> Thanks David

agree

patyjs

1 min

-> Thanks Pat

agree

Romina Berardi: Indeed!

6 mins

-> Thanks Romina

disagree

Barbara Duffus: shelf life generally refers to a period after manufacture during which product may be sold and used - not once package opened

6 mins

-> Yes, but if one specifies "after opening packaging" then this confusion doesn't exist

agree

Rebecca Hendry: Concise and quite suitable!

59 mins

-> Thanks Rebecca

disagree

Ian Wrentmore: Thanks - your own FDA quote proves my point. It refers to stockpiled pills in a warehouse (P.5) where the market package remains intact (P.4). Shelf-life and 'once opened, consume within...' are clearly not the same thing.

1 hr

-> It absolutely is used for pharmaceutical products- see references above and Lia's comments below

disagree

Silvia Brandon-Pérez: Does not have to do with shelf life, but with spoilage of product once opened.

1 hr

-> Shelf-life may also refer to this

agree

Lia Fail (X): Disagree with the Disagrees. Agree with David, similar to my independently arrived at answer, but points shd be his not mine:-)

2 hrs

-> Thanks Lia, and excellent references should put argument beyond doubt!

agree

Rachel Fell: shelf-life after (reconstitution and/or) first opening of the product here: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-...

9 hrs

-> Thanks Rachel. Who would have thought the question would cause so much debate?

neutral

liz askew: i

23 hrs

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Periodo de validez (después de abrir el envase)

English translation: Shelf-life (after opening the packaging)

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