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German to English translations [PRO] Medical - Medical: Pharmaceuticals / Drug side effects
German term or phrase:PT-Gesichtsödem
This is one of the side effects of cisplatin. Can't seen to find out what PT stands for. I tried everything plausible that the https://www.medizinische-abkuerzungen.de site suggested but to no avail: perkutanes, partielles, post transfusionem...
Symptome die für anaphylaktoide Reaktionen berichtet wurden wie Gesichtsödem (PT-Gesichtsödem), Giemen, Bronchospasmus, Tachykardie und Hypotonie
Explanation: I agree with Steffen about PT = Platin/platinum, even though no references can be found for "Platin-Gesichtsödem" or the like.
In the first place, however, "PT-Gesichtsödem" seems to be copied from the Cisplatin Fachinformation which in turn adopted "PT-Gesichtsödem" as a literal translation from the English summary of product characteristics ("PT–facial edema"), since the English SmPC is usually the "core document" in EMA marketing authorisation procedures.
See, for example https://www.medicines.org.uk/emc/product/3788/smpc "Symptoms reported for anaphylactoid reaction such as facial oedema (PT–face oedema), wheezing, bronchospasm, tachycardia, and hypotension will be included in the parentheses for anaphylactoid reaction in the AE frequency table."
https://www.accord-healthcare.de/sites/default/files/2018-06... "Für anaphylaktoide Reaktionen berichtete Symptome wie Gesichtsödem (PT-Gesichtsödem), pfeifendes Atmen, Bronchospasmus, Tachykardie und Hypotension werden in der UAW-Häufigkeitstabelle in Klammern für anaphylaktoide Reaktionen angegeben."
Marcus, if you can't ask the client and are not sure but want to use PT, I'd recommend you stick to face, not facial (o)edema, as it is the preferred term and it shows up like this at the link Anne posted.
In any case, I'd seriously consider dropping the hyphen--unless you know someone whose edema was caused by their platinum face (1st option w/ hyphen) or a beauty treatment ("facial" option w/ hyphen).
Stammt von 2016 und dort steht nichts in Klammern; USA hat MedDRA seit ca. 2018, wenn ich das richtig las; Kanada keine Ahnung.
Ich bin nun kein Medizinübersetzer und halte ich bei solchen Fragen normalerweise raus. Im juristischen Sinne, um den es im Endeffekt bei solchen Angaben geht, sehe ich allerdings keinerlei Nutzen darin, eine Nebenwirkung so in der Klassifikation zu beschränken, gerade in Nordamerika, wo doch noch mehr Leute als in Deutschland klagen =)
Vielleicht stand "PT" tatsächlich mal für "preferred term" in einem anderen englischen (Studien)Dokument und wurde einfach in diese Liste (wo es keinen Sinn ergibt) und dann wiederum einfach ins Deutsche übernommen (wo es ebenfalls keinen Sinn ergibt). Vielleicht kann man das einfach weglassen? Ich würde den Kunden fragen.
I understand that. Rather, my point was why "Giemen, Bronchospasmus, Tachykardie und Hypotonie" were all not caused by the platinum or nor exclusively, given the fact that it says "anaphylaktoid," which is a "nonimmunologic anaphylaxis": https://www.worldallergy.org/ask-the-expert/questions/anaphy...
In this case, all of the adverse effects described must be related to cisplatinum, no?
And even though I get your point, I don't understand Anne's or Marga's reasoning. If this is indeed platinum-induced (which is what I'd prefer as a term; I don't know what a platinum face edema is supposed to be), the question remains why, from all those anaphylactoid reactions to a platinum derivative, the edema is the only one for which PT is added. To me, this makes it as plausible as the other suggestion, as facial edema was the term used but face (o)edema is the standard MedDRA term. Maybe someone should call the manufacturer =)
The English of the whole paragraph you quoted doesn't make much sense to me ;-)
The jury's still out on this question, though - I'm not sure either what PT (hyphenated) means here. The MedDRA reference/interpretation (PT = preferred term) may or may not be applicable in this case.
I just found a report from the National Vaccine Information Center in the US: "She still has some residual facial edema, and not sure if the rash are Rosacea (preferred term: Rosacea). The outcome of the events not sure if the rash are rosacea, facial edema and with worsening rash on face was unknown. The events not sure if the rash are rosacea, facial edema and with worsening rash were considered serious with seriousness criteria of important medical event." http://www.medalerts.org/vaersdb/findfield.php?EVENTS=on&PAG...
Not that this makes much sense to me, but they seem to repeat the same term if necessary. What does look odd, though, I agree, is that there's a hyphen between both words (in German) and that they only use PT for one of these adverse effects.
Why would they add "PT" in this sense just after "Gesichtsödem", and not after one or more of the other terms? Does "PT" (or rather "Pt") perhaps just stand for "platinum"? Platinum-induced facial (o)edema?
As far as I can tell, PT is a MedDRA-derived term. From Australia: "The term used to describe an adverse event in the Database of Adverse Event Notifications - medicines is the MedDRA 'preferred term', which describes a single medical concept.
Each MedDRA system organ class has a number of MedDRA preferred terms associated with it. For example, the system organ class 'cardiac disorders' includes (among others) the following preferred terms:
From what I've found, the use of MedDRA terminology is mandatory in Europe and Japan and I think it's required in the States now, too. Not sure about Canada. What you could do is put "MedDRA preferred term" in parenthesis and use face edema, or oedema (two MedDRA entries, it seems), as Kim suggested (can't be 100% sure, but I believe it's correct).
ya I think you're right Björn. It just seems tautological to write "preferred term" in the parentheses when "facial edema" is already mentioned earlier, or I could just simply write:
"Symptoms reported for anaphylactoid reactions such as facial edema (preferred term), wheezing, bronchospasm, tachycardia and hypotension"
Here's another drug manual (not the same you're translating but close): "Für anaphylaktoide Reaktionen berichtete Symptome wie Gesichtsödem (PT-Gesichtsödem), pfeifendes Atmen, Bronchospasmus, Tachykardie und Hypotension werden in der UAW-Häufigkeitstabelle in Klammern für anaphylaktoide Reaktionen angegeben." https://www.accord-healthcare.de/sites/default/files/2018-06...
On p. 6, it says: "Sensitivity reactions can include anaphylactoid reactions consisting of facial edema, flushing, wheezing or respiratory difficulties, tachycardia, and hypotension"
Seems you don't need it; if "facial edema" is good enough for the British Columbian government, it should be good enough for this manual.
Explanation: I agree with Steffen about PT = Platin/platinum, even though no references can be found for "Platin-Gesichtsödem" or the like.
In the first place, however, "PT-Gesichtsödem" seems to be copied from the Cisplatin Fachinformation which in turn adopted "PT-Gesichtsödem" as a literal translation from the English summary of product characteristics ("PT–facial edema"), since the English SmPC is usually the "core document" in EMA marketing authorisation procedures.
See, for example https://www.medicines.org.uk/emc/product/3788/smpc "Symptoms reported for anaphylactoid reaction such as facial oedema (PT–face oedema), wheezing, bronchospasm, tachycardia, and hypotension will be included in the parentheses for anaphylactoid reaction in the AE frequency table."
https://www.accord-healthcare.de/sites/default/files/2018-06... "Für anaphylaktoide Reaktionen berichtete Symptome wie Gesichtsödem (PT-Gesichtsödem), pfeifendes Atmen, Bronchospasmus, Tachykardie und Hypotension werden in der UAW-Häufigkeitstabelle in Klammern für anaphylaktoide Reaktionen angegeben."
Anne Schulz Germany Local time: 13:43 Specializes in field Native speaker of: German PRO pts in category: 179
Grading comment
Thank you everyone for your input! We could always rely on our Proz family for a lively elucidating debate
Notes to answerer
Asker: thanks Anne and Steffen, yes platinum is highly plausible because cisplatin contains platinum as one of its active ingredients, and my text is all about platinum side effects. I'll settle with PT-face edema since that's what you see in the literature anyway