Term

approved

preferred

acceptable in PL

not to be used

Comments

Go to

acetylsalicylic acid

X

According to the case, refer to ASA in package leaflets (e.g. for interactions) as follows: "acetylsalicylic acid <a substance present in many medicines used to relieve pain and lower fever> or <a substance present in many medicines used to prevent blood clotting>". Alternatively, as appropriate, use: " acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting "

For the translations of the ASA statements in the EU official languages, plus Icelandic and Norwegian, please click

active ingredient

X

active substance

active substance

X

adolescents

X

age 12 years to 17 years (Note for guidance on clinical investigation of medicinal products in children,

adverse effects

X

undesirable effects, adverse events, adverse reactions

adverse reactions

X

is to be used where there is a causal relationship with the use the medicinal product

undesirable effects, adverse events, adverse reactions

adverse events

X

is to be used where it occurs during the use of the medicinal product but its causal relationship is not yet established. Note that adverse events without at least a suspected causal relationship should not be listed in the SPC.

undesirable effects, adverse events, adverse reactions

aspirin

X

acetylsalicylic acid

breast-feeding

X

children

X

age 2 years to 11 years (Note for guidance on clinical investigation of medicinal products in children,

children, young

X

see Note for guidance on clinical investigation of medicinal products in children, CPMP/EWP/462/97.

children, infants and toddlers (depending on age)

clinical studies

X

correct term, if chosen must be used consistently throughout text without alternating with "clinical trials".

clinical trials

X

correct term, if chosen must be used consistently throughout text without alternating with "clinical studies".

dextrose

X

Not in Ph. Eur.

glucose

dosage

X

to be used in package leaflets instead of "posology".

posology

drug

X

active substance; medicinal product

drug substance

X

active substance; medicinal product

excipients

X

to be used in SPC. In PL: "other ingredients" is accepted.

other ingredients

expiration

X

expiry, expiry date

expiry

X

expiry date

X

formulation

X

medicinal product

glucose

X

Ph. Eur.

health experts

X

Reference to "health experts" generally means "best medical practice". It is advised to use the wording "It is recommended

HIV

X

HIV negative

HIV associated

X

should not be hyphenised, as a hyphen at the end of a line can be mistaken for a negative sign.

HIV infected

X

HIV positive

HIV negative

X

HIV positive

X

HIV+

X

HIV infected/HIV positive

HIV-infected

X

the hyphen at the end of a line can be mistaken for a negative

HIV infected

inactive ingredient

X

"excipients" in SPC, "other ingredients" in PL

inactive substance

X

"excipients" in SPC, "other ingredients" in PL

infants and toddlers

X

age 28 days to 23 months (Note for guidance on clinical investigation of medicinal products in children,

intramuscular route

X

intramuscular use

intramuscular use

X

"Standard Terms" published by the Council of Europe.

intravenous

X

intravenous route

X

intravenous use

intravenous use

X

"Standard Terms" published by the Council of Europe.

lactating mothers

X

nursing mothers

medication

X

medicinal product

medicinal product

X

medicine

X

medicinal product

nursing mothers

X

other ingredients

X

to be used in package leaflet. In SPC use "excipients".

excipients

overdose

X

overdosage

X

overdose

pack size

X

posology

X

to be used in SPC. In package use "dosage".

presentation

X

ambiguous can mean "pack size" or "pharmaceutical form"

pack size

pre-term new-born infants

X

<36 weeks of gestation (Note for guidance on clinical investigation of medicinal products in children,

rash

X

Is sometimes left in EN in translations. Preferred terms in all languages must be established.

Radio-active medicinal product

X

Radiopharmaceuticals

Radiopharmaceuticals

X

saline

X

sodium chloride solution

side effects

X

for use in PL or labelling only.

undesirable effects, adverse reactions

sodium chloride solution

X

specify concentration, e.g. "sodium chloride 9 mg/ml (0.9%) solution for injection"

subcutaneous use

X

"Standard Terms" published by the Council of Europe.

new-born infants

X

age 0-27 days (Note for guidance on clinical investigation of medicinal products in children, CPMP/EWP/462/97)

Keys

approved

preferred

acceptable in PL

not to be used

Definitions

Approved

X

Terms used in legislation and templates, or originating from other official sources

Preferred

X

Terms which cannot be traced to a specific source, but which the group understands to constitute "good practice" and prefers to any other of the same meaning

Acceptable in PL

X

Terms considered to be correctly used in Package Leaflet (which requires "patient-friendly" terms). Such terms are accompanied by a "Go to" reference to the approved term

Not to be used

X

Terms which the group deems unsuitable for use because misleading, unclear, obsolete or for other reasons. The "Go to" reference always leads to the approved term.