Collocational patterns vary within and among languages and represent one of the greatest challenges for translators. The ability to recognise the tendency for certain word combinations to co-occur in a given language is required to successfully understand and transfer lexical meaning and communicative purpose. It is essential to be able to recognise patterns of collocation in one’s native language prior to addressing collocational issues in translation.

“The tendency of lexemes to work together in predictable ways is known as collocation”. (Crystal, 2005, p. 194). Collocation refers to the degree of predicatability with which certain words occur together in any language. For instance, ‘severe stomach pain’ cannot be translated in Italian as ‘dolore severo allo stomaco’ but is commonly known as ‘intenso dolore addominale’. Likewise, it would be inappropriate to translate ‘effetti collaterali’ into English as ‘collateral effects’ since these are conventionally referred to as ‘side effects’ or ‘adverse/undesired effects’ in medical texts.

In this article I will touch on cross-cultural aspects characterising language for specific purposes (LSP) and briefly outline collocational features, collocative meaning, textuality and register. I will then examine collocations, word combinations and sequences typically found in patient information leaflets (PILs) used as the mode to impart specific consumer medicine information, referring particularly to 2 Italian texts: ZIMOX 250 mg/5 ml suspension and MACLADIN® J01FA09 Claritromicina. These drugs belong to two different groups of antibiotics, penicillin and clarithromycin respectively, and are both used to treat a range of bacterial infections in children. They may be obtained via prescription, although in Italy they are also easily available as over the counter (OTC) medication. For the purposes of comparison I will also draw on a similar English PIL exemplar for AUGMENTIN DUO 400 suspension for pediatric use, belonging to the penicillin group of antibiotics. Particular attention will be given to different types of collocation and recurring terminology. All selected lexical units will be organised into three broad categories: specific medical terms which are a feature of specialised language and which provide the most elements for discussion, semi-technical terms used frequently in medical language, and general terms normally found in association with such texts. After identifying functional examples in each category, I shall discuss the nature of the challenges arising from the most significant collocational patterns. Finally an overview of regulatory aspects is offered to illustrate the legal background for PILs.

Cross-cultural aspects
As showed by Cacchiani (2006, p. 28) in her contrastive analysis of Italian and English PILs, the implications for the translator are great when faced with linguistic, cultural and social discrepancies between the two languages. She introduces the notion of adequacy in translation and in particular stresses that:

[...] functionally adequate translations are coherent with the target
language audience and conventions and meet the communicative
purpose for which they are needed. In the case of PILs, it can be
argued that the well being of the patient justifies adjustments to
stylistic and terminological conventions of the target language.

LSP
This cross-cultural divergence is also considered intrinsic to LSP, a branch of applied linguistics concerned with language as used in specific fields in relation to genre, style and technical lexis. LSP phraseology is the study of specialised (technical/scientific/medical) terminology based on collocation content and recurring word combinations (Méndez-Cendón, 2009). In her paper on genre and LSP translation, Scarpa (1999, p. 315) maintains that:

If successful translation is intercultural communication taking place,
it is of paramount importance that the LSP translator recognizes not only
these recurrent patterns in the source text but also the regular discontinuties between source and target text that reflect shifts in
users’expectations across different cultures.

Although unusual or novel collocations are certainly possible in many text types, the scope for arbitrary collocations in PILs is clearly limited due to requirements of consistency and legibility. The collocational range of compatible words is also restricted due to the high frequency with which certain semantic and syntactic connections co-occur. Moreover, the collocational spectrum may be narrowed down by selectional restrictions, depending on whether words collocate between sentient or non-sentient entities (Baker, 2011, p. 13). Accordingly, the adjective ‘cronica’ [chronic] is used to refer to a specific disease/infection/condition and not to a patient.

Lexical collocation and grammatical colligation
The concept of collocation embraces lexical collocation and grammatical colligation. The first is related to the co-occurrence of lexical items, such as ‘agitare bene’ or ‘agitare prima di ogni uso’ to indicate that a given product or suspension should be shaken well before measuring out the dose to be administered. The second implies the relationship between words within a grammatical pattern and the likelihood of their co-occurring in a text, as in the case of the verb ‘inibito’ followed by the preposition ‘da’ [inhibited by] or the verb ‘inteferire’ linked to the preposition ‘con’ [interfere with].

Textuality
Collocation is also related to textuality since the recursive combination of certain words is connected to the topic discussed within the text. According to Halliday and Matthiessen, the textual metafunction is relevant to the context (2004, p. 61). This implies that the PILs under scrutiny may be expected to contain medical, pharmaceutical and health-related terminology, and a successful identification and understanding of all collocations is essential to further aid the patient/reader’s interpretation of the text.

Register
It is crucial to bear in mind that register plays a key role in collocational patterns and may be problematic in translation. Halliday and Matthiessen (2004, p. 577) suggest that:

“[...] collocations are often fairly specifically associated with one
or another particular register, or functional variety of the language.
This is true, of course, of individual lexical items, many of which
we regard as ‘technical’ because they appear exclusively, or almost
exclusively, in one kind of text”.

Whereas collocations such as ‘indicazioni terapuetiche’ may appear naturally in Italian PILs, where

it is assumed that the user is familiar with specific terminology, an English target audience (TA)

would not be comfortable with ‘therapeutic compliance’ or ‘indications for therapy’, therefore the

translator needs to resort to a different approach to meet readership expectations. According to

Community guidelines and to the UK guideline on readability: “Always Read the Leaflet – getting

the best information with every medicine” published by the Medicines and Healthcare products

Regulatory Agency (MHRA), PILs should be made more usable to promote an improved

understanding of patient information. This may be achieved by adopting a more informal register

and formulating sentences in an active and direct style via rhetorical questions such as: ‘what is

XXX used for?’ as in the English sample.

Collocative meaning
Collocative meaning defines the meaning which certain words acquire by co-occurrence and regular association. For instance, the word ‘assunzione’ by itself may mean assumption or acceptance, but when it collocates with ‘concomitante’, it takes on the meaning of concurrent intake or consumption, thus referring to combined therapy in which drugs are used in conjunction with other medicines. It follows that “what a word means often depends on its association with certain collocates” (Baker, 2011, p. 57). Failure to acknowledge the way collocations behave within a text of a technical nature such as a PIL may have a negative impact on the translation process. In this genre the onus is on the safe and appropriate use of drugs, therefore the misinterpretation of collocations relating to risk communication or side effects could affect product usage.

PIL headings
It may be observed that Italian PILs are mostly written in very small print with few or no images/diagrams/dosage tables. As stated by AIFA, The Italian Medicines Agency, (‘Il foglio illustrativo’), the standard format more or less always contains a number of section headings which may be broadly classified as collocations in their own right. These include ‘categoria farmaceutica’, stating what group of medicines a drug belongs to; ‘indicazioni terapeutiche’, which illustrates what the drug is and what it is used for; ‘controindicazioni’, which explains all possible adverse reactions; ‘precauzioni per l’uso’, which lists all special precautions required for use; ‘interazioni’, which indicates any potential overlapping interactions with other drugs, food or alcohol; ‘avvertenze speciali’, which includes special warnings related to possible risks, prolonged treatment, use during pregnancy and breast-feeding; ‘dose, modo e tempo di somministrazione’ or ‘posologia’, which refer to the dosage to be administered; ‘sovradosaggio’, which suggests the appropriate guidelines to be followed in the event of an overdose; ‘effetti indesiderati’, which defines any potential side-effects; ‘scadenza e conservazione’, which refers to storage and product expiry date; ‘composizione’, which describes the ingredients contained in the medication; ‘forma farmaceutica e contenuto’, which specifies in what form the drug is manufactured (capsules, tablets, suppositories, suspension and so on); ‘produttore’ and/or ‘titolare dell’autorizzazione all’immissione in commercio’, which indicate the pharmaceutical manufacturers and suppliers. These headings introduce specific passages and content elements and indicate the order in which the topics appear, therefore their conventional wording is all-important in translation in order to meet precise user expectations on the structure of the package insert.

Corpus
So what collocations may be defined as conventional in this genre? Which word combinations are typical in Italian PILs? How is medical terminology relayed in English PILs? Are verbs collocational factors in medical writing? To what extent are collocations a challenge in PIL translation? In order to answer these questions, a small corpus of 3 PILs is analysed. On parallel examination of the selected MACLADIN and ZIMOX Italian PILs, similar patterns can be seen emerging, therefore all findings are identified, aggregated and reported jointly. Reference to the AUGMENTIN (R) DUO English PIL is pivotal in order to grasp the inherent differences and the degree of dis/similarity across the genres in their respective languages.

Specific medical terms
The sections entitled ‘controindicazioni’ and ‘effetti indesiderati’ yield a variety of specialised medical terminology in both Italian PILs. For example, ‘mononucleosi infettiva’ is a widespread concept and is extremely culture-specific in Italy (Baker, 2011, pp. 63-64), where most children are inoculated against this disease in spite of the corresponding vaccination being optional. It is best known to Engish-speaking laypersons as ‘glandular fever’ and is only referred to as ‘mononucleosis’ between brackets in the English PIL. Among a wealth of listed side-effects, ‘alterazioni del gusto’ is a common collocation translated plainly in the English sample as ‘abnormal taste’ rather than ‘alteration of taste’, which would be more appropriate in a clinical trial or a medical case report. On the basis of legislative requirements, it is felt that since PILs are aimed at a wide audience, providing over-technical information would result in a loss of user attention.

Baker mentions a tension between accuracy and naturalness when making translation choices and explains that “the nearest acceptable collocation in the target language will often involve some change in meaning” (2011, p. 60). Two examples are given by the following word sequences frequently found in several Italian PILs: ‘pazienti con insufficienza epatica grave’ and ‘soggetti con insufficienza renale di grado moderato o severo’. The first lexical unit may be translated as ‘patients suffering from severe (not grave) hepatic impairment/liver failure’, and the main drawback in this instance lies in the failure to acknowledge ‘grave’ as a false friend, since this lexical item is not a cognate and cannot overlap in the source language (SL) and in the target language (TL) alike. It is common for translators to encounter similar pitfalls stemming from the interference with their native tongue. Baker defines this as “misinterpreting the meaning of a source-language collocation” (2011, p. 59), which leads translators to naturally assume that the collocational mapping of certain terms is possible between the SL and the TL. The second word combination could be translated either as ‘moderate to severe chronic kidney disease’ (known as CKD) or ‘acute renal failure’ (known as ARF) depending on the reversibility of the disease itself, and would normally appear in articles on life sciences and bio/medical research or in any other scientific and academic publishing. However, since English PILs aim to be readily accessible, these two collocation issues may be sidestepped and simplified as ‘patients with liver or kidney problems’, as per the English sample. This solution is preferable not because of a lack of acceptable collocations in English, but because in English PILs a more informal style is mandatory.

The ‘avvertenze speciali’ and ‘precauzioni per l’uso’ sections of the examined Italian PILs provide several examples of co-occurring word combinations in Italian, many of which also have synonyms or corresponding explanations in English. For example, ‘episodi di diarrea’ can be translated simply as ‘diarrhoea’ or expanded as ‘several loose bowel movements per day’, if an additional explanation is required, and ‘candidosi orale o vaginale’ is known by its scientific name as ‘oral or vaginal candidasis’, although it is normally referred to as ‘thrush’ or ‘yeast infection’. Another indicative example is ‘disturbi gastro-intestinali’, which is converted to a more generic ‘pain in the stomach’ in the English PIL, since expounding on digestive diseases or gastrointestinal disorders is considered incompatible with this genre. The English PIL is less alienating and detached than its Italian counterpart and tends to establish greater contact with the user, therefore in this case the translator may safely opt for the less learned word associations in the TL.

Marked collocations
According to Baker, “unusual combinations of words are sometimes used in the source text in order to create new images” (2011, p. 65). This concept introduces the feature of marked collocations, through which the source text (ST) communicates an unusual image or element to the target text (TT) reader. An interesting example of this is provided by etymologically hybrid combinations such as ‘rash cutaneo’. This particular collocation is currently favoured in Italy over more universally acknowledged word associations such as ‘irritazioni cutanee/dermatologiche’ implying an allergic reaction and itching. It also succeeds in drawing attention to the fact that the first term is of English derivation and of relatively recent usage in Italian medical writing. This collocation is translated as ‘rash’ or ‘skin rash’ in the English PIL. It is easy to see how similar problems might arise in the translation of anglicisms adopted in Italian PILs including the eponyms ‘test di Coombs’ and ‘sindrome di Stevens-Johnson’ which may have eponymic equivalents or acronyms in the TL, or ‘efflux transporter’ and ‘steady state’, which require more in-depth investigation prior to assessing whether they should remain identical in translation or fall into different collocational patterns. Given that laypersons are unacquainted with such collocations, these are virtually absent in the English PIL genre.


Use of Latin in PILs
It is perhaps worth dwelling on the habitual use of Latin in Italian PILs. It is not uncommon for example, to come across ‘per os’, literally meaning by mouth and indicating that a certain drug must be taken orally. The selected exemplars are no exception to this rule. Apart from two italicised examples referring to specific bacteria, namely ‘clostridium difficile’ and ‘helicobacter pylori’ which would remain unaltered in translation, the Latin collocation ‘die’ deserves to be further explored. The latter may be found in association with dosage information and precisely with the exact quantity to be administered according to weight and frequency of administration. It is still very much in use in Italian PILs and means ‘daily dosage’ or ‘dose per day’. The potential challenge facing the translator lies in debating whether to preserve the Latin in the TL, by verifying to what extent this practice is followed in the TL genre, or again aim for the reader/patient’s ease of understanding. As regards dosage administration, the English sample examined advises how often the suspension must be taken and indicates that the dose may vary depending on the child’s weight, according to more basic instructions.

Verbs and collocation
Italian PILs tend to reduce the amount of verb tenses and moods to a minimum and the third person singular of the indicative mood usually prevails. It is possible to observe frequent impersonal verb forms and reflexive passives such as ‘si consiglia di’ [it is recommended], ‘si può riscontrare’ [XXX may occur/arise], ‘si può notare’ [it may be noticed/observed that]. A restricted number of recurring verbs is preferred including ‘causare’ [to cause], ‘segnalare’ [to report], ‘avvertire’ [to warn], ‘assumere’ [to take], ‘usare’ [to use], ‘eseguire’ [to carry out], ‘preparare’ [to prepare], which are usually nominalised by resorting to ellipsis. For instance ‘la preparazione della sospensione’ is used instead of ‘per preparare la sospensione’ to indicate how to go about preparing the suspension to be administered. The greatest translational issue in nominalisation lies in preserving the thematic patterning of the SL in the TL genre. This preamble is necessary to better understand how verbs work in this genre and in what way they collocate. Generally speaking, in Italian PILs precautions are adopted (‘devono essere adottate precauzioni’), interactions are observed (‘sono state osservate interazioni con’), cases are reported and observed (‘sono stati segnalati/osservati/riferiti casi’), clinical studies show or highlight evidence (‘gli studi clinici hanno mostrato/dimostrato/evidenziato’), and a drug may cause or bring about undesired effects (‘come tutti i medicinali, XXX può causare/provocare effetti indesiderati’). With reference to the compared exemplars, the treatment or dosage are changed in English whereas in Italian medical writing these are modified (‘modificare la terapia’). Likewise the English PIL advises not to stop giving the medication or not to give any more when referring to therapy discontinuation, whereas in the Italian sample treatment is interrupted or suspended, not stopped or discontinued (‘interruzione/sospensione del trattamento’).

‘Natural’ vs ‘unnatural’ usage
Gibson (2011, ‘Translating for health: How far do we take ‘faithful translations?’) argues that words which combine naturally vary from one language to another and questions whether certain terms may be taken as natural collocates just because of some “centralised decison making”. He observes that:

In Patient Information Leaflets, we have the English ‘to take a medicine’
typically by mouth), ‘to use a medicine’ (typically a cream) or ‘to be given
medicine’ (e.g. an infusion or injection administered by a healthcare
professional or a carer). These phrases have been carried over into the
respective languages of EU Member States.

Certainly this true of Italian PILs, where such word combinations work as natural collocates and whose usage is widely endorsed by pharmaceutical companies, medical experts and the public alike. However, Scarpa (1999, p. 317) suggests that the concept of naturalness in LSP domains remains subjective and argues that:

The increasing volume of LSP translation work being undertaken is in fact
slowly but surely changing the accepted meaning of ‘anomalous usage’
in the target language, with certain imports beginning to be regarded as typical
of a certain LSP (e.g. “suggerire” for suggest in Italian medical journals).

Semi-technical terms
The second category of semi-technical terms detected in both Italian PILS embraces word associations which form customary collocations. ‘In caso di ingestione/assunzione accidentale’ [in the event of accidental ingestion/if XXX is taken by accident], ‘controlli periodici’ [regular check-ups], ‘trattamento prolungato’ [prolonged/continuing treatment] represent but a few collocations making up a stratum of subtechnical terminology based on general language which confined to medical writing takes on a more specific meaning. By cross-referencing the selected PILs, the headings ‘in caso di assunzione ad alte dosi’ or ‘sovradosaggio’ in the Italian samples correspond to the overdose instructions in the English exemplar, where the term ‘overdose’ is merely placed between brackets. This collocation is duly converted to a question in the English PIL: what do I do if I give too much? Again, by using an interrogative and a personal pronoun, a closer relationship is established with the patient/reader, possibly to encourage the latter to rely more strongly on the written information provided.

General terms
Lastly, it is possible to observe an array of general terms in the examined Italian PILs including ‘bambini’ (children), ‘granulato’ (powder) and ‘data’ (date) to cite but a few, which form collocative phrases typical of this genre: ‘tenere fuori dalla portata e dalla vista dei bambini’ (keep out of the reach and sight of children), ‘granulato per sospensione orale’ (powder for suspension) and ‘data di scadenza indicata sulla confezione’ (expiry date printed on the pack). Even the Italian translation for PIL is made up of two terms ‘foglio/foglietto’ (paper) and ‘illustrativo’ (illustrative) which are used individually in a host of general senses and which acquire an entirely different meaning when coupled with other collocates in a different context. As it is, ‘foglio/foglietto illustrativo’ is the only acceptable translation for patient information leaflet and represents the only collocation available to refer to a PIL. These collocations are not translatorial issues as such, although ultimately a sound knowledge of the topic and an awareness of the intricacies of collocational associations are indispensable to transfer even the more basic content.

Legal background
Finally, European manufacturers of medicinal products are now required to have their PILs readability-tested prior to product approval, in compliance with the ‘Guideline on the readibility of the labelling and package leaflet of medicinal products for human use’ (2009) set out by the European Commission. This means that pharmaceutical companies must meet precise readibility standards and criteria and that PILs need to adhere to the template established by the European Medicines Agency (EMEA) which is available in 25 languages, although this in itself is no guarantee of an accurate translation in any given EU language. As reported in an issue of the AIFA newsletter (‘bollettino d’informazione sui farmaci’, 2004, p. 51), it is possible to find 2 PIL types in Italy. Most drugs are currently approved by the Ministero della Salute [Ministry of Health] and are furnished with product instructions formally drawn up by a network of medical experts according to pharmacovigilance guidelines. This is why Italian PILs are still not entirely user-friendly and, as shown in my analysis concentrating on collocational aspects in this genre, a grasp of scientific terminology is mostly taken for granted. However, as stated by AIFA, a small number of centrally approved drugs is already complemented by package inserts approved by EMEA, which are more user-orientated and legible. These PILs have started to accommodate the new legal framework, which in turn implies a higher match in design and layout, print, font, use of symbols and pictograms and inevitably in relation to style, syntax and collocation across PILs in different languages. Wherever possible passivisation is reduced to a minimum as a more direct approach is ensured via active verb forms. Such adjustments entail a more consistent patterning across languages and, as a result, fewer shifts in translation are likely to take place. This is not to say that validating procedures automatically strip PILs of all their culture-specific and collocational content, since this text-type requires particular emphasis in transmitting comprehensible information, especially via well-established linguistic configurations and word combinations which vary across languages and which may be distorted or manipulated only to a certain degree. Culture-specific lexical items will continue to be problematic for translators, due to the challenge of identifying how these items collocate within distinctive lexical patterns in the languages involved prior to carrying out their translation task. Nevertheless, translators should be aware that in this genre the main focus is always on the patient and on the safe and effective use of the medicinal product, and this priority should be reflected in the judicious use of language.


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