natgillin/translations-raw huggingface dataset:
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Listen over de pågældende lægemiddelnavne fremgår af bilag I.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The CHMP gave a positive opinion on 21 September 2006 recommending the harmonisation of the SPC, labelling and package leaflet for Agopton and associated names.
De faglige konklusioner findes i bilag II og det ændrede produktresumé, etikettering og indlægsseddel i bilag III.
The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.
Europa- Kommissionen traf en afgørelse den 13. december 2006.
A Decision was issued by the European Commission on 13 December 2006.
London, 1 oktober 2007 EMEA/ CHMP/ 432352/ 2007
London, 1 October 2007 EMEA/ CHMP/ 432352/ 2007
UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 31 OM Agreal og tilknyttede navne (se bilag I)
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL FOR Agreal and associated names (see annex I)
BAGGRUNDSOPLYSNINGER *
BACKGROUND INFORMATION*
Veraliprid blev godkendt i 6 EU- medlemsstater:
Veralipride was authorised in 6 European Member States:
Belgien, Frankrig, Italien, Luxembourg og Portugal.
Belgium, France, Italy, Luxembourg and Portugal.
Den 7. september 2006, efter tilbagetrækning af veraliprid fra det spanske marked som følge af indberetninger af alvorlige bivirkninger i nervesystemet, henviste Europa- Kommissionen sagen til EMEA i henhold til artikel 31 i direktiv 2001/ 83/ EF.
On 7 September 2006, following the withdrawal of veralipride from the Spanish market due to reports of serious side effects affecting the nervous system, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/ 83/ EC.
Den udpegede rapportør og medrapportør var henholdsvis Eric Abadie og Barbara van Zwieten- Boot.
Eric Abadie and Barbara van Zwieten-Boot, respectively.
Der blev afgivet mundtlige redegørelser den 20. juni 2007.
Oral explanations were given on 20 June 2007.
På grundlag af vurderingen af de aktuelt foreliggende oplysninger og evalueringsrapporterne fra rapportørerne var CHMP af den opfattelse, at benefit/ risk- forholdet for lægemidler indeholdende veraliprid er negativt, og vedtog således en udtalelse den 19. juli 2007, hvori det anbefaledes at tilbagekalde markedsføringstilladelsen for samtlige lægemidler indeholdende veraliprid.
On 19 July 2007, based on evaluation of the currently available data and the Rapporteurs’ assessment reports, the CHMP considered that the benefit/ risk profile of veralipride-containing medicinal products is negative and therefore adopted an opinion recommending the withdrawal of the Marketing Authorisation for all medicinal products containing veralipride.
Den endelige udtalelse blev omdannet til en afgørelse truffet af Europa- Kommissionen den 1 oktober 2007.
The final opinion was converted into a Decision by the European Commission on 1 October 2007.
* Bemærkning:
* Note:
Oplysningerne i dette dokument og bilagene afspejler CHMP’ s udtalelse af 19. juli 2007.
The information given in this document and Annexes reflects the CHMP Opinion dated 19 July 2007.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, INDEHAVER AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Kapsel, hard
Capsule, hard
Sanofi- Aventis France 1- 13 Boulevard Anatole France Frankrig
Sanofi-Aventis France 1-13 Boulevard Anatole France France
Sanofi- Synthelabo S. P. A. via Messina, 38
Sanofi-Synthelabo S. P. A. via Messina, 38
Sanofi- Synthelabo, Twin Squares, Navona Building, Luxembourg
Sanofi-Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c, Luxembourg
PRT Empreendimento Lagoas Park – Edificio 7 –
PRT Empreendimento Lagoas Park - Edifício 7 -
2° e 3° Porto Salvo PT – 2740 – 244 Portugal
2º e 3º Porto Salvo PT - 2740-244 Portugal
FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR TILBAGEKALDELSE AF MARKEDSFØRINGSTILLADELSEN FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATION PRESENTED BY THE EMEA
CHMP/ 309507/ 2007 FAGLIGE KONKLUSIONER
CHMP/ 309507/ 2007 SCIENTIFIC CONCLUSIONS
Spanien tilbagekaldte derfor markedsføringstilladelsen for veraliprid den 27. juni 2005.
Spain therefore withdrew veralipride’ s marketing authorisation on 27 June 2005.
Også i visse andre EU- medlemsstater, hvor produktet er godkendt, greb tilsynsmyndighederne ind og indførte begrænsninger i produktinformationen med henblik på at mindske risikoen for bivirkninger.
Regulatory actions were also taken in some other EU Member States where the product is authorised and veralipride’ s product information was restricted with the aim to reduce the risk of patients developing side effects.
Europa- Kommissionen indledte derfor en indbringelsesprocedure den 7. september 2006 og anmodede CHMP om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for produkter indeholdende veraliprid burde opretholdes, ændres, suspenderes eller tilbagekaldes i hele EU efter vurdering af disse sikkerhedsrisici og deres betydning for benefit/ risk- vurderingen for veraliprid.
Consequently, the European Commission triggered a referral procedure on 7 September 2006 and requested the CHMP to give its opinion on whether the marketing authorisations for products containing veralipride should be maintained, varied, suspended or withdrawn across the European Union following the assessment of these safety risks their impact on the benefit/ risk assessment of veralipride.
Virkning I denne gennemgang vurderede CHMP alle de foreliggende oplysninger om sikkerheden og virkningen af veraliprid.
Efficacy In this review, the CHMP assessed all of the available information on the safety and efficacy of veralipride.
600 kvindelige patienter, hvor veraliprid blev sammenlignet med placebo, og to andre undersøgelser med tilsammen ca.
This included mainly 11 studies involving around 600 women, in which veralipride was compared with placebo, and two studies in around 100 women where it was compared with conjugated oestrogens.
(Der blev således som regel ikke angivet baseline- værdier, hvorfor fyldestgørende vurdering af den observerede bedring ikke er mulig, og hverken den statistiske signifikans eller kliniske betydning af virkningen kan kvantificeres nøjagtigt, da den statistiske plan var uklar eller helt manglede, og da beskrivelsen af resultaterne var mangelfuld.)
The benefit could be qualified as limited, however the effect size cannot be accurately quantified due to methodological deficiencies of available studies (e. g. in most cases baseline values were not stated, precluding an adequate assessment of the improvement observed; neither the statistical nor the clinical significance of this effect size could be precisely quantified, as the statistical plan was not clear or was absent; the presentation of the results was poor).
Der foreligger kun få data, der rækker ud over 3 måneder, og disse er hovedsagelig fra ikke- sammenlignende undersøgelser.
Few data are available beyond 3 months, mostly in non comparative studies.
Sikkerhed De 27 års markedsføring har givet mulighed for overvågning af sikkerhedsprofilen i lang tid.
Safety The 27-year post-marketing period offers a long period of safety profile surveillance.
Dette giver grund til reel betænkelighed, da den potentielt er alvorlig og irreversibel.
Neurological adverse events referred to extrapyramidal symptoms and particularly tardive dyskinesias have been reported with veralipride and represent a real concern due to their potential seriousness and irreversibility.
Der er imidlertid også beskrevet tilfælde af tardiv dyskinesi inden for de første 3 måneders behandling.
dyskinesia have also been reported within the first 3 months of treatment.
Veraliprid er kontraindiceret ved prolaktinafhængige tumorer som f. eks. prolaktinomer i hypofysen samt brystkræft.
Veralipride treatment is contra-indicated in patients with prolactin- dependent tumours such as pituitary gland prolactinoma and breast cancer.
Den foreslåede intermitterende behandling på 20 dage efterfulgt af en 10- dages behandlingsfri periode kan muligvis dæmpe effekten på prolaktinindholdet, men det vides ikke, om den vil få indflydelse på bivirkningsmønsteret.
The proposed intermittent treatment of 20 days, followed by a 10 day period of non-treatment, may temper this effect on the prolactin level, but it is unknown whether this measure has any effect on the adverse event pattern.
Endelig er forlænget QT- interval en klassevirkning af dopaminantagonister.
Lastly, QT-prolongation is a class-effect of dopamine-antagonists.
At der i databasen ikke findes tilfælde, der tyder på QT- forlængelse, er ikke tilstrækkeligt til at konkludere, at denne effekt ikke optræder i forbindelse med veraliprid.
The absence of cases of suggestive QT-prolongation in the database is not sufficient to conclude that this effect does not occur with veralipride.
Der blev ikke udført undersøgelser til vurdering af, om veraliprid har indvirkning på QT- intervallet.
No studies were performed to evaluate whether veralipride has an effect on QT.
Benefit/ risk- forhold På baggrund af de foreliggende kliniske data konkluderede CHMP, at de risici, der er forbundet med anvendelse af veraliprid til behandling af hedeture forbundet med menopausen, især de neurologiske reaktioner (dyskinesi, ekstrapyramidale lidelser, Parkinson- syndrom) og psykiske reaktioner (depression, angst, abstinenssyndrom), opvejer de begrænsede fordele.
Benefit/ risk In view of the available clinical data the CHMP concluded that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause, mainly the neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) outweigh the limited benefits.
I forbindelse med anvendelse af veraliprid er beskrevet tilfælde af uforudsigelig og potentielt irreversibel tardiv dyskinesi samt tidlige ekstrapyramidale symptomer, depression, angst og abstinenssyndrom; sammen med risikoen for hyperprolaktinæmi og for QT- forlængelse, der er en klasseeffekt, findes disse risici at give anledning til betænkelighed.
Cases of not predictable and potentially irreversible tardive dyskinesia, as well as early extrapyramidal symptoms, depression, anxiety and withdrawal reactions have been reported with veralipride treatment; these risks together with the risk of hyperprolactinemia, and the class effect risk on QT- prolongation are considered a concern.
CHMP noterede sig de forslag til begrænsning af sådanne risici, der var stillet af indehaveren af markedsføringstilladelsen, og hvoraf nogle allerede var indført i nogle stater, således:
The CHMP took note of the MAH’ s proposals, some of which had already been introduced in some countries, in an effort to limit these risks like:
- Indskrænkning af behandlingsvarigheden til 3 måneder kombineret med undersøgelse en gang om måneden med henblik på at begrænse psykiske og neurologiske bivirkninger.
-Restriction of the treatment duration to 3 months in combination with monthly examination in an effort to limit the psychiatric and neurological adverse events.
- Indførelse af kontraindikationerne Parkinsons sygdom og kombination med andre neuroleptika og dopaminagonister.
-Introduction of the contraindications in patients with Parkinson’ s disease, or in combination with other neuroleptics and dopaminergic agonists.
- Indførelse af advarsler om neuroleptikas klassevirkninger (malignt neuroleptikasyndrom, QT - forlængelse, tardiv dyskinesi) og abstinenssymptomer som angst og depressivt syndrom.
-Introduction of warnings regarding class effects of neuroleptic medicines (neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia) and withdrawal symptoms such as anxiety and depressive syndrome.
- Anbefalinger om lægelig overvågning af brysterne og intermitterende doseringsplan (20 dage efterfulgt af 10 dage uden behandling) for at mindske risikoen for hyperprolaktinæmi med henblik på at øge sikkerheden for brysterne (det vides dog ikke, om denne foranstaltning har nogen virkning på det iagttagne bivirkningsmønster knyttet til hyperprolaktinæmi, således mammahypertrofi, galaktorré og risici for patienter med prolaktinafhængige tumorer som f. eks. hypofyse- prolaktinom og brystcancer).
-Recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10- day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breast safety (however, it is unknown whether this measure has any effect on the observed adverse event pattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).
CHMP konkluderede derfor den 19. juli 2007, at benefit/ risk- forholdet for lægemidler indeholdende veraliprid ikke er gunstigt under normale anvendelsesbetingelser.
The CHMP therefore concluded on 19 July 2007 that the benefit/ risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
• udvalget behandlede indbringelsen i henhold til artikel 31 i Rådets direktiv 2001/ 83/ EF, med senere ændringer, for lægemidler indeholdende veraliprid • udvalget fandt, at de forelagte data kun viser begrænset virkning af veraliprid til behandling af hedeture knyttet til menopausen • udvalget tog i betragtning, at der i forbindelse med anvendelse af veraliprid er beskrevet neurologiske reaktioner (dyskinesi, ekstrapyramidale lidelser, Parkinson- syndrom) og psykiske reaktioner (depression, angst, abstinenssyndrom), herunder potentielt irreversibel tardiv dyskinesi.
• The Committee considered the referral made under article 31 of Directive 2001/ 83/ EC, as amended, for medicinal products containing veralipride • The Committee considered that veralipride containing medicinal products only showed limited efficacy in the treatment of hot flushes associated with the menopause; • The Committee considered that neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) have been reported with veralipride, including tardive dyskinesia which may be potentially irreversible.
Også hyperprolaktinæmi og risikoen for QT- forlængelse giver anledning til betænkelighed • udvalget konkluderede på baggrund af de foreliggende data, at risiciene ved anvendelse af veraliprid til behandling af hedeture i forbindelse med menopausen opvejer de begrænsede fordele.
In addition, hyperprolactinemia and the risk of QT prolongation are also concerns; • The Committee concluded, in view of available data, that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause outweigh the limited benefits.
Udvalget tog desuden i betragtning, at de foreslåede tiltag til risikominimering ikke gør det muligt at mindske risiciene til et acceptabelt niveau eller forudsige, hvilke kvinder, der kan være udsat for risiko • CHMP konkluderede derfor, at benefit/ risk- forholdet for lægemidler indeholdende veraliprid ikke er gunstigt under normale anvendelsesbetingelser
In addition, the Committee considered that the proposed risk minimisation activities were not able to reduce the risks to an acceptable level or predict which women may be at risk; • The Committee, as a consequence, concluded that the benefit/ risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
anbefalede CHMP tilbagekaldelse af markedsføringstilladelserne for de i bilag I omhandlede lægemidler indeholdende veraliprid.
The CHMP has recommended the withdrawal of the Marketing Authorisations for the medicinal products containing veralipride referred to in Annex I.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM( ER), STYRKE( R), INDGIVELSESVEJ( E), ANSØGER( E), INDEHAVER( E) AF MARKEDSFØRINGSTILLADELSE( R) I MEDLEMSSTATERNE Medlemsstat
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Indehaver af markedsføringstilladelse >
Marketing Authorisation
Ansøger
Route of
Særnavn Navn
Member State
Lægemiddelform
Applicant
HEXAL A/ S Kanalholmen 8- 12, 2650 Hvidovre, Denmark
HEXAL A/ S Kanalholmen 8-12, 2650 Hvidovre, Denmark
Alendronat HEXAL 10 mg
Alendronat HEXAL
10 mg per tablet
10 mg per tablet
Alendronate Sandoz 10 mg 10 mg tabletten
Alendronate Sandoz 10mg tabletten
Alendonicht 10 mg
Alendonicht
Forosa10 mg 10 mg
Forosa
2 BILAG II
2 ANNEX II
FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRING AF PRODUKTRESUMÉET, ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
3 FAGLIGE KONKLUSIONER
3 SCIENTIFIC CONCLUSIONS
Osteoporose siges at være til stede, når rygsøjlens eller hoftens knoglemineraltæthed er 2, 5 standardafvigelser under gennemsnitsværdien for en normal ung population, eller når der har været et foregående osteoporotisk brud uanset knoglemineraltætheden.
Osteoporosis is defined as bone mineral density (BMD) of the spine or hip 2.5 standard deviations below the mean value of a normal young population or as a previous fragility fracture, irrespective of bone mineral density.
Ansøgeren blev anmodet om nærmere at underbygge den brede indikation "behandling af osteoporose hos mænd" for Alendronat HEXAL.
The applicant was asked to further justify the broad indication “ treatment of osteoporosis in men” for Alendronate HEXAL.
Der er imidlertid ikke påvist virkning på ikke- vertebrale frakturer i denne population.
An effect on non- vertebral fractures has nonetheless not been demonstrated in this population.
- den af ansøgeren forelagte litteratur dokumenterer, at 10 mg dagligt kan øge
- the literature provided by the applicant provide evidence that 10 mg daily could increase bone
mineraltætheden både i vertebrae og i andre knogler hos mænd med primær osteoporose
mineral density both at vertebral as well as non vertebral level in men with primary osteoporosis,
- virkning på ikke- vertebrale frakturer er imidlertid ikke påvist i denne population
- an effect on non-vertebral fractures has nonetheless not been demonstrated in this population.
anbefalede CHMP følgende indikation, der er i overensstemmelse med retningslinjen for vurdering af lægemidler til behandling af primær osteoporose (CHMP/ EWP/ 552/ 95 Rev. 2):
The CHMP has recommended the following indication, which is in accordance with the guideline on the evaluation of medicinal products in the treatment of primary osteoporosis (CHMP/ EWP/ 552/ 95 Rev.2)
"Behandling af osteoporose hos mænd med forhøjet risiko for frakturer.
“ Treatment of osteoporosis in men at increased risk of fracture.
Reduktion af frakturincidensen er påvist for vertebrale frakturer, men ikke for ikke- vertebrale frakturer ".
A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated .”
4 BILAG III
4 ANNEX III
5 PRODUKTRESUME
5 SUMMARY OF PRODUCT CHARACTERISTICS
Alendronat HEXAL og tilhørende navne (Se bilag I) 10 mg tabletter
Alendronate HEXAL and associated names (see Annex I) 10 mg tablets
Hver tablet indeholder 10 mg alendronsyre (som natriumalendronattrihydrat)
Each tablet contains 10mg alendronic acid (as sodium alendronate trihydrate).
103, 95 mg laktosemonohydrat per tablet.
103.95 mg lactose monohydrate per tablet
Hvid til råhvid, kapselformet tablet præget med "AN10" på den ene side og "Arrow- logo" på den anden side.
Tablet White to off-white, capsule-shaped tablet, embossed "AN 10" on one side and "Arrow logo" on the other.
Alendronat mindsker risikoen for vertebral - og hoftefrakturer.
Alendronate reduces the risk of vertebral and hip fractures.
Postmenopausal osteoporose:
Post-menopausal osteoporosis:
Den anbefalede dosis er 10 mg en gang dagligt.
The recommended dosage is 10 mg once daily.
Osteoporose hos mænd:
Osteoporosis in men:
Glukokortikoidudløst osteroporose:
Glucocorticoid-induced osteoporosis:
Alendronat HEXAL- tabletterne skal indtages fastende med postevand umiddelbart efter, at patienten er stået op om morgenen og mindst 30 minutter før, der indtages nogen former for mad, drikke eller andre lægemidler.
To obtain satisfactory absorption of alendronate Alendronate HEXAL tablets must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day.
4. 5).
Other drinks (including mineral water), food and some medicines are likely to reduce the absorption of alendronate (see section 4.5).
4. 4): • Alendronat HEXAL- tabletterne skal indtages med et helt glas postevand (mindst 200 ml), så snart patienten er stået op om morgenen. • Alendronat HEXAL- tabletterne skal synkes hele.
7 To assist delivery to the stomach and thus reduce the risk of irritation/ side effects locally and in the oesophagus (see section 4.4) • Alendronate HEXAL tablets should only be swallowed on rising for the day with a whole glass of water (not less than 200 ml or 7 fl. oz). • Alendronate HEXAL tablets should be swallowed whole.
Tabletterne må ikke tygges, suges eller opløses i munden på grund af risiko for oropharyngeal ulceration. • Patienterne må ikke lægge sig ned, før de har indtaget dagens første måltid, og dette måltid må først indtages mindst 30 minutter efter tabletindtagelsen. • Patienterne må ikke ligge ned i de første 30 minutter efter indtagelsen af Alendronat HEXAL - tabletterne. • Alendronat HEXAL- tabletter må ikke indtages ved sengetid, eller før man står op.
The tablets should not be chewed, sucked or allowed to dissolve in the mouth on account of the risk of oropharyngeal ulceration. • Patients should not lie down until after the first meal of the day, which must be at least 30 minutes after taking the tablet. • Patients should not lie down within 30 minutes of taking Alendronate HEXAL tablets. • Alendronate HEXAL tablets should not be taken at bedtime or before arising for the day.
4. 4.).
Patients should be given a calcium and vitamin D supplement if the diet is inadequate (see section 4.4).
Der er ikke fundet aldersrelaterede forskelle med hensyn til alendronats effekt - eller sikkerhedsprofiler i kliniske undersøgelser.
In clinical trials there was no age-related difference with regard to efficacy or safety profiles of alendronate.
Dosisjustering er ikke nødvendig hos patienter med en glomerulær filtrationshastighed (GFR), der er større end 35 ml/ min.
Use in impaired renal function No dose adjustment is necessary in patients with a glomerular filtration rate (GFR) greater than 35 ml/ min.
På grund af manglende erfaring anbefales alendronat ikke til patienter med nedsat nyrefunktion, hvis GFR er mindre end 35 ml/ min.
Alendronate is not recommended for patients with impaired renal function if the GFR is less than 35 ml/ min, as there is no experience of this.
Dosisjustering er ikke nødvendig.
Use in impaired hepatic function No dose adjustment is necessary.
Alendronat HEXAL bør ikke anvendes til børn pga. manglende dokumentation for sikkerhed og virkning.
Use in children Alendronate HEXAL is not recommended for use in children due to a lack of data on safety and efficacy.