FrancophonIA/ELRC3.0 huggingface dataset:
English: A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Tovanor Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Croatian: Objedinjenom analizom 6- i 12-mjesečnih ključnih ispitivanja uočen je u bolesnika koji su primali Tovanor Breezhaler statistički značajno viši postotak bolesnika koji su odgovorili s poboljšanjem od 4 boda ili više u SGRQ-u u usporedbi s placebom nakon 26 tjedana (57,8% odnosno 47,6%, p<0,001).
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Bol u ekstremitetima
English: • Cough with sputum
Croatian: • Kašalj s iskašljajem
English: Multipack comprising 3 packs (30 capsules + 1 inhaler)
Croatian: Višestruko pakiranje koje sadrži 3 pakiranja (30 kapsula + 1 inhalator)
English: How much Tovanor Breezhaler to use
Croatian: Koliko Tovanor Breezhalera primjenjivati
English: What Tovanor Breezhaler is
Croatian: Što je Tovanor Breezhaler
English: 2) Reports have been received from post-approval marketing experience in association with the use of Tovanor Breezhaler.
Croatian: 1) Učestalije za glikopironij nego za placebo samo u bazi 12-mjesečnih podataka 2) Dobivena su izvješća iz iskustva nakon stavljanja lijeka u promet, povezana s primjenom Tovanor Breezhalera.
English: • Swelling mainly of the tongue, lips, face or throat (possible signs of angioedema) If you get any of these side effects, tell your doctor immediately.
Croatian: • Oticanje prvenstveno jezika, usana, lica ili grla (mogući znakovi angioedema)
English: Mouthpiece
Croatian: • Mučnina
English: What Tovanor Breezhaler is used for
Croatian: Za što se koristi Tovanor Breezhaler
English: 24 x 1 capsules + 1 inhaler.
Croatian: 24 x 1 kapsule + 1 inhalator.
English: Musculoskeletal chest pain
Croatian: Mišićno-koštana bol
English: Do not remove from the blister until immediately before use.
Croatian: Izvaditi iz blistera tek neposredno prije primjene.
English: How to use Tovanor Breezhaler
Croatian: Kako primjenjivati Tovanor Breezhaler
English: Elimination After intravenous administration of [
Croatian: Nakon primjene glikopironijevog bromida označenog sa [
English: How to store Tovanor Breezhaler
Croatian: Kako čuvati Tovanor Breezhaler
English: 30 x 1 capsules + 1 inhaler.
Croatian: 30 x 1 kapsula + 1 inhalator.
English: • Vomiting
Croatian: • Utrnulost
English: Immediate hypersensitivity reactions have been reported after administration of Tovanor Breezhaler.
Croatian: Nakon primjene Tovanor Breezhalera zabilježene su neposredne reakcije preosjetljivosti.
English: - Dispose of each inhaler after after all capsules in that pack have been used.
Croatian: - Bacite inhalator iz svakog pakiranja nakon što su sve kapsule u tom pakiranju iskorištene.
English: Chec k
Croatian: Provje ra
English: • Painful and frequent urination
Croatian: • Bolno i učestalo mokrenje
English: Your Seebri Breezhaler Inhaler pack contains: • One Seebri Breezhaler inhaler
Croatian: Vaše pakiranje Tovanor Breezhaler inhalatora sadrži:
English: • Numbness
Croatian: • Svrbež
English: • Throat irritation
Croatian: • Nadraženo grlo
English: Tovanor Breezhaler 44 mcg inhalation powder glycopyrronium
Croatian: Tovanor Breezhaler 44 µg prašak inhalata glikopironij
English: Renal and urinary disorders Urinary tract infection
Croatian: Poremećaji bubrega i mokraćnog sustava Infekcija mokraćnog trakta
English: Cap
Croatian: Poklopac
English: If you forget to use Tovanor Breezhaler
Croatian: Kada inhalirati Tovanor Breezhaler
English: THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Croatian: SLJEDEĆE INFORMACIJE NAMIJENJENE SU SAMO ZDRAVSTVENIM RADNICIMA
English: Cardioxane is also contraindicated in the following circumstances:
Croatian: Cardioxane je također kontraindiciran u sljedećim okolnostima:
English: Currently available data are described in section 4.3, 4.4, 4.8, 5.1 and 5.2.
Croatian: Trenutno dostupni podaci opisani su u dijelu 4.3, 4.4, 4.8, 5.1 i 5.2.
English: Your doctor will advise on benefits and risks of this medicine.
Croatian: Vaš će vas liječnik savjetovati o koristi i rizicima ovog lijeka.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Croatian: Ove informacije o lijeku ishod su arbitražnog postupka na koji se odnosi ova odluka Komisije.
English: The long-term benefits and risks of this medicine in children and adolescents are not yet clear.
Croatian: Dugoročna korist i rizici ovog lijeka u djece i adolescenata još nisu ustanovljeni.
English: What you need to know before you are given Cardioxane You must not be given Cardioxane
Croatian: Uputa o lijeku Što morate znati prije nego što počnete primati Cardioxane Nemojte primati Cardioxane
English: Children and adolescents up to 18 years of age (see sections 4.4 and 4.8).
Croatian: Djeca i adolescenti u dobi do 18 godina (vidjeti dijelove 4.4 i 4.8).
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure with the following amendments (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below: A. Summary of Product Characteristics
Croatian: Važeći sažetak opisa svojstava lijeka, označivanje i uputa o lijeku konačne su verzije dobivene tijekom postupka koji je provodila Koordinacijska grupa, sa sljedećim izmjenama (umetnuti, zamijeniti ili izbrisati tekst, kako je prikladno) kako bi odgovarale dogovorenom tekstu kako je navedeno niže: A.
English: The safety and efficacy of Cardioxane in children aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Cardioxane u djece u dobi od 0 do 18 godina nisu ustanovljene.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu naknadno ažurirati informacije o lijeku, gdje je prikladno u suradnji s referentnom državom članicom, u skladu s postupcima navedenima u poglavlju 4. glave III.
English: Cardioxane is contraindicated in children and adolescents up to 18 years of age (see section 4.3).
Croatian: Cardioxane je kontraindiciran u djece i adolescenata u dobi do 18 godina (vidi odjeljak 4.3).
English: Cardioxane is contraindicated in children and adolescents up aged 0 to 18 years of age who are planned to receive a cumulative dose of less than 300 mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline.
Croatian: Cardioxane je kontraindiciran u djece i adolescenata do u dobi od 0 do 18 godina godina za koje je planirano da prime kumulativnu dozu od manje od 300 mg/m2 doksorubicina ili ekvivalentnu kumulativnu dozu drugog antraciklina.
English: − If you are under 18 years old and your planned dose of anthracycline is considered low - talk to your doctor about this.
Croatian: Ako ste mlađi od 18 godina i vaša se planirana doza antraciklina smatra niskom
English: Cardioxane is contraindicated in children aged 0 to 18 years who are planned to receive a cumulative dose of less than 300 mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline (see sections 4.4 and 4.8).
Croatian: Cardioxane je kontraindiciran u djece u dobi od 0 do 18 godina za koju je planirano da prime kumulativnu dozu od manje od 300 mg/m2 doksorubicina ili ekvivalentnu kumulativnu dozu drugog antraciklina (vidjeti dijelove 4.4. i 4.8.).
English: Annex III Amendments to the relevant sections of the Product information
Croatian: Izmjene i dopune odgovarajućih dijelova informacija o lijeku
English: B. Package Leaflet
Croatian: Sažetak opisa svojstava lijeka
English: If you are allergic to:
Croatian: Ako ste alergični na:
English: Date of first authorisation: 12 December 2018
Croatian: Datum prvog odobrenja: 12. Prosinca 2018.
English: Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primite ovo cjepivo jer sadrži Vama važne podatke.
English: • the active ingredients or any of the other ingredients of this medicine (listed in section 6)
Croatian: • djelatnu tvar ili bilo koje druge sastojke ovog cjepiva (navedene u dijelu 6)
English: These antibodies neutralise influenza viruses.
Croatian: Ova protutijela neutraliziraju viruse influence.
English: In this age group, 235 paediatric subjects received one dose and 340 subjects received two doses.
Croatian: U ovoj dobnoj skupini, 235 pedijatrijskih ispitanika primilo je jednu dozu a 340 ispitanika primilo je dvije doze.
English: Currently available safety and immunogenicity data are described in sections 4.8 and 5.1 but no recommendation on posology can be made.
Croatian: Trenutno dostupni podaci o sigurnosti i imunogenosti opisani su u dijelovima 4.8 i 5.1 međutim nije moguće dati preporuke o doziranju.
English: Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koji se dobivaju bez recepta ili ako ste nedavno primili bilo koje drugo cjepivo.
English: Adults and children from 9 years of age: One dose of 0.5 ml
Croatian: Odrasli i djeca od navršenih 9 godina nadalje: Jedna doza od 0,5 ml
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza i reproduktivne i razvojne toksičnosti.
English: Seqirus Vaccines Limited Gaskill Road, Speke L24 9GR Liverpool United Kingdom
Croatian: Seqirus Vaccines Limited Gaskill Road, Speke L24 9GR Liverpool Ujedinjeno Kraljevstvo
English: 475 Green Oaks Parkway
Croatian: 475 Green Oaks Parkway Holly Springs
English: For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet:
English: Fever was common in adolescents and children.
Croatian: Vrućica je bila česta u adolescenata i djece.
English: None of the ingredients in the vaccine can cause flu.
Croatian: Nijedan od sastojaka u cjepivu ne može uzrokovati gripu.
English: It is important that procedures are in place to avoid injury from faints.
Croatian: Važno je poduzeti postupke kako bi se spriječile ozljede zbog gubitka svijesti.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus.
Croatian: Kada osoba primi cjepivo, imunološki sustav (prirodni obrambeni sustav tijela) stvorit će vlastitu zaštitu protiv virusa influence.
English: • You should tell your doctor if you have an acute illness associated with fever.
Croatian: • Morate reći svom liječniku ako imate akutnu bolest s vrućicom.
English: A single syringe contains 0.5 ml of suspension for injection.
Croatian: Jedna štrcaljka sadrži 0,5 ml suspenzije za injekciju.
English: • You should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).
Croatian: • Morate obavijestiti svojeg liječnika ako je Vaš imunološki sustav oslabljen ili ako ste podvrgnuti liječenju koje utječe na imunološki sustav, npr. s lijekovima protiv raka (kemoterapija) ili kortikosteroidnim lijekovima (pogledajte dio „Drugi lijekovi i Flucelvax Tetra”).
English: Abbreviations: GMT = geometric mean titre; CI = confidence interval.
Croatian: Skraćenice: GMT (geometric mean titer) = geometrijska srednja vrijednost titra; CI (confidence interval) = interval pouzdanosti.
English: Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Flucelvax Tetra.
English: The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.
Croatian: Cjepivo se ne smije ubrizgati intravenski, supkutano ili intradermalno i ne smije se miješati s drugim cjepivima u istoj štrcaljki.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovo cjepivo se ne smije miješati s drugim lijekovima.
English: BEFORE receiving the vaccine
Croatian: PRIJE primanja cjepiva
English: B * Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy of each influenza vaccine relative to placebo based on the Sidak-corrected score confidence intervals for the two relative risks.
Croatian: B * Simultani jednostrani 97,5% intervali pouzdanosti za djelotvornost svakog cjepiva protiv influence u odnosu na placebo na temelju Šidakove korekcije intervala pouzdanosti za dva relativna rizika.
English: For instructions on the handling of the vaccine before administration, see section 6.6.
Croatian: Za upute o rukovanju cjepivom prije primjene, vidjeti dio 6.6.
English: The non-inferiority data observed are summarised in Table 2.
Croatian: Podaci o neinferiornosti sažeti su u tablici 2.
English: For intramuscular injection only.
Croatian: Samo za intramuskularnu injekciju.
English: All Culture-Confirmed Influenza Overall
Croatian: Sve influence potvrđene staničnom kulturom Općenito
English: Tell your doctor immediately if you experience any of the following side effects - you may need medical attention:
Croatian: Odmah obavijestite svog liječnika ako osjetite bilo koju od sljedećih nuspojava - možda ćete trebati liječničku pomoć:
English: Bold = Non-inferiority criterion met.
Croatian: Masno tiskano = Kriterij neinferiornosti je zadovoljen.
English: Male fertility has not been assessed in animals.
Croatian: Plodnost u mužjaka nije procjenjivana kod životinja.
English: Vaccine Efficacy = (1 - Relative Risk) x 100%; ** There were too few cases of influenza due to vaccine-matched influenza A/H3N2 or B to adequately assess vaccine efficacy.
Croatian: Djelotvornost cjepiva = (1 - relativni rizik) x 100%; ** Bilo je premalo slučajeva influence uzrokovane virusima koji su se podudarali s virusima cjepiva A/H3N2 ili B za adekvatnu procjenu djelotvornosti cjepiva.
English: Your doctor may decide to delay your vaccination until your fever is gone.
Croatian: Liječnik može odlučiti odgoditi cijepljenje dok vrućica ne prođe.
English: Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect - you may need urgent medical attention or hospitalisation:
Croatian: Odmah obavijestite svojeg liječnika ili se uputite u hitnu službu najbliže bolnice ako primijetite sljedeću nuspojavu - možda će vam biti potrebna hitna medicinska pomoć ili hospitalizacija:
English: Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Croatian: Odgovarajuće liječenje i medicinski nadzor trebaju uvijek biti lako dostupni u slučaju rijetkog anafilaktičkog događaja nakon primjene cjepiva.
English: You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.* Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: Hardening or swelling at the site of the injection, headache, muscle pain, and fatigue were common in the elderly.
Croatian: Otvrdnuće ili oticanje na mjestu injekcije, glavobolja, bol u mišićima i umor bili su česti u starijih osoba.
English: Children less than 9 years of age reported similar rates of adverse reactions compared to older children.
Croatian: U djece mlađe od 9 godina zabilježena je slična stopa nuspojava u usporedbi sa starijom djecom.
English: Compared to adults 18 years of age and older, paediatric subjects generally reported higher rates of local and systemic adverse reactions.
Croatian: U usporedbi s odraslim ispitanicima u dobi od 18 i više godina, u pedijatrijskih ispitanika je općenito zabilježena veća stopa lokalnih i sistemskih nuspojava.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog cjepiva potrebno je jasno evidentirati.
English: However, inactivated influenza vaccines can be used in all stages of pregnancy.
Croatian: Međutim, inaktivirana cjepiva protiv influence smiju se primjenjivati u svim stadijima trudnoće.
English: Annual revaccination with current influenza vaccines is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus may change from year to year.
Croatian: Preporučuje se ponovno cijepljenje svake godine, s cjepivom protiv influence za aktualnu sezonu, zato što imunitet tijekom godine nakon cijepljenja opada, a cirkulirajući sojevi virusa influence mogu se mijenjati iz godine u godinu.
English: • Your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration.
Croatian: • Vaš liječnik ili medicinska sestra osigurat će dostupnost medicinskog liječenja i nadzora u slučaju rijetke anafilaktičke reakcije (vrlo teške alergijske reakcije sa simptomima kao što su teškoće pri disanju, omaglica, slab i ubrzan puls i kožni osip) nakon primjene.
English: % Lower Limit of OneSided 97.5% CI
Croatian: % Donja granica jednostranog 97,5% CI
English: For egg-derived influenza vaccines larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.
Croatian: Za cjepiva protiv influence koja su dobivena iz jaja dostupno je više podataka o sigurnosti primjene u drugom i trećem tromjesečju, u usporedbi s prvim tromjesečjem; ipak, podaci dobiveni na temelju primjene cjepiva protiv influence u cijelom svijetu ne ukazuju na neželjene posljedice za plod i majku koji se mogu pripisati cjepivu.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Croatian: Može biti popraćeno s nekoliko neuroloških znakova poput prolaznog poremećaja vida, parestezije i toničko-kloničkih pokreta udova tijekom oporavka.
English: Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI).
Croatian: Slučajevi influence identificirani su aktivnim i pasivnim praćenjem bolesti slične gripi. (ILI, engl. influenza-like illness).
English: • Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.
Croatian: • Nakon ili čak i prije bilo kakvog uboda iglom (injekcijom) može doći do gubitka svijesti, stoga recite liječniku ili medicinskoj sestri ako Vam se to dogodilo prilikom ranijih injekcija.
English: Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.
Croatian: Nadalje, protutijelo na jednu varijantu antigena virusa influence ne mora štititi protiv novih varijanti antigena virusa istog tipa ili podtipa.
English: • You should tell your doctor if you have a bleeding problem or bruise easily.
Croatian: • Morate obavijestiti svojeg liječnika ako imate problema s krvarenjem ili Vam lako nastaju modrice.
English: It should be noted that both V58P12 and V58P13 were performed in the 2007-2008 northern hemisphere influenza season.
Croatian: Potrebno je napomenuti da su oba ispitivanja, i V58P12 i V58P13 provedena na sjevernoj polutki tijekom sezone influence 2007.-2008.
English: Similar rates of local and system adverse reactions were reported in the overall paediatric population 4 to < 18 years of age.
Croatian: Slična stopa lokalnih i sistemskih nuspojava zabilježena je u općoj pedijatrijskoj populaciji u dobi od 4 do < 18 godina.
English: Do not use this vaccine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „EXP”.
English: No effects on breast fed newborn/infant are anticipated.
Croatian: Ne predviđaju se učinci na novorođenčad i dojenčad koja se doje.
English: ILI was defined according to Centers for Disease Control and Prevention (CDC) case definition, i.e., a fever (oral temperature ≥100.0°F / 38°C) and cough or sore throat.
Croatian: ILI je definiran prema definiciji Centra za kontrolu i prevenciju bolesti, tj. kao vrućica (oralno mjerena temperatura ≥100,0 °F / 38 °C) s kašljem ili bolnim ždrijelom.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Croatian: Sinkopa (gubitak svijesti) može se dogoditi nakon, ili čak i prije svakog cijepljenja kao psihogeni odgovor na ubod iglom.
English: After shaking, the normal appearance of the vaccine is a clear to slightly opalescent suspension.
Croatian: Nakon protresanja normalni izgled cjepiva je bistra do blago opalescentna suspenzija.
English: Pharmacotherapeutic group: Influenza vaccine, ATC code: J07BB02
Croatian: Farmakoterapijska skupina: Cjepivo protiv influence, ATK oznaka: J07BB02 Mehanizam djelovanja
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Flucelvax Tetra in children 6 months to 4 years of age in the prevention of influenza.
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja cjepiva Flucelvax Tetra u djece u dobi od 6 mjeseci do 4 godine za sprečavanje influence.
English: a The comparator vaccine for noninferiority comparisons for A/H1N1, A/H3N2 and B1 is TIV1c, for B2 it is
Croatian: a Kontrolno cjepivo za usporedbu neinferiornosti za A/H1N1, A/H3N2 i B1 je TIV1c, za B2 to je TIV2c.
English: Keep the pre filled syringe in the outer carton in order to protect from light.
Croatian: Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Influenza vaccinations can be used at any stage of pregnancy.
Croatian: Cjepivo protiv influence smije se primijeniti u bilo kojem stadiju trudnoće.
English: • beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.
Croatian: • beta-propiolakton, cetiltrimetilamonijev bromid ili polisorbat 80, koji su ostaci iz procesa proizvodnje prisutni u tragovima.
English: Name and address of the manufacturer(s) responsible for batch release Seqirus Vaccines Ltd
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Seqirus Vaccines Ltd