FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been fatal cases of inadvertent intrathecal administration of VELCADE.
Slovenian: Nenamerna intratekalna uporaba zdravila VELCADE je privedla do smrtnih primerov.
English: Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Slovenian: #, bronhospazem, kronična obstruktivna pljučna bolezen*, hipoksemija*, kongestija dihal*, hipoksija, plevritis*, kolcanje, izcedek iz nosu, disfonija, piskanje v pljučih
English: • Drooling
Slovenian: • driska
English: • that VELCADE 1 mg is only for IV use
Slovenian: • Zdravilo VELCADE 1 mg se lahko uporablja samo intravensko.
English: White to off-white cake or powder.
Slovenian: prašek za raztopino za injiciranje bela do belkasta pogača ali prašek
English: When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the VELCADE, 21-day treatment cycle.
Slovenian: Če boste prejeli zdravilo VELCADE skupaj z deksametazonom, boste prejeli zdravilo VELCADE v veno v 21-dnevnem krogu zdravljenja in 20 mg deksametazona peroralno na 1., 2., 4., 5., 8., 9., 11. in 12. dan kroga zdravljenja z zdravilom VELCADE.
English: Common Dysacusis (inc tinnitus)* Uncommon Vertigo*, Hearing impaired (up to and inc deafness) Cardiac disorders Common Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction*
Slovenian: Pogosti fibrilacija srca (vključno z atrijsko), aritmija*, srčno popuščanje (vključno s popuščanjem levega in desnega prekata)*, ishemija miokarda, moteno delovanje prekatov*
English: Hazard ratio (95% CI)
Slovenian: 15,0 mesecev razmerje tveganja (95% CI) p-vrednost
English: When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 21-day treatment cycle.
Slovenian: Če jemljete zdravilo VELCADE skupaj z deksametazonom, boste prejeli zdravilo VELCADE v veno v 21-dnevnem krogu zdravljenja in 40 mg deksametazona peroralno na 1., 2., 3., 4., 8., 9., 10. in 11. dan kroga zdravljenja z zdravilom VELCADE.
English: • Hearing loss, deafness
Slovenian: • okvara sluha, gluhost
English: #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
Slovenian: #, akne*, mehurček*, motnje pigmentacije*
English: When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 21-day treatment cycle.
Slovenian: Če jemljete zdravilo VELCADE skupaj z deksametazonom boste prejeli zdravilo VELCADE v veno ali v podkožje v 21-dnevnem krogu zdravljenja in 40 mg deksametazona peroralno na 1., 2., 3., 4., 8., 9., 10. in 11. dan kroga zdravljenja z zdravilom VELCADE.
English: p-value from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history
Slovenian: p-vrednost za stopnjo odziva (CR+PR) po Cochran-Mantel-Haenszel hi-kvadratnem testu, prilagojena na osnovi stratifikacijskih dejavnikov
English: Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy
Slovenian: Redki poškodba roženice*, ekzoftalmus, vnetje mrežnice, skotom, očesne bolezni (vključno z vekami) NOS, pridobljen dakrioadenitis, fotofobija, fotopsija, optična nevropatija različne stopnje okvare vida (vse do slepote)*
English: When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the VELCADE, 21-day treatment cycle.
Slovenian: Če boste prejeli zdravilo VELCADE skupaj z deksametazonom, boste prejeli zdravilo VELCADE v veno ali v podkožje v 21-dnevnem krogu zdravljenja in 20 mg deksametazona peroralno na 1., 2., 4., 5., 8., 9., 11. in 12. dan kroga zdravljenja z zdravilom VELCADE.
English: At least 6 months after prior therapy, VELCADE was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Slovenian: Po najmanj 6 mesecih po predhodnem zdravljenju, so zdravilo VELCADE uvedli v odmerku, ki ga je bolnik pri predhodnem zdravljenju še prenašal, 1.3 mg/m2 (n = 93) ali ≤ 1.0 mg/m2 (n = 37).
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with VELCADE treatment.
Slovenian: Med zdravljenjem z zdravilom VELCADE se zelo pogosto pojavijo toksični učinki na prebavila, kot so slabost, driska, bruhanje in zaprtje.
English: Very Common Thrombocytopenia*, Neutropenia*, Anaemia* Common
Slovenian: Zelo pogosti trombocitopenija*, febrilna nevtropenija, nevtropenija *, levkopenija*, anemija*, limfopenija*
English: Six VELCADE cycles are recommended, although for patients with a response first documented at cycle 6, two additional VELCADE cycles may be given.
Slovenian: Priporočamo, da bolniki, ki dosežejo odgovor šele v 6. krogu, prejmejo dva dodatna kroga zdravljenja.
English: Muscle spasms*, Pain in extremity, Muscular weakness Uncommon Muscle twitching, Joint swelling, Arthritis*, Joint stiffness, Myopathies*,Sensation of heaviness
Slovenian: Občasni trzanje mišic, otekanje sklepov, artritis*, okorelost sklepov, miopatije*, občutek teže
English: Hazard ratio (95% CI) p-value
Slovenian: 14,0 mesecev razmerje tveganja (95% CI) p-vrednost
English: #, Different degrees of visual impairment (up to blindness)*
Slovenian: Občasni vertigo*, okvara sluha (vse do in vključno z gluhostjo)
English: Dosing Slide Rule shall contain the following key elements:
Slovenian: Navodila za odmerjanje zdravila morajo vsebovati naslednje ključne elemente:
English: One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a VELCADE-containing regimen were retreated upon progression.
Slovenian: Bolnike, ki so predhodno imeli vsaj delni odgovor na režim zdravljenja z zdravilom VELCADE so ponovno zdravili po napredovanju bolezni.
English: Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Slovenian: Populacijo, pri kateri je prišlo do odziva, predstavljajo bolniki, pri katerih so lahko ovrednotili bolezen pred začetkom zdravljenja.
English: • Itching of skin
Slovenian: • pordelost kože
English: Day 8
Slovenian: 8 krogov.
English: • Joint effusion
Slovenian: • otekle bezgavke
English: VELCADE 1 mg powder for solution for injection is available for intravenous administration only.
Slovenian: Zdravilo VELCADE 1 mg prašek za raztopino za injiciranje je namenjeno samo za intravensko uporabo.
English: Renal impairment*
Slovenian: Pogosti okvara ledvic*
English: Very Common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Slovenian: Zelo pogosti zvišana telesna temperatura*, izčrpanost, astenija Pogosti edem (vključno s perifernim), mrazenje, bolečina*, oslabelost*
English: Posology for previously untreated multiple myeloma patients not eligible for haematopoietic stem cell transplantation
Slovenian: Priporočeno odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in niso primerni za presaditev krvotvornih matičnih celic
English: Very Common Decreased appetite Common
Slovenian: Pogosti zmanjšana telesna masa
English: • Chest pains or shortness of breath with exercise
Slovenian: • bolečine v prsih, zasoplost pri telesnem naporu
English: When VELCADE is given alone, you will receive 4 doses of VELCADE intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period' without treatment.
Slovenian: Odmerke vam bodo injicirali v veno ali v podkožje (subkutano) 1., 4., 8. in 11. dan, temu pa bo sledil 10-dnevni premor zdravljenja.
English: Discontinue VELCADE
Slovenian: Shranjevanje zdravila VELCADE
English: • Feeling dizzy
Slovenian: • bolečina v danki
English: • Fracture
Slovenian: • zlomi
English: Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with VELCADE.
Slovenian: Za ugotavljanje učinkovitosti in varnosti ponovnega zdravljenja z zdravilom VELCADE so izvedli odprto, enokračno, študijo faze II MMY-2036 (RETRIEVE) pri stotrideset bolnikih (starih ≥ 18 let) z diseminiranim plazmocitomom.
English: • Psoriasis like skin condition
Slovenian: • luskavici podobno obolenje kože
English: • Intestinal ulcers
Slovenian: • okužba sečil
English: Rare cases of hepatic failure have been reported in patients receiving VELCADE and concomitant medicinal products and with serious underlying medical conditions.
Slovenian: Pri bolnikih z obstoječimi resnimi boleznimi, ki so zdravilo VELCADE prejemali sočasno z drugimi zdravili, so poročali o redkih primerih odpovedi jeter.
English: Common Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*,
Slovenian: Zelo pogosti zmanjšan apetit Pogosti hipokalemija*, nenormalne koncentracije glukoze v krvi *, hiponatriemija *, sladkorna bolezen*, zastajanje tekočine
English: VELCADE 1 mg powder for solution for injection is administered via intravenous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and
Slovenian: Priporočeni odmerek je 1,3 mg/m2 telesne površine, dvakrat na teden dva tedna, na dan 1, 4, 8 in 11 v
English: Combination therapy with dexamethasone and thalidomide VELCADE 1 mg powder for solution for injection is administered via intravenous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 28 day treatment cycle.
Slovenian: Priporočeni odmerek je 1,3 mg/m2 telesne površine, dvakrat na teden dva tedna, na dan 1, 4, 8 in 11 v 28 dnevnem krogu zdravljenja.
English: 4.2 mo
Slovenian: 4,2 mesecev
English: 9/l on a VELCADE dosing day (other than day 1)
Slovenian: • Če je na dan odmerjanja zdravila VELCADE (razen1.
English: Very Common Pyrexia*, Fatigue, Asthenia Common Oedema (inc peripheral), Chills, Injection site reaction*,
Slovenian: Zelo pogosti zvišana telesna temperatura*, izčrpanost, astenija Pogosti edem (vključno s perifernim), mrazenje, reakcija na mestu injiciranja*, splošno slabo počutje*
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Slovenian: Na osnovi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja odmerka na 1,0 mg/m2 ali zmanjšanja odmerka na 0,5 mg/m huda
English: The best time to do this is in the evening.
Slovenian: Najbolj primeren čas za vkapavanje je zvečer.
English: Long-term safety in children has not yet been established.
Slovenian: Dolgotrajna varnost pri otrocih ni bila dokazana.
English: Do not use Xalatan more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.
Slovenian: Ne uporabljajte zdravila Xalatan več kot enkrat na dan, ker se lahko pri pogostejši uporabi zmanjša učinkovitost zdravljenja.
English: The next updated version of the Risk Management Plan (RMP) will have to include all relevant annexed documents and amendments to reflect the following:
Slovenian: Naslednja posodobljena različica načrta za obvladovanje tveganja mora vključevati vse ustrezne dodane dokumente in spremembe, ki morajo odražati naslednje:
English: The short term safety profiles in the different paediatric subsets were also similar (see Section 5.1).
Slovenian: Kratkotrajni varnostni profili v različnih pediatričnih podskupinah so bili prav tako podobni (glejte poglavje 5.1).
English: If you put too many drops into the eye, it may lead to some minor irritation in the eye and the eyes may water and turn red.
Slovenian: Če boste kanili preveč kapljic v oko, boste mogoče občutili rahlo draženje očesa, oči se lahko solzijo in postanejo rdeče.
English: The usual dosage for adults (including the elderly) and children is one drop once a day in the affected eye(s).
Slovenian: Običajni odmerek za odrasle (vključno s starejšimi) in za otroke je ena kapljica enkrat na dan v obolelo oko (oboleli očesi).
English: 4.5 Interaction with other medicinal products and other forms of interaction Paediatric population
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: †Adjusted estimate based on an analysis of covariance (ANCOVA) model.
Slovenian: SN: standardna napaka †Prilagojena ocena na osnovi modela analize kovariance (ANCOVA).
English: Vetenskapsvagen 10, SE 191 90 Sollentuna Sweden
Slovenian: SE 191 90 Sollentuna Sweden
English: National Competent Authorities (NCAs), coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders (MAHs):
Slovenian: Nacionalni pristojni organi, ki jih po potrebi koordinira referenčna država članica, naj zagotovijo, da imetniki dovoljenj za promet z zdravilom izpolnijo naslednje pogoje:
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA , PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Rivium Westlaan 142 2909 LD Capelle a/d IJssel
Slovenian: 2909 LD Capelle a/d IJssel
English: ANNEX III CONDITIONS OF THE MARKETING AUTHORISATION(S)
Slovenian: DODATEK III POGOJI DOVOLJENJ(A) ZA PROMET Z ZDRAVILOM
English: This medicine has been prescribed for you or for your child. Do not pass it on to others.
Slovenian: Zdravilo je bilo predpisano vam osebno ali vašemu otroku in ga ne smete dajati drugim.
English: After using Xalatan you should wait 15 minutes before putting the contact lenses back into the eyes.
Slovenian: Po uporabi zdravila Xalatan počakajte najmanj 15 minut, preden zopet vstavite kontaktne leče.
English: - make clear/provide reassurance that Adverse Drug Reactions are transmitted to NCAs within the legal timelines; - include information with regard to the absolute frequency or maximum time interval between audits for the Pharmacovigilance system for Drug Safety and Surveillance.
Slovenian: - pojasnil/zagotovil, da se vsi neželeni učinki v okviru pravno določenih časovnih rokov posredujejo nacionalnim pristojnim organom; - vključil podatke o absolutni pogostnosti ali najdaljših časovnih obdobjih med revizijami sistema farmakovigilance za varnost in nadzor zdravil.
English: The effect on IOP was seen after the first week of treatment and was maintained throughout the 12 week period of study, as in adults.
Slovenian: Učinek na očesni tlak je bil viden po prvem tednu zdravljena in se je ohranil skozi celotno 12 tedensko študijo, kot pri odraslih.
English: In two short term clinical trials ( 12 weeks) involving 93 (25 and 68) paediatric patients the safety profile was similar to that in adults and no new adverse events were identified.
Slovenian: V dveh kratkotrajnih kliničnih preskušanjih ( 12 tednov), ki sta vključevali 93 (25 in 68) pediatričnih bolnikov, je bil varnostni profil teh študij podoben kot pri odraslih, pri tem pa niso ugotovili novih neželenih učinkov.
English: Latanoprost acid systemic exposure was approximately 2-fold higher in 3 to <12 year olds and 6fold higher in children <3 years old compared with adults, but a wide safety margin for systemic adverse effects was maintained (see section 4.9).
Slovenian: Sistemska izpostavljenost kislini latanoprosta je bila približno 2-krat večja pri 3 do < 12 let starih in 6-krat višja pri otrocih starih < 3 let, v primerjavi z odraslim, toda široka meja varnosti za sistemske neželene učinke je bila ohranjena (glejte poglavje 4.9).
English: If you or your child wear contact lenses, they should be removed before using Xalatan.
Slovenian: Če nosite vi ali vaš otrok kontaktne leče, jih morate pred uporabo zdravila Xalatan odstraniti.
English: The final version of the CRF will be annexed to the study A6111143 protocol; - The MAH discussion whether the OCT (optical coherence tomography) technique can be recommended in the protocol's Appendix 1 “recommended assessment methods”; - The PASS (Post-Authorisation Safety) studies will include a comparison between macular oedema reported in aphakin and non-aphakin patients;
Slovenian: Končna različica CRF bo dodana protokolu študije A6111143; - imetnik dovoljenja za promet z zdravilom naj prouči, ali se tehnika OCT (optična koherentna tomografija) lahko priporoči v Dodatku 1 protokola, „priporočene metode ocenjevanja“; - varnostne študije po izdaji dovoljenja za promet z zdravilom bodo vključevale primerjavo med poročanim makularnim edemom pri bolnikih z afakijo in pri tistih brez afakije;
English: 28108 Alcobendas, (Madrid)
Slovenian: Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid)
English: You can still use{Invented name}, but follow the instruction for contact lens wearers in Section 3
Slovenian: Zdravilo Xalatan lahko še vedno uporabljate, vendar sledite navodilom za uporabnike kontaktnih leč v poglavju 3.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or the doctor treating your child or your pharmacist.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, zdravnika, ki zdravi vašega otroka ali farmacevta.
English: Efficacy and safety data in the age group < 1 year (4 patients) are very limited (see Section 5.1).
Slovenian: Podatki o učinkovitosti in varnosti v starostni skupini < 1 leta (4 bolniki) so zelo omejeni (glejte poglavje 5.1).
English: Median time to reach peak plasma concentration was 5 minutes post-dose across all age groups.
Slovenian: Srednja vrednost za dosego najvišje koncentracije v plazmi je bila 5 minut po odmerku za vse starostne skupine.
English: All age groups were treated with latanoprost 0.005%, one drop daily in each eye for a minimum of 2 weeks.
Slovenian: Vse starostne skupine so bile zdravljene z eno kapljico 0,005% latanoprosta na dan v vsako oko, najmanj 2 tedna.
English: In all age groups studied (0 to <3 years, 3 to <12 years and 12 to 18 years of age) the mean IOP reduction at Week 12 in the latanoprost group was similar to that in the timolol group.
Slovenian: V vseh preučevanih starostnih skupinah (starih 0 do < 3 let, 3 do < 12 let in 12 do 18 let) je bilo povprečno znižanje očesnega taka v 12. tednu v skupini z latanoprostom podobno, kot v skupini s timololom.
English: An open-label pharmacokinetic study of plasma latanoprost acid concentrations was undertaken in 22 adults and 25 paediatric patients (from birth to < 18 years of age) with ocular hypertension and glaucoma.
Slovenian: Odprto farmakokinetično študijo koncentracije kisline latanoprosta v plazmi so izvedli pri 22 odraslih in 25 otrocih (od rojstva do starosti < 18 let) z očesno hipertenzijo in glavkomom.
English: Data in the age group < 1 year (4 patients) are very limited (see Section 5.1).
Slovenian: Podatki za starostno skupino < 1 leto (4 bolniki) so zelo omejeni (glejte poglavje 5.1).
English: Adverse events seen more frequently in the paediatric population as compared to adults are: nasopharyngitis and pyrexia.
Slovenian: Neželeni učinki, ki so se pojavili bolj pogosto kot pri odrasli populaciji so: nazofaringitis in pireksija.
English: 9 Riverwalk National Digital Park Citywest Business Campus
Slovenian: 9 Riverwalk National Digital Park
English: Please tell your doctor, the doctor treating your child or pharmacist if you or your child are taking or have taken any other medicines including those medicines (or eye drops) obtained without a prescription.
Slovenian: Obvestite svojega zdravnika, zdravnika, ki zdravi vašega otroka ali farmacevta, če vi ali vaš otrok jemljete ali ste pred kratkim jemali katerokoli zdravilo (vključno s kapljicami za oko), tudi če ste ga dobili brez recepta.
English: HOW TO USE {INVENTED NAME}
Slovenian: Izmišljeno ime Ime
English: WHAT IS {INVENTED NAME} AND WHAT IS IT USED FOR?
Slovenian: KAJ JE ZDRAVILO XALATAN IN ZA KAJ GA UPORABLJAMO
English: - Risk of drug interactions in paediatric patients as important missing information; - Cystoid macular oedema assessment using the study Adverse Event (AE) report page in the case report form (CRF).
Slovenian: - nevarnost interakcij z drugimi zdravili pri pediatričnih bolnikih kot pomembno manjkajočo informacijo; - oceno cističnega makularnega edema na strani s poročili o neželenih učinkih, na obrazcu za poročanje o primerih (CRF).
English: Within the next updated version of the Detailed Description of the Pharmacovigilance System (DDPS) the MAH will:
Slovenian: V naslednji posodobljeni različici podrobnega opisa sistema farmakovigilance bo imetnik dovoljenja za promet z zdravilom:
English: Ramsgate Road Sandwich, Kent CT13 9NJ
Slovenian: Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
English: The efficacy of latanoprost in paediatric patients ≤18 years of age was demonstrated in a 12-week, doublemasked clinical study of latanoprost compared with timolol in 107 patients diagnosed with ocular hypertension and paediatric glaucoma.
Slovenian: Učinkovitost latanoprosta pri pediatričnih bolnikih starih ≤ 18 let se je pokazala pri 12-tedenski dvojno slepi klinični študiji latanoprosta v primerjavi s timololom pri 107 bolnikih z diagnozo očesne hipertenzije in otroškim glavkomom.
English: Nevertheless, efficacy data in the age group 0 - < 3 year old were based on only 13 patients for latanoprost and no relevant efficacy was shown from the 4 patients representing the age group 0 -< 1 year old in the clinical paediatric study.
Slovenian: Vendar pa so podatki o učinkovitosti v starostni skupini 0 do < 3 let osnovani le na 13 bolnikih za latanoprost in ustrezne učinkovitosti timolola pri štirih bolnikih, ki so predstavljali starostno skupino 0 do < 1 leta, v klinični pediatrični študiji niso pokazali.
English: Neonates were required to be at least 36 weeks gestational age.
Slovenian: Novorojenčki so morali biti rojeni vsaj po 36. tednih nosečnosti.
English: Pfizer Holding France Xalatan
Slovenian: Pfizer Holding France
English: If you use more {Invented name} than you should
Slovenian: Če ste uporabili večji odmerek zdravila Xalatan, kot bi smeli
English: Paediatric population: {Invented name} eye drops may be used in paediatric patients at the same posology as in adults.
Slovenian: Xalatan kapljice za oko se lahko pri pediatričnih bolnikih uporabljajo v enakih odmerkih kot pri odraslih.
English: Interaction studies have only been performed in adults.
Slovenian: Pediatična populacija Študije o medsebojnem delovanju z drugimi zdravili so bile izvedene le na odraslih.
English: {Invented name} is also used to treat increased eye pressure and glaucoma in all ages of children and babies.
Slovenian: Zdravilo Xalatan se uporablja tudi za zdravljenje povišanega očesnega tlaka in glavkoma pri otrocih vseh starosti in pri dojenčkih.
English: IOP reductions among subjects in the primary congenital/infantile glaucoma (PCG) subgroup were similar between the latanoprost group and the timolol group.
Slovenian: Znižanje očesnega tlaka med osebami v podskupini s primarnim kongenitalnim/otroškim glavkomom (PCG) je bilo podobno med skupinama z latanoprostom in timololom.