natgillin/translations-raw huggingface dataset:
When VELCADE is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration.
Pri sočasni uporabi zdravila VELCADE z drugimi zdravili glejte Povzetke glavnih značilnosti teh zdravil za navodila za odmerjanje.
Name and address of the manufacturer responsible for batch release Janssen Pharmaceutica NV
Ime in naslov izdelovalca, odgovornega za sproščanje serije
Concomitant medicinal products
Sočasno jemanje zdravil
Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE treatment cycle.
Deksametazon boste jemali peroralno v odmerku 40 mg na 1., 2., 3., 4., 8., 9., 10. in 11. dan 28dnevnega kroga zdravljenja z zdravilom VELCADE.
The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma.
Biotransformacija Po enkratnem ali večkratnem intravenskem dajanju odmerkov 1,0 mg/m2 ali 1,3 mg/m2 bolnikom z diseminiranim plazmocitomom je bil povprečni volumen porazdelitve (Vd) 1,659 l do 3,294 l. To nakazuje, da se bortezomib v veliki meri porazdeljuje v periferna tkiva.
Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache* Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome
Občasni tremor, periferna senzorična in motorična nevropatija, diskinezija*, motnje koordinacije in ravnotežja v malih možganih*, izguba spomina (brez demence)*, encefalopatija*, posteriorni reverzibilni encefalopatični sindrom nevrotoksičnost, motnje s krči*, post-herpetična nevralgija, motnje govora*, sindrom nemirnih nog, migrena, išias, motnje pozornosti, nenormalni refleksi*, parozmija
Uncommon Angioedema
Redki hipotiroidizem
> 1 prior line of therapy
> 1 predhodna vrsta zdravljenja
• Hepatitis
• glavobol
• Weight increase
• oteženo požiranje
In the Phase III study, treatment with VELCADE led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
Pri vseh bolnikih, kot tudi pri bolnikih, ki so pred tem že prejeli eno vrsto terapije, je študija faze III zdravljenja z zdravilom VELCADE vodilo do statistično značilno daljšega časa do napredovanja bolezni, statistično značilno podaljšanega preživetja in statistično značilno boljšega odziva na zdravljenje v primerjavi z zdravljenjem z deksametazonom (glejte preglednico 14).
• Confirm the dose and concentration in the syringe prior to use.
• Pred dajanjem zdravila preverite odmerek in koncentracijo v brizgi (prepričajte se, da je na brizgi oznaka za subkutano dajanje).
Retreatment of patients with relapsed multiple myeloma In a study in which VELCADE retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a VELCADE-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
Najpogostejši neželeni učinki (vseh stopenj), ki so se pojavili pri najmanj 25% bolnikov, so bili trombocitopenija (55%), nevropatija (40%), anemija (37%), diareja (35%) in zaprtje (28%).
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether VELCADE (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m 2) and prednisone
(9 mg/m 2) in prednizonom (60 mg/m 2) prispeva k podaljšanju časa do napredovanja bolezni (Time To Progression-TTP) v primerjavi z zdravljenjem samo z melfalanom (9 mg/m 2) in prednizonom
VELCADE treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however VELCADE may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Zdravilo VELCADE pa lahko aplicira tudi zdravstveno osebje, ki ima izkušnje z zdravljenjem s kemoterapevstkimi učinkovinami.
Table 4: Posology for VELCADE combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Preglednica 4: Odmerjanje zdravila VELCADE pri bolnikih, s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih je presaditev krvotvornih matičnih celic primerna.
Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction, Rare
Občasni krvavitev iz nožnice, bolečina v spolovilih*, erektilna disfunkcija
Hypotension*, Orthostatic hypotension, Hypertension* Uncommon Cerebrovascular accident
Pogosti hipertenzija*, hipotenzija*, ortostatska hipotenzija
After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Po rekonstituciji praška 1 ml raztopine za intravensko injiciranje vsebuje 1 mg bortezomiba.
Posology for previously untreated multiple myeloma patients eligible for haematopoietic stem cell transplantation (induction therapy)
Odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in so primerni za presaditev krvotvornih matičnih celic (uvajalno zdravljenje) Kombinirano zdravljenje z deksametazonom
Moderate
Presnova
The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Rekonstituirano raztopino morate pred uporabo vizualno pregledati, da ugotovite če vsebuje morebitne delce in če je spremenila barvo.
• Multi-organ failure
• odpoved več organov
sometimes associated with pain or bleeding, poor movement of the intestines (including blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting of blood
• okužbe ali vnetja v ustih, razjede v ustih, požiralniku, želodcu in črevesju, ki jih včasih spremlja bolečina ali krvavitev, počasno gibanje črevesja (vključno z zaporo), nelagodje v trebuhu ali požiralniku, oteženo požiranje, bruhanje krvi
VELCADE may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Uporaba tega zdravila je lahko povezana z utrujenostjo (zelo pogosto), omotico (pogosto), sinkopami (občasno) in ortostatsko oz. posturalno hipotenzijo ali zamegljenim vidom (pogosto), zato morajo biti bolniki pri vožnji ali upravljanju s stroji previdni.
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 21-day treatment cycle.
Priporočeni odmerek je 1,3 mg/m2 telesne površine, dvakrat na teden dva tedna, na 1., 4., 8. in 11. dan v 21 dnevnem krogu zdravljenja.
Therefore, caution should be used during handling and preparation.
Opozorilo: VELCADE je citotoksično zdravilo, zato je med pripravo in ravnanjem z njim potrebna previdnost.
Nine treatment cycles of this combination therapy are administered.
Zdravljenje z zdravilom VELCADE traja devet krogov.
Grade of hepatic impairment*
Občasni pancitopenija*
There have been fatal cases of inadvertent intrathecal administration of VELCADE.
Nenamerna intratekalna uporaba zdravila VELCADE je privedla do smrtnih primerov.
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
#, bronhospazem, kronična obstruktivna pljučna bolezen*, hipoksemija*, kongestija dihal*, hipoksija, plevritis*, kolcanje, izcedek iz nosu, disfonija, piskanje v pljučih
• Drooling
• driska
• that VELCADE 1 mg is only for IV use
• Zdravilo VELCADE 1 mg se lahko uporablja samo intravensko.
White to off-white cake or powder.
prašek za raztopino za injiciranje bela do belkasta pogača ali prašek
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.
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.
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*
Pogosti fibrilacija srca (vključno z atrijsko), aritmija*, srčno popuščanje (vključno s popuščanjem levega in desnega prekata)*, ishemija miokarda, moteno delovanje prekatov*
Hazard ratio (95% CI)
15,0 mesecev razmerje tveganja (95% CI) p-vrednost
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.
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.
• Hearing loss, deafness
• okvara sluha, gluhost
#, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
#, akne*, mehurček*, motnje pigmentacije*
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.
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.
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
p-vrednost za stopnjo odziva (CR+PR) po Cochran-Mantel-Haenszel hi-kvadratnem testu, prilagojena na osnovi stratifikacijskih dejavnikov
Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy
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)*
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.
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.
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.
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).
Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with VELCADE treatment.
Med zdravljenjem z zdravilom VELCADE se zelo pogosto pojavijo toksični učinki na prebavila, kot so slabost, driska, bruhanje in zaprtje.
Very Common Thrombocytopenia*, Neutropenia*, Anaemia* Common
Zelo pogosti trombocitopenija*, febrilna nevtropenija, nevtropenija *, levkopenija*, anemija*, limfopenija*
Six VELCADE cycles are recommended, although for patients with a response first documented at cycle 6, two additional VELCADE cycles may be given.
Priporočamo, da bolniki, ki dosežejo odgovor šele v 6. krogu, prejmejo dva dodatna kroga zdravljenja.
Muscle spasms*, Pain in extremity, Muscular weakness Uncommon Muscle twitching, Joint swelling, Arthritis*, Joint stiffness, Myopathies*,Sensation of heaviness
Občasni trzanje mišic, otekanje sklepov, artritis*, okorelost sklepov, miopatije*, občutek teže
Hazard ratio (95% CI) p-value
14,0 mesecev razmerje tveganja (95% CI) p-vrednost
#, Different degrees of visual impairment (up to blindness)*
Občasni vertigo*, okvara sluha (vse do in vključno z gluhostjo)
Dosing Slide Rule shall contain the following key elements:
Navodila za odmerjanje zdravila morajo vsebovati naslednje ključne elemente:
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.
Bolnike, ki so predhodno imeli vsaj delni odgovor na režim zdravljenja z zdravilom VELCADE so ponovno zdravili po napredovanju bolezni.
Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Populacijo, pri kateri je prišlo do odziva, predstavljajo bolniki, pri katerih so lahko ovrednotili bolezen pred začetkom zdravljenja.
• Itching of skin
• pordelost kože
Day 8
8 krogov.
• Joint effusion
• otekle bezgavke
VELCADE 1 mg powder for solution for injection is available for intravenous administration only.
Zdravilo VELCADE 1 mg prašek za raztopino za injiciranje je namenjeno samo za intravensko uporabo.
Renal impairment*
Pogosti okvara ledvic*
Very Common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Zelo pogosti zvišana telesna temperatura*, izčrpanost, astenija Pogosti edem (vključno s perifernim), mrazenje, bolečina*, oslabelost*
Posology for previously untreated multiple myeloma patients not eligible for haematopoietic stem cell transplantation
Priporočeno odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in niso primerni za presaditev krvotvornih matičnih celic
Very Common Decreased appetite Common
Pogosti zmanjšana telesna masa
• Chest pains or shortness of breath with exercise
• bolečine v prsih, zasoplost pri telesnem naporu
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.
Odmerke vam bodo injicirali v veno ali v podkožje (subkutano) 1., 4., 8. in 11. dan, temu pa bo sledil 10-dnevni premor zdravljenja.
Discontinue VELCADE
Shranjevanje zdravila VELCADE
• Feeling dizzy
• bolečina v danki
• Fracture
• zlomi
Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with VELCADE.
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.
• Psoriasis like skin condition
• luskavici podobno obolenje kože
• Intestinal ulcers
• okužba sečil
Rare cases of hepatic failure have been reported in patients receiving VELCADE and concomitant medicinal products and with serious underlying medical conditions.
Pri bolnikih z obstoječimi resnimi boleznimi, ki so zdravilo VELCADE prejemali sočasno z drugimi zdravili, so poročali o redkih primerih odpovedi jeter.
Common Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*,
Zelo pogosti zmanjšan apetit Pogosti hipokalemija*, nenormalne koncentracije glukoze v krvi *, hiponatriemija *, sladkorna bolezen*, zastajanje tekočine
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
Priporočeni odmerek je 1,3 mg/m2 telesne površine, dvakrat na teden dva tedna, na dan 1, 4, 8 in 11 v
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.
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.
4.2 mo
4,2 mesecev
9/l on a VELCADE dosing day (other than day 1)
• Če je na dan odmerjanja zdravila VELCADE (razen1.
Very Common Pyrexia*, Fatigue, Asthenia Common Oedema (inc peripheral), Chills, Injection site reaction*,
Zelo pogosti zvišana telesna temperatura*, izčrpanost, astenija Pogosti edem (vključno s perifernim), mrazenje, reakcija na mestu injiciranja*, splošno slabo počutje*
Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
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
The best time to do this is in the evening.
Najbolj primeren čas za vkapavanje je zvečer.
Long-term safety in children has not yet been established.
Dolgotrajna varnost pri otrocih ni bila dokazana.
Do not use Xalatan more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.
Ne uporabljajte zdravila Xalatan več kot enkrat na dan, ker se lahko pri pogostejši uporabi zmanjša učinkovitost zdravljenja.
The next updated version of the Risk Management Plan (RMP) will have to include all relevant annexed documents and amendments to reflect the following:
Naslednja posodobljena različica načrta za obvladovanje tveganja mora vključevati vse ustrezne dodane dokumente in spremembe, ki morajo odražati naslednje:
The short term safety profiles in the different paediatric subsets were also similar (see Section 5.1).
Kratkotrajni varnostni profili v različnih pediatričnih podskupinah so bili prav tako podobni (glejte poglavje 5.1).
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.
Če boste kanili preveč kapljic v oko, boste mogoče občutili rahlo draženje očesa, oči se lahko solzijo in postanejo rdeče.
The usual dosage for adults (including the elderly) and children is one drop once a day in the affected eye(s).
Običajni odmerek za odrasle (vključno s starejšimi) in za otroke je ena kapljica enkrat na dan v obolelo oko (oboleli očesi).
4.5 Interaction with other medicinal products and other forms of interaction Paediatric population
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
†Adjusted estimate based on an analysis of covariance (ANCOVA) model.
SN: standardna napaka †Prilagojena ocena na osnovi modela analize kovariance (ANCOVA).
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):
Nacionalni pristojni organi, ki jih po potrebi koordinira referenčna država članica, naj zagotovijo, da imetniki dovoljenj za promet z zdravilom izpolnijo naslednje pogoje:
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA , PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
ANNEX III CONDITIONS OF THE MARKETING AUTHORISATION(S)
DODATEK III POGOJI DOVOLJENJ(A) ZA PROMET Z ZDRAVILOM
This medicine has been prescribed for you or for your child. Do not pass it on to others.
Zdravilo je bilo predpisano vam osebno ali vašemu otroku in ga ne smete dajati drugim.
After using Xalatan you should wait 15 minutes before putting the contact lenses back into the eyes.
Po uporabi zdravila Xalatan počakajte najmanj 15 minut, preden zopet vstavite kontaktne leče.
- 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.
- 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.
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.
Učinek na očesni tlak je bil viden po prvem tednu zdravljena in se je ohranil skozi celotno 12 tedensko študijo, kot pri odraslih.
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.
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.
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).
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).
If you or your child wear contact lenses, they should be removed before using Xalatan.
Če nosite vi ali vaš otrok kontaktne leče, jih morate pred uporabo zdravila Xalatan odstraniti.
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;
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;
You can still use{Invented name}, but follow the instruction for contact lens wearers in Section 3
Zdravilo Xalatan lahko še vedno uporabljate, vendar sledite navodilom za uporabnike kontaktnih leč v poglavju 3.
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.
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.
Efficacy and safety data in the age group < 1 year (4 patients) are very limited (see Section 5.1).
Podatki o učinkovitosti in varnosti v starostni skupini < 1 leta (4 bolniki) so zelo omejeni (glejte poglavje 5.1).