natgillin/translations-raw huggingface dataset:
Almindelig Leukopeni*, lymfopeni* Ikke almindelig
Leukopenia*, Anaemia*, Lymphopenia* Uncommon Pancytopenia*
• problemer med nyrerne
• kidney problems
• Smerter i munden
• Mouth pain
• Hævede lymfekirtler
Tumour lysis syndrome
Efter rekonstitution indeholder 1 ml injektionsvæske 1 mg bortezomib.
After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.
Den færdigblandede injektionsvæske er stabil i 8 timer ved 25 °C ved opbevaring i det originale hætteglas og/eller en sprøjte.
However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe.
• hukommelsestab, nedsat tankevirksomhed, gangbesvær eller synstab.
• memory loss, trouble thinking, difficulty with walking or loss of vision.
OR e(95 % CI) = 1,428 (0,749;
e (95% CI)=1.428 (0.749; 2.722) p-value g=0.275
Psykiske forstyrrelser Almindelig Søvnforstyrrelser* Nervesystemet
Common Sleep disorders and disturbances*
• Smerter i endetarmen
• Pain in limbs
• Væskeophobning
• Fluid retention
Leversvigt
Mild
Der gives ni behandlingscyklusser med denne kombinationsbehandling.
Nine treatment cycles of this combination therapy are administered.
overfladisk eller besværet vejrtrækning eller stop i vejrtrækningen, hvæsende vejrtrækning
tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Almindelig Hypokaliæmi*, unormal blodglucose*, hyponatriæmi*, diabetes mellitus*, væskeretention
Common Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*,
Lot
Age
Median c (95 % CI) (måneder)
Median a (95% CI)
N = 242 (ITT-population)
N=240 (ITT population) N=242 (ITT population)
> 1,0-1,5 x ULN
> 1.0 x 1.5 x ULN Any
Hvert hætteglas indeholder 3,5 mg bortezomib (som mannitolboronsyreester).
Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
• Ledeffusion
• Joint effusion
Patienter med moderat eller alvorligt nedsat leverfunktion skal starte med en reduceret dosis af VELCADE på 0,7 mg/m2 pr. injektion i den første behandlingscyklus;
Patients with moderate or severe hepatic impairment should be started on VELCADE at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m 2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Primært endepunkt
* Primary endpoint
Tremor, perifer sensomotorisk neuropati, dyskinesi*, forstyrrelser i cerebellar koordination og balanceforstyrrelser*, hukommelsestab (ekskl.
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
#, gastrointestinal inflammation*, dysfagi, colon irritabile, uspecificeret sygdom i mave-tarm-kanalen, belagt tunge, forstyrrelser af mave-tarmkanalens funktion*, sygdom i spytkirtlerne* Sjælden Akut pankreatitis, peritonitis*, tungeødem*, ascites, øsofagitis, læbebetændelse, fækal inkontinens, analsfinkteratoni, fækalom*, gastrointestinal ulcus og perforation*, gingival hypertrofi, megacolon, rektalt udflåd, blisterdannelse i hals og svælg*, læbesmerter, parodontitis, analfissur, forandringer i peristaltikken, proktalgi, anormal fæces Lever og galdeveje Almindelig Abnorme leverenzymer* Ikke almindelig
Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces
synkope), encefalopati*, perifer sensomotorisk neuropati, svimmelhed*, dysgeusi*, autonom neuropati
Very Common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* Common Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
venstre og højre ventrikel)*, arytmi*, takykardi*, palpitationer, angina pectoris, perikarditis (inkl.
#, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
• Hovedpine
• Hepatitis
9 celler/l, kan
9/l or ANC
Kombinationsbehandling med dexamethason og thalidomid VELCADE 1 mg pulver til injektionsvæske, opløsning administreres som intravenøs injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverflade to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 28-dages behandlingscyklus.
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.
Kombinationsbehandling med dexamethason og thalidomid VELCADE 3,5 mg pulver til injektionsvæske, opløsning administreres som intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverflade to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 28-dages behandlingscyklus.
Combination therapy with dexamethasone and thalidomide VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous 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.
Må ikke administreres via andre indgiftsveje.
For single use only Do not give by other routes.
9/l eller, ved kombinationsbehandling med melphalan og prednison, når trombocyttallet er ≤ 30 x 10
VELCADE therapy should be withheld when the platelet count is < 25,000/l or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/l (see section 4.2).
VELCADE kan så genoptages med et reduceret dosisniveau (fra 1,3 mg/m2 til
Then, VELCADE may be reinitiated with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to
#, bronkospasme, KOL*, hypoksæmi*, luftvejskongestion*, hypoksi, pleuritis*, hikke, rinoré, dysfoni, hvæsende vejrtrækning
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
• Mavesmerter, oppustethed
• Stomach pain, bloating
Kvalme og opkastning*, diarré*, obstipation
Very Common Nausea and vomiting symptoms*, Diarrhoea*, Constipation Common
Kombinationsbehandling med pegyleret liposomal doxorubicin VELCADE 3,5 mg pulver til injektionsvæske, opløsning administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
Combination therapy with pegylated liposomal doxorubicin VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous 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.
fra slimhinde)*, dyspepsi, stomatitis*, abdominal distension, orofaryngeale smerter*, abdominalsmerter (inkl.
Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence
Kombinationsbehandling med pegyleret liposomal doxorubicin VELCADE 1 mg pulver til injektionsvæske, opløsning administreres via intravenøs injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
Combination therapy with pegylated liposomal doxorubicin 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.
Når VELCADE gives sammen med dexamethason, får du VELCADE intravenøst som en 21-dages behandlingscyklus, og dexamethason 20 mg gives gennem munden på dag 1, 2, 4, 5, 8, 9, 11 og 12 i den 21-dages behandlingscyklus med VELCADE.
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.
på dag 1, cyclophosphamid 750 mg/m 2 i.v.
rituximab 375 mg/m 2 IV on day 1; cyclophosphamide 750 mg/m 2 IV on day 1; doxorubicin 50 mg/m
Når VELCADE gives sammen med dexamethason, får du VELCADE intravenøst eller subkutant som en 21-dages behandlingscyklus, og dexamethason 20 mg gives gennem munden på dag 1, 2, 4, 5, 8, 9, 11 og 12 i den 21-dages behandlingscyklus med VELCADE.
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.
• Muskelsmerter, knoglesmerter
Musculoskeletal and connective tissue disorders
Det skal du vide, før du begynder at bruge VELCADE Sådan skal du bruge VELCADE Bivirkninger
What VELCADE is and what it is used for What you need to know before you use VELCADE How to use VELCADE
Når VELCADE gives sammen med dexamethason, får du VELCADE intravenøst eller subkutant som en 21-dages behandlingscyklus, og dexamethason 40 mg gives gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i hver VELCADE 21-dages behandlingscyklus.
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.
VELCADE 1 mg pulver til injektionsvæske, opløsning administreres via intravenøs injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
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.
Alle
OR
TTP = Tid til progression
NA=not applicable, NE=not estimated TTP-Time to Progression
• Misfarvning af blodkarrene
• Discoloration of the veins
VELCADE 3,5 mg pulver til injektionsvæske, opløsning administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous 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.
Når VELCADE gives sammen med dexamethason, får du VELCADE intravenøst i en 21-dages behandlingscyklus, og dexamethason 40 mg gives gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i hver VELCADE 21-dages behandlingscyklus.
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.
døvhed)
severe).
Hjertetamponade
Heart failure
• Bleg hud
• Redness of skin
• Brok
HR
VELCADE 3,5 mg pulver til injektionsvæske, opløsning administreres som intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverflade to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous 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.
Krampeanfald
infestations
CR + nCR+ PR+MR Median varighed dage (måneder)
CR+nCR+ PR+MR
Øjenblødning*, øjenlågsinfektion*, chalazion
Eye swelling*, Vision abnormal*, Conjunctivitis* Uncommon Eye haemorrhage*, Eyelid infection*, Chalazion Blepharitis
375 mg/m 2 i.v.
0.7 mg/m2).
Pyreksi*, træthed, asteni
• Tiredness (fatigue), feeling weak
Oversigt over bivirkningerne i tabelform
SUMMARY OF PRODUCT CHARACTERISTICS
• Betændelse i bugspytkirtlen, tilstoppelse af galdegangen
• Inflammation of the pancreas, obstruction of the bile duct
• Urinvejsinfektion
• Tooth infection
• Hikke
• Headache
Pancytopeni*, febril neutropeni, koagulopati*, leukocytose*, lymfadenopati, hæmolytisk anæmi# Sjælden Dissemineret intravaskulær koagulation, trombocytose*, hyperviskositetssyndrom, uspecificeret påvirkning af trombocytfunktionen, trombotisk mikroangiopati (herunder trombocytopenisk purpura)
Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)*
• Stakåndethed ved fysisk udfoldelse
• Shortness of breath with exercise
Hos patienter med fremskreden myelom var sværhedsgraden af trombocytopeni relateret til trombocyttallet før behandlingen: for trombocyttal ved baseline < 75 x 10
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/l, 90% of 21 patients had a count ≤ 25,000/l during the study, including 14% < 10,000/l; in contrast, with a baseline platelet count > 75,000/l, only 14% of 309 patients had a count ≤ 25,000/l during the study.
og subkutan (s.c.) anvendelse
SGOT (AST) levels
kardiogent shock)
Grade of hepatic impairment*
SE: standardfejl
SE: standard error.
Sikkerhed ved langtidsbrug hos børn er ikke klarlagt.
Long-term safety in children has not yet been established.
Det kan være skadeligt for andre, selv om de har de samme symptomer, som De har.
It may harm them, even if their symptoms are the same as yours.
MOM Park „F” Ép.,
MOM Park "F" Ép., Hungary
Det er bedst at dryppe øjnene om aftenen.
The best time to do this is in the evening.
De nationale kompetente myndigheder, koordineret af referencemedlemsstaten, hvor dette er relevant, skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelsen:
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):
Floridsdorfer Hauptstraße 1
Floridsdorfer Hauptstrasse 1
Hvis De drypper for mange dråber Xalatan i øjet, kan der opstå let irritation i øjet, og øjnene kan løbe i vand og blive røde.
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.
Justeret estimat baseret på kovarians-analyse (ANCOVA) modellen.
†Adjusted estimate based on an analysis of covariance (ANCOVA) model.
Brug ikke Xalatan mere end 1 gang dagligt, da hyppigere drypning kan nedsætte virkningen af behandlingen.
Do not use Xalatan more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.
4.5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction Paediatric population
Den næste opdaterede udgave af risikostyringsplanen skal omfatte alle relevante vedlagte dokumenter og ændringer med henblik på at afspejle følgende:
The next updated version of the Risk Management Plan (RMP) will have to include all relevant annexed documents and amendments to reflect the following:
Det primære effektendepunkt var den gennemsnitlige reduktion i det intraokulære tryk (IOP) fra baseline ved uge 12 af undersøgelsen.
The primary efficacy endpoint was the mean reduction in intraocular pressure (IOP) from baseline at Week 12 of the study.
p-værdi vs. timolol
p-value vs. timolol
Der blev set effekt på IOP efter den første uge af behandlingen (se graf), og effekten blev opretholdt gennem hele den 12 uger lange forsøgsperiode, som hos voksne.
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.
Pædiatrisk population Interaktionsforsøg er kun udført hos voksne.
Interaction studies have only been performed in adults.
- gøre det klart/give sikkerhed for, at information om bivirkninger fremsendes til de nationale kompetente myndigheder inden for de forskriftsmæssige tidsfrister, - medtage information om den absolutte hyppighed eller det maksimale tidsinterval mellem revisionerne, hvad angår lægemiddelovervågningssystemet for lægemiddelsikkerhed og -tilsyn.
- 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.
Tabel: Reduktion i IOP (mmHg) ved uge 12 samt behandlings undergrupper og baseline-diagnose Latanoprost N=53
Table: IOP reduction (mmHg) at week 12 by active treatment group and baseline diagnosis Latanoprost N=53
Fremsendelse af en halvårlig periodisk, opdateret sikkerhedsindberetning (PSUR) i løbet af de to første år efter Europa-Kommissionens afgørelse og herefter årligt;
Submission of a 6-monthly Period Safety Updated Report (PSUR) during the first 2 years following the European Commission decision and then after yearly;
BILAG III BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN/-ERNE
ANNEX III CONDITIONS OF THE MARKETING AUTHORISATION(S)
De kan stadig bruge Xalatan, men De skal følge vejledningen for kontaktlinsebrugere i afsnit 3
You can still use{Invented name}, but follow the instruction for contact lens wearers in Section 3
Den sædvanlige dosis til voksne (herunder ældre) og børn er 1 dråbe dagligt i det/de angrebne øje/øjne.
The usual dosage for adults (including the elderly) and children is one drop once a day in the affected eye(s).
Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 Ireland
9 Riverwalk National Digital Park Citywest Business Campus
Hos børn i alderen 0 til < 3 år, som primært lider af primær kongenit glukom (PCG), er operation (f.eks. trabekulotomi/goniotomi) stadig førstevalgsbehandling.
In children from 0 to < 3 years old) that mainly suffers from PCG (Primary Congenital Glaucoma), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
Median tid til at nå maksimal plasmakoncentration var 5 minutter efter indgivelse af dosis for alle aldersgrupper.
Median time to reach peak plasma concentration was 5 minutes post-dose across all age groups.
- risikoen for lægemiddelinteraktioner hos pædiatriske patienter som vigtig manglende information, - en vurdering af cystoidt maculaødem ved hjælp af indberetningsformularens (CRF's) side om utilsigtede hændelser (AE'er) i undersøgelsen.
- 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).
The Netherlands mikrogram/ml
The Netherlands microgram/ml
Desuden var korttids-sikkerhedsprofilerne ens i de pædiatriske undergrupper (se pkt.
The short term safety profiles in the different paediatric subsets were also similar (see Section 5.1).
Systemisk eksposition for latanoprost-syre var ca. 2 gange højere hos børn i alderen 3 - < 12 år og 6 gange højere hos børn < 3 år sammenlignet med voksne, men en bred sikkerhedsmargin mht. systemiske bivirkninger blev opretholdt (se pkt.
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).
Median plasmahalveringstid var kort (< 20 minutter), var den samme for pædiatriske og voksne patienter og resulterede ikke i akkumulering af systemisk latanoprost ved steady-state.
The median plasma elimination half-life was short (<20 minutes), similar for paediatric and adult patients, and resulted in no accumulation of latanoprost acid in the systemic circulation under steady-state conditions.
Xalatan kan anvendes hos voksne mænd og kvinder (herunder ældre) og børn fra fødslen til 18 år.
BEFORE YOU USE {INVENTED NAME} {Invented name} can be used in adult men and women (including the elderly) and in children from birth to 18 years of age.
Hvis De eller Deres barn bruger kontaktlinser, skal disse tages ud, inden De drypper øjnene med Xalatan.
If you or your child wear contact lenses, they should be removed before using Xalatan.
Pfizer AB Vetenskabsvägen 10, SE-191 90 Sollentuna Sweden
Vetenskapsvagen 10, SE 191 90 Sollentuna Sweden
Den endelige udgave af CRF'en skal vedlægges protokollen for undersøgelse A6111143, - en redegørelse fra indehaveren af markedsføringstilladelsen om, hvorvidt OCT-teknikken (optisk kohærenstomografi) kan anbefales, i protokollens bilag I om "anbefalede vurderingsmetoder", - PASS-undersøgelserne (sikkerhedsundersøgelserne efter godkendelsen) skal omfatte en sammenligning mellem maculaødem, som er indberettet hos patienter uden øjelinse og hos patienter med øjelinse,
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;
Reduktion af forhøjet intraokulært tryk hos børn med forhøjet intraokulært tryk og pædiatrisk glaukom.
Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.
De periodiske, opdaterede sikkerhedsindberetninger skal omfatte en separat gennemgang af lægemiddelinteraktionerne hos den pædiatriske population samt af de aktuelle tal og tallene for personer, der er tabt for follow-up, i PASS-undersøgelserne.
The PSURs will include a separate review on drug interaction in the paediatric population and on the current and lost to follow up numbers in PASSs;
Efter drypning med Xalatan skal De vente 15 minutter, inden De sætter kontaktlinserne i igen.
After using Xalatan you should wait 15 minutes before putting the contact lenses back into the eyes.
For nyfødte skulle gestationsalderen være mindst 36 uger.
Neonates were required to be at least 36 weeks gestational age.
Effekt- og sikkerhedsdata i aldersgruppen < 1 år (4 patienter) er meget begrænsede (se pkt.
Efficacy and safety data in the age group < 1 year (4 patients) are very limited (see Section 5.1).
I to korttids-kliniske forsøg (≤ 12 uger) med 93 pædiatriske patienter (henholdsvis 25 og 68) svarede sikkerhedsprofilen til den, der blev set for voksne, og der blev ikke se nogen nye bivirkninger.
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.
Brug Xalatan, som Deres læge eller Deres barns læge har anvist, indtil De får besked på at ophøre med behandlingen.
Use Xalatan as instructed by your doctor, or the doctor treating your child until they tell you to stop.
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E)OG INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES