natgillin/translations-raw huggingface dataset:
Når Pemetrexed Krka gives sammen med cisplatin, bør der desuden før og efter cisplatindosen gives medicin mod kvalme (for at forhindre opkastning) samt væsketilskud (for at forhindre dehydrering).
When Pemetrexed Krka is given with cisplatin, an antiemetic medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
For at mindske bivirkningerne ved bør patienten under behandlingen med Pemetrexed Krka få binyrebarkhormon (en type lægemiddel, der mindsker inflammation), folsyre (en type vitamin) og indsprøjtninger med B12vitamin.
To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Krka.
Hvordan er Pemetrexed Krka blevet undersøgt?
How has Pemetrexed Krka been studied?
Hvis patienten får lave blodtal, eller der opstår visse andre bivirkninger, bør behandlingen udsættes eller standses, eller dosis nedsættes.
Treatment should be delayed or stopped, or the dose reduced, in patients whose blood cell counts are low or who have certain other side effects.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pemetrexed Krka.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Krka have been included in the summary of product characteristics and the package leaflet.
Pemetrexed Krka fås som et pulver, der efter opløsning indgives ved infusion (drop) i en blodåre.
Pemetrexed Krka is available as a powder that is made up into a solution for infusion (drip) into a vein.
I kræftceller omdannes pemetrexed hurtigere til den aktive form end i normale celler.
Pemetrexed is converted into its active form more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Dannelsen af DNA og RNA bremses derved af den aktive form af pemetrexed.
As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing.
Hvordan virker Pemetrexed Krka?
How does Pemetrexed Krka work?
Hvordan anvendes Pemetrexed Krka?
How is Permetrexed Krka used?
Proceduren indledtes den 17. oktober 2002.
The procedure started on 17 October 2002.
CPMP vedtog derfor en positiv udtalelse den 20. februar 2003.
The CPMP adopted a positive opinion on 20 February 2003.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 25. juni
The final opinion was converted into a decision by the European Commission on 25 June 2003.
London, 20 August 2003 EMEA/CPMP/4260/03/da
London, 20 August 2003 EMEA/CPMP/4260/03/en
Referencemedlemsstaten under den gensidige anerkendelsesprocedure er Irland med Østrig, Belgien, Danmark, Tyskland, Grækenland, Island, Italien, Luxembourg, Norge, Portugal, Spanien og Sverige som berørte medlemsstater.
The Reference Member State for this MRP was Ireland with Austria, Belgium, Denmark, Germany, Greece, Finland, Iceland, Italy, Luxembourg, Norway, Portugal, Spain, and Sweden as Concerned Member States.
Indehaveren af markedsføringstilladelsen fremsendte yderligere oplysninger den 11. november 2002 og fremsendte yderligere skriftlige redegørelser den 5. februar 2003.
Supplementary information was provided by the Marketing Authorisation Holder on 11 November 2002 and further written explanations on 5 February 2003.
De faglige konklusioner og begrundelserne for ændringen af produktresuméet fremgår af bilag II.
The scientific conclusions and the grounds for the amendment of the Summary of Product Characteristics are set out in Annex II.
Primær hyperhydrosis er en kronisk idiopatisk sygdom med kraftig og ukontrollerbar sveden.
Primary hyperhydrosis is a chronic idiopathic disorder of excessive and uncontrolled sweating.
I juni 2002 ansøgte Allergan Pharmaceuticals (Irland) Ltd, indehaveren af markedsføringstilladelsen, om en ny indikation under proceduren for gensidig anerkendelse af markedsføringstilladelserne for Botox vedrørende behandling af aksillær hyperhidrosis.
In June 2002, the Marketing Authorisation Holder, Allergan Pharmaceuticals (Ireland) Ltd applied for a new indication through Mutual Recognition Procedure (MRP), for Botox for the treatment of axillary hyperhidrosis.
Den 3. september 2002 blev der i henhold til artikel 29 i direktiv 2001/83/EF indbragt en sag med henblik på voldgift af Tyskland og Italien, som berørte væsentlige indsigelser vedrørende virkning og klinisk sikkerhed af lægemidlet Botox til den nye indikation.
On September 3rd 2002 a referral for arbitration according to article 29 of Directive 2001/83/EC was triggered by Germany and Italy regarding the major objections on the clinical safety and efficacy of this new indication for the medicinal product Botox.
Botox blev godkendt første gang i Den Europæiske Union i 1994 til intramuskulær behandling af neuromuskulære lidelser.
Botox was first licensed in the European Union in 1994 for neuromuscular disorders via intramuscular route.
Efter at CPMP har behandlet de punkter, hvorom der er uenighed, og de svar, der er afgivet af indehaveren af markedsføringstilladelsen, er CPMP af den opfattelse, at de af Tyskland og Italien rejste indsigelser ikke bør forhindre udstedelse af en markedsføringstilladelse for den nye indikation, forudsat at en række vigtige betingelser til sikring af en sikker og effektiv anvendelse af lægemidlet er opfyldt.
The CPMP, having considered the points of disagreement and the responses provided by the Marketing Authorisation Holder, was of the opinion that the objections raised by Germany and Italy should not prevent the granting of a Marketing Authorisation for the new indication “persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment” subject to certain essential conditions for the safe and effective use of the medicinal product.
Virkemåden for Botox ved hyperhidrosis anses for at være hæmning af kolinergt induceret heftig sveden ved at blokere de autonome sympatiske nervefibre, som innerverer svedkirtlerne.
The mechanism of action of Botox in hyperhidrosis is thought to be the inhibition of cholinergically-induced excessive sweating by blockage of autonomic sympathetic nerve fibres innervating sweat glands.
Botox [Clostridium botulinum toksin type A neurotoksinkompleks] hæmmer frigivelse af acetylkolin ved præsynaptisk membran på kolinerge neuroner.
Botox [Clostridium botulinum toxin type A neurotoxin complex] inhibits the release of acetylcholine at the presynaptic membrane on cholinergic neurons.
UDVALGET FOR FARMACEUTISKE SPECIALITETER (CPMP) SAMMENFATTENDE OPLYSNINGER OM UDTALELSEN OM DEN INDBRAGTE SAG EFTER VOLDGIFTEN I HENHOLD TIL ARTIKEL 29 I DIREKTIV 2001/83/EF BOTOX Aktivt stof: Clostridium botulinum type A neurotoksinkompleks
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) SUMMARY INFORMATION ON REFERRAL OPINION FOLLOWING ARBITRATION PURSUANT TO ARTICLE 29 OF COUNCIL DIRECTIVE 2001/83/EC FOR
Yderligere oplysninger).
Further information).
Desuden skal der fremsendes en opdateret RMP:
In addition, an updated RMP should be submitted:
Risikostyringsprogram (RPM)
Risk Management plan (RMP)
Se venligst produktinformationen for:
Please consult the Product Information of:
Loc. Bellaria - 53018 Rosia - Sovicille (SI) Italien
Loc. Bellaria - 53018 Rosia - Sovicille (SI) Italy
Influenzavaccine, ATC-kode: J07BB02
Influenza vaccine, ATC Code: J07BB02
De rapporterede bivirkninger er opstillet efter følgende hyppighed: Meget almindelig (1/10),
Adverse reactions reported are listed according to the following frequency: Very common (1/10),
Fortæl det til lægen, hvis du har nogen kendte allergier.
Tell your doctor if you have any known allergies.
Ingen af ingredienserne i vaccinen kan give influenza.
None of the ingredient in the vaccine can cause flu.
Immunisering bør udskydes hos patienter med alvorlig febril sygdom eller akut infektion.
Immunisation should be postponed in patients with severe febrile illness or acute infection.
I sådanne tilfælde skal du være klar over, at bivirkningerne kan være mere intense.
In such cases, you should be aware that the side effects may be more intense.
Lægerne er opmærksomme på denne mulighed og har nødbehandling til rådighed i disse tilfælde.
Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Co-administration blev ikke associeret med højere forekomster af lokale eller systemiske reaktioner sammenlignet med administration af Focetria alene.
Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Focetria alone.
Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Der blev udført et klinisk studie hos børn med den samme vaccine.
A clinical study was conducted with the same vaccine in children.
- hvis du har en alvorlig infektion og feber (temperatur over 38 °C).
• if you have a severe infection with a high temperature (over 38°C).
I disse tilfælde vil Western Blot-teknikken give et negativt resultat.
In such cases, the Western Blot method is negative.
Induration var en almindelig reaktion hos børn, men mindre almindelig hos spædbørn.
Induration was a common reaction in toddlers but was less common in infants.
CHMP er enig i PRAC's videnskabelige konklusioner.
The CHMP agrees with the scientific conclusions made by the PRAC.
• Når der modtages nye oplysninger, der kan have indflydelse på den gældende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Der var færre bivirkninger efter den anden vaccination end efter den første.
There were fewer reactions after the second vaccination compared with the first.
I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
• Official batch release In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
De almindelige reaktioner forsvinder som regel inden for 1-2 dage uden behandling.
The common reactions usually disappear within 1-2 days without treatment.
Immunresponset over for sæsonbetingede antigener var tilfredsstillende.
The immune response to the seasonal antigens was satisfactory.
Der findes sikkerhedsdata for gravide kvinder, som er blevet eksponeret for Focetria, især under andet og tredje trimester.
Safety data are available in pregnant women exposed to Focetria in particular during second and third trimesters.
Vaccinen indeholder et ‘adjuvans' (MF59C.1), der skal stimulere en bedre reaktion.
The vaccine contains an ‘adjuvant' (MF59C.1) to stimulate a better response.
Farmakoterapeutisk klassifikation: Vacciner.
Pharmacotherapeutic group: Vaccines.
Dette er en flerdosisbeholder.
This is a multidose container.
Det er almindeligt accepteret, at adjuvanseffekten, som medfører øget immunogenicitet, er forbundet med en let forøget hyppighed af lokale reaktioner (især lette smerter) sammenlignet med konventionelle, ikke-adjuverede influenzavacciner.
It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
Vaccinen vil blive sprøjtet ind i en muskel (normalt i overarmen).
The vaccine will be injected into a muscle (usually in the upper arm).
Disse bivirkninger forsvinder normalt i løbet af 1-2 dage uden behandling.
These side effects usually disappear within 1-2 days without treatment.
Disse bivirkninger kan opstå i forbindelse med Focetria.
These side effects may occur with Focetria.
Pakninger med 1 og 10.
Packs of 1 and 10.
Lægemidlets PSUR-cyklus skal følge en halvårlig cyklus, indtil andet aftales med CHMP.
The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP
Focetria bør anvendes i overensstemmelse med officielle retningslinjer.
Focetria should be used in accordance with Official Guidance.
Under hensyntagen til PRAC's vurderingsrapport om PSUR'erne for Focetria er PRAC nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for Focetria, the scientific conclusions of PRAC are as follows:
Herudover er bivirkningerne i listen nedenfor er opstået i dagene eller ugerne efter vaccinationen med adjuverede og ikke-adjuverede vacciner, som gives rutinemæssigt en gang om året for at forebygge influenza.
In addition, the side effects listed below have occurred in the days or weeks after vaccination with adjuvanted and non-adjuvanted vaccines given routinely every year to prevent flu.
• Senest 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering)
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Systemisk
Systemic
Disse forbigående falsk-positive reaktioner kan skyldes produktion af IgM som respons på vaccinen.
These transitory false positive results may be due to IgM production in response to the vaccine.
Som med alle injicerbare vacciner skal relevant medicinsk behandling samt mulighed for overvågning altid være let tilgængelig i tilfælde af en sjælden anafylaktisk reaktion efter indgift af vaccinen.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Feber ≥ 40° C
Fever ≥ 40° C
I de kliniske studier med vaccinen var de fleste bivirkninger milde og kortvarige.
In the clinical studies with the vaccine, most side effects were mild in nature and short term.
Adjuvans MF59C.1, som indeholder: squalen
Adjuvant MF59C.1 containing: squalene
9,75 milligram polysorbat 80
9.75 milligrams polysorbate 80
Vasculitis med forbigående nyrepåvirkning og ekssudativ erythema multiforme.
Vasculitis with transient renal involvement and exudative erythema multiforme.
I lyset af de tilgængelige data vedrørende anvendelse af Focetria under graviditet vurderede PRAC derfor, at ændringerne i produktresumeet var berettigede.
Therefore, in view of available data regarding the use of Focetria during pregnancy, the PRAC considered that changes to the product information were warranted.
Bivirkninger under kliniske studier med børn
Side effects from clinical studies in children
De fleste reaktioner var milde, kortvarige og kvalitativt på samme niveau som dem, der blev induceret af konventionelle sæson-influenzavacciner.
Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Sundhedspersonalet skal afveje fordelene i forhold til de potentielle risici ved at administrere Focetria vaccine til gravide kvinder under hensyntagen til de officielle anbefalinger.
Health care providers need to assess the benefits and potential risks of administering Focetria vaccine to pregnant women, taking into consideration official recommendations.
21 dage efter 2. dosis (dag 43)
21 days after 2nd dose (day 43)
Sikkerhedsdata efter første og anden dosis i børn og unge indikerer en tilsvarende sikkerhedsprofil som rapporteret for H5N1 mock-up vaccine-formuleringen.
Safety data after the first and second dose in children and adolescents suggest a comparable safety profile with that reported for the H5N1 mock-up vaccine formulation.
- hvis du skal have taget en blodprøve for at afgøre, om du har bestemte virusinfektioner.
• if you are having a blood test to look for evidence of infection with certain viruses.
• De dataelementer, der som minimum skal oplyses i individuelle sikkerhedsindberetninger for at muliggøre evaluering og identificering af den specifikke vaccine, der er anvendt til hver enkelt person, herunder produktnavn, producenten af vaccinen og batchnummeret.
• The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the batch number.
Focetria indeholder
Focetria contains
En mindre infektion, såsom en forkølelse, er normalt ikke nogen hindring, men din læge eller sygeplejerske afgør, om du alligevel kan vaccineres med Focetria.
A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with Focetria,
Bivirkningerne i listen nedenfor er opstået i dagene eller ugerne efter vaccinationen med Focetria.
The side effects listed below have occurred in the days or weeks after vaccination with Focetria.
Spontant rapporterede bivirkninger efter markedsføringen, et interventionsstudie og store observationsstudier indikerer ikke direkte eller indirekte skadelige påvirkninger hos gravide, der eksponeres for Focetria.
Postmarketing spontaneously reported adverse events, an interventional study and large observational studies do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Børn under 6 måneder: Det anbefales ikke at vaccinere denne aldersgruppe
Children aged less than 6 months of age: Vaccination is currently not recommended in this age group.
Instruktioner i indgivelse af vaccinen:
Instructions for administration of the vaccine:
• Sikkerheds- og immunogenicitetsdata indhentet efter administration af en eller to doser Focetria
• Safety and immunogenicity data obtained after administration of a one or two doses of Focetria
Mellem hver brug returneres multidosishætteglas til anbefalede opbevaringsbetingelser mellem 2 og 8° C (36° og 46° F).
Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C (36° and 46° F).
Bivirkningerne nedenfor er opstået under kliniske studier med Focetria hos voksne, inklusive ældre:
The side effects listed below have occurred with Focetria in clinical studies in adults, including the elderly:
Det anbefales ikke at vaccinere denne aldersgruppe.
Vaccination is not currently recommended in this age group.
• Studier hos voksne og ældre
• Studies in adults and elderly
Opbevares i køleskab (2° C - 8° C).
Store in a refrigerator (2°C - 8°C).
Immunogenicitetsdata, indhentet tre uger efter en dosis Focetria H1N1v, indikerer, at en enkelt dosis kan være tilstrækkeligt.
Immunogenicity data obtained at three weeks after one dose of Focetria H1N1v suggest that a single dose may be sufficient.
Det er vigtigt at være særlig opmærksom på personer, der lider af epilepsi, og lægen skal informere personerne (eller forældrene) om risikoen for at opleve kramper (se pkt.
Particular attention should be given to subjects suffering from epilepsy and the physician should inform the subjects (or parents) about the possibility to experience convulsion.
Bortskaffes i henhold til lokale krav.
Dispose of in accordance with local requirements
Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Focetria can cause side effects, although not everybody gets them.
Sjælden: Forbigående trombocytopeni.
Rare: Transient thrombocytopenia.
Citronsyre,
Citric acid,
Data fra vaccinationer med sæsonbestemte inaktiverede trivalente vacciner hos gravide kvinder indikerer heller ikke, at negative resultater hos føtus eller moder skyldtes vaccinen.
Further, data from vaccinations with seasonal interpandemic inactivated trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Bivirkningerne ligner generelt dem, der også opstår i forbindelse med vaccinen mod sæsonbetinget influenza.
The side-effects are generally similar to those related to the seasonal flu vaccine.
Data antyder, at multidosishætteglas kan anvendes op til maksimalt 72 timer efter første udtrækning, men en sådan forlænget opbevaring bør ikke udgøre en foretrukket måde.
Data are available that suggest that multidose vials could be used up to a maximum of 72 hours after first withdrawal, although such pro-longed storage periods should not be the preferred option.
Det bør bemærkes, at bivirkningerne i så fald kan forstærkes.
It should be noted that the adverse reactions may be intensified.
Dette lægemiddel indeholder mindre en 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) per 0,5 ml dosis, hvilket betyder, at det i princippet er natrium- og kaliumfrit.
This medicinal contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium free.
• Indehaveren af markedsføringstilladelsen skal sammen med medlemslandene indgå aftale om tiltag, der vil gøre det lettere at identificere og spore A/H1N1-vaccinen, som administreres til den enkelte patient, for derved at reducere medicineringsfejl og hjælpe patienter og sundhedspersonale med at indberette bivirkninger.
• The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Nervesystemet Meget almindelig: hovedpine Sjælden: konvulsioner
Nervous system disorders Very common: headache Rare: convulsions
1,175 milligram sorbitantrioleat
1.175 milligrams sorbitan trioleate
- Aktivt stof:
- The active substance is:
Børn under 6 måneder:
Children aged less than 6 months:
Du eller dit barn vil modtage én dosis på 0,5 ml vaccine.
You or your child will receive one dose of 0.5 ml vaccine.
10 x 10-doser på 0,5 ml vaccine (5 ml)
10 x 10 doses of 0.5 ml vaccine (5 ml)
Meget almindelige reaktioner hos 233 spædbørn og børn mellem 6 og 35 måneder:
Very common reactions reported in 233 infants and toddlers 6 to 35 months of age:
Lægen bør oplyse dig om, at der kan være en risiko for, at du får kramper, særlig hvis du tidligere har haft krampeanfaldi.
The physician should inform you about the possibility to experience convulsion, in particular if you have had previous history of epilepsy.
- Via Fiorentina, 1 - Siena, Italien.
- Via Fiorentina, 1 - Siena, Italy.
* dyrket i æg ** udtrykt i mikrogram hæmagglutinin
* propagated in eggs ** expressed in microgram haemagglutinin.
Registrér dato og klokkeslet for første udtagning af dosis på mærkaten.
Record date and time of the first dose withdrawal on the vial label.
Doseringsanbefalingerne er baseret på sikkerheds- og immunogenicitetsdata fra kliniske studier med raske forsøgspersoner.
The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects.
Der er indberettet tilfælde af kramper med og uden feber hos personer, der var blevet vaccineret med Focetria.
Cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria.
Baseret på resultaterne fra et observationsstudie med deltagelse af >2.000 gravide, som afspejler brug af Focetria hos gravide kvinder, er influenza A (H1N1) vaccination med Focetria, især i andet og tredje trimester af graviditeten, tilsyneladende ikke forbundet med øget risiko for negative graviditetsresultater.
Based on the findings of an observational study conducted in >2000 pregnant women, reflecting the use of Focetria in pregnant women, influenza A (H1N1) vaccination with Focetria does not seem to be associated with an increased risk of adverse pregnancy outcomes, especially in the second or third trimesters of pregnancy.
Ældre: Én dosis (0,5 ml) af vaccinen og endnu en dosis på 0,5 ml efter mindst tre uger.
Elderly: A dose (0.5 ml) of the vaccine and a second dose of 0.5 ml at least three weeks later.