natgillin/translations-raw huggingface dataset:
Det gennemsnitlige procentvise fald i lipidparametre var ens for begge kohorter, uanset om forsøgspersonerne fik uændret initialdosis eller fik fordoblet initialdosis.
The mean percent decreases in lipid parameters were similar for both cohorts, regardless of whether subjects remained at their initial dose or doubled their initial dose.
Legemsvægt var den eneste signifikante covariant i den farmakokinetiske model for atorvastatinpopulationen.
Body weight was the only significant covariate in atorvastatin population PK model.
<[Udfyldes nationalt]> {Navn og adresse} <{tlf}> <{fax}> <{email}>
[To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Kohorte A omfattede 15 børn i alderen 6-12 år i Tanner-stadie 1.
Cohort A included 15 children, 6 to 12 years of age and at Tanner Stage 1.
Børn og unge bør kun behandles af specialister inden for pædiatrisk hyperlipidæmi, og patienterne bør regelmæssigt revurderes for at vurdere virkningen af behandlingen.
Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-evaluated on a regular basis to assess progress.
• Indsendelse af PSUR genstartes for Zarator (og tilhørende navne) som følger: o Halvårlige PSUR, indtil der er opnået to års erfaring med den pædiatriske indikation i EU o Årlige PSUR i de efterfølgende 2 år o Derefter PSUR hvert 3. år Disse PSUR bør fokusere på brug hos den pædiatriske population.
• Restart the cycle of PSUR submission for Sortis and associated names as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Almindelig: Forhøjet alaninaminotransferase, forhøjet serum-kreatinfosfokinase Ud fra de tilgængelige data forventes frekvens, type og alvorlighed af bivirkningerne hos børn og unge at være de samme som hos voksne.
Common: Alanine aminotransferase increased, blood creatine phosphokinase increased Based on the data available, frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
s r.o., Stroupežnického 17, 150 00 Prague 5, Czech Republic
s r.o., Stroupežnického 17, 150 00 Prague 5,
UDLØBSDATO EXP
EXPIRY DATE EXP:
Hyperkolesterolæmi:
Hypercholesterolaemia:
Lægen vil vurdere, om dosis skal justeres efter 4 uger.
Your doctor will adapt the dosage at intervals of 4 weeks or more.
BILAG II ÆNDRINGER TIL PRODUKTRESUMÉ, MÆRKNING OG INDLÆGSSEDDEL
ANNEX II AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
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 PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Et særligt klinisk program (”compassionate use”) med patienter med svær hyperkolesterolæmi (inklusive homozygot hyperkolesterolæmi) omfattede 46 pædiatriske patienter behandlet med atorvastatin titreret til respons (nogle patienter fik 80 mg atorvastatin dagligt).
A compassionate use study in patients with severe hypercholesterolaemia (including homozygous hypercholesterolaemia) included 46 paediatric patients treated with atorvastatin titrated according to response (some subjects received 80 mg atorvastatin per day).
RMP skal desuden inkludere det igangværende kliniske forsøg A2581173 (3-year study of the safety and follow-up study of efficacy of atorvastatin treatment of children and adolescents aged 6 years to less than 18 years with heterozygous familial hypercholesterolaemia).
The Risk Management Plan should include the ongoing study A2581173 (3-year study of the safety and follow-up study of efficacy of atorvastatin treatment of children and adolescents aged 6 years to less than 18 years with heterozygous familial hypercholesterolaemia).
Vigtig information om nogle af de øvrige indholdsstoffer i Zarator Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt dem, at De ikke tåler visse sukkerarter.
Important information about some of the ingredients of {PRODUCT NAME} If youhave been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Kohorte B omfattede 24 børn i alderen 10-17 år i Tanner-stadie ≥ 2.
Cohort B included 24 children, 10 to 17 years of age and at Tanner Stage 2.
Der er begrænset erfaring med behandling af børn i alderen 6-10 år (se pkt.
There is limited experience in children between 6-10 years of age (see section 5.1).
Blisteren består af en folie af polyamid/aluminiumsfolie/polyvinylchlorid samt en alluminiumsfolie/vinyl/acryl varmeforseglet bagside.
The blisters consist of a forming foil made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl/acryl heat-seal coating.
Erfaring med brug hos børn er begrænset til et lille antal patienter (4-17 år) med svær dyslipidæmi som f.eks. homozygot familiær hyperkolesterolæmi.
Experience in pediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
Zarator tyggetabletter kan tygges eller synkes hele med et glas vand og kan tages på alle tider af døgnet, med eller uden mad.
{PRODUCT NAME} tablets can be chewed or swallowed whole with a drink of water, and can be taken at any time of day, with or without food.
1 Zarator 5 mg tyggetablet indeholder 0,625 mg aspartam.
Each {PRODUCT NAME} 5 mg chewable tablet contains 0.625 mg aspartame.
Zarator tyggetabletter skal kan tygges eller synkes hele med et glas vand og kan tages på et hvilket som helst tidspunkt af døgnet med eller uden mad.
{PRODUCT NAME} tablets can be chewed or should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food.
Zarator findes som tyggetabletter på 5 mg, 10 mg, 20 mg og 40 mg, samt som filmovertrukne tabletter på 10 mg, 20 mg, 40 mg og 80 mg.
This medicine is available as 5 mg, 10 mg, 20 mg and 40 mg chewable tablets and 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets.
Ved uge 8 var den gennemsnitlige procentvise ændring fra baseline i LDL-cholesterol og total-cholesterol hhv. ca. 40 % og 30 % over hele gruppen.
At Week 8, on average, the percent change from baseline in LDL-C and TC was approximately 40% and 30%, respectively, over the range of exposures.
Gennemsnitlig LDL-cholesterol på 3,38 mmol/l (1,81-6,26 mmol/l) i atorvastatingruppen sammenlignet med 5,91 mmol/l (3,93-9,96 mmol/l) i placebogruppen blev nået i løbet af de første 26 uger (dobbelt-blindede fase).
The mean achieved LDL-C value was 3.38 mmol/l (range: 1.81-6.26 mmol/l) in the atorvastatin group compared to 5.91 mmol/l (range: 3.93-9.96 mmol/l) in the placebo group during the 26week double-blind phase.
Øvrige indholdsstoffer: calciumcarbonat, mikrokrystallinsk cellulose, croscarmellosenatrium, polysorbat 80, hydroxypropylcellulose, pregelatineret stivelse, mannitol, aspartam, sucralose, vindruesmag samt magnesiumstearat.
{PRODUCT NAME} tablets also contain the inactive ingredients: calcium carbonate, microcrystalline cellulose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, amylum pregelificatum, mannitol, aspartame, sucralose, grape flavour and magnesium stearate.
Hvide til råhvide, runde tyggetabletter med lyserøde til violette prikker, præget med ”5” på den ene side og ”Pfizer” på den anden side.
White to off-white, round chewable tablets with pink to purple specks, debossed "5" on one side and “Pfizer” on the other measuring 5.6 mm in diameter.
Atorvastatin-dosis var 10 mg 1 gang dagligt i de første 4 uger og blev derefter titreret til 20 mg, hvis LDL-cholesterol var > 3,36 mmol/l.
The dosage of atorvastatin (once daily) was 10 mg for the first 4 weeks and up-titrated to 20 mg if the LDL-C level was >3.36 mmol/l.
Kan være skadelig for patienter med fenylketonuri (PKU, Føllings sygdom).
May be harmful for people with phenylketonuria.
Pædiatrisk brug Udviklingsmæssig sikkerhed i den pædiatriske population er ikke blevet undersøgt (se pkt.
Developmental safety in the paediatric population has not been established (see section 4.8).
Heterozygot familiær hyperkolesterolæmi hos pædiatriske patienter i alderen 6-17 år
Heterozygous Familial Hypercholesterolaemia in Paediatric Patients aged 6-17 years old
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 30 tyggetabletter
PHARMACEUTICAL FORM AND CONTENTS 30 chewable tablets
Den tilsyneladende clearance efter oral administration var sammenlignelig med voksnes efter korrektion for legemsvægt ved allometrisk skalering.
Apparent oral clearance of atorvastatin in paediatric subjects appeared similar to adults when scaled allometrically by body weight.
Heterozygot familiær hyperkolesterolæmi hos pædiatriske patienter i alderen 10-17 år
Heterozygous Familial Hypercholesterolaemia in Paediatric Patients aged 10-17 years old
4.5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction {To be completed nationally}.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister
MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTERS
Zarator tyggetabletter indeholder aspartam, en phenylalaninkilde.
{PRODUCT NAME} chewable tablet contains aspartame which is a source of phenylalanine.
Et 8-ugers, open-label klinisk forsøg til evaluering af farmakokinetik, farmakodynamik samt sikkerhed og tolerabilitet af atorvastatin blev udført med børn og unge med genetisk bekræftet heterozygot familiær hyperkolesterolæmi og baseline LDL-cholesterol ≥ 4 mmol/l.
An 8-week, open-label study to evaluate pharmacokinetics, pharmacodynamics, and safety and tolerability of atorvastatin was conducted in children and adolescents with genetically confirmed heterozygous familial hypercholesterolemia and baseline LDL-C 4 mmol/L.
Den sædvanlige startdosis af Zarator er 10 mg 1 gang dagligt til voksne og børn over 10 år.
The usual starting dose of {PRODUCT NAME} is 10 mg once a day in adults and children aged 10 years or older.
- Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
If you have any further questions, ask your doctor or pharmacist.
• Indsendelse af et risikostyringsprogram (RMP) (eller opdatering heraf) for Zarator (og tilhørende navne) på nationalt niveau.
• Submit a Risk Management Plan (or its update) for Sortis and associated names at National level, taking into account the new paediatric data and the CHMP recommendations.
I et dobbelt-blindet, placebokontrolleret klinisk forsøg efterfulgt af en periode med open-label blev 187 drenge og piger (der havde fået første menstruation) i alderen 10-17 år (gennemsnit 14,1 år) med heterozygot familiær hyperkolesterolæmi eller svær hyperkolesterolæmi randomiseret til enten atorvastatin (n=140) eller placebo (n=47) i 26 uger, hvorefter alle fik atorvastatin i 26 uger.
In a double-blind, placebo controlled study followed by an open-label phase, 187 boys and postmenarchal girls 10-17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolaemia (FH) or severe hypercholesterolaemia were randomised to atorvastatin (n=140) or placebo (n=47) for 26 weeks and then all received atorvastatin for 26 weeks.
Aktivt stof: atorvastatin.
The active substance of {PRODUCT NAME} is atorvastatin.
Heriblandt var 7 patienter < 6 år, 14 patienter var mellem 6 og 9 år og 228 patienter var mellem 10 og 17 år.
The clinical safety database includes safety data for 249 paediatric patients who received atorvastatin, among which 7 patients were < 6 years old, 14 patients were in the age range of 6 to 9, and 228 patients were in the age range of 10 to 17.
Børn og unge Børn bør kun behandles af specialister.
Pediatric use should only be carried out by specialists.
4.9 Overdosering [Udfyldes nationalt]
4.9 Overdose {To be completed nationally}.
1 tablet indeholder 5 mg atorvastatin som atorvastatincalciumtrihydrat.
Each tablet contains 5 mg of atorvastatin as atorvastatin calcium trihydrate.
Zarator er indiceret som supplement til diæt ved forhøjet total-cholesterol, LDL-cholesterol, apolipoprotein B og forhøjede triglycerider hos patienter voksne, unge samt børn over 10 år med primær hyperkolesterolæmi inklusive familiær hyperkolesterolæmi (heterozygot variant) eller kombineret hyperlipidæmi (svarende til type IIa og IIb i Fredericksons klassifikation), hvor diæt og andre ikke farmakologiske foranstaltninger er utilstrækkelige.
Hypercholesterolaemia {PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
I et 8-ugers, open-label klinisk forsøg, blev børn i alderen 6-17 år og i Tanner-stadie 1 (n=15) eller Tanner-stadie ≥ 2 (n=24) med heterozygot familiær hyperkolesterolæmi og baseline LDL-cholesterol ≥ 4 mmol/l behandlet med hhv. 5 mg eller 10 mg tyggetabletter eller 10 mg eller 20 mg filmovertrukne tabletter 1 gang dagligt.
In an openlabel, 8-week study, Tanner Stage 1 (N=15) and Tanner Stage 2 (N=24) paediatric patients (ages 6-17 years) with heterozygous familial hypercholesterolemia and baseline LDL-C 4 mmol/L were treated with 5 or 10 mg of chewable or 10 or 20 mg of filmcoated atorvastatin tablets once daily, respectively.
Zarator findes i en blisterpakning, der indeholder 30 tyggetabletter.
{PRODUCT NAME} are available in blister packs containing 30 chewable tablets.
Det europæiske Lægemiddelagentur (EMA) har dispenseret fra kravet om fremlæggelse af resultaterne fra studier med atorvastatin hos børn i alderen 0-6 år til behandling af heterozygot hyperkolesterolæmi og hos børn i alderen 0-18 år til behandling af af homozygot familiær hyperkolesterolæmi, kombineret hyperkolesterolæmi, primær hyperkolesterolæmi og til forebyggelse af kardiovaskulære hændelser (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with atorvastatin in children aged 0 to less than 6 years in the treatment of heterozygous hypercholesterolaemia and in children aged 0 to less than 18 years in the treatment of homozygous familial hypercholesterolaemia, combined (mixed) hypercholesterolaemia, primary hypercholesterolaemia and in the prevention of cardiovascular events (see section 4.2 for information on paediatric use).
6.2 Uforligeligheder [Udfyldes nationalt]
6.2 Incompatibilities {To be completed nationally}.
Atorvastatin sænkede signifikant total-cholesterol, LDL-cholesterol, triglycerider og apolipoprotein B i de første 26 uger
Atorvastatin significantly decreased plasma levels of totalC, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
ÆNDRINGER TIL DE RELEVANTE DELE AF MÆRKNINGSTEKSTEN
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE LABELLING
Forebyggelse af kardiovaskulære hændelser hos patienter, som har en høj risiko for debut af en kardiovaskulær hændelse (se pkt.
Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event (see Section 5.1), as an adjunct to correction of other risk factors.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 tyggetablet indeholder 5 mg atorvastatin (som atorvastatincalciumtrihydrat).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 5 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Ved behandling af børn og unge skal der tages højde for de oven for nævnte interaktioner for voksne og for advarslerne i pkt.
The above mentioned interactions for adults and the warnings in section 4.4 should be taken into account for the paediatric population.
Der er begrænset erfaring med sikkerhed ved langtidsbehandling hos børn og unge.
There is currently limited experience with respect to longterm safety in the paediatric population.
Zarator er også indiceret til at nedsætte total-cholesterol og LDL-cholesterol hos patientervoksne med homozygot familiær hyperkolesterolæmi som supplement til anden lipidsænkende behandling, f.eks. LDL-aferese, eller hvis anden behandling ikke er tilgængelig.
{PRODUCT NAME} is also indicated to reduce total-C and LDL-C in patients adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
6.4 Særlige opbevaringsforhold [Udfyldes nationalt]
6.4 Special precautions for storage {To be completed nationally}.
VoksneDe må højst tage 80 mg Zarator 1 gang dagligt og børn må højst tage 20 mg 1 gang dagligt.
The maximum dose of {PRODUCT NAME}is 80 mg once daily for adults and 20 mg once daily for children.
Anbefalet startdosis til patienter over 10 år er 10 mg dagligt, der kan optitreres til 20 mg dagligt.
For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day.
Dette forsøg viste, at atorvastatin (n=25) gav en singnifikant reduktion af LDL-cholesterol ved uge 26 (p<0,05) sammenlignet med colestipol (n=31).
An additional paediatric study of atorvastatin versus colestipol in patients with hypercholesterolaemia aged 10-18 years demonstrated that atorvastatin (N=25) caused a significant reduction in LDL-C at week 26 (p<0.05) compared with colestipol (N=31).
Brug ikke Zarator efter den udløbsdato (anv.
Do not use {PRODUCT NAME} after the expiry date {EXP:} which is stated on the blister container and outer packaging.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER [Udfyldes nationalt]
OTHER SPECIAL WARNING(S), IF NECESSARY [To be completed nationally].
Magnesiumstearat Hydroxypropylcellulose Pregelatineret stivelse
Hydroxypropyl cellulose
Zarator 5 mg tyggetabletter er runde og hvide til råhvide med lyserøde til violette prikker.
What {PRODUCT NAME} looks like and contents of the pack {PRODUCT NAME} 5 mg chewable tablets are white to off-white with pink to purple specks with a round shape.
LÆGEMIDLETS NAVN Zarator 5 mg tyggetabletter Atorvastatin
NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 5 mg chewable tablets Atorvastatin
INFORMATION I BRAILLE-SKRIFT Zarator 5 mg tyggetabletter
INFORMATION IN BRAILLE {PRODUCT NAME} 5 mg chewable tablets
4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines {To be completed nationally}.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 tyggetablet indeholder 5 mg atorvastatin (som atorvastatincalciumtrihydrat)
STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 5 mg atorvastatin (as calcium salt trihydrate).
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN <[Udfyldes nationalt]> {Navn}
NAME OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally] {Name}
Calciumcarbonat Mikrokrystallinsk cellulose Croscarmellosenatrium Polysorbat 80
Microcrystalline cellulose
Gennemsnitsværdier for LDL-cholesterol, total-cholesterol, VLDL-cholesterol og apolipoprotein B faldt ved uge 2 hos alle forsøgspersoner.
Mean values for LDL-C, TC, VLDL-C, and Apo B decreased by Week 2 among all subjects.
ÆNDRINGER TIL DE RELEVANTE AFSNIT I PRODUKTRESUMÉET
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Denne indlægsseddel blev sidst revideret <måned> <år>
This leaflet was last approved in {MM/YYYY}.
Det skal De vide, før De begynder at tage Zarator 3.
Before you take {PRODUCT NAME} 3.
Tilsvarende hermed sås fald i LDL-cholesterol og total-cholesterol i forhold til atorvastatinog o-hydroxyatorvastatin-niveauer.
Consistent decreases in LDL-C and TC were observed over the range of atorvastatin and o-hydroxyatorvastatin exposures.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
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 pharmacist.
6.6 Regler for destruktion [Udfyldes nationalt]
6.6 Special precautions for disposal {To be completed nationally}.
Virkning og anvendelse 2.
What {PRODUCT NAME} is and what it is used for 2.
ÆNDRINGER TIL DE RELEVANTE DELE AF INDLÆGSSEDLEN
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
Sådan skal De tage Zarator 4.
How to take {PRODUCT NAME} 4.
Atorvastatindosis kunne fordobles, hvis patienten ikke havde nået target-LDL-cholesterol på < 3,35 mmol/l i uge 4, og hvis atorvastatin var veltolereret.
The initial dose of atorvastatin was 5 mg daily of a chewable tablet in Cohort A and 10 mg daily of a tablet formulation in Cohort B. The atorvastatin dose was permitted to be doubled if a subject had not attained target LDL-C of <3.35 mmol/L at Week 4 and if atorvastatin was well tolerated.
-[Udfyldes nationalt]
{To be completed nationally}.
- Lægen har ordineret Zarator til Dem personligt.
This medicine has been prescribed for you.
<[Se bilag I - Udfyldes nationalt]> [For referral procedures]
MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
6.5 Emballagetype og pakningsstørrelser Blisterpakning med 30 tyggetabletter.
Blister packs containing 30 chewable tablets.
BIVIRKNINGER [Udfyldes nationalt]
POSSIBLE SIDE EFFECTS {To be completed nationally}.
Særlige patientgrupper: -[Udfyldes nationalt] - Børn: Der findes ikke farmakokinetiske data hos børn.
Paediatric: Pharmacokinetic data in the paediatric population are not available.
Hyperkolesterolæmi
Calcium carbonate
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use {To be completed nationally}.
Advarsler og forforsigtighedsregler
Warnings and precautions
Produktinformationen kan efterfølgende opdateres af medlemsstaternes kompetente myndigheder i overensstemmelse med proceduren i kapitel 4 i afsnit III i direktiv 2001/83 / EF i samarbejde med referencemedlemsstaten.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Disse ændringer til de relevante afsnit af produktinformationen er resultatet af henvisningsproceduren.
These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Derfor anbefales administration af <produkt> til forebyggelse af lungebetændelse ikke.
Therefore, the administration of <product> to prevent pneumonia is not recommended.
[For alle produkter i bilag I ændres den eksisterende produktinformation (indsættelse, udskiftning eller sletning af teksten, hvor det er relevant) for at afspejle den aftalte formulering som angivet nedenfor]
[For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Der foreligger ingen data fra kliniske undersøgelser, der kan påvise, at brugen af <produkt> kan forebygge lungebetændelse.
No data from clinical studies are available to demonstrate that the use of <product> can prevent pneumonia.
Anvendelse af <produkt> til forebyggelse af lungebetændelse anbefales ikke, da der ikke foreligger data fra kliniske undersøgelser, der kan påvise en sådan virkning.
The use of <product> in the prevention of pneumonia is not recommended, as no data from clinical studies are available to demonstrate such effect.
Bilag III Ændringer til relevante afsnit af produktinformationen
Annex III Amendments to relevant sections of the Product Information
Profylakse af tilbagevendende øvre luftvejsinfektioner (RTI) hos <aldersgruppe>.
Prophylaxis of recurrent upper respiratory tract infections (RTI) in <age group>.