natgillin/translations-raw huggingface dataset:
Dette kan være personer, som har en kræftsygdom eller som tager medicin, der svækker immunforsvaret. • har mave- tarm- problemer. • har forstyrrelser i udviklingen mht. vægt og vækst. • blev for tidligt født, idet graden af beskyttelse opnået ved vaccination er ukendt for disse børn.
50 Take special care with Rotarix Inform your doctor/health care professional if your child: • has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system. • has any disorder of the gastrointestinal system. • has not been gaining weight and growing as expected. • was born prematurely, because the level of protection afforded by the vaccine is unknown in this case.
Dette gælder også andre vacciner eller medicin, som ikke er købt på recept.
Using other vaccines Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Rotarix kan gives samtidigt med, at dit barn får andre anbefalede vacciner, så som vacciner mod difteri, stivkrampe, kighoste, Haemophilu influenzae type b, polio (oral eller inaktiveret) og hepatitis B, samt pneumokok- vaccine serotype C konjugeret og meningokok- vaccine.
Rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C conjugate vaccines.
Brug af Rotarix sammen med mad og drikke Der er ingen begrænsninger for, hvad dit barn indtager af mad eller drikke hverken før eller efter vaccination.
Using Rotarix with food and drink There are no restrictions on your child’s consumption of food or liquids, either before or after vaccination.
Amning Baseret på viden fra kliniske forsøg, nedsætter amning ikke den beskyttelse mod rotavirus- infektion, som Rotarix giver.
Breast-feeding Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix.
Vigtige information om nogle af de øvrige indholdsstoffer i Rotarix Hvis din lægen har fortalt, at dit barn ikke kan tåle visse sukkerarter, bør du kontakte din læge inden dit barn bliver vaccineret.
Important information about some of the ingredients of Rotarix If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, contact your doctor before using this vaccine.
SÅDAN SKAL ROTARIX GIVES
HOW ROTARIX IS GIVEN
Dit barn skal have to doser af vaccinen.
Your child will receive two doses of the vaccine.
De vil blive givet ved hvert sit besøg med et interval på mindst 4 uger mellem doserne.
Each dose will be given on a separate occasion with an interval of at least 4 weeks between the two doses.
Første dosis gives fra 6- ugers alderen.
The first dose may be given from the age of 6 weeks.
De to doser skal være givet i 24- ugers alderen, dog helst inden 16- ugers alderen.
The two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age.
Hvis dit barn spytter det meste af den indgivne vaccinedosis ud eller eller gylper den op, kan en erstatningsdosis gives med det samme.
In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.
Hvis dit barn modtager Rotarix som første dosis, anbefales det, at dit barn også modtager Rotarix som anden dosis (og ikke en anden slags rotavirus- vaccine).
When Rotarix is given to your child for the first dose, it is recommended that your child also receives Rotarix (and not another rotavirus vaccine) for the second dose.
Hvis du glemmer et besøg, bør du kontakte din læge.
If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.
44 Rotarix kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
51 Like all medicines, Rotarix can cause side effects, although not everybody gets them.
Bivirkninger, som viste sig under de kliniske forsøg med Rotarix, er følgende:
Side effects that occurred during clinical trials with Rotarix were as follows:
♦ Meget almindelig (det sker ved flere end 1 ud af 10 vaccinedoser): • Tab af appetit • Irritabilitet
♦ Very common (These may occur with 1 in 10 doses or more of the vaccine): • loss of appetite • irritability
♦ Almindelig (det sker ved op til 1 ud af 10 vaccinedoser): • Feber, træthed • Diaré, opkastning, gylp af mad, tarmluft, mavesmerter
♦ Common (These may occur with up to 1 in 10 doses of the vaccine): • fever, tiredness • diarrhoea, vomiting, regurgitation of food, flatulence, abdominal pain
♦ Ikke almindelig (det sker ved op til 1 ud af 100 vaccinedoser): • Gråd • Søvnforstyrrelser, søvnighed • Forstoppelse
♦ Uncommon (These may occur with up to 1 in 100 doses of the vaccine): • crying • sleep disorder, sleepiness • constipation
♦ Sjælden (det sker ved op til 1 ud af 1. 000 vaccinedoser): • Infektion i øvre luftveje, hæshed, næseflåd • Betændelse i huden, udslæt • Muskelkramper
♦ Rare (These may occur with up to 1 in 1,000 doses of the vaccine): • infection of the upper respiratory system, hoarseness, runny nose • inflammation of the skin, rash • muscle cramp
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller dit barn får bivirkninger, som ikke er nævnt i 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.
SÅDAN OPBEVARER DU ROTARIX
HOW TO STORE ROTARIX
Brug ikke Rotarix efter den udløbsdato, der står på pakningen.
Do not use Rotarix after the expiry date which is stated on the carton.
Såfremt den rekonstituerede vaccine ikke anvendes inden for 24 timer, bør den smides ud.
If the reconstituted vaccine is not used within 24 hours, it should be discarded.
Rotarix indeholder
What Rotarix contains
-
- The other ingredients in Rotarix are:
Saccharose, dextran, sorbitol, aminosyrer, Dulbecco’ s Modified Eagle Medium
Powder: sucrose, dextran, sorbitol, amino acids, Dulbecco’s Modified Eagle Medium (DMEM)
Calciumcarbonat, xanthangummi, sterilt vand
52 Solvent: calcium carbonate, xanthan gum, sterile water
Rotarix ’ udseende og pakningstørrelse
What Rotarix looks like and contents of the pack
Rotarix sælges som hvidligt pulver i et enkeltdosis glasbeholder og en separat oral applikator fyldt med solvens, som består af et langsomt bundfældende hvidt pulver og en farveløs ovenstående væske.
Rotarix is supplied as a whitish powder in a single dose glass container and a separate oral applicator of solvent which contains a slow settling white deposit and a colourless supernatant.
Det er ikke nødvendigvis alle pakningsstørrelser der er på markedet.
Not all pack sizes may be marketed.
Hvis du vil have yderligere oplysninger om Rotariax skal du henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
46 Ελλάδα GlaxoSmithKline A. E. B. E Tηλ: + 30 210 68 82 100
53 Ελλάδα GlaxoSmithKline A.E.B.E Tηλ: + 30 210 68 82 100
Denne indlægsseddel blev senest godkendt den MM/ ÅÅÅÅ
This leaflet was last approved in {MM/YYYY}.
Du kan finde yderligere information om Rotarix på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu. --------------------------------------------------------------------------------------------------------------------------- Følgende oplysninger er tiltænkt læger og sundhedspersonale:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. ------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
I den orale applikator, som indeholder solvens, ses under opbevaring et hvidt bundfald og en klar væske.
A white deposit and clear supernatant is observed upon storage of the oral applicator containing the solvent.
Solvensen bør inspiceres visuelt for fremmede partikler såvel før som efter omrystning, og for unormalt udseende inden rekonstituering.
The solvent should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to reconstitution.
47 Den rekonstituerede vaccine er en smule mere uklar end solvensen og har et mælkehvidt udseende.
54 The reconstituted vaccine is slightly more turbid than the solvent and is milky white in appearance.
Instruktion for rekonstituering og administration af vaccinen:
Instructions for reconstitution and administration of the vaccine:
Fjern plastikhætten fra glasbeholderen der indeholder pulveret 2.
Remove the plastic cover from the glass container containing the powder.
Injicér hele den orale applikators indhold i glasbeholderen der indeholder pulveret 7.
Transfer the entire content of the oral applicator into the glass container containing the powder.
Træk hele blandingen tilbage i den orale applikator 9.
Withdraw the entire mixture back into the oral applicator.
Indgiv hele indholdet af den orale applikator oralt (indgiv hele indholdet at den orale applikator på indersiden af kinden).
Administer the entire content of the oral applicator orally (by administering the entire content of the oral applicator on the inside of the cheek).
Må ikke injiceres Hvis den rekonstituerede vaccine skal opbevares midlertidigt inden administration, skal den orale applikator påsættes beskyttelseshætten.
If the reconstituted vaccine is to be stored temporarily before administration, replace the protective tip cap on the oral applicator.
48 Overførsels - aggregat
55 Transfer adapter
Fjern plastikforseglingen fra glasbeholderen med frysetørret pulver.
Remove the plastic cover from the glass container containing the powder
Sæt overførselsaggregatet på glasbeholderen ved at presse nedad indtil overførselsaggregatet er placeret sikkert på toppen af glasbeholderen.
Connect the transfer adapter onto the glass container by pushing it downwards until the transfer adapter is properly and securely placed
Omryst kraftigt den orale applikator med suspension.
Shake the oral applicator containing the solvent vigorously.
Den omrystede suspension vil fremstå som en uklar væske med et langsomt sættende hvidt bundfald.
The shaken suspension will appear as a turbid liquid with a slow settling white deposit
orale applikator er påsat og kontroller, at pulveret er suspenderet.
With the oral applicator still attached, shake the glass container and examine it for complete suspension of the powder.
INDLÆGSSEDDEL:
56 PACKAGE LEAFLET:
Lad derfor være med at give Rotarix til andre.
Do not pass it on to others.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller dit barn får bivirkninger, som ikke
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Rotarix hjælper ved at beskytte dit barn fra 6- ugers alderen mod mavetarmkatar (diaré og opkastning), som skyldes en rotavirus - infektion.
Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection.
De fleste børn med rotavirus - infektion bliver selv raske.
Most children with rotavirus diarrhoea recover on their own.
Giv ikke Rotarix: • hvis dit barn tidligere har haft en overfølsomhedsreaktion (allergisk reaktion) over for en rotavirus - vaccine eller et af indholdsstofferne i Rotarix.
Rotarix should not be given: • if your child has previously had any allergic reaction to rotavirus vaccines or any component contained in Rotarix.
Det kan være nødvendigt at udsætte vaccinationen indtil dit barn er raskt.
It might be necessary to postpone the vaccination until recovery.
Det kan være nødvendigt at udsætte vaccinationen indtil barnet er raskt.
A minor infection such as a cold should not be a problem, but talk to your doctor first. • if your child has diarrhoea or is vomiting.
Fortæl det til lægen eller sygeplejersken hvis dit barn:
It might be necessary to postpone the vaccination until recovery.
Dette kan være personer, som har en kræftsygdom eller som tager medicin, der svækker immunforsvaret. • har mave- tarm- problemer. • har forstyrrelser i udviklingen mht. vægt og vækst. • blev for tidligt født, idet graden af beskyttelse opnået ved vaccination er ukendt for disse børn.
57 Take special care with Rotarix Inform your doctor/health care professional if your child: • has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system. • has any disorder of the gastrointestinal system. • has not been gaining weight and growing as expected. • was born prematurely, because the level of protection afforded by the vaccine is unknown in this case.
Rotarix kan gives samtidigt med, at dit barn får andre anbefalede vacciner, så som vacciner mod difteri, stivkrampe, kighoste, Haemophilu influenzae type b, polio (oral eller inaktiveret) og hepatitis B, samt pneumokok- vaccine og serotype C konjugeret meningokok- vaccine.
Rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C conjugate vaccines.
Vigtige information om nogle af de øvrige indholdsstoffer i Rotarix Hvis din læge har fortalt, at dit barn ikke kan tåle visse sukkerarter, bør du kontakte din læge inden dit barn bliver vaccineret.
Important information about some of the ingredients of Rotarix If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, contact your doctor before using this vaccine.
Lægen eller sygeplejersken vil give barnet den anbefalede dosis Rotarix.
The doctor or nurse will administer the recommended dose of Rotarix to your child.
Vaccinen (1 ml væske) gives i munden.
The vaccine (1.5 ml liquid) will be given orally.
De vil blive givet ved hvert sit besøg med et interval på mindst 4 - uger mellem doserne.
Each dose will be given on a separate occasion with an interval of at least 4 weeks between the two doses.
De to doser skal være givet i 24 ugers alderen, dog helst inden 16- ugers alderen.
The two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age.
Hvis dit barn spytter det meste af den indgivne vaccinedosis ud eller gylper den op, kan en erstatningsdosis gives med det samme.
In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.
Rotarix kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Rotarix can cause side effects, although not everybody gets them.
3 ♦ Meget almindelig (det sker ved flere end 1 ud af 10 vaccinedoser): • Tab af appetit • Irritabilitet
♦ Very common (These may occur with 1 in 10 doses or more of the vaccine): • loss of appetite • irritability
-
- The other ingredients in Rotarix are: sucrose, Di-sodium Adipate, Dulbecco’s Modified Eagle
Saccharose, dinatriumadipat, Dulbecco’ s Modified Eagle Medium (DMEM), sterilt vand
59 Medium (DMEM), sterile water
Oral suspension i en fyldt oral applikator
Oral suspension in pre-filled oral applicator.
4 Rotarix sælges som en klar farveløs væske i en enkeltdosis fyldt oral applikator (1, 5 ml).
Rotarix is supplied as clear and colourless liquid in a single dose pre-filled oral applicator (1.5 ml).
France Laboratoire GlaxoSmithKline
France Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
România GlaxoSmithKline (GSK) SRL
România GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208 www.gsk.ro
Vaccinen til oral administration er en klar, farveløs væske, fri for synlige partikler.
The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration.
Vaccinen er klar til brug (rekonstituering eller fortynding er ikke påkrævet).
The vaccine is ready to use (no reconstitution or dilution is required).
Vaccinen er til oral administration uden forudgående opblanding med andre vacciner eller opløsninger.
The vaccine is to be administered orally without mixing with any other vaccines or solutions.
Vaccinen skal undersøges visuelt for fremmede partikler og/ eller udsædvanligt udseende inden administration.
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Instruktion for administration af vaccinen:
61 Instructions for administration of the vaccine:
Indgiv hele indholdet af den orale applikator oralt (indgiv hele indholdet at den orale applikator på indersiden af kinden).
Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the oral applicator.
Må ikke injiceres
Do not inject.
Beskyttelses - hætte på den oral applikator
Oral applicator Tip-Cap
Administrer hele indholdet af den orale applikator oralt (indgiv hele indholdet af den orale applikator på indersiden af kinden).
Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the oral
7 INDLÆGSSEDDEL:
62 PACKAGE LEAFLET:
Tegn på overfølsomhedsreaktioner indbefatter kløende hududslæt, stakåndethed og hævelse i ansigtet eller af tungen. • hvis dit barn tidligere har haft invagination (en tarmlidelse, hvor et stykke af tarmen bliver foldet ind i et andet stykke af tarmen). • hvis dit barn er født med en misdannelse i maven og/ eller tarmen, som kan medføre invagination. • hvis dit barn har en sygdom, der nedsætter modstandsdygtigheden over for infektion. • hvis dit barn har en alvorlig infektion med forhøjet temperatur.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • if your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment). • if your child was born with a malformation of the gut that could lead to intussusception. • if your child has any disease which reduces his/her resistance to infection. • if your child has a severe infection with a high temperature.
Det kan være nødvendigt at udsætte vaccinationen indtil barnet er raskt.
It might be necessary to postpone the vaccination until recovery.
En mindre infektion såsom forkølelse bør ikke være noget problem, men spørg lægen inden vaccination. • hvis dit barn har diaré eller kaster op.
A minor infection such as a cold should not be a problem, but talk to your doctor first. • if your child has diarrhoea or is vomiting.
Dette kan være personer, som har en kræftsygdom eller som tager medicin, der svækker immunforsvaret. • har mave- tarm- problemer. • har forstyrrelser i udviklingen mht. vægt og vækst. • blev for tidligt født, idet graden af beskyttelse opnået ved vaccination er ukendt for disse børn.
63 Take special care with Rotarix Inform your doctor/health care professional if your child: • has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system. • has any disorder of the gastrointestinal system. • has not been gaining weight and growing as expected. • was born prematurely, because the level of protection afforded by the vaccine is unknown in this case.
Første dosis gives fra 6- ugers- alderen.
The first dose may be given from the age of 6 weeks.
De to doser skal være givet i 24 ugers- alderen, dog helst inden 16- ugers- alderen.
The two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age.
Bivirkninger, som viste sig under de kliniske førsøg med Rotarix, er følgende:
Side effects that occurred during clinical trials with Rotarix were as follows:
♦ Meget almindelig (det sker ved flere end 1 ud af 10 vaccinedoser):
♦ Very common (These may occur with 1 in 10 doses or more of the vaccine): • loss of appetite • irritability
Saccharose, dinatriumadipat, Dulbecco’ s Modified Eagle Medium (DMEM), sterilt vand
65 Medium (DMEM), sterile water
Rotarix sælges som en klar farveløs væske i en enkeltdosis blød tube (1, 5 ml).
Rotarix is supplied as clear and colourless liquid in a single dose squeezable tube (1.5 ml).
10 Rotarix findes i pakninger á 1, 10 eller 50 stk.
Rotarix is available in a pack of 1, 10 or 50.
France Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44
France Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
România GlaxoSmithKline (GSK) SRL Tel: +40 (0) 21 3028 208
România GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208 www.gsk.ro
Instruktion for administration af vaccinen:
67 Instructions for administration of the vaccine:
12 4.
4.
Tubelåg
Tube Cap
Topforseglin
Tip seal
Toppen af tuben
Tube tip
13
68
RotaTeq er en oral vaccine, der leveres som opløsning i en enkeltdosistube.
RotaTeq is an oral vaccine, presented as a solution in a single dose tube.
Den indeholder fem levende rotavirus- stammer, alle med forskellige antigener (G1, G2, G3, G4 og P1[ 8]).
It contains five live rotavirus strains, each carrying a different antigen (G1, G2, G3, G4 and P1[8]).
RotaTeq er en vaccine, der gives til spædbørn fra seksugersalderen til forebyggelse af gastroenteritis (diarré og opkastning) forårsaget af rotavirus infektion.
RotaTeq is a vaccine given to babies from six weeks of age to prevent gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Indholdet i RotaTeq- tuben gives direkte i spædbarnets mund.
The content of the tube of RotaTeq is given directly into the mouth of the baby.
Første dosis gives fra barnet er mellem seks og 12 uger gammelt.
The first dose is given when the baby is between six and 12 weeks of age.
Det er bedst, hvis den sidste dosis gives, inden barnet er 20 til 22 uger gammelt, og alle tre doser bør under alle omstændigheder gives, inden barnet er 26 uger (seks måneder) gammelt.
It is better if the last dose is given before the child is aged 20 to 22 weeks, and in any case, all three doses should have been given by the time the child is 26 weeks (six months) old.
RotaTeq kan gives samtidigt med andre vaccinationer (bortset fra oral polio- vaccine, hvor der kræves to ugers interval mellem administreringen af de 2 vacciner).
RotaTeq can be given at the same time as other vaccinations (except the oral polio vaccine, when a two-week interval is needed between administration of the two vaccines).
Den første dosis bør gives seks uger efter fødslen.
The first dose should be given six weeks after birth.
Et antigen er en bestemt struktur, som kroppen kan genkende som ” fremmed ”, og som den kan producere et antistof mod, et bestemt protein, som kan neutralisere eller ødelægge antigenet.
An antigen is a specific structure that the body can recognise as ‘ foreign’ and against which it can make an antibody, a special protein that can neutralise or destroy the antigen.
Når et barn modtager vaccinen, producerer immunsystemet (det system, som bekæmper sygdomme) antistoffer mod disse antigener, hvilket bidrager til at forebygge mod infektioner forårsaget af rotavirus, som forekommer naturligt, og som har de samme eller meget lignende antigener.
When a child is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these antigens, which help prevent infections caused by rotaviruses that occur naturally that carry the same or very similar antigens.