FrancophonIA/ELRC3.0 huggingface dataset:
English: • if your child experienced problems of the nervous system (such as repetitive fits, decrease of consciousness) within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease.
Danish: • hvis dit barn har haft problemer med nervesystemet (såsom gentagne anfald, manglende bevidsthed) inden for 7 dage efter tidligere vaccination mod kighoste.
English: ♦ Very common (more than 1 per 10 doses of vaccine):
Danish: ♦ Meget almindelig (mere end 1 ud af 10 doser vaccine):
English: The HIB component of the vaccine does not protect against diseases due to capsular serotypes other than type b of Haemophilus influenzae or against meningitis caused by other organisms.
Danish: HIB komponenten i vaccinen beskytter ikke mod sygdomme som skyldes type b af Haemophilus influenzae eller mod meningitis forårsaget af andre organismer.
English: 2adsorbed on aluminium phosphate
Danish: 2adsorberet til aluminiumfosfat
English: METHOD AND ROUTE(S) OF ADMINISTRATION intramuscular use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intramuskulær anvendelse
English: Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 2
Danish: Haemophilus influenzae type b polysakkarid (polyribosylribitolfosfat) 2
English: 1 adsorbed on aluminium hydroxide, hydrated
Danish: 1adsorberet til aluminiumhydroxidhydrat
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: BEFORE YOUR CHILD RECEIVES QUINTANRIX In the following cases, Quintanrix should not be given to your child. You must tell your doctor:
Danish: FØR DIT BARN MODTAGER QUINTANRIX I følgende tilfælde bør Quintanrix ikke gives til dit barn.
English: Tetanus toxoid1
Danish: Stivkrampe toxoid1
English: Total: 0.26 milligrams Al3+
Danish: Total: 0.26 milligram Al3+
English: Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death.
Danish: Kighoste kan også forårsage øreinfektioner, langvarig bronkitis, lungebetændelse, anfald, hjerneskade og endda dødsfald.
English: • if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, pertussis (whooping cough), hepatitis B or Haemophilus influenzae type b diseases.
Danish: • hvis dit barn tidligere har haft en allergisk reaktion overfor andre vacciner mod difteri, stivkrampe, kighoste, hepatitis B eller Haemophilus influenzae type b.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Efter rekonstituering indeholder 1 dosis (0.5 ml): Difteri toxoid1
English: Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4) 4.9 Overdose
Danish: Apnø hos meget tidligt fødte børn (≤ 28 uger af svangerskabet) (se pkt.
English: More than 99% of subjects were considered to have responded to the pertussis component of the vaccine, which was defined as the appearance of antibodies in initially seronegative subjects (i.e. subjects with pre-vaccination titres < 15 ELU/ml) or a post-vaccination titre at least equal to pre-vaccination levels in subjects initially seropositive due to maternallyderived antibodies.
Danish: Mere end 99 % af individerne havde responderet på kighostekomponenten i vaccinen, hvilket var defineret som forekomsten af antistoffer hos initialt seronegative individer (dvs. individer med præ-vaccinationstitre < 15 ELU/ml) eller en post-vaccinationstiter der mindst svarer til præ-vaccinations niveauerne hos individer der initialt var seropositive pga. antistoffer fra moderen.
English: A history of febrile convulsions,a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Quintanrix.
Danish: En anamnese med feberkramper, en famileanamnese med kramper eller Sudden Infant Death Syndrome (SIDS) er ikke en kontraindikation for brug af Quintanrix.
English: More than 99% of subjects were considered to have responded to the pertussis component of the vaccine , which was defined as the appearance of antibodies in initially seronegative subjects (i.e. subjects with pre-vaccination titres < 15 ELU/ml) or a post-vaccination titre at least equal to pre-vaccination levels in subjects initially seropositive due to maternallyderived antibodies.
Danish: Mere end 99 % af individerne havde responderet på kighostekomponenten i vaccinen, hvilket var defineret som forekomsten af antistoffer hos initialt seronegative individer (dvs. individer med præ-vaccinationstitre < 15 ELU/ml) eller en post-vaccinationstiter der mindst svarer til præ-vaccinationsniveauerne hos individer der initialt var seropositive pga. antistoffer fra moderen.
English: Storing Quintanrix
Danish: OPBEVARING AF QUINTANRIX
English: In the following cases, Quintanrix should not be given to your child. You must tell your doctor:
Danish: I følgende tilfælde bør Quintanrix ikke gives til dit barn.
English: Limited data show that there is no interference with the response to Measles-Mumps-Rubella (MMR) and OPV antigens.
Danish: Begrænsede data viser, at der ikke er interferens med responset til mæslinger fåresyge røde hunde (MFR) og OPV antigenerne.
English: not less than 30 International Units
Danish: mindst 30 International Units
English: In these trials, the most common reactions occurring after vaccine administration were pain at the site of injection, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) and irritability, which were associated with about 50% of the doses administered.
Danish: I disse studier var de mest almindelige reaktioner, efter administration af vaccine, smerte ved injektionsstedet, feber (axillær ≥ 37.5 °C; rektalt≥ 38 °C) og irritabilitet, som kunne associeres med ca. 50 % af den administrerede dosis.
English: not less than 60 International Units
Danish: mindst 60 International Units
English: Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.
Danish: Quintanrix er til dyb intramuskulær injektion, anterolateralt på låret.
English: Sometimes people who have been infected do not look or feel ill. Others have signs of mild flu, but some people can become very ill.
Danish: Nogle gange vil personer, som er blevet smittet ikke se syge ud eller føle sig syge.
English: B-1330 Rixensart
Danish: B-1330 Rixensart Belgium
English: 100 x 2 doses (1 ml)
Danish: 100 x 2 doser (1 ml)
English: These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Danish: Hævelser ved øjne og i ansigtet, åndedræts- og synkebesvær, et pludseligt fald i blodtrykket og bevidstløshed.
English: not less than 4 International Units
Danish: mindst 4 International Units
English: Respiratory, thoracic and mediastinal disorders rare: bronchitis, coughing
Danish: Sygdomme i åndedrætsorganer, brysthule og mediastinum: Sjælden: bronchitis, hoste
English: 5-10 micrograms
Danish: 5-10 mikrogram
English: Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life.
Danish: Quintanrix er indiceret til primær immunisering af spædbørn (under første leveår) mod difteri, stivkrampe, kighoste, hepatitis B og angribende sygdom forårsaget af Haemophilus influenzae type b, og til booster immunisering af småbørn under 2. leveår.
English: ♦ Rare (less than 1 per 1000 but more than 1 per 10 000 doses of vaccine):
Danish: ♦ Sjælden (mindre end 1 ud af 1000 men mere end 1 ud af 10 000 doser vaccine):
English: • Pertussis (Whooping cough): Pertussis is a highly infectious illness.
Danish: • Kighoste (): Kighoste er en meget smitsom sygdom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Efter rekonstituering indeholder 1 dosis (0,5 ml): Difteri toxoid1
English: The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death.
Danish: Bakterien frigiver et toxin (giftstof), som kan forårsage muskelstivhed, smertefulde muskelspasmer, anfald og endda død.
English: 5 ml of suspension in a vial (type I glass) for 10 doses with a stopper (rubber butyl) in a pack size of 50 vials of powder plus 50 vials of suspension.
Danish: 5 ml suspension i et hætteglas (type I glas) til 10 doser med en prop (butylgummi) i en pakkestørrelse på 50 hætteglas med pulver samt 50 hætteglas med suspension.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DTPw HBV for Quintanrix
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) DTPw HBV for Quintanrix
English: Quintanrix is a vaccine used in children to prevent five infectious diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b (a type of bacteria).
Danish: Quintanrix er en vaccine som anvendes til børn for at forebygge fem infektionssygdomme: difteri, stivkrampe (krampe i tyggemusklerne), kighoste, hepatitis B og Haemophilus influenzae type b (en type bakterie).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION HIB for Quintanrix
Danish: LÆGEMIDLETS NAVN, STYRKE OG / ELLER INDGIVELSESVEJ(E) HIB for Quintanrix
English: Gastrointestinal disorders: very common: loss of appetite rare: vomiting
Danish: Gastrointestinale sygdomme: Meget almindelig: appetitløshed Sjælden: opkast
English: ♦ Common (less than 1 per 10 but more than 1 per 100 doses of vaccine):
Danish: ♦ Almindelig (mindre end 1 ud af 10 men mere end 1 ud af 100 doser vaccine):
English: For 10 doses: - pack size of 50 vials of powder plus 50 vials of liquid
Danish: Til 10 doser: - Pakkestørrelse med 50 hætteglas med pulver samt 50 hætteglas med væske.
English: 100 x 1 dose (0.5 ml)
Danish: 100 x 1 dosis (0,5 ml)
English: Nervous system disorders: very common: drowsiness rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions Respiratory, thoracic and mediastinal disorders rare: bronchitis, coughing
Danish: Sjælden: kollaps eller shock lignende tilstand (hypotonisk-hyporesponsiv episode), kramper Sygdomme i åndedrætsorganer, brysthule og mediastinum Sjælden: bronchitis, hoste
English: • if after previously having Quintanrix or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse (floppiness) or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/fits with or without a high temperature within 3 days of vaccination
Danish: ♦ Kollaps (slaphed) eller shock-lignende tilstand inden for 48 timer efter vaccination ♦ Vedvarende gråd i 3 timer eller mere inden for 48 timer efter vaccination ♦ Anfald/kramper med eller uden høj feber inden for 3 dage efter vaccination
English: Gastrointestinal disorders: very common: loss of appetite
Danish: Gastrointestinale sygdomme: Meget almindelig: appetitløshed
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOR MULTIDOSE PRESENTATIONS
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FOR FLERDOSIS PRÆPARATERNE
English: The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.
Danish: Bakterien firgiver desuden et toxin (giftstof), som kan medføre nerveskade, hjerteproblemer, og endda dødsfald.
English: Quintanrix is available in the following pack sizes: - pack size of 1 vial of powder plus 1 vial of liquid - pack size of 100 vials of powder plus 100 vials of liquid.
Danish: Quintanrix findes i følgende pakningsstørrelser - pakkestørrelse med 1 hætteglas med pulver samt 1 hætteglas med væske - pakkestørrelse med 100 hætteglas med pulver samt 100 hætteglas med væske.
English: Adverse reactions are listed below.
Danish: Bivirkninger er opstillet herunder.
English: Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed) - The active substances contained in 1 dose (0.5 ml) of Quintanrix are:
Danish: Quintanrix, pulver og væske til suspension til injektion Difteri, stivkrampe, kighoste (hel celle), hepatitis B (rDNA) og hæmofilus type b konjugeret vaccine (adsorberet) - De aktive substanser i 1 dosis (0,5 ml) af Quintanrix er:
English: 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl) in the following pack sizes: - pack size of 1 vial of powder plus 1 vial of suspension - pack size of 100 vials of powder plus 100 vials of suspension.
Danish: 1 ml suspension i et hætteglas (type I glas) til 2 doser med en prop (butylgummi) i følgende pakningsstørrelser: - pakkestørrelse med 1 hætteglas med pulver samt 1 hætteglas med suspension - pakkestørrelse med 100 hætteglas med pulver samt 100 hætteglas med suspension.
English: Psychiatric disorders: very common: irritability
Danish: Psykiske lidelser: Meget almindelig: irritabilitet
English: Total: 0.40 milligrams Al3+ 3 produced in Saccharomyces cerevisae cells by recombinant DNA technology
Danish: Total: 0.40 milligram Al3+ 3 Fremstillet i Saccharomyces cerevisae celler vha. rekombinant DNA teknologi.
English: Total: 0.40 mg Al3+ 3 produced in Saccharomyces cerevisae cells by recombinant DNA technology
Danish: Total: 0.40 mg Al3+ 3Fremstillet i Saccharomyces cerevisae celler vha. rekombinant DNA teknologi.
English: Tel: +49 6421 39 29 17 Fax: +49 6421 39 47 20
Danish: Fax: +49 6421 39 47 20
English: The vaccine cannot cause diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B or Haemophilus influenzae type b infections.
Danish: Vaccinen kan ikke medføre difteri, stivkrampe, kighoste, hepatitis B eller Haemophilus influenzae type b infektioner.
English: General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C) Quintanrix was administered as a booster to 435 infants in the second year of life.
Danish: Meget almindelig: smerte, rødme og hævelse, feber (axillær ≥ 37.5 °C; rektalt ≥ 38 °C) Almindelig: induration, feber (axillær > 39 °C; rektalt > 39.5 °C) Quintanrix blev administreret som en booster til 435 spædbørn i det andet leveår.
English: Quintanrix is a white slightly milky liquid obtained by mixing the vial containing the diphtheria (D), tetanus (T), whole cell pertussis (Pw) and hepatitis B (HBV) liquid (DTPw-HBV) with the vial containing the Haemophilus influenzae type b (HIB) powder.
Danish: Quintanrix er en hvid, lidt mælkeagtig, væske som fås ved at blande hætteglasset indeholdende difteri (D), tetanus (stivkrampe) (T), Pertussis (kighoste) (Pw) og hepatitis B (HBV) væske (DTPw HBV) med hætteglasset indeholdende Haemophilus influenzae type b (HIB) pulveret.
English: Powder and suspension for suspension for injection The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid white suspension.
Danish: Den flydende difteri, stivkrampe, kighoste (hel celle), hepatitis B (DTPw HBV) komponent er en uklar hvid suspension.
English: 2.5 µg conjugated to tetanus toxoid as a carrier
Danish: 2.5 µg konjugeret til stivkrampe toxoid som bærestof
English: Chiron-Behring GmbH & Co. Postfach 1630-35006 Marburg Germany
Danish: Postfach 1630-35006 Marburg Tyskland
English: Marketing authorisation holder and Manufacturer: GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89
Danish: GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89
English: Psychiatric disorders very common: irritability
Danish: Psykiske lidelser: meget almindelig: irritabilitet
English: Nervous system disorders: very common: drowsiness
Danish: Sygdomme i nervesystemet: Meget almindelig: døsighed
English: Nervous system disorders: very common: drowsiness rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions
Danish: Sjælden: kollaps eller shock-lignende tilstand (hypotonisk-hyporesponsiv episode), kramper
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/301/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/301/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/301/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/301/005
English: • Fits
Danish: • Hoste
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER TIL ENKELTDOSIS PRÆPARATER
English: THE MARKETING AUTHORISATION HOLDER
Danish: Indehaver af markedsføringstilladelsen og fremstiller:
English: Powder in a vial (type I glass) for 1 dose with a stopper (rubber butyl).
Danish: Pulver i hætteglas (type I glas) til 1 dosis med en prop (butylgummi).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/301/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/301/003
English: Powder in a vial (type I glass) for 2 doses with a stopper (rubber butyl).
Danish: Pulver i hætteglas (type I glas) til 2 doser med en prop (butylgummi).
English: 50 x 10 doses (5 ml)
Danish: 1 Hætteglas: Suspension 50 x 10 doser (5 ml)
English: 2.5 micrograms conjugated to tetanus toxoid as a carrier
Danish: 2.5 microgram konjugeret til stivkrampe toxoid som bærestof
English: For 2 doses : - pack size of 1 vial of powder plus 1 vial of liquid - pack size of 100 vials of powder plus 100 vials of liquid
Danish: Til 2 doser: - Pakkestørrelse med 1 hætteglas med pulver samt 1 hætteglas med væske - Pakkestørrelse med 100 hætteglas med pulver samt 100 hætteglas med væske.
English: Diphtheria toxoid, tetanus toxoid, pertussis (whole cell):
Danish: Difteri toxoid, tetanus toxoid, kighoste (hel celle): Chiron-Behring GmbH & Co.
English: Powder in a vial (type I glass) for 10 doses with a stopper (rubber butyl).
Danish: Pulver i hætteglas (type I glas) til 10 doser med en prop (butylgummi).
English: General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: fever (axillary > 39°C; rectal > 39.5°C) uncommon: induration
Danish: Meget almindelig: smerte, rødme og hævelse, feber (axillær ≥ 37.5 °C; t ≥ 38 °C) Almindelig: feber (axillær > 39 °C; rektalt > 39.5 °C) Usædvanlig: induration
English: General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C)
Danish: Meget almindelig: smerte, rødme og hævelse, feber (axillær ≥ 37.5 °C; rektalt ≥ 38 °C) Almindelig: induration, feber (axillær > 39 °C; rektalt > 39.5 °C)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 doses
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 10 doser
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 2 doser
English: 0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in the following pack sizes: - pack size of 1 vial of powder plus 1 vial of suspension - pack size of 100 vials of powder plus 100 vials of suspension Not all pack sizes may be marketed.
Danish: 0,5 ml suspension i et hætteglas (type I glas) til 1 dosis med en prop (butylgummi) i følgende pakningsstørrelser: - pakkestørrelse med 1 hætteglas med pulver plus 1 hætteglas med suspension.
English: 2 doses (1 ml)
Danish: 1 Hætteglas: Suspension 2 doser (1 ml)
English: Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
Danish: Difteri, stivkrampe, kighoste (hel celle), hepatitis B (rDNA) og hæmofilus type b konjugeret vaccine (adsorberet)
English: 1 dose (0.5 ml)
Danish: 1 Hætteglas: Suspension 1 dosis (0,5 ml)
English: A
Danish: Almindelig
English: • Induration (hard lump)
Danish: • Hård infiltration
English: In drinking water use.
Danish: Anvendelse i drikkevand.
English: The marketing authorisation application was submitted to the United Kingdom as reference Member State and Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Slovakia, Spain and The Netherlands as concerned Member States.
Danish: Ansøgningen om markedsføringstilladelse blev indgivet til Det Forenede Kongerige som referencemedlemsstat og med Østrig, Belgien, Tjekkiet, Danmark, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Luxembourg, Polen, Portugal, Slovakiet, Spanien og Nederlandene som berørte medlemsstater.
English: Add the following text in the relevant sections of the product information:
Danish: Tilføj følgende tekst i de relevante afsnit I produktinformationen:
English: Having considered all the data submitted the CVMP concluded that:
Danish: Efter gennemgang af alle de forelagte oplysninger konkluderede CVMP følgende:
English: During the decentralised procedure Denmark, as a concerned Member State, considered that Solamocta may present a potential serious risk to human and animal health.
Danish: Under den decentrale procedure fandt Danmark som berørt medlemsstat, at Solamocta kan udgøre en potentiel alvorlig risiko for menneskers og dyrs helbred.
English: Prepare the solution with fresh tap water immediately before use.
Danish: Klargør opløsningen med friskt postevand umiddelbart før anvendelsen.
English: Any unused medicated water should be discarded after 12 hours.
Danish: Overskydende medicineret vand skal kasseres efter 12 timer.
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Danish: Hvis dette ikke er muligt, skal behandlingen baseres på lokale (regionalt eller bedriftsniveau) epidemiologiske oplysninger om de relevante bakteriers følsomhed.
English: Each of these excipients is well-established and widely used in medicinal products and foodstuffs.
Danish: Hvert af disse hjælpemidler er almindelig anerkendt og vidt udbredt i lægemidler og foderstoffer.
English: After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Danish: Efter afslutning af behandlingsperioden skal vandforsyningssystemet rengøres korrekt for at undgå indtag af subterapeutiske mængder af det aktive indholdsstof.
English: Exemption from the requirement for bioequivalence studies
Danish: Fritagelse fra kravet om bioækvivalensundersøgelser
English: The CVMP was asked to consider the issues raised by Denmark and conclude whether marketing authorisations for Solamocta should be granted.
Danish: CVMP blev anmodet om at gennemgå de af Danmark rejste spørgsmål og konkludere, om der burde udstedes markedsføringstilladelser for Solamocta.
English: However, both products are aqueous oral solutions at the time of administration, containing an identical concentration of amoxicillin.
Danish: Begge produkter er imidlertid på administrationstidspunktet vandige orale opløsninger med samme koncentration af amoxicillin.
English: Use of the product should be based on susceptibility testing of the bacteria isolated from the animal.
Danish: Anvendelse af produktet skal baseres på følsomhedstest af bakterier isoleret fra dyret.
English: In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated.
Danish: Med henblik på at sikre, at det medicinerede vand indtages, skal man sørge for, at dyrene ikke har adgang til anden vandforsyning, mens de er i behandling.
English: Cross-resistance is observed between amoxicillin and other penicillins, particularly with aminopenicillins.
Danish: Der ses krydsresistens mellem amoxicillin og andre penicilliner, især med aminopenicilliner.