FrancophonIA/ELRC3.0 huggingface dataset:
English: The bactericidal action of orbifloxacin results from interference with the enzymes DNA topoisomerase II (DNA-gyrase) and DNA topoisomerase IV which are needed for the synthesis and maintenance of bacterial DNA.
Icelandic: Bakteríudrepandi verkun orbifloxazins verður vegna hömlunar ensímanna DNA tópóísómerasa II (DNA-gýrasa) og DNA tópóísómerasa IV, sem eru nauðsynleg til myndunar og viðhalds á DNA bakteríanna.
English: Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population.
Icelandic: Ef treyst er um of á notkun sýklalyfja af einum flokki sýklalyfja getur það leitt til myndunar ónæmis hjá bakteríunum.
English: 17.5 mL and 35.1 mL: 28 days
Icelandic: 17,5 ml og 35,1 ml: 28 sólarhringar.
English: Orbifloxacin is a synthetic broad-spectrum bactericidal agent classified as a quinolone carboxylic acid derivative, or more specifically, a fluoroquinolone.
Icelandic: Orbifloxacin er efnafræðilega framleitt breiðvirkt bakteríudrepandi lyf, flokkað sem kínólón karboxýlsýruafleiða, eða nánar sem flúorókínólón.
English: MIC50
Icelandic: Min Max MIC50
English: Cross-resistance across the fluoroquinolone class of antibiotics is common.
Icelandic: Krossónæmi innan flúorókínólónflokks sýklalyfja er algengt.
English: The underlying cause should be identified and treated.
Icelandic: Greina skal undirliggjandi orsök og meðhöndla hana.
English: Do not use after the expiry date, which is stated on the label.
Icelandic: Notið ekki eftir fyrningardagsetningu á umbúðunum.
English: Malassezia pachydermatis resistance to azoles, including posaconazole, has not been reported.
Icelandic: Ekki hefur verið greint frá þoli Malassezia pachydermatis gegn azolum, þ.m.t. posaconazoli.
English: Do not use in case of hypersensitivity to the active substances, to any of the ingredients, to corticosteroids, to other azole antifungal agents or to other fluoroquinolones.
Icelandic: Gefið ekki dýrum sem hafa ofnæmi fyrir virku efnunum, einhverju hjálparefnanna, barksterum, öðrum azol-sveppalyfjum eða öðrum flúorókínólónum.
English: Do not use if the eardrum is perforated.
Icelandic: Notið ekki ef gat er á hljóðhimnu.
English: Paraffin, Liquid
Icelandic: Eyrnadropar, dreifa.
English: Fluoroquinolones are known to cross the placenta and to be distributed into milk.
Icelandic: Flúorókínólónar fara yfir fylgju og skiljast út í brjóstamjólk.
English: EXPIRY DATE EXP {month /year} Once opened use within 28 days.
Icelandic: FYRNINGARDAGSETNING EXP {mánuður/ár}
English: METHOD AND ROUTE OF ADMINISTRATION For auricular use only.
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR) Eingöngu til notkunar í eyra.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box 8.8 mL
Icelandic: YTRI UMBÚÐUM Askja sem inniheldur 8,8 ml
English: Bacterial and fungal otitis is often secondary in nature.
Icelandic: Eyrnabólga af völdum baktería og sveppa er í eðli sínu oft afleiðing annarra sjúkdóma.
English: The extent of percutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Icelandic: Umfang frásogs staðbundinna lyfja um húð ræðst af mörgum þáttum, þ. á m. því hve heilbrigð húðin er.
English: In case of accidental exposure, rinse the affected area with copious quantities of water.
Icelandic: Ef sá sem annast lyfjagjöf hellir dýralyfinu á sig fyrir slysni skal skola svæðið vandlega með miklu vatni.
English: Like other topical corticosteroids, it has anti-inflammatory and anti-pruritic properties.
Icelandic: Eins og við á um aðra barkstera til staðbundinnar notkunar hefur það bólgueyðandi og kláðastillandi verkun.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/06/2008
Icelandic: 23/06/2008 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: PACKAGE SIZE 8.8 mL
Icelandic: 8,8 ml
English: Systemic absorption of the active ingredients was determined in single-dose studies with [14C]orbifloxacin, [3H]-mometasone furoate and [14C]-posaconazole contained within the Posatex formulation and placed into the ear canals of normal Beagle dogs.
Icelandic: Frásog virku efnanna var ákvarðað í rannsóknum sem gerðar voru á stökum skömmtum af [14C]-orbifloxacini, [3H]-mometasonfuroati og [14C]-posaconazoli, virku efnunum í Posatex, en þeir voru settir í eyrnaganga heilbrigðra Beagle hunda.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening the immediate packaging: 8.8 mL: 7 days
Icelandic: Geymsluþol eftir að innri umbúðir hafa verið rofnar: 8,8 ml: 7 sólarhringar.
English: It is prudent to reserve fluoroquinolones for the treatment of clinical conditions, which have responded poorly or are expected to respond poorly to other classes of antibiotics.
Icelandic: Rétt er að nota ekki flúorókínólóna nema til meðferðar á þeim sýkingum sem hafa ekki látið undan meðferð eða talið er að munu ekki láta undan meðferð með sýklalyfjum af öðrum flokkum sýklalyfja.
English: STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS Orbifloxacin
Icelandic: VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Orbifloxacin
English: After application, the base of the ear may be massaged briefly and gently to allow the veterinary medicinal product to penetrate the lower part of the ear canal.
Icelandic: Eftir gjöf dýralyfsins má nudda neðsta hluta eyrans örlítið og létt til þess að lyfið renni inn í neðri hluta eyrnagangsins.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box 17.5 mL and 35.1 mL
Icelandic: YTRI UMBÚÐUM Askja sem inniheldur 17,5 ml og 35,1 ml
English: After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate the lower part of the ear canal.
Icelandic: Eftir gjöf dýralyfsins má nudda neðsta hluta eyrans örlítið og létt til þess að dýralyfið renni inn í neðri hluta eyrnagangsins.
English: Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: Decrease of the bacterial wall permeability, expression of efflux pump, or mutation of enzymes responsible for the molecule's binding site.
Icelandic: Með minnkun á gegndræpi bakteríuveggsins, með tjáningu útflæðisdælu, eða vegna stökkbreytinga á ensímum sem leggja til bindistað sameindarinnar.
English: N Min
Icelandic: N
English: The use of the veterinary medicinal product is not recommended during lactation.
Icelandic: Ekki er mælt með notkun dýralyfsins við mjólkurgjöf.
English: Quinolone class veterinary medicinal products have been associated with cartilage erosions in weightbearing joints and other forms of arthropathy in immature animals of various species.
Icelandic: Lyf af flokki kínólóna hafa tengst brjóskeyðingu í liðamótum sem bera þunga og einnig öðrum liðsjúkdómum, hjá ungum dýrum ýmissa dýrategunda.
English: Pregnancy: Do not use during the whole or part of the pregnancy.
Icelandic: Dýralyfið má ekki nota á neinum hluta meðgöngu.
English: Dogs weighing 2 - 15 kg, apply 4 drops to the ear once a day.
Icelandic: Gefið hundum 2-15 kg að þyngd, 4 dropa í eyra einu sinni á sólarhring.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle 17.5 mL and 35.1 mL
Icelandic: INNRI UMBÚÐUM Flaska 17,5 ml og 35,1 ml
English: Studies with a range of proprietary ear cleaners have shown no chemical incompatibilities.
Icelandic: Ekki hefur verið sýnt fram á efnafræðilegan ósamrýmanleika í rannsóknum með mismunandi eyrnahreinsiefnum.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/081/001
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/08/081/001
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Auricular use.
Icelandic: SKAMMTAR FYRIR HVERJA DÝRATEGUND, ÍKOMULEIÐ(IR)
English: Mild erythematous lesions have been observed.
Icelandic: Væg roðaútbrot hafa komið fram.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/081/002
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/08/081/002
English: Manufacturer for the batch release:
Icelandic: Geymsluþol eftir að umbúðir hafa verið rofnar:
English: Quinolone class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species.
Icelandic: Dýralyf af flokki kínólóna hafa tengst brjóskeyðingu í liðamótum sem bera þunga og einnig öðrum liðsjúkdómum, hjá ungum dýrum ýmissa dýrategunda.
English: Paraffin liquid
Icelandic: A. ÁLETRANIR
English: Dogs weighing 15 kg or more, apply 8 drops to the ear once a day.
Icelandic: 15 kg eða þyngri, 8 dropa í eyra einu sinni á sólarhring.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Posatex ear drops for dogs
Icelandic: HEITI DÝRALYFS Posatex eyrnadropar, handa hundum.
English: Dogs weighing less than 2 kg, apply 2 drops to the ear once a day.
Icelandic: Gefið hundum léttari en 2 kg, 2 dropa í eyra einu sinni á sólarhring.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle 8.8 mL
Icelandic: INNRI UMBÚÐUM Flaska 8,8 ml
English: QUANTITY OF THE ACTIVE SUBSTANCES Orbifloxacin
Icelandic: VIRKRA INNIHALDSEFNA Orbifloxacin
English: Excipients:
Icelandic: Meðganga:
English: Auricular use.
Icelandic: Til notkunar í eyra.
English: Max
Icelandic: C.
English: Minimum Inhibitory Concentrations vs. Orbifloxacin - Summary Pathogen
Icelandic: Lágmarksheftistyrkur (MIC) fyrir Orbifloxacin
English: Pharmacotherapeutic group: Otologic - Corticosteroids and anti-infectives in combination.
Icelandic: Eyrnalyf - Barksterar og sýkingalyf í blöndum.
English: TARGET SPECIES
Icelandic: Sýkingarvaldur
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Icelandic: Upplýsingar á íslensku eru á http://www.serlyfjaskra.is TAKMARKANIR Á SÖLU, DREIFINGU OG/EÐA NOTKUN Á ekki við.
English: PACKAGE LEAFLET FOR: Posatex ear drops suspension dogs
Icelandic: HEITI DÝRALYFS Posatex eyrnadropar, dreifa handa hundum
English: 5% Gel
Icelandic: 5% Hlaup
English: Uni-Pharma Kleon Tsetis Farmakeftika Ergastria ABEE 14 Km.
Icelandic: Uni-Pharma Kleon Tsetis Farmakeftika Ergastria ABEE 14 Km. Nat.
English: Olvos Science AE Eleftherias 4
Icelandic: AE Eleftherias 4
English: Allée de la Recherche, 60 1070 Bruxelles Belgium
Icelandic: Allée de la Recherche, 60 1070 Bruxelles
English: Ag. Dimitriou 63 17456, Alimos, Athens Greece
Icelandic: Dimitriou 63 17456, Alimos, Athens Greece
English: Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul.
Icelandic: Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul. J. Lea 208
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, and marketing authorisation holders in the Member States
Icelandic: Listi yfir heiti, lyfjaform, styrkleika lyfjanna, íkomuleiðir og markaðsleyfishafa í aðildarlöndunum
English: Partyzancka 133/151
Icelandic: z o.o. ul. Partyzancka 133/151
English: Nat. Road Athens-Lamia 14564, K. Kifisia Greece
Icelandic: Road Athens-Lamia 14564, K. Kifisia Greece
English: 180 00 Praha 8
Icelandic: 180 00 Praha 8 Czech Republic
English: Slovak Republic UCB s.r.o Thámova 13
Icelandic: UCB s.r.o Thámova 13
English: 1,6 mg/g Syrup
Icelandic: 1,6 mg/g Saft
English: United Kingdom UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE
Icelandic: UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE United Kingdom
English: UCB Magyarország Kft. Árpád fejedelem útja 26-28 1023 Budapest Hungary
Icelandic: Árpád fejedelem útja 26-28
English: AH 3 N Tabletten 25 mg
Icelandic: 3 N Tabletten 25 mg
English: Via Gadames 57 20151 Milano Italy
Icelandic: UCB Pharma S.p.a. Via Gadames 57 20151
English: UCB Pharma S.p.a.
Icelandic: Lúxemborg UCB Pharma S.A.
English: Hydroxyzine dihydrochloride Propyphenazone Codeine phosphate
Icelandic: Hýdroxýzíntvíhýdróklóríð Própýfenazón Kódein fosfat
English: Syrup
Icelandic: Slóvakía
English: UCB Pharma Oy Finland Itsehallintokuja 6
Icelandic: Itsehallintokuja 6
English: Hydroxyzinum VP 10 mg
Icelandic: Hydroxyzinum VP
English: UCB Pharma B.V. Lage Mosten 33
Icelandic: Lage Mosten 33
English: 100 mg Coated tablet
Icelandic: 100 mg Húðuð tafla
English: UCB Pharma GmbH Alfred-Nobel-Str. 10 40789 Monheim Germany
Icelandic: Þýskaland UCB Pharma GmbH Alfred-Nobel-Str.
English: Intramuscular use
Icelandic: Stungulyf, lausn
English: 84 (3 x 28 capsules) (multipack)
Icelandic: 84 (3 x 28 hylki) (fjölpakkning)
English: If you miss a scheduled injection, talk to your doctor and arrange another visit.
Icelandic: Ef þú missir af áætlaðri bólusetningu á að tala við lækninn og finna annan tíma.
English: Most people recover completely but the illness is usually severe enough to keep people off work for about a month.
Icelandic: Flestir ná sér að fullu en sjúkdómurinn er venjulega það slæmur að fólk er veikt í u.þ.b. mánuð.
English: Pack sizes of 1, 10 and 50 with or without needles.
Icelandic: 1, 10 og 50 með eða án nála.
English: 0.2 milligrams Al3+
Icelandic: 0,2 mg Al3+
English: Swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise, fever (≥ 37.5°C)
Icelandic: Bólga á stungustað, viðbrögð á stungustað (svo sem mar), þreyta, lasleiki, hiti (≥ 37,5°C)
English: 0.025 milligrams Al3+
Icelandic: 0,025 mg Al3+
English: 0.2 milligrams Al3+ - The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.
Icelandic: 0,2 mg Al3+ - Önnur innihaldsefni í Twinrix Paediatric eru: natríumklóríð, vatn fyrir stungulyf.
English: Very common (these may occur with more than 1 in 10 doses of the vaccine) • Pain and redness at the injection site
Icelandic: Mjög algengar (geta komið fyrir við fleiri en 1 af hverjum 10 skömmtum bóluefnis): • Verkur og roði á stungustað
English: Your doctor will advise on the possible need for extra doses, and future booster dosing.
Icelandic: Læknirinn mun segja til um hugsanlega þörf á viðbótarskömmtum og örvunarskammti í framtíðinni.
English: Twinrix Paediatric is available in packs of 1, 10 and 50 with or without needles.
Icelandic: Twinrix Paediatric er fáanlegt með 1, 10 og 50 sprautum í pakkningu, með eða án nála.
English: The proportion of subjects reaching anti-HBs ≥ 10 mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone.
Icelandic: Hlutfall einstaklinga sem náðu HBs-mótefnum ≥ 10 ma.e./ml var 98,3% við samhliða bólusetningu og 100% fyrir Twinrix eitt sér.
English: • Infection around the brain which may give severe headache with stiff neck and sensitivity to light
Icelandic: Sýking í kringum heilann sem getur valdið alvarlegum höfuðverk ásamt stífum hnakka og ljósnæmi
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Icelandic: Hugsanlegar aukaverkanir Eins og við á um öll lyf getur þetta bóluefni valdið aukaverkunum en það gerist þó ekki hjá öllum.
English: Signs of serious allergic reactions may be 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.
Icelandic: Einkenni alvarlegra ofnæmisviðbragða geta verið útbrot sem geta verið með kláða eða blöðrum, bólga í augum og andliti, öndunar- og kyngingarerfiðleikar, skyndilegt blóðþrýstingsfall og meðvitundarleysi.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Twinrix Paediatric should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Paediatric therapy to the woman.
Icelandic: Ákvörðun um hvort halda eigi áfram/hætta brjóstagjöf eða halda áfram/hætta meðferð með Twinrix Paediatric skal tekin með tilliti til gagnsemi brjóstagjafar fyrir barnið og gagnsemi meðferðar með Twinrix Paediatric fyrir móðurina.
English: Twinrix Paediatric has no or negligible influence on the ability to drive and use machines.
Icelandic: Twinrix Paediatric hefur engin eða hverfandi áhrif á aksturshæfni eða hæfni til að stjórna vinnuvélum.
English: Talk to you doctor or pharmacist before you receive Twinrix Paediatric if:
Icelandic: Leitið ráða hjá lækninum eða lyfjafræðingi áður en Twinrix Paediatric er notað ef:
English: The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age.
Icelandic: Mælt er með 0,5 ml skammti (360 ELISA HA / 10 míkróg HBsAg) fyrir börn og unglinga á aldrinum frá 1 árs til og með 15 ára.
English: What Twinrix Paediatric is and what it is used for What you need to know before you receive Twinrix Paediatric How Twinrix Paediatric is given Possible side effects
Icelandic: Upplýsingar um Twinrix Paediatric og við hverju það er notað Áður en þú færð Twinrix Paediatric Hvernig gefa á Twinrix Paediatric Hugsanlegar aukaverkanir
English: The safety profile presented below is based on data from approximately 800 subjects.
Icelandic: Upplýsingar um aukaverkanir sem koma fram hér á eftir eru byggðar á gögnum frá u.þ.b. 800 einstaklingum.
English: Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Icelandic: Þar sem inndæling í húð eða í rassvöðva (gluteal) getur leitt til ófullnægjandi ónæmissvörunar, ætti að forðast þessar leiðir.
English: The standard primary course of vaccination with Twinrix Paediatric consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose.
Icelandic: Stöðluð frumónæmisaðgerð með Twinrix Paediatric samanstendur af þremur skömmtum, þeim fyrsta á einhverjum völdum degi, þeim næsta mánuði síðar og þeim þriðja sex mánuðum eftir fyrsta skammt.
English: The most commonly reported adverse reactions following Twinrix Paediatric administration are pain and redness occurring in a per dose frequency of 28.5% and 11.5% respectively.
Icelandic: Algengustu aukaverkanirnar eftir gjöf Twinrix Paediatric eru verkir, sem koma fram eftir 28,5% allra skammta og roði sem kemur fram eftir 11,5% skammta.
English: EU/1/97/029/001 - pack of 1 without needle EU/1/97/029/002 - pack of 10 without needle EU/1/97/029/008 - pack of 50 without needle EU/1/97/029/006 - pack of 1 with 1 needle EU/1/97/029/007 - pack of 10 with 10 needles
Icelandic: EU/1/97/029/001 - pakkning með 1 án nálar EU/1/97/029/002 - pakkning með 10 án nála EU/1/97/029/008 - pakkning með 50 án nála EU/1/97/029/006 - pakkning með 1 með 1 nál EU/1/97/029/007 - pakkning með 10 með 10 nálum EU/1/97/029/009 - pakkning með 1 með 2 nálum EU/1/97/029/0010 - pakkning með 10 með 20 nálum
English: Guidelines for boosting are based on the assumption that antibodies are required for protection.
Icelandic: örvunarskammta eru byggðar á þeirri forsendu að þörf sé á mótefnum til varnar.
English: In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 89% of the subjects one month after the first dose and in 100% one month after the third dose (i.e. month 7).
Icelandic: Í klínísku rannsóknunum greindust sérhæfð vessabundin (“humoral”) mótefni gegn lifrarbólgu A í u.þ.b. 89% einstaklinga einum mánuði eftir fyrsta skammtinn og í 100% einum mánuði eftir þriðja skammtinn (þ.e. sjö mánuðum eftir að ónæmisaðgerðin hófst).
English: Twinrix Paediatric is a white, slightly milky liquid presented in a glass pre-filled syringe (0.5 ml).
Icelandic: Twinrix Paediatric er hvítur, mjólkurkenndur vökvi í áfylltri glersprautu (0,5 ml).
English: ≥ 1/10,000 to < 1/1,000
Icelandic: ≥1/10.000 til <1/1.000
English: ≥ 1/1,000 to < 1/100
Icelandic: ≥1/1.000 til <1/100
English: 0.025 milligrams Al3+ Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Icelandic: 0,025 mg Al3+ Framleitt í gersveppafrumum (saccharomyces cerevisiae) með DNA-raðbrigðatækni 4Aðsogað á álfosfat
English: In two long term clinical trials, persistence of anti-HAV and anti-HBs antibodies has been demonstrated up to 10 years in children aged 12-15 years and up to 5 years in children aged 1-11
Icelandic: Í tveimur klínískum langtímarannsóknum var sýnt fram á að hjá meirihluta bólusettra entust HAV- og HBs-mótefni í allt að 10 ár hjá börnum á aldrinum 12-15 ára og í allt að 5 ár hjá börnum á aldrinum 1-11 ára.
English: • you have a poor immune system due to illness or drug treatment.
Icelandic: ónæmiskerfi þitt er veiklað vegna veikinda eða lyfjameðferðar.
English: None of the components in the vaccine are infectious.
Icelandic: Enginn þáttanna í bóluefninu getur valdið smiti.
English: The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh muscle of your child.
Icelandic: Læknirinn gefur Twinrix Paediatric sem inndælingu í upphandleggsvöðva eða lærvöðva barnsins.
English: The excretion of Twinrix Paediatric in milk has not been studied in animals.
Icelandic: Útskilnaður á Twinrix Paediatric í mjólk hjá dýrum hefur ekki verið rannsakaður.
English: It is not known if Twinrix Paediatric passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.
Icelandic: Ekki er vitað hvort Twinrix Paediatric berst í brjóstamjólk, hins vegar er ekki gert ráð fyrir að bóluefnið valdi vandamálum hjá börnum á brjósti.
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
Icelandic: 0,5 ml af stungulyfi, dreifu, í áfylltri sprautu (gler af gerð I) með stimpiltappa (bútýlgúmmí).
English: It is advised that vaccines other than Cervarix should not be administered at the same time as Twinrix Paediatric.
Icelandic: Mælt er gegn því að önnur bóluefni en Cervarix séu gefin á sama tíma og Twinrix Paediatric.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 February 1997
Icelandic: 10. febrúar 1997 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 50 PRE-FILLED SYRINGES WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
Icelandic: 1 ÁFYLLT SPRAUTA ÁN NÁLAR 10 ÁFYLLTAR SPRAUTUR ÁN NÁLA 50 ÁFYLLTAR SPRAUTUR ÁN NÁLA 1 ÁFYLLT SPRAUTA
English: The safety and immunogenicity of Twinrix Paediatric administered as a booster dose following a three dose primary course have not been evaluated.
Icelandic: Öryggi og ónæmingargeta Twinrix Paediatric þegar það er gefið sem örvunarskammtur í framhaldi af þriggja skammta frumónæmisaðgerð hafa ekki verið metin.
English: How to store Twinrix Paediatric Contents of the pack and other information
Icelandic: Hvernig geyma á Twinrix Paediatric Pakkningar og aðrar upplýsingar
English: Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Paediatric on pregnancy or on the health of the fetus/newborn child.
Icelandic: Upplýsingar varðandi útkomu takmarkaðs fjölda þungana hjá konum sem hafa verið bólusettar benda ekki til að Twinrix Peadiatric hafi neinar aukaverkanir á meðgöngu eða heilbrigði fósturs/nýbura.
English: What Twinrix Paediatric is and what it is used for
Icelandic: Upplýsingar um Twinrix Paediatric og við hverju það er notað
English: In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric can be given.
Icelandic: Við aðstæður sem kalla á örvunarskammta gegn bæði lifrarbólgu A og B er hægt að gefa Twinrix Paediatric.
English: • Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
Icelandic: Fjólubláir eða rauðfjólubláir nabbar á húð (flatskæningur), alvarleg útbrot á húð (regnbogaroði)
English: 10 micrograms
Icelandic: 10 míkróg
English: Make sure you finish the complete vaccination course of three injections.
Icelandic: Gættu þess að þú fáir alla þrjá skammtana.
English: Twinrix Paediatric confers immunity against HAV and HBV infection by inducing specific anti-HA and anti-HBs antibodies.
Icelandic: Twinrix Paediatric veitir ónæmi gegn HAV- og HBV-sýkingu með því að hvetja til myndunar sérhæfðra HAV- og HBs-mótefna.