FrancophonIA/ELRC3.0 huggingface dataset:
English: Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated (see section 5.1).
Icelandic: Ivabradin er ætlað til meðferðar við langvinnri hjartabilun með NYHA flokkun II til IV ásamt slagbilstruflun, hjá sjúklingum með sínus takt og hjartsláttartíðni ≥75 slög/mín.
English: - Non cardiovascular QT prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole,
Icelandic: - Lyf sem lengja QT og eru ekki hjarta- og æðalyf (t.d. pimozid, ziprasidon, sertindol, mefloquin, halofantrin, pentamidin, cisaprid, erytromycin gefið í bláæð).
English: How to store Ivabradine JensonR Contents of the pack and other information
Icelandic: Útlit Ivabradine JensonR og pakkningastærðir
English: Ivabradine is indicated: - in adults unable to tolerate or with a contraindication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
Icelandic: Ábendingar ivabradin meðferðar eru: - fyrir fullorðna sem þola ekki beta blokka eða mega ekki nota beta blokka.
English: How does Ivabradine JensonR work
Icelandic: Ivabradine JensonR inniheldur
English: Mon → Tue → Wed → Thu → Fri → Sat → Sun
Icelandic: YTRI UMBÚÐUM OG INNRI UMBÚÐUM ASKJA/MERKIMIÐI Á GLASI
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Icelandic: - kinidin, disopyramid, ibutilid, sotalol, amiodaron (til meðferðar við hjartsláttartruflunum)
English: Common (may affect more than 1 in 10 people):
Icelandic: Algengar (geta komið fyrir hjá fleiri en 1 af hverjum 10 einstaklingum):
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride)
Icelandic: Hver filmuhúðuð tafla inniheldur 7,5 mg af ivabradini (sem hýdróklóríð)
English: Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Ivabradine JensonR or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions: - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Icelandic: Gætið þess að segja lækninum frá því ef eftirfarandi lyf eru notuð, þar sem breyta getur þurft skammti Ivabradine JensonR eða veita eftirlit: - fluconazol (sveppalyf) - rifampicin (sýklalyf) - barbitúröt (við svefnerfiðleikum eða flogaveiki) - fenytoin (við flogaveiki)
English: If you think that the effect of Ivabradine JensonR is too strong or too weak, talk to your doctor or pharmacist.
Icelandic: Leitaðu til læknisins eða lyfjafræðings ef þér finnst áhrifin af Ivabradine JensonR vera of mikil eða of lítil.
English: The
Icelandic: Svimi
English: Diplopia Visual impairment
Icelandic: Tvísýni Sjónskerðing
English: The study showed no difference in the rate of the primary composite outcome in the ivabradine group by comparison to the placebo group (relative risk ivabradine: placebo 1.00, p = 0.945).
Icelandic: Rannsóknin sýndi engan mun á tíðni hvað varðar aðal niðurstöðu í ivabradin hópnum í samanburði við lyfleysuhópinn (hlutfallsleg áhætta ivabradin:
English: Talk to your doctor or pharmacist before taking Ivabradine JensonR - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems
Icelandic: - ef þú ert með alvarlega hjartabilun eða hjartabilun með óeðlilegu hjartalínuriti (ECG) sem kallast „greinrof (bundle branch block)“, - ef þú ert með langvarandi sjúkdóm í sjónu augans, - ef þú ert með í meðallagi alvarlegan lifrarsjúkdóm, - ef þú ert með alvarlegan nýrnasjúkdóm.
English: Eosinophilia
Icelandic: 13. LOTUNÚMER
English: Fatigue, possibly related to bradycardia
Icelandic: Yfirlið, líklega tengt hægslætti
English: Pharmacokinetic interactions
Icelandic: Pharmaceutical Trading Co.
English: What you need to know before you take Ivabradine JensonR
Icelandic: Áður en byrjað er að nota Ivabradine JensonR
English: Biotransformation
Icelandic: Filmuhúð
English: STATEMENT OF ACTIVE SUBSTANCE) Each film-coated tablet contains 5 mg ivabradine (as hydrochloride)
Icelandic: Hver filmuhúðuð tafla inniheldur 5 mg af ivabradini (sem hýdróklóríð)
English: Contraindication of concomitant use
Icelandic: Tilkynning aukaverkana
English: Very rare (may affect up to 1 in 10,000 people): Irregular heart beats.
Icelandic: Mjög sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum):
English: Ivabradine JensonR with food and drink Avoid grapefruit juice during treatment with Ivabradine JensonR.
Icelandic: Forðast skal neyslu greipaldinsafa þann tíma sem meðferð með Ivabradine JensonR varir.
English: 2 years
Icelandic: 2 ár Aðeins fyrir glös:
English: INFORMATION IN BRAILLE Ivabradine JensonR 5 mg film-coated tablets
Icelandic: MEÐ BLINDRALETRI Ivabradine JensonR 5 mg filmuhúðaðar töflur
English: CARTON/BOTTLE LABEL
Icelandic: Mylan bvba/sprl
English: Ivabradine JensonR (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Icelandic: Ivabradine JensonR (ivabradin) er hjartalyf sem notað er til meðferðar við:
English: (Invented) name Strength Pharmaceutical form
Icelandic: (Sér)heiti Styrkleiki
English: 1 pre-filled syringe
Icelandic: ESB markaðsleyfisnúmer
English: Suspension (inactivated)
Icelandic: Dreifa (óvirkjuð)
English: * Tissue culture infectious dose 50%.
Icelandic: ≥2,0 a.e.*** * Skammtur sem dugar til að sýkja 50% smitaðra vefjarækta (tissue culture infectious dose 50%).
English: Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB
Icelandic: Leptospira interrogans sermishópur Australis sermisgerð Bratislava, stofn MSLB 1088
English: --1 Lyophilisate (live attenuated) Canine distemper virus, strain CDV Bio 11/A
Icelandic: Frostþurrkað stungulyf (lifandi veiklað) Hundafársveira, stofn CDV Bio 11/A
English: Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB
Icelandic: Leptospira interrogans sermishópur Canicola sermisgerð Canicola, stofn MSLB 1090
English: Package size Withdrawal period
Icelandic: ESB markaðsleyfisnúmer
English: This does not constitute a sign of
Icelandic: Þetta er ekki merki um
English: The cough may last for 1-2 months or longer.
Icelandic: Hóstinn getur staðið í 1-2 mánuði eða lengur.
English: Vaccination is the best way to protect against these diseases.
Icelandic: Ónæmisaðgerð er besta leiðin til þess að verjast þessum sjúkdómum.
English: If additional injections are necessary, the doctor will tell you.
Icelandic: Ef þörf er á aukasprautum lætur læknirinn vita.
English: If your child misses a scheduled injection, talk to your doctor and arrange another visit.
Icelandic: Ef barnið missir af áætlaðri sprautu á að tala við lækninn og finna annan tíma.
English: • collapse or periods of unconsciousness or lack of awareness have been reported within 2 to 3 days
Icelandic: Yfirlið eða tímabundið meðvitundarleysi eða skert athygli hafa verið skráð innan 2 til 3 daga
English: Such reactions may occur before leaving the doctor's surgery.
Icelandic: Slík viðbrögð geta komið fram áður en heimsókn til læknis er lokið.
English: If not, your child may not be fully protected against the diseases.
Icelandic: Ef svo er ekki er óvíst hvort barnið hafi fulla vörn gegn sjúkdómunum.
English: MARKETING AUTHORISATION NUMBER EU/1/96/014/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/96/014/001/IS
English: not less than 30 IU not less than 60 IU not less than 4 IU 10 micrograms
Icelandic: ekki minna en 30 a.e. ekki minna en 60 a.e. ekki minna en 4 a.e.
English: Tell your doctor if your child has any known allergies.
Icelandic: Greindu lækninum frá því ef barnið hefur eitthvað þekkt ofnæmi.
English: Date of latest renewal: 19 July 2006.
Icelandic: Dagsetning síðustu endurnýjunar markaðsleyfis: 19. júlí 2006.
English: 2-4-6 months; 3-4-5 months and 3-4½-6 months
Icelandic: 6-10-14 vikur 2-4-6 mánuðir; 3-4-5 mánuðir og 3-4½-6 mánuðir
English: Read all of this leaflet carefully before your child starts receiving this vaccine.
Icelandic: Lesið allan fylgiseðilinn vandlega áður en farið er að bólusetja barnið.
English: Your child will remain under medical supervision for 30 minutes after each injection.
Icelandic: Barnið verður undir eftirliti læknis/hjúkrunarfræðings í 30 mínútur eftir hverja sprautu.
English: Novartis Vaccines and Diagnostics GmbH & Co. KG
Icelandic: Novartis Vaccines and Diagnostics GmbH & Co.
English: Official batch release: in accordance with Article 114 of Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Icelandic: Opinber lokasamþykkt: samkvæmt ákvæðum 114. greinar í tilskipun 2001/83/EB með síðari breytingum annast opinber rannsóknarstofa eða rannsóknarstofa sem tilnefnd er til þessa, opinbera
English: • if your child has a bleeding problem or bruises easily
Icelandic: ef barnið hefur blæðingakvilla eða fær auðveldlega marbletti
English: • if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of this
Icelandic: ef barnið hefur tilhneigingu til að fá krampa/flog vegna hita eða ef fjölskyldusaga er um slíkt
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Icelandic: Lyfjastofnunar Evrópu (EMEA) http://www.emea.europa.eu./.
English: PSUR: The Marketing Authorisation Holder will continue to submit Periodic Safety Update Reports on a 2
Icelandic: Markaðsleyfishafi mun halda áfram að senda reglulega inn skýrslur um öryggi (Periodic Safety Update Reports), með 2 ára millibili.
English: • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination
Icelandic: Hjá börnum sem fædd eru mikið fyrir tímann (eftir 28 vikna meðgöngu eða fyrr) getur liðið lengri tími en venjulega á milli andardrátta, í 2-3 daga eftir bólusetningu.
English: • fever (more than 38°C)
Icelandic: Hiti (yfir 30°C).
English: 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.
Icelandic: Látið lækninn eða lyfjafræðing vita ef barnið er að nota eða hefur nýlega notað önnur lyf, einnig þau sem fengin eru án lyfseðils.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.3)
Icelandic: Þetta lyf inniheldur tíómersal (lífrænt kvikasilfurssamband) sem rotvarnarefni og því er hugsanlegt að . ofnæmisviðbrögð komi fram (sjá kafla 4.3).
English: Convulsions with or without fever, occurring within 3 days.
Icelandic: Krampaköst með eða án hita, innan 3 daga frá ónæmisaðgerð.
English: • drowsiness, irritability, unusual crying
Icelandic: Syfja, pirringur, óvenjulegur grátur.
English: A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do not constitute contra-indications.
Icelandic: Saga um hitakrampa, fjölskyldusaga um krampa eða vöggudauða (Sudden Infant Death Syndrome, SIDS) og fjölskyldusaga um aukaverkun eftir bólusetningu með Tritanrix HepB eru ekki frábendingar.
English: See section 6.5 for the number of doses per vial.
Icelandic: Sjá kafla 6.5 um fjölda skammta í hverju hettuglasi.
English: Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause.
Icelandic: Hiti ≥ 40,0°C innan 48 klst. frá bólusetningu, sem ekki er af annarri þekktri ástæðu.
English: Store in the original package, in order to protect from light.
Icelandic: Geymið í upprunalegum umbúðum til varnar gegn ljósi.
English: Frequencies are defined as follows:
Icelandic: Tíðnin er skilgreind á eftirfarandi hátt:
English: Extensive tests have demonstrated that these particles display the characteristic properties of the natural HBsAg.
Icelandic: Yfirgripsmiklar rannsóknir hafa leitt í ljós að þessar agnir sýna einkennandi eiginleika náttúrulegs HBsAg.
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.
Icelandic: Þetta geta verið staðbundin eða útbreidd útbrot með kláða eða blöðrum, þroti í augum og andliti, erfiðleikar við öndun eða kyngingu, skyndilegt blóðþrýstingsfall og meðvitundarleysi.
English: Four different schedules have been studied (6-10-14 weeks, 2-4-6 months; 3-4-5 months and 3-4½-6 months) according to routine vaccination practices in different countries with three doses administered within the first
Icelandic: Fjórar mismunandi áætlanir hafa verið rannsakaðar (6-10-14 vikna, 2-4-6 mánaða, 3-4-5 mánaða og 341/2-6 mánaða) samkvæmt viðteknum venjum um bólusetningar í mismunandi löndum, með þremur skömmtum gefnum fyrstu sex mánuðina eftir fæðingu.
English: Your child will receive a total of three injections with an interval of at least one month between each one.
Icelandic: Barnið fær samtals þrjár sprautur og líður a.m.k. mánuður á milli þeirra.
English: When using a multidose vial, each dose should be taken with a sterile needle and syringe.
Icelandic: Þegar margskammta hettuglas er notað, skal taka hvern skammt með dauðhreinsaðri nál og sprautu.
English: Do not use Tritanrix HepB after the expiry date which is stated on the carton.
Icelandic: Ekki skal nota Tritanrix HepB eftir fyrningardagsetningu sem tilgreind er á umbúðunum.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE
Icelandic: SKILYRÐI EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN VIÐ
English: For this reason, the vaccinee should remain under medical supervision for 30 minutes after vaccination.
Icelandic: Af þessum ástæðum skulu þeir sem bólusettir eru vera undir eftirliti í 30 mínútur eftir bólusetningu.
English: • if after previously having Tritanrix HepB 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 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
Icelandic: ♦ hár hiti (yfir 40°C) innan 48 stunda frá ónæmisaðgerð ♦ yfirlið eða ástand sem líkist losti innan 48 stunda frá ónæmisaðgerð ♦ viðvarandi grátur í 3 klukkustundir eða meira innan 48 stunda frá ónæmisaðgerð ♦ krampar/flog án eða með háum hita innan þriggja daga frá ónæmisaðgerð
English: After control of the disease the vaccine should be administered
Icelandic: Bóluefnið skal gefið eftir að náðst hefur stjórn á sjúkdómnum.
English: As with all injectable vaccines, appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of the vaccine.
Icelandic: Eins og á við um öll bóluefni til inndælingar skal viðeigandi læknishjálp alltaf vera tiltæk án tafar ef fram koma bráðaofnæmisviðbrögð í kjölfarið á gjöf bóluefnisins.
English: Tel: + 420 2 22 00 11 11 gsk.czmail@gsk.com
Icelandic: + 420 2 22 00 11 11 gsk.czmail@gsk.com
English: DTPw-HBV (combined)
Icelandic: Hópur 1 DTPw-HBV (samsett)
English: Make sure your child finishes the complete vaccination course of three injections.
Icelandic: Það þarf að sjá til þess að barnið fái allar þrjár sprautur ónæmisaðgerðarinnar.
English: Where HBV vaccine is not given at birth, the combined vaccine can be administered beginning as early as 8 weeks of age.
Icelandic: B (HBV) er ekki gefið við fæðingu má gefa samsetta bóluefnið frá og með átta vikna aldri.
English: ≥ 30 IU ≥ 60 IU ≥ 4 IU 10 µg
Icelandic: ≥ 30 a.e. ≥ 60 a.e. ≥ 4 a.e. 10 míkróg
English: The disease affects the airways causing severe spells of coughing that may interfere with normal breathing.
Icelandic: Hann hefur áhrif á öndunarveginn og veldur alvarlegum hóstaköstum sem geta truflað eðlilega öndun.
English: Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or wood splinters.
Icelandic: Þau sár sem sérlega er hætt við sýkingu eru brunasár, beinbrot, djúp sár eða sár sem mold, ryk, húsdýraáburður eða flísar hafa komist í.
English: As for any vaccination, the risk-benefit of immunising with Tritanrix HepB or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
Icelandic: Eins og á við um allar bólusetningar, skal meta vandlega áhættu/ávinning við ónæmisaðgerð með Tritanrix HepB eða frestun bólusetningar, hjá ungbarni eða barni sem þjáist af alvarlegum taugasjúkdómi, sem er nýtilkominn eða í framrás.
English: When Tritanrix HepB is given according to the 6-10-14 weeks schedule, it is recommended to administer a dose of HBV vaccine at birth to improve protection.
Icelandic: HepB er gefið samkvæmt 6-10-14 vikna áætluninni er ráðlagt að gefa skammt af bóluefni gegn lifrarbólgu
English: Group 2
Icelandic: Hópur 2
English: The primary vaccination schedule consists of three doses within the first six months of life.
Icelandic: Áætlun fyrir frumónæmisaðgerð felst í þremur skömmtum, innan sex mánaða frá fæðingu.
English: • if your child has previously had any allergic reaction to Tritanrix HepB, or any ingredient contained in this vaccine.
Icelandic: ef barnið hefur áður fengið ofnæmisviðbrögð fyrir Tritanrix HepB eða einhverju innihaldsefni bóluefnisins.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or
Icelandic: Þar sem ávinningur af bólusetningu er mikill hjá þessum hópi ungbarna, skal ekki hætt við
English: This HBsAg expressed in yeast cells is purified by several physico-chemical steps.
Icelandic: Þetta HbsAg tjáð í gersveppafrumum er fínhreinsað með nokkrum eðlisefnafræðilegum skrefum.
English: For each component of the vaccine, the following immune responses have been documented one month after completion of the primary vaccination schedule.
Icelandic: Eftirfarandi ónæmissvörun fyrir hvern einstakan hluta bóluefnisins hefur verið skjalfest, einum mánuði eftir að frumbólusetningu hefur verið lokið.
English: Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
Icelandic: Viðvarandi, óhuggandi grátur sem varir ≥ 3 klst., innan 48 klst. frá ónæmisaðgerð.
English: Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
Icelandic: Yfirlið eða ástand sem líkist losti (minnkuð vöðvaspenna, minnkuð svörun við áreiti) innan 48
English: In these circumstances, vaccination with the combined vaccine should start at 6 weeks of age.
Icelandic: Við slíkar aðstæður á að gefa fyrsta skammtinn af samsetta bóluefninu við sex vikna aldur.
English: • pain or discomfort at the injection site
Icelandic: Verkur eða óþægindi á stungustað.
English: The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death.
Icelandic: Bakterían gefur frá sér toxín (eitur) sem getur valdið vöðvastífni, sársaukafullum vöðvakrömpum, flogum og jafnvel dauða.
English: • if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy.
Icelandic: ef barnið þjáist af sjúkdómi í heila sem ekki hefur verið greindur eða sem ágerist, eða illviðráðanlegri flogaveiki.
English: The HBsAg assembles spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in average diameter containing non-glycosylated HBsAg polypeptide and a lipid matrix consisting mainly of phospholipids.
Icelandic: HbsAg safnast sjálfkrafa saman, án efnameðferðar, í hringlaga agnir, með að meðaltali 20 nm þvermál, sem innihalda óglýkósýleruð HbsAg-pólýpeptíð og fitunet sem samanstendur aðallega af fosfólípíðum.
English: The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy.
Icelandic: Fullkomin ónæmissvörun næst e.t.v. ekki hjá ónæmisbældum sjúklingum, t.d. sjúklingum á ónæmisbælandi meðferð.
English: Evaluation of pharmacokinetic properties is not required for vaccines.
Icelandic: Ekki er þörf á rannsóknum á lyfjahvörfum bóluefna.
English: Very common (≥1/10)
Icelandic: Mjög algengar: (≥1/10)
English: Tritanrix HepB can be administered simultaneously at separate sites or in any temporal relationship with other paediatric vaccines if this fits conveniently in the immunisation scheme.
Icelandic: Hægt er að gefa Tritanrix HepB á sama eða svipuðum tíma og önnur bóluefnum fyrir börn, á mismunandi staði, ef það fellur vel að ónæmisaðgerðaráætluninni.
English: * reported by the parents as adversely affecting the child's daily activities For both vaccination groups, the majority of the reactions were short lasting.
Icelandic: * hafði slæm áhrif á daglegar athafnir barnsins að mati foreldra.
English: Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Icelandic: Öndunarstöðvun hjá fyrirburum sem fæðst hafa mikið fyrir tímann (≤ 28 vikna meðganga) (sjá
English: Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.
Icelandic: Yfirleitt bólgnar öndunarvegur og veldur það alvarlegum öndunarerfiðleikum og stundum köfnun.
English: The D and T toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formalin inactivation using established technology.
Icelandic: Barnaveiki og stífkampatoxóíðin eru fengin með þekktum aðferðum af formaldehýðmeðferð á Corynebacterium diphteriae og Clostridium tetani toxínum, sem gerir þau óvirk.
English: The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.
Icelandic: Bakterían gefur einnig frá sér toxín (eitur) sem getur valdið taugaskemmdum, hjartakvillum og jafnvel
English: Take special care with Tritanrix HepB:
Icelandic: Gæta skal sérstakrar varúðar við notkun Tritanrix HepB:
English: Tel: + 44 (0)808 100 9997 customercontactuk@gsk.com
Icelandic: + 44 (0)808 100 9997 customercontactuk@gsk.com