FrancophonIA/ELRC3.0 huggingface dataset:
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml)
Latvian: Tilpums, ko iegūst, 1 flakonu suspensijas (2,5 ml) sajaucot ar 1 flakonu emulsijas (2,5 ml), atbilst 10 vakcīnas devām (5 ml)
English: Follow up of 50 subjects aged 18-60 years who had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 at 0 and 21 days showed that 84% were seroprotected (HI titre ≥1:40) at day 42 compared with 54% at day 180.
Latvian: 50 indivīdu vecumā no 18 līdz 60 gadiem, kuri bija saņēmuši divas devas vakcīnas ar AS03 adjuvantu, kas satur 3,75 µg HA, iegūta no A/Vietnam/1194/2004, 0. un 21. dienā, novērošana parādīja, ka 84% bija seroloģiski aizsargāti (HI titrs ≥1:40) 42. dienā, salīdzinot ar 54% 180. dienā.
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgium
Latvian: 89, rue de l'Institut B-1330 Rixensart Beļģija
English: OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with suspension before administration
Latvian: CITI ĪPAŠI BRĪDINĀJUMI, JA NEPIECIEŠAMS Emulsija pirms lietošanas noteikti jāsajauc ar suspensiju
English: Emulsion for emulsion for injection 25 vials: emulsion
Latvian: ZĀĻU FORMA UN SATURS Emulsija emulsijas injekcijām pagatavošanai 25 flakoni: emulsija
English: A minor infection such as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Latvian: Nelielai infekcijai, piemēram, saaukstēšanās gadījumā, nevajadzētu būt problēmai, taču to, vai Jūs varat vakcinēties ar Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg, noteiks ārsts.
English: • two packs containing 25 vials of 2.5 ml emulsion (adjuvant) for 10 doses
Latvian: • divi iepakojumi ar 25 flakoniem, kuros ir 2,5 ml emulsijas (adjuvants) 10 devām.
English: 21 days after 1st dose N=55
Latvian: diena pēc 1. devas N=55
English: In another clinical study, 152 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Latvian: Citā klīniskā pētījumā 152 indivīdi vecumā > 60 gadiem (sadalīti vecuma grupās no 61 līdz 70, no 71 līdz 80 un > 80 gadiem) saņēma vai nu vienu, vai dubultu devu vakcīnas ar AS03 adjuvantu, kas satur 3,75 µg HA, iegūta no A/Vietnam/1194/2004 (H5N1), 0. un 21. dienā.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ ĀRĒJĀ IEPAKOJUMA IEPAKOJUMS AR 25 FLAKONIEM, KUROS IR EMULSIJA
English: If you are older than 80 years of age, you may receive two double injections of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Latvian: Ja esat vecāks par 80 gadiem, Jūs varat saņemt divas dubultas Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg injekcijas.
English: Vial B
Latvian: B flakons
English: In a different study in 50 subjects aged 18-60 years the anti-HA antibody seroprotection rates 21 days after the second dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 20% against A/Indonesia/5/2005, 35% against A/Anhui/01/2005 and 60% against A/Turkey/Turkey/1/2005.
Latvian: Citā pētījumā 50 indivīdiem vecumā no 18 līdz 60 gadiem 21 dienu pēc vakcīnas ar AS03 adjuvantu, kas satur 3,75 µg HA, iegūta no A/Vietnam/1194/2004, otrās devas ievadīšanas anti-HA antivielu seroloģiskās aizsardzības raksturlielumi bija 20% pret A/Indonesia/5/2005, 35% pret A/Anhui/01/2005 un 60% pret A/Turkey/Turkey/1/2005.
English: * haemagglutinin
Latvian: * hemaglutinīna
English: Like all medicines, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can cause side effects, although not everybody gets them.
Latvian: Tāpat kā citas zāles, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg var izraisīt blakusparādības, kaut arī ne visiem tās izpaužas.
English: • Pain, redness, swelling or a hard lump at the injection site
Latvian: • sāpes, apsārtums, tūska vai cieta mezgliņa veidošanās injekcijas vietā
English: • Warmth, itching or bruising at the injection site
Latvian: • siltuma sajūta, nieze vai asinsizplūdums injekcijas vietā
English: • if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Latvian: • ja Jums ir bijusi alerģiska reakcija, kas nav uzskatāma par pēkšņu dzīvībai bīstamu alerģisku reakciju, pret kādu no vakcīnas sastāvdaļām, pret tiomersālu, pret olu vai cāļu olbaltumvielām, ovalbumīnu, formaldehīdu, gentamicīna sulfātu (antibiotika) vai nātrija deoksiholātu (skatīt apakšpunktu 6. “Sīkāka informācija”);
English: Tell the doctor requesting these tests that you have recently received Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals
Latvian: Pasakiet ārstam, kurš liek veikt šīs analīzes, ka Jūs nesen esat vakcinēts ar Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
English: In the event of either being observed, discard the vaccine.
Latvian: Ja konstatējamas kādas no minētajām pazīmēm, vakcīna jāiznīcina.
English: In 152 subjects aged > 60 years the anti-HA antibody seroprotection and seroconversion rates against A/Indonesia/5/2005 at day 42 after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 23% and the seroconversion factor was 2.7.
Latvian: 152 indivīdiem vecumā > 60 gadiem 42. dienā pēc vakcīnas ar AS03 adjuvantu, kas satur 3,75 µg HA, iegūta no A/Vietnam/1194/2004, divu devu ievadīšanas anti-HA antivielu seroloģiskās aizsardzības un serokonversijas raksturlielumi pret A/Indonesia/5/2005 bija 23%, un serokonversijas koeficients bija 2,7.
English: Suspension for emulsion for injection 50 vials: suspension
Latvian: ZĀĻU FORMA UN SATURS Suspensija emulsijas injekcijām pagatavošanai 50 flakoni: suspensija
English: To be mixed with Vial B before administration
Latvian: LIETOŠANAS METODE Pirms ievadīšanas jāsajauc ar B flakona saturu
English: • Aching muscles, joint pain
Latvian: • sāpes muskuļu un locītavās
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
Latvian: Retāk (var rasties līdz 1 reizei no 100 vakcīnas devām):
English: In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 in subjects aged 18-60 years the anti-haemagglutinin (antiHA) antibody responses were as follows:
Latvian: Imūnreakcija pret A/Vietnam/1194/2004: Klīniskajos pētījumos, kuros tika vērtēta vakcīnas ar AS03 adjuvantu, kas satur 3,75 µg HA, iegūta no A/Vietnam/1194/2004, imunogenitāte indivīdiem vecumā no 18 līdz 60 gadiem, antihemaglutinīna (anti-HA) antivielu atbildes reakcija bija šāda: anti-HA antivielas
English: In a clinical study, subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
Latvian: Klīniskā pētījumā indivīdi vecumā no 18 līdz 60 gadiem saņēma vakcīnas ar AS03 adjuvantu, kas satur 3,75 µg HA, iegūta vai nu no A/Vietnam/1194/2004, vai Indonesia/5/2005, devu sešus mēnešus pēc tam, kad bija saņēmuši vienu vai divas primārās devas vakcīnas ar AS03 adjuvantu, kas satur 3,75 µg HA, iegūta no A/Vietnam/1194/2004, attiecīgi 0. dienā vai 0. un 21. dienā.
English: Common (these may occur with up to 1 in 10 doses of the vaccine):
Latvian: Bieži (var rasties līdz 1 reizei no 10 vakcīnas devām):
English: Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Latvian: Ievadot vakcīnu cilvēkiem, kam ir zināma paaugstināta jutība (izņemot anafilaktisku reakciju) pret aktīvo vielu, kādu no palīgvielām, tiomersālu vai atliekvielām (olu un cāļu olbaltumvielām, ovalbumīnu, formaldehīdu, gentamicīna sulfātu un nātrija deoksiholātu), jāievēro piesardzība.
English: PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:
Latvian: PSUR iesniegšana, ja Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg tiek lietota gripas pandēmijas laikā:
English: In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Latvian: Citā klīniskā pētījumā 39 indivīdi vecumā no 18 līdz 60 gadiem saņēma vakcīnas devu ar AS03 adjuvantu, kas satur 3,75 µg HA, iegūta no A/Indonesia/5/2005, četrpadsmit mēnešu pēc tam, kad bija saņēmuši divas devas vakcīnas ar AS03 adjuvantu, kas satur 3,75 µg HA, iegūta no A/Vietnam/1194/2004, ievadītas 0. un 21. dienā.
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkustraße 40, D-01069 Dresden Germany
Latvian: KG Zirkustraße 40, D-01069 Dresden Vācija
English: 2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4fold increase in titre;
Latvian: 2revakcinācijas serokonversijas līmenis: indivīdu daļa, kuri vai nu pirms revakcinācijas bija seronegatīvi, bet kuriem pēc revakcinācijas bija aizsargājošs titrs ≥ 1:40, vai arī kuri pirms revakcinācijas bija seropozitīvi un kuriem titrs paaugstinājies četrkārtīgi; 3revakcinācijas koeficients: vidējā ģeometriskā antivielu titra (GMT) attiecība pēc un pirms revakcinācijas.
English: Do not have Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg if any of the above apply to you.
Latvian: Nelietojiet Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg, ja kaut kas no iepriekš norādītā attiecas uz Jums.
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension (10 x 0.25 ml doses) with a stopper
Latvian: Vienā iepakojumā ir: - viena paka ar 50 flakoniem (I klases stikls), kuros ir 2,5 ml suspensijas (10 x 0,25 ml devas), ar aizbāzni (butila gumija); - divas pakas ar 25 flakoniem (I klases stikls), kuros ir 2,5 ml emulsijas (10 x 0,25 ml devas), ar aizbāzni (butila gumija).
English: • Narrowing or blockage of blood vessels with kidney problems
Latvian: • Asinsvadu sašaurināšanās vai aizsprostošanās, izraisot nieru darbības traucējumus.
English: • Dizziness
Latvian: • bezmiegs
English: Very common (these may occur with more than 1 in 10 doses of the vaccine):
Latvian: Ļoti bieži (var rasties līdz 1 reizei vai vairāk no 10 vakcīnas devām):
English: You will receive two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Latvian: Jūs saņemsiet divas Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg devas.
English: A complete vaccination course with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two doses.
Latvian: Pilns vakcinācijas kurss ar Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg sastāv no divām devām.
English: • Swollen glands in the neck, armpit or groin
Latvian: • palielināti kakla, padušu vai cirkšņa limfmezgli
English: The volume of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (5 ml) after mixing corresponds to 10 doses of vaccine.
Latvian: Pēc sajaukšanas iegūtais Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg tilpums (5 ml) atbilst 10 vakcīnas devām.
English: If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can still be given but your response to the vaccine may be poor.
Latvian: Ja lietojat citas zāles, kas samazina imunitāti pret infekcijām, vai saņemat jebkāda cita veida terapiju (piemēram, staru terapiju), kas ietekmē imūnsistēmu, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
English: There are no data regarding the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg during lactation.
Latvian: Nav datu par Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg lietošanu zīdīšanas periodā.
English: Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant or breastfeeding.
Latvian: Ja esat grūtniece vai barojat bērnu ar savu pienu, ārstam jāizvērtē ieguvumi un iespējamais risks saistībā ar vakcīnas ievadīšanu.
English: Posology
Latvian: SĒRIJAS NUMURS
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Latvian: GlaxoSmithKline Biologicals 3.75 µg un kādam nolūkam to lieto Pirms Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg lietošanas Kā lietot Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
English: How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Latvian: Kā uzglabāt Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
English: These side effects may occur with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Latvian: Šīs blakusparādības var rasties Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg ievadīšanas gadījumā.
English: There are no data on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg given at the same time as other vaccines.
Latvian: Nav datu par Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg lietošanu vienlaikus ar citām vakcīnām.
English: How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Latvian: Ko Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
English: Nervous system disorders
Latvian: Vaskulīts ar pārejošiem nieru darbības traucējumiem.
English: Immune response to A/Indonesia/5/2005 0, 6 months schedule 7 days after 2nd dose
Latvian: Atbildes reakcija pret A/Indonesia/5/2005 N = 924
English: There is no information on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in pregnant or breast-feeding women.
Latvian: Nav informācijas par Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg lietošanu grūtniecēm un sievietēm, kas baro bērnu ar krūti.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Latvian: GlaxoSmithKline Biologicals 3.75 µg suspensija un emulsija emulsijas pagatavošanai injekcijām Pirmspandēmijas gripas vakcīna (H5N1) (šķelts, inaktivēts virions, ar adjuvantu)
English: • Sleepiness
Latvian: • nogurums
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): • Temporary inflammation of the brain and nerves causing pain, weakness and paralysis that may
Latvian: • Īslaicīgs galvas smadzeņu un nervu iekaisums, kas izraisa sāpes, vājumu un paralīzi, kas var izplatīties pa visu ķermeni.
English: No data have been generated in pregnant women with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg or with any other vaccine that contains the AS03 adjuvant.
Latvian: Nav apkopoti dati par Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg vai citas adjuvantu AS03 saturošas vakcīnas lietošanu grūtniecēm.
English: Booster seroconversion rate2
Latvian: Revakcinācijas serokonversijas līmenis2
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection Prepandemic influenza vaccine (H5N1)
Latvian: GlaxoSmithKline Biologicals 3.75 µg suspensija emulsijas injekcijām pagatavošanai Pirmspandēmijas gripas vakcīna (H5N1)
English: Booster factor3
Latvian: Revakcinācijas koeficients3
English: Patients should be advised to carefully read them.
Latvian: Pacientiem jāiesaka tos rūpīgi izlasīt.
English: Wait 5 to 15 minutes;
Latvian: Nogaidiet 5-15 minūtes;
English: You must let it fully dry, this can take up to 24 hours.
Latvian: Jums jāļauj tam pilnībā nožūt, tas var ilgt līdz 24 stundām ilgi.
English: (See Table 1).
Latvian: (skatīt 1. tabulu).
English: Your doctor will tell you how long to use this medicine for.
Latvian: Jūsu ārsts pastāstīs Jums, cik ilgi Jums šīs zāles jālieto.
English: Note: There were some differences in analysis methods across the 3 studies.
Latvian: Piezīme: visos 3 pētījumos tika konstatētas atšķirības analīžu metodēs.
English: There are no data available for children under 12 years of age.
Latvian: Nav pieejami dati par bērniem līdz 12 gadu vecumam.
English: The applicant is requested to submit periodic analysis of the CF study every 6 months for 3 years and annually for 2 years.
Latvian: Pieteikuma iesniedzējam tiek lūgts iesniegt periodisku CF pētījuma analīzi ik pēc sešiem mēnešiem trīs gadus un reizi gadā divus gadus.
English: - Use a new inhaler each week.
Latvian: - Katru nedēļu izmantojiet jaunu inhalatoru.
English: Elderly patients (≥65 years)
Latvian: Gados vecāki pacienti (≥65 gadi)
English: o The need for monitoring and when to withhold treatment.
Latvian: o Nepieciešamība veikt uzraudzību un kad jāpārtrauc ārstēšana.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Latvian: Pašlaik pieejamie dati ir izklāstīti 4.8., 5.1. un 5.2. apakšpunktā, bet ieteikumus par devām nav iespējams sniegt.
English: If the capsule has not emptied you may need to repeat steps 6 to 8.
Latvian: Ja kapsula nav iztukšojusies, Jums var būt jāatkārto 6.-8. punktā minētās darbības.
English: If this does not happen, the capsule may be stuck.
Latvian: Ja tā nenotiek, kapsula var būt iesprūdusi.
English: - Do not use a double dose to make up for a forgotten dose.
Latvian: - Nelietojiet dubultu devu, lai aizvietotu aizmirsto devu.
English: Treatment dose (2-week packs) - You must use Bronchitol every day.
Latvian: Ārstēšanas deva (divu nedēļu iepakojumi) - Jums jālieto Bronchitol katru dienu.
English: This is because piercing the capsule more than once may make it split or break-up.
Latvian: Dariet to tikai vienreiz, jo kapsulas caurduršana vairāk nekā vienu reizi var izraisīt tās sadalīšanos vai salūšanu.
English: This happens commonly.
Latvian: Tas notiek bieži.
English: ATC code: R05CB16
Latvian: ATĶ kods: R05CB16
English: Do not stop using your Bronchitol without talking to your doctor first, even if you feel better.
Latvian: Nepārtrauciet lietot Bronchitol, vispirms nekonsultējoties ar ārstu, pat ja jūtaties labāk.
English: The mean terminal half-life in adults was approximately 4 to 5 hours from serum and approximately 3.66 hours from urine.
Latvian: Vidējais terminālais pusperiods pieaugušajiem bija aptuveni 4-5 stundas no seruma un aptuveni 3,66 stundas no urīna.
English: The first dose is taken in 4 steps:
Latvian: Pirmo devu lieto četros posmos:
English: Talk to your doctor if the cough won't go away or worries you.
Latvian: Konsultējieties ar ārstu, ja klepus neizzūd vai sagādā Jums raizes.
English: The suggested order is as follows, unless otherwise advised by your doctor:
Latvian: Ierosinātā secība ir šāda, izņemot gadījumus, kad ārsts ir norādījis citādi:
English: FEV1 (95% CI)
Latvian: FEV1 (95 % TI)
English: - Take a steady deep breath in, to fill your lungs - then hold your breath for 5 seconds.
Latvian: - Veiciet vienmērīgu dziļu ieelpu, lai piepildītu plaušas - tad aizturiet elpu uz piecām sekundēm.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Latvian: Neizlietotās zāles vai izlietotie materiāli jāiznīcina atbilstoši vietējām prasībām.
English: Put in the capsule - First make sure your hands are dry.
Latvian: Ielieciet kapsulu - Vispirms pārliecinieties, vai Jūsu rokas ir sausas.
English: Aluminium/polyamide/PVC/aluminium blisters.
Latvian: Alumīnija/poliamīda/PVH/ alumīnija blisteros.
English: Inhaled antibiotics (if applicable)
Latvian: 5. inhalējamas antibiotikas (ja piemērojams).
English: All FEV1 measurements and SpO2 monitoring should be performed 60 seconds after dose inhalation.
Latvian: Visi FEV1 mērījumi un SpO2 uzraudzība jāveic 60 sekundes pēc devas inhalēšanas.
English: If you forget to use Bronchitol - If you forget a dose, use it as soon as you remember it and carry on as usual.
Latvian: Ja esat aizmirsis lietot Bronchitol - Ja esat aizmirsis lietot devu, lietojiet to, tiklīdz par to atceraties un turpiniet zāļu lietošanu ierastā veidā.
English: The 2-week treatment pack is for treatment use.
Latvian: Divu nedēļu ārstēšanas iepakojumu izmanto ārstēšanai.
English: Below is a diagram that shows what the inhaler looks like.
Latvian: Tālāk ir diagramma, kurā redzams, kā inhalators izskatās.
English: - Worsening of symptoms.
Latvian: - simptomu pastiprināšanās.
English: No formal interaction studies have been conducted.
Latvian: Oficiāli mijiedarbības pētījumi nav veikti.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Latvian: Plašāka informācija par šīm zālēm ir pieejama Eiropas Zāļu aģentūras tīmekļa vietnē: http://www.ema.europa.eu/.
English: • acute bleeding ≥240 ml in a 24-hour period
Latvian: • akūta asiņošana ≥240 ml 24 stundu laikā;
English: The educational material for Healthcare Professionals should be a leaflet that includes information on the following key elements:
Latvian: Izglītojošais materiāls veselības aprūpes speciālistiem jāveido kā lapiņa, kurā iekļauta informācija par šādiem pamatelementiem:
English: As a result you may get a ‘productive cough', which also helps to remove mucus from your lungs.
Latvian: Tā rezultātā var rasties “produktīvs klepus”, kas arī palīdz izvadīt gļotas no plaušām.