natgillin/translations-raw huggingface dataset:
How to use HBVAXPRO 40 micrograms/ ml 4.
Kako uporabljati HBVAXPRO 40 mikrogramov/ ml 4.
How to store HBVAXPRO 40 micrograms/ ml 6.
Shranjevanje HBVAXPRO 40 mikrogramov/ ml 6.
WHAT HBVAXPRO 40 micrograms/ ml IS AND WHAT IT IS USED FOR
KAJ JE HBVAXPRO 40 mikrogramov/ ml IN ZA KAJ GA UPORABLJAMO
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients.
Cepivo je indicirano za aktivno imunizacijo proti okužbi z vsemi znanimi podtipi virusa hepatitisa B pri bolnikih pred dializo in na dializi.
It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Pričakujemo lahko, da cepljenje s HBVAXPRO prepreči tudi hepatitis D (ki ga povzroča agens delta), ker se ta pri osebah, ki niso okužene s hepatitisom B, ne pojavi.
BEFORE YOU USE HBVAXPRO 40 micrograms / ml
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI HBVAXPRO 40 mikrogramov/ ml
Do not use HBVAXPRO 40 micrograms/ ml:
Ne uporabljajte cepiva HBVAXPRO 40 mikrogramov/ ml:
Take special care with HBVAXPRO 40 micrograms/ ml:
Pri uporabi cepiva HBVAXPRO 40 mikrogramov/ ml bodite posebno pozorni:
82 This vaccine can be administered simultaneously with hepatitis B immunoglobulin, at a separate injection site.
To cepivo se lahko uporabi hkrati z imunoglobulinom proti hepatitisu B, a na drugem vbodnem mestu.
HOW TO USE HBVAXPRO 40 micrograms/ ml
KAKO UPORABLJATI HBVAXPRO 40 mikrogramov/ ml
The recommended dose for each injection (1 ml) is 40 micrograms for predialysis and dialysis adult patients
Priporočeni odmerek za bolnike pred dializo in na dializi je 40 mikrogramov na injekcijo (1 ml).
The schedule is two injections with an interval of one month followed by a third injection 6 months after the first administration (0,1,6 months).
Shema cepljenja je dve injekciji v presledku enega meseca, ki jima sledi tretja injekcija 6 mesecev po prvi (0, 1 in 6 mesecev).
A booster dose must be considered in these vaccinees if the antibody level against hepatitis B virus surface antigen is less than 10 IU/ l.
O obnovitvenem odmerku je treba razmisliti pri tistih ceplenih osebah, pri katerih je raven protiteles proti površinskemu antigenu virusa hepatitisa B (anti- HBsAg) pod 10 i. e. / l.
If you forget one dose of HBVAXPRO 40 micrograms/ ml:
Če pozabite en odmerek HBVAXPRO 40 mikrogramov/ ml:
83 Other side effects are reported very rarely: low platelet count, lymph node disease, allergic reactions, nervous system disorders such as pins and needles, facial paralysis, nerve inflammations including Guillain-Barre Syndrome, inflammation of the nerve of the eye that leads to impaired vision, brain inflammation, exacerbation of multiple sclerosis, multiple sclerosis, convulsions, headache, dizziness and fainting, low blood pressure, blood vessel inflammation, asthma-like symptoms, vomiting, nausea, diarrhoea, abdominal pain, skin reactions such as eczema, rash, hair loss, itching, hives and skin blistering, joint pain, arthritis, muscle pain, pain in extremity, fatigue, fever, vague illness, flu-like symptoms and elevations of liver enzymes.
O drugih neželenih učinkah poročajo zelo redko: majhno število trombocitov, bolezen limfnih vozlov, alergijske reakcije, bolezni živčevja kot so ščemenje in zbadanje, paraliza obraza, vnetje živcev vključno z Guillain- Barréjevim sindromom, vnetje očesnega živca, ki lahko povzroči slabši vid, vnetje možganov, poslabšanje multiple skleroze, multipla skleroza, krči, glavobol, omotica in omedlevica, nizek krvni tlak, vnetje krvnih žil, astmi podobni simptomi, bruhanje, slabost, driska, bolečine v trebuhu, kožne reakcije kot je ekcem, izpuščaj, izpadanje las, koprivnica, mehurčki na koži, bolečine v sklepih, artritis, bolečine v mišicah, boleči udi, utrujenost, zvišana telesna temperatura, nedoločena bolezen, gripi podobni simptomi, povišane vrednosti jetrnih encimov.
HOW TO STORE HBVAXPRO 40 micrograms/ ml
SHRANJEVANJE HBVAXPRO 40 mikrogramov/ ml
What HBVAXPRO 40 micrograms/ ml contains
Kaj vsebuje HBVAXPRO 40 mikrogramov/ ml
Hepatitis B virus surface antigen, recombinant (HBsAg) *...................
Zdravilna učinkovina v enem 1 ml odmerku je: rekombinantni površinski antigen virusa hepatitisa B (HBsAg) *..........
What HBVAXPRO 40 micrograms/ ml looks like and contents of the pack
Izgled cepiva HBVAXPRO 5 mikrogramov/ 0, 5 ml in vsebina pakiranja
This leaflet was last approved in ………….
Navodilo je bilo odobreno
The active substance of HBVAXPRO, Hepatitis B (Recombinant) vaccine, is purified Hepatitis B virus surface antigen, recombinant (HBsAg).
Zdravilna učinkovina cepiva HBVAXPRO, t. j. hepatitis B (rekombinantnega) cepiva, je prečiščen površinski antigen virusa hepatitis B, t. j. rekombinanten HbsAg.
HBVAXPRO is a vaccine inducing a specific humoral and cellular immune response against HBsAg, which results in an active immunisation against Hepatitis B virus infection.
Cepivo HBVAXPRO sproži specifičen humoralni in celični imunski odgovor proti HbsAg, kar povzroči aktivno imunizacijo pred okužbo z virusom hepatitisa B.
The benefits with HBVAXPRO are the protective efficacy against Hepatitis B in all age groups in absence of thiomersal in the finished product.
Korist HBVAXPRO je učinkovitost zaščite pred hepatitisom B pri vseh starostnih skupinah v odsotnosti tiomersala v končnem produktu.
Issues pertaining to the relatively low immunogenicity of the Hepatitis B (HepB) component contained in the vaccines containing the recombinant Hepatitis B component from SPMSD have been assessed and extensively discussed by the CHMP and its Working Parties (Biotechnology Working Party, Vaccines Working Party).
Vprašanja družbe SPMSD glede relativno nizke imunogenosti sestavine hepatitisa B (HepB) v cepivu z rekombinatno sestavino hepatitisa B je obravnaval Odbor za zdravila za uporabo v humani medicini (CHMP) in njegove delovne skupine (delovna skupina za biotehnologijo, delovna skupina za cepiva).
On 26 May 2005, the CHMP agreed on the need to convene an Ad Hoc Expert Group Meeting on Hepatitis short and long-term protection afforded by recombinant Hepatitis B vaccines.
CHMP je 26. maja 2005 sklenil sklicati ad hoc zasedanje strokovne skupine glede kratkoročne in dolgoročne zaščite pred hepatitisom, ki jo dajejo rekombinantna cepiva proti hepatitisu B.
The CHMP expressed concerns that there is evidence of unpredictable variability in Hepatitis B antibody response following vaccination with Hexavac.
CHMP je izrazil zaskrbljenost glede dokazane nepredvidljive variabilnosti pri odgovoru protiteles za hepatitis B po cepljenju z izdelkom Hexavac.
As a consequence the data obtained so far must be interpreted with caution since they were generated using the paediatric (5µg) dose of Hep B vaccine produced before 2001.
Zato je treba do sedaj zbrane podatke pazljivo razlagati, saj so bili sproženi z otroškim (5µg) odmerkom cepiva Hep B, izdelanim pred letom 2001.
There are some indications that the Hep B vaccine currently produced is less immunogenic than the vaccine produced in the 1990’ s.
Nekaj indikacij kaže na to, da je cepivo Hep B, ki se trenutno izdeluje, manj imunogeno kot cepivo, izdelano v 90- ih letih prejšnjega stoletja.
On 13 February 2006, the European Commission (EC) triggered the procedure under Article 20 of Regulation (EC) No 726/ 2004, after the CHMP expressed concerns on the low immunogenicity of the HepB component of HBVAXPRO.
726/ 2004.
The CHMP was requested to give an opinion as to whether the marketing authorisation for HBVAXPRO should be maintained, varied, suspended or withdrawn in the context of an Article 20 of Regulation (EC) No.
Evropska komisija je prosila CHMP za mnenje o tem, ali naj dovoljenje za promet za cepivo HBVAXPRO ohrani, spremeni, ukine ali umakne v skladu s postopkom člena 20 Uredbe (ES) št.
DISCUSSION
1 RAZPRAVA
From the quality point of view, there are no technical, analytical or animal tools able to predict immunogenicity of recombinant hepatitis B components in man.
Z vidika kakovosti ni nobenega tehničnega, analitičnega ali živalskega orodja, s katerim bi lahko napovedali imunogenost rekombinantnih sestavin hepatitisa B pri človeku.
Analytical tools can be used as consistency criteria, but not as correlates for safety and efficacy (immunogenicity) of Hepatitis B batches produced at SPMSD.
Analitično orodje lahko uporabimo kot kriterij doslednosti, vendar ne kot navezavo na varnost in učinkovitost (imunogenost) serij hepatitisa B, izdelanih pri družbi SPMSD.
As there is no in vitro or in vivo system suitable to predict acceptable immunogenicity in man, it is important to note at this stage that the C3H mouse model suggested by the MAH appears to be able to discriminate between Hepatitis B lots which are acceptable and those who are not.
Ker za napoved imunogenosti pri človeku primeren sistem in vitro ali in vivo ne obstaja, je pomemben podatek to, da model C3H pri miših, ki ga je predlagal imetnik dovoljenja za promet, lahko razloči med sprejemljivimi in nesprejemljivimi pošiljkami hepatitisa B.
Notwithstanding, the new proposed model will have only predictive value once it has been fully validated and has shown to be able to discriminate batches of HBVAXPRO that have elicited a high vs. a low immune response during clinical trials.
Ne glede na to bo imel nov predlagan model, ko bo popolnoma odobren in ko bo med kliničnim preizkušanjem zmožen razlikovati serije HBVAXPRO z visokim od tistih z nizkim imunskim odgovorom, le napovedno vrednost.
The interim outcome of a clinical trial with the ‘ process upgraded’ recombinant Hepatitis B batches confirms that the immunogenicity of the current HBVAXPRO vaccine is at the historic standard, and provides evidence for a consistent trend to higher GMTs with HBVAXPRO manufactured with the process modification.
Vmesni izid kliničnega preizkušanja serij rekombinantnega hepatitisa, pridobljenih s posodobljenim postopkom B, potrjuje, da je imunogenost trenutnega cepiva HBVAXPRO na standardu izpred nekaj let in kaže nepretrgan trend višanja vrednosti GMT (geometric mean titre) pri cepivu HBVAXPRO, izdelanim s spremenjenim postopkom.
These trials were carried out in different risk groups and age categories, i. e. children born to Hepatitis B positive mothers, infants, healthy young adults and healthy subjects between 16-35 years of age.
Preizkušanje so izvedli v različnih skupinah tveganja in starostnih kategorijah, npr. otrocih, rojenih hepatitis B pozitivnim materam, dojenčkih, zdravih mladih odraslih in zdravih osebah, starih od 16 do 35 let.
Although in some of the trials conducted in the past 5 years, the GMTs of the hepatitis B vaccines were lower than responses observed in the early 1990’ s, the clinical data generated by the sponsor in the trials described above, demonstrate consistent, high anti-HBs seroprotective rates, which is the established correlate of effectiveness.
Kljub temu, da so bili v nekaterih preizkušanjih, izvedenih v zadnjih petih letih, vrednosti GMT cepiv proti hepatitisu B nižje od odgovorov, opazovanih v začetku 90- ih let prejšnjega stoletja, so podatki, ki jih je v zgoraj omenjenih preizkušanjih zbral sponzor, pokazali visoke zaščitne ravni protiteles, kar je uveljavljena soodnosnost z učinkovitostjo.
In addition, a review of clinical performance as assessed by protection against disease as noted in the V121-018 trial supports the conclusion that the hepatitis B vaccines remain effective in decreasing hepatitis B infection and its serious sequelae.
Poleg tega pregled kliničnih učinkov, opredeljenih kot zaščita pred boleznijo, kot je navedeno v preizkušanju V121- 018, podpira zaključek, da ostajajo cepiva proti hepatitisu B učinkovita pri zmanjševanju okužb s hepatitisom B in njihovih resnih posledic.
The most recent immunogenicity data comes from the interim analysis of the V232-054 trial, this is the third trial in the past few years to study the current product (from the BTMC manufacturing facility) in young adults using the same dosing schedule (the other two trials are V501-011 and V232- 052).
Najnovejši podatki imunogenosti prihajajo iz vmesne analize preizkušanja V232- 054, to je tretjega preizkušanja v zadnjih nekaj letih, ki preučuje trenutni proizvod (iz proizvodne ustanove BTMC) na mladih odraslih z enakim urnikom odmerjanja (drugi dve preizkušanji sta V501- 011 in V232- 052).
The CHMP requested the MAH to conduct studies regarding neonates, infants, older adults, renal dialysis patients, dose ranging and a booster study with the current formulation and the process upgraded product to further ensure that the vaccine provides a sufficient level of long-term protection against Hepatitis B.
CHMP je prosil imetnika dovoljenja za promet, naj izvede raziskave o novorojenčkih, dojenčkih, starejših odraslih, bolnikih na ledvični dializi, raziskavo z razponom odmerkov in poživitveno
In view of the lack of analytical tools to predict immunogenicity in man, the need for regular testing of recombinant HepB batches in clinical trials was considered, in order to ensure consistent high immunogenicity of HBVAXPRO produced in particular according to the new updated/ improved process.
Zaradi pomanjkanja analitičnih orodij za napoved imunogenosti pri človeku se je pojavila potreba po rednem testiranju serij rekombinantnega HepB v kliničnih preizkušanjih, z namenom zagotoviti nepretrgano visoko imunogenost cepiva HBVAXPRO, posebej izdelanega v skladu z novim/ izboljšanim postopkom.
The CHMP agreed with the MAH that in 4 years time, in the absence of ongoing clinical studies of immunogenicity with the MAH’ s hepatitis B antigen, the MAH will conduct a study of vaccine immunogenicity no less frequently than every four years to confirm that experience with manufactured product remains current and that clinical performance meets expectations.
CHMP je z imetnikom dovoljenja za promet sklenil, da bo po štirih letih imetnik dovoljenja za promet, v odsotnosti potekajočih kliničnih raziskav imunogenosti z antigenom hepatitisa B, ki je last imetnika dovoljenja za promet, izvedel raziskavo imunogenosti cepiva najmanj vsake štiri leta, in s tem potrdil, da je izkušnja s proizvedenim izdelkom veljavna in da klinično delovanje ustreza pričakovanju.
Pending the outcome of the studies, the MAH committed to amend the SPC sections 4.2, 4.4, 4.5 (where relevant) and 5.1 as follows:
V pričakovanju izida raziskav se imetnik dovoljenja za promet zavezuje k dopolnitvi poglavij 4. 2, 4. 4, 4. 5 (kjer je primerno) in 5. 1 v SPC z naslednjim besedilom:
• The need of the 4th dose at 12 months has been reinforced, when the compressed administration schedule 0, 1, 2 and 12 months is used • The recommendations for serologic testing, and administration of additional doses if needed, in immunocompromised patients, in non-responders of other high risk groups, and in the case of presumed exposure to hepatitis B, have been strengthened. • The concomitant administration of pneumococcal conjugate vaccine is not recommended since this has not been sufficiently studied for HBVAXPRO. • In renal dialysis patients in whom insufficient antibody titre is achieved after boosting, the use of alternative hepatitis B vaccines should be considered.
• Pri skrčeni shemi odmerjanja pri 0, 1, 2 in 12 mesecih se je povečala potreba po četrtem odmerku pri 12- ih mesecih. • Priporočila za serološko testiranje in odmerjanje dodatnih odmerkov, če so potrebni, pri imunsko oslabljenih bolnikih, pri bolnikih drugih tveganih skupin, ki se ne odzivajo, in v primeru predpostavljene izpostavljenosti hepatitisu B, so bili ojačani. • Sočasno uporaba pnevmokoknega konjugiranega cepiva ni priporočena, saj tovrstne raziskave za HBVAXPRO niso bile opravljene. • Pri bolnikih na ledvični dializi, ki po poživitvenem odmerku ne dosežejo zadostnega titra protiteles, je smiselna uporaba drugih cepiv proti hepatitisu B.
The CHMP also considered the commitments given by the MAH in response to CHMP’ s requests to meticulously control the performance of HBVAXPRO from now on in a broad array of appropriate clinical trials including all age and risk categories.
Prav tako je CHMP upošteval obljubo imetnika dovoljenja za promet, kot odgovor na prošnjo odbora CHMP, naj od sedaj dalje temeljito preverja delovanje cepiva HBVAXPRO v širokem spektru primernih kliničnih preizkušanj, vključno z vsemi starostnimi kategorijami in kategorijami tveganja.
Considering all points raised, including time lines required to fully explore all issues related to low HepB immunogenicity following vaccination with HBVAXPRO and further to the assessment of the data provided by the MAH, the CHMP concluded that the MA of HBVAXPRO should be varied in accordance with Article 5(1) of Regulation (EC) No.
Ob upoštevanju vseh različnih točk, vključno s časovno razporeditvijo, potrebno za pregled vseh vprašanj glede nizke imunogenosti HepB po cepljenju s HBVAXPRO, do ocene podatkov, ki jih je podal imetnik dovoljenja za promet, je CHMP zaključil, da mora biti dovoljenje za promet s cepivom HBVAXPRO spremenjeno v skladu s členom 5( 1) Uredbe (ES) št.
GROUNDS FOR THE VARIATION OF THE MARKETING AUTHORISATION OF HBVAXPRO
3 PODLAGA ZA SPREMEMBO DOVOLJENJA ZA PROMET S CEPIVOM HBVAXPRO
WHEREAS
OB UPOŠTEVANJU NASLEDNJEGA
Potential remaining risks will be minimised to an acceptable level by the fundamentally revised SPC.
Temeljito popravljen SPC bo ostala možna tveganja zmanjšal na sprejemljivo stopnjo.
• The CHMP considered that the benefit/ risk balance of HBVAXPRO concerning protection against hepatitis B virus infection caused by all known subtypes in all age categories considered at risk of exposure to hepatitis B virus remains favourable.
• CHMP je mnenja, da je razmerje med koristmi in tveganji cepiva HBVAXPRO, glede zaščite pred okužbo z virusom hepatitisa B z vsemi znanimi podtipi virusa pri vseh starostnih skupinah, ki jih ogroža okužba s tem virusom, ugodno.
The CHMP has recommended the variation of the Marketing Authorisations for HBVAXPRO in accordance with Article 5(2) of Regulation (EC) No.
CHMP je priporočil spremembo dovoljenja za promet s cepivom HBVAXPRO v skladu s členom 5( 2) Uredbe (ES) št.
The powder is the active substance 13C-urea (45 mg for children or 75 mg for adults).
Prašek je zdravilna učinkovina 13C- sečnina (45 mg za otroke ali 75 mg za odrasle).
Firstly, the patient collects two breath samples, using the tubes or bags supplied with Helicobacter Test INFAI.
Bolnik najprej odvzame dva vzorca izdihanega zraka, pri čemer si pomaga s cevkami ali vrečkami, ki so priložene zdravilu Helicobacter Test INFAI.
The patient then takes a ‘ test meal’ (either 200 ml of pure orange juice or 1 g of citric acid dissolved in 200 ml water), followed by the solution of Helicobacter Test INFAI dissolved in water.
Bolnik nato vzame „ testni obrok “ (200 ml čistega pomarančnega soka ali 1 g citronske kisline, raztopljene v 200 ml vode), za tem pa raztopino zdravila Helicobacter Test INFAI, raztopljenega v vodi.
In children aged three to 11 years, the ‘ test meal’ should be 100 ml of pure orange juice.
Pri otrocih, starih od treh do 11 let, je „ testni obrok “ 100 ml čistega pomarančnega soka.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged H. pylori contain enzymes called ureases that make it able to break down urea into carbon dioxide, which is then removed in the breath.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako zdravilo Helicobacter Test INFAI deluje?
When the patient takes Helicobacter Test INFAI, the 13C-urea contained in the test is broken down by H Pylori into carbon dioxide that also contains 13C.
Zdravilna učinkovina v zdravilu Helicobacter Test INFAI, 13C- sečnina, je naravna kemična sečnina, ki je bila označena z ogljikom- 13 (13C).
This labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry.
Ko bolnik vzame zdravilo Helicobacter Test INFAI, H. pylori razgradi 13 C- sečnino, ki je v testu, v ogljikov dioksid, ki prav tako vsebuje 13C.
All received 75 mg of 13C-urea, except 204 children under the age of 11 who received 45 mg.
Vsi so prejeli 75 mg 13C- sečnine, razen 204 otrok, mlajših od 11 let, ki so je prejeli 45 mg.
One of the studies in adults was carried out in patients after they had received antibiotics to treat their infection.
Ena izmed študija z odraslimi je bila izvedena z bolniki, potem ko so le- ti prejeli antibiotike za zdravljenje okužbe.
In all studies, the results of the test done using Helicobacter Test INFAI agreed with the results obtained with the endoscopy and histology in over 95% of cases.
V vseh študijah so se rezultati testa, izvedenega z uporabo zdravila Helicobacter Test INFAI, v več kot 95% primerov ujemali z rezultati, pridobljenimi z endoskopijo in histologijo.
The Committee for Medicinal products for Human Use (CHMP) decided that Helicobacter Test INFAI’ s benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection in adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years for the evaluation of the success of eradication treatment, or when invasive tests cannot be performed, or when there are discordant results arising from invasive tests.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Helicobacter Test INFAI za in vivo diagnostiko okužb želodca in dvanajstnika s H. pylori pri odraslih, mladostnikih, pri katerih obstaja sum, da imajo peptični ulkus, in otrocih, starih od treh do 11 let, za ocenitev uspešnosti eradikacijske terapije (izkoreninjenja) ali kadar invazivnih testov ni mogoče izvesti oz. kadar so njihovi rezultati protislovni, večje od z njim povezanih tveganj.
The European Commission granted a marketing authorisation valid throughout the European Union for Helicobacter Test INFAI to INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH on 14 August 1997.
Evropska komisija je dovoljenje za promet z zdravilom Helicobacter Test INFAI, veljavno po vsej Evropski uniji, odobrila družbi INFAI, Institut für biomedizinische Analytik & NMR- Imaging GmbH dne 14. avgusta 1997.
The marketing authorisation was renewed on 14 August 2002 and 14 August 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano 14. avgusta 2002 in 14. avgusta 2007.
EU/ 1/ 97/ 045/ 001
Za peroralno plastenka (polistirena) 75 mg 13C sečnine EU 1/ 97/ 045/ 001
jar (polystyrene)
1plastenka, 4 Epruvete
75 mg 13C-urea
Za peroralno plastenka (polistirena) 75 mg 13C sečnine
EU/ 1/ 97/ 045/ 003
Za peroralno plastenka (polistirena) 45 mg 13C sečnine EU 1/ 97/ 045/ 003
Helicobacter Test INFAI for children of the age 3-11
Test Helicobacter INFAI za 45 mg otroke v starosti 3- 11 let
jar (polystyrene)
uporabo Za peroralno plastenka (polistirena) 75 mg 13C sečnine
1 jar, as part of a multicomponent kit with sample tubes
1plastenka, 4 Epruvete
75 mg
Test Helicobacter INFAI 75 mg
One jar contains 75 mg of 13C-urea powder.
1 kocarek vsebuje 75 mg praška 13C uree Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Clear, colourless solution.
prašek za peroralno raztopino Bistra, brezbarvna raztopina
Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in:
Test Helicobacter INFAI lahko uporabljamo za in vivo diagnosticiranje gastroduodenalne okužbe Helicobacter pylori pri:
- adults,
- odraslih,
- adolescents, who are likely to have peptic ulcer disease.
- mladostnikih, pri katerih obstaja verjetnost peptične razjede.
Helicobacter Test INFAI is a breath test for single administration.
Test Helicobacter INFAI je dihalni test za enkratno uporabo.
Patients from the age of 12 must take the content of 1 jar with 75 mg.
Bolniki, stari 12 let ali več, morajo vzeti vsebino enega 75- miligramskega kozarca.