natgillin/translations-raw huggingface dataset:
Standard and reduced dose calculations according to body surface area for starting doses of capecitabine of 1250 mg/m2 and 1000 mg/m2 are provided in tables 1 and 2, respectively.
Standardni in zmanjšani odmerki so za začetni odmerek zdravila Kapecitabin Teva 1.250 mg/m2 glede na telesno površino izračunani v preglednici 1, za 1.000 mg/m pa v preglednici 2.
Monotherapy with capecitabine in metastatic colorectal cancer Data from two identically-designed, multicentre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of capecitabine for first line treatment of metastatic colorectal cancer.
Podatki dveh enako zasnovanih multicentričnih, randomiziranih, kontroliranih preskušanj faze III (SO14695, SO14796) podpirajo uporabo kapecitabina v prvi liniji zdravljenja metastatskega kolorektalnega raka.
STOP taking Capecitabine Teva immediately and contact your doctor if any of these symptoms occur:
Če se pojavi kateri koli od navedenih simptomov, takoj PRENEHAJTE z jemanjem zdravila Kapecitabin Teva in nemudoma pokličite zdravnika:
53% to 60% of all-grades HFS was observed in capecitabine monotherapy trials (comprising studies in adjuvant therapy in colon cancer, treatment of metastatic colorectal cancer, and treatment of breast cancer) and a frequency of 63% was observed in the capecitabine/docetaxel arm for the treatment of metastatic breast cancer.
Če so bolniki kapecitabin prejemali v odmerku 1.250 mg/m dvakrat na dan od 1. do 14. dneva vsake 3 tedne, je bila pogostnost vseh stopenj sindroma roka-noga v preskušanjih, pri katerih so bolniki prejemali le kapecitabin (študije adjuvantnega zdravljenja pri raku kolona, zdravljenja metastatskega kolorektalnega raka in raka dojk), 53- do 60-%, pogostnost v skupini z metastatskim rakom dojk, ki je prejemala kapecitabin v kombinaciji z docetakselom, pa je bila 63-%.
Altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
Pri bolnikih, ki so kapecitabin jemali sočasno s kumarinskimi antikoagulanti, kot sta varfarin in fenprokomon, so se pojavili spremenjeni testi koagulacije ali krvavitve ali oboje.
Capecitabine was at least equivalent to IV 5-FU/LV in disease-free survival in per protocol population (hazard ratio 0.92; 95% CI 0.80-1.06).
Glede na preživetje brez bolezni v populaciji po protokolu je bil kapecitabin vsaj ekvivalenten intravenskemu 5-FU/LV (razmerje ogroženosti 0,92; 95-% interval zaupanja 0,80−1,06).
Very rare side effects (may affect up to 1 in 10,000 people) include:
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) vključujejo:
You must not take brivudine (an anti-viral medicines for treatment of shingles or chickenpox) at the same time as capecitabine treatment (including during any rest periods when you are not taking any capecitabine tablets).
Med zdravljenjem s kapecitabinom (vključno z obdobji premora, ko tablet kapecitabina ne jemljete), ne smete jemati brivudina (protivirusnega zdravila za zdravljenje pasovca ali noric).
• liver failure
Ledvična okvara
Uncommon side-effects (may affect up to 1 in 100 people) include:
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) vključujejo:
Angina unstable, Angina pectoris, Myocardial ischaemia, Atrial fibrillation, Arrhythmia, Tachycardia, Sinus tachycardia, Palpitations
Srčne bolezni nestabilna angina pektoris, angina pektoris, miokardna ishemija, atrijska fibrilacija, aritmija, tahikardija, sinusna tahikardija, palpitacije ventrikularna fibrilacija (redki), podaljšanje intervala QT (redki), torsade de pointes (redki), bradikardija (redki), vazospazem (redki)
Capecitabine Teva 500 mg film-coated tablets Each film-coated tablet contains 52.0 mg lactose.
Kapecitabin Teva 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 52,0 mg laktoze.
The film-coated tablets are oval biconvex light peach, 11.5 mm x 5.4 mm with inscription “C” on one side and “150”on the other side.
Kapecitabin Teva 150 mg filmsko obložene tablete Filmsko obložene tablete so ovalne, bikonveksne filmsko obložene tablete, svetlo breskove barve, 11,5 mm x 5,4 mm z oznako »C« na eni strani in »150« na drugi strani.
Combination therapy in second-line treatment of metastatic colorectal cancer Data from a multicentre, randomised, controlled phase III clinical study (NO16967) support the use of capecitabine in combination with oxaliplatin for the second-line treatment of metastastic colorectal cancer.
Podatki iz multicentrične, randomizirane, kontrolirane klinične študije faze III (NO16967) podpirajo uporabo kapecitabina v kombinaciji z oksaliplatinom v drugi liniji zdravljenja metastatskega kolorektalnega raka.
NAME OF THE MEDICINAL PRODUCT Capecitabine Teva 500 mg film-coated tablets capecitabine
IME ZDRAVILA Kapecitabin Teva 500 mg filmsko obložene tablete kapecitabin
Appetite decreased Hypokalaemia, Hyponatraemia,
Presnovne in prehranske motnje zmanjšan apetit hipokaliemija, hiponatriemija, hipomagneziemija, hipokalcemija, hiperglikemija
Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, ASAT and ALAT had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Populacijsko farmakokinetično študijo so opravili po zdravljenju 505 bolnikov s kolorektalnim rakom, ki so prejemali 1.250 mg/m kapecitabina dvakrat na dan. Spol, prisotnost ali odsotnost zasevkov v jetrih, splošno bolnikovo stanje, celokupni bilirubin, serumski albumin, AST in ALT niso statistično značilno vplivali na farmakokinetiko 5´-DFUR, 5-FU in FBAL.
CLINICAL PARTICULARS 4.1 Therapeutic indications Capecitabine Teva is indicated for the treatment of: - for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
- za adjuvantno zdravljenje bolnikov po operaciji raka kolona stadija III (Dukes C) (glejte poglavje 5.1).
The film-coated tablets are oval biconvex light peach, 16.0 mm x 8.5 mm with inscription “C” on one side and “500”on the other side.
Kapecitabin Teva 500 mg filmsko obložene tablete Filmsko obložene tablete so ovalne, bikonveksne filmsko obložene tablete, svetlo breskove barve, 16,0 mm x 8,5 mm z oznako »C« na eni strani in »500« na drugi strani.
INFORMATION IN BRAILLE Capecitabine Teva 500 mg film-coated tablets
PODATKI V BRAILLOVI PISAVI Kapecitabin Teva 500 mg filmsko obložene tablete
Capecitabine Teva contains sodium
Zdravilo Kapecitabin Teva vsebuje natrij
Rare side effects (may affect up to 1 in 1,000 people) include:
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) vključujejo:
You must not take Capecitabine Teva if you are pregnant or think you might be.
- če ste noseči ali dojite.
Ophthalmologic complications
Oftalmološki neželeni učinki
The MTD of capecitabine was 2000 mg/m2 per day when combined with interferon alpha- 2a (3 MIU/m2 per day) compared to 3000 mg/m2 per day when capecitabine was used alone.
Pri sočasnem jemanju kapecitabina z interferonom alfa (3 mio i. e./m na dan) je bil največji prenosljivi odmerek kapecitabina 2.000 mg/m2 na dan, pri jemanju samega kapecitabina pa
- Capecitabine Teva 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine.
- Kapecitabin Teva 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
Contents of the pack and other information What Capecitabine Teva contains - The active substance is capecitabine.
Kaj vsebuje zdravilo Kapecitabin Teva - Učinkovina je kapecitabin.
A total of 156 patients were randomised to treatment with 5-FU (800 mg/m2 per day, continuous infusion on days 1 to 5 every 3 weeks) and cisplatin (80 mg/m2 as a 2-hour infusion on day 1, every 3 weeks).
V zdravljenje s 5-FU (800 mg/m2 na dan, v kontinuirani infuziji od 1. do 5. dne vsake 3 tedne) in cisplatinom (80 mg/m2, v 2-urni infuziji 1. dan, vsake 3 tedne) pa so skupno randomizirali 156 bolnikov.
• bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort,
• zaprtje črevesja, zbiranje tekočine v trebuhu, vnetje debelega ali tankega črevesja, želodca ali požiralnika, bolečine v spodnjem delu trebuha, slabo počutje v spodnjem delu trebuha, zgaga (dviganje hrane iz želodca), kri v blatu
• blood infection, urinary tract infection, infection of the skin, infections in the nose and throat,
• zastrupitev krvi, vnetje sečnega trakta, okužbe kože, okužbe nosu in grla, glivične okužbe (vključno z okužbami ust), gripa, gastroenteritis, zobni absces
Diabetes, Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglycerida emia
Presnovne in prehranske motnje anoreksija dehidracija, zmanjšanje telesne mase sladkorna bolezen, hipokaliemija, motnje apetita, podhranjenost, hipertrigliceridemija
skin loss, skin inflammation, nail disorder
razbarvanje kože, izgubo kože, vnetje kože, spremembe na nohtih
Talk to your doctor or pharmacist before taking Capecitabine Teva - if you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD) - if you have liver or kidney diseases - if you have or had heart problems (for example an irregular heartbeat or pains to the chest, jaw and back brought on by physical effort and due to problems with the blood flow to the heart) - if you have brain diseases (for example, cancer that has spread to the brain, or nerve damage
- če imate ali ste imeli druge bolezni, kot so težave s srcem (na primer nereden srčni utrip ali bolečine v prsih, čeljusti ali hrbtu, ki se pojavijo zaradi fizičnega napora in problemi s tokom krvi v srce).
INFORMATION IN BRAILLE Capecitabine Teva 150 mg film-coated tablets
PODATKI V BRAILLOVI PISAVI Kapecitabin Teva 150 mg filmsko obložene tablete
Capecitabine Teva 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine.
Kapecitabin Teva 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
NAME OF THE MEDICINAL PRODUCT Capecitabine Teva 150 mg film-coated tablets capecitabine
IME ZDRAVILA Kapecitabin Teva 150 mg filmsko obložene tablete kapecitabin
Hepatic failure (rare), Cholestatic hepatitis (rare)
žolčnika in žolčevodov hiperbilirubinemija, nenormalni testi jetrne funkcije zlatenica odpoved jeter (redki), holestatični hepatitis (redki)
Table 4 Summary of related ADRs reported in patients treated with capecitabine monotherapy Body System Very Common All grades
Preglednica 4 Povzetek z zdravljenjem povezanih neželenih učinkov, o katerih so poročali pri bolnikih, zdravljenih v monoterapiji s kapecitabinom.
P=0.30
12,1 meseca p = 0,30
Table 8 Key efficacy results for AIO KRK study XELOX + bevacizumab
Preglednica 8 Glavni rezultati o učinkovitosti za študijo AIO KRK
Oval biconvex light peach film-coated tablets with inscription “C” on one side and “500” on the other side.
Kapecitabin Teva 500 mg filmsko obložene tablete Ovalne, bikonveksne filmsko obložene tablete, svetlo breskove barve z oznako »C« na eni strani in »500« na drugi strani.
Oval biconvex light peach film-coated tablets with inscription “C” on one side and “150” on the other side.
Kapecitabin Teva 150 mg filmsko obložene tablete Ovalne, bikonveksne filmsko obložene tablete, svetlo breskove barve z oznako »C« na eni strani in »150« na drugi strani.
- Capecitabine Teva 150 mg film-coated tablets
- Kapecitabin Teva 150 mg filmsko obložene tablete
How to store Capecitabine Teva
Shranjevanje zdravila Kapecitabin Teva
In combination with other medicines the usual dose for adults may be less than 1250 mg/m2 of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period).
V kombinaciji z drugimi zdravili je lahko običajni odmerek za odrasle manjši od 1.250 mg/m2 telesne površine.
You must not breast-feed if you are taking Capecitabine Teva and for 2 weeks after the last dose.
Med zdravljenjem z zdravilom Kapecitabin Teva in še 2 tedna po zadnjem odmerku zdravila ne smete dojiti.
Capecitabine Teva 150 mg film-coated tablets
Kapecitabin Teva 150 mg filmsko obložene tablete
5 mg/kg intravenous 30-90 mins
5 mg/kg intravensko
• fluid collection in the kidneys, increased frequency of urination during the night, incontinence,
• zadrževanje tekočin v ledvicah, povečano uriniranje ponoči, inkontinenco, kri v urinu, povečanje kreatina v krvi (znak nedelovanja ledvic)
NAME OF THE MEDICINAL PRODUCT Capecitabine Teva 150 mg film-coated tablets Capecitabine Teva 500 mg film-coated tablets
Kapecitabin Teva 150 mg filmsko obložene tablete Kapecitabin Teva 500 mg filmsko obložene tablete
Neurotoxicity, Tremor, Neuralgia,
glavobol nevtrotoksičnost, tremor, nevralgija, preobčutljivostne reakcije, hipestezija
Vaginal haemorrhage
Okvare ledvic
In this trial, 1987 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m2 leucovorin IV followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
V tem preskušanju so randomizirali 1.987 bolnikov v zdravljenje s kapecitabinom (1.250 mg/m dvakrat na dan 2 tedna, sledil je enotedenski premor, dobili so 3-tedenske cikle v 24 tednih) ali s 5-FU in levkovorinom (shema Mayo:
Very Common All grades
Zelo pogosti
XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
Preglednica 7 Glavni rezultati o učinkovitosti za analizo ne-inferiornosti v študiji NO16966 OSNOVNA ANALIZA XELOX/XELOX + P/ XELOX + BEVACIZUMAB (EPP*: N=967; ITT**: N=1.017)
QUALITATIVE AND QUANTITATIVE COMPOSITION Capecitabine Teva 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Kapecitabin Teva 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, epistaksa, kašelj, rinoreja pljučna embolija, pnevmotoraks, hemoptiza, astma, dispneja ob naporu
Capecitabine Teva 150 mg film-coated tablets Each film-coated tablet contains 15.6 mg lactose.
Ena filmsko obložena tableta vsebuje 15,6 mg laktoze.
If you forget to take Capecitabine Teva
Če ste pozabili vzeti zdravilo Kapecitabin Teva Ne zaužijte izpuščenega odmerka.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 500 mg capecitabine.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
• vein inflammation
• mišični krči
There are no side effects caused by stopping treatment with capecitabine.
Če ste prenehali jemati zdravilo Kapecitabin Teva Po prenehanju zdravljenja s kapecitabinom se ne pojavijo neželeni učinki.
Common side-effects (may affect up to 1 in 10 people) include:
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) vključujejo:
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg capecitabine.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
• vertigo, ear pain
• vrtoglavica, bolečine v ušesih
Jaundice
Driska
Pyrexia, Weakness, +Lethargy, Temperature intolerance
Splošne težave in spremembe na mestu aplikacije pireksija, šibkost, +letargija,
For the capecitabine dose of 1000 mg/m2 twice daily on days 1 to 14 every 3
V zdravljenje s kapecitabinom (1.000 mg/m dvakrat na dan dva tedna, čemur je sledil
Hypertension,
Bolezni jeter,
Tinnitus, Hypoacusis
vključno z motnjami labirinta tinitus, hipakuza
Pharyngolaryngeal pain, Dysphonia
Psihiatrične motnje motnje spanja, tesnoba
Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopeni a, Leukopenia, Haemolytic anaemia,
Bolezni krvi in limfatičnega sistema nevtropenija, anemija febrilna nevtropenija, pancitopenija, granulocitopenija, trombocitopenija, levkopenija, hemolitična anemija, zvišano internacionalno normalizirano razmerje/podaljšan protrombinski čas
Central or peripheral nervous system disease
- če imate jetrno ali ledvično bolezen.
Capecitabine Teva contains lactose.
Zdravilo Kapecitabin Teva vsebuje laktozo
(neuropathy) - if you have calcium imbalances (seen in blood tests) - if you have diabetes - if you cannot keep food or water in your body because of severe nausea and vomiting - if you have diarrhoea - if you are, or become dehydrated - if you have imbalances of ions in your blood (electrolyte imbalances, seen in tests) - if you have a history of eye problems as you may need extra monitoring of your eyes - if you have a severe skin reaction
- če imate neravnovesje ionov v krvi (elektrolitsko neravnovesje, vidno v testih).
Package leaflet: Information for the user Capecitabine Teva 150 mg film-coated tablets Capecitabine Teva 500 mg film-coated tablets capecitabine
Kapecitabin Teva 150 mg filmsko obložene tablete Kapecitabin Teva 500 mg filmsko obložene tablete kapecitabin
- ECF: epirubicin (50 mg/m2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m2 as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m2 daily given by continuous infusion via a central line).
1. dan vsake 3 tedne) in 5-FU (200 mg/m na dan v kontinuirani infuziji skozi centralni venski kateter); - ECX: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/m2 v 2-urni infuziji 1. dan vsake 3 tedne) in kapecitabin (625 mg/m dvakrat na dan neprekinjeno); - EOF: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m2 v 2-urni infuziji 1. dan vsake tri tedne) in 5-FU (200 mg/m2 na dan v kontinuirani infuziji skozi centralni venski kateter); - EOX: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m2 v 2-urni infuziji 1. dan vsake tri tedne) in kapecitabin (625 mg/m2 dvakrat na dan neprekinjeno).
Rash, Alopecia, Erythema, Dry skin, Pruritus, Skin hyperpigmentatio n, Rash macular, Skin desquamation, Dermatitis, Pigmentation disorder, Nail disorder
Bolezni kože in podkožja alopecija, spremembe na nohtih hiperhidroza, eritematozni izpuščaj, urtikarija, nočno znojenje
The marketing authorisation was renewed on 10 February 2002 and on 10 February 2007.
Dovoljenje za promet je bilo podaljšano dne 10. februarja 2002 in 10. februarja 2007.
The only difference between the two vaccines is the amount of vaccine in each vial or syringe.
Edina razlika med obema cepivoma je količina cepiva v vsaki viali ali injekcijski brizgi.
The additional studies showed that the presence of antibodies was maintained for at least four years.
Dodatne študije so pokazale, da ostanejo protitelesa v telesu prisotna vsaj štiri leta.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
It is used in infants, children and adolescents aged between one and 15 years who are not already immune to these two diseases and who are at risk of contracting both of them.
Uporablja se pri dojenčkih, otrocih in mladostnikih, starih med enim in 15 leti, ki še niso imuni na ta dva virusa in pri katerih obstaja tveganje, da se okužijo z njima.
Two studies were carried out in a total of 180 children and adolescents, all of whom received Twinrix Paediatric.
Dve študiji so izvedli pri skupno 180 otrocih in mladostnikih, ki so vsi prejemali zdravilo Twinrix Paediatric.
All children had satisfactory antibody levels to hepatitis A by two months, and almost 100% had protective levels of antibodies to hepatitis B by six months (just before the third vaccine dose).
Vsi otroci so imeli zadovoljive ravni protiteles na virus hepatitisa A po dveh mesecih, skoraj 100 % otrok pa je imelo zaščitne ravni protiteles proti virusu hepatitisa B po šestih mesecih (neposredno pred tretjim odmerkom cepiva).
In the future, the immune system will be able to make antibodies more quickly when it is exposed to the viruses.
V prihodnosti lahko imunski sistem ob izpostavitvi virusom hitreje ustvari protitelesa.
Further studies looked at the persistence of antibody levels after vaccination.
V nadaljnjih študijah so opazovali ohranjanje ravni protiteles po cepljenju.
Twinrix Paediatric is identical to the vaccine Twinrix Adult, which has been available in the European Union (EU) since 1996.
Zdravilo Twinrix Paediatric je identično cepivu Twinrix Adult, ki je v Evropski uniji (EU) na voljo od leta 1996.
The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Površinski antigeni virusa hepatitisa B se izdelujejo z metodo, ki se imenuje „tehnologija rekombinantne DNA“: proizvajajo jih kvasovke, ki so prejele gen (DNA), zaradi katerega lahko tvorijo te beljakovine.
The main measure of effectiveness was the proportion of the children who had developed protective levels of antibodies to hepatitis A and hepatitis B.
Glavno merilo učinkovitosti je bil delež otrok, pri katerih se je pojavila zaščitna raven protiteles za virusa hepatitisa A in hepatitisa B.
It is recommended that individuals who receive the first dose should complete all three doses of Twinrix Paediatric.
Priporočeno je, da posamezniki, ki prejmejo prvi odmerek, prejmejo vse tri odmerke zdravila Twinrix Paediatric.
The recommended vaccination schedule for Twinrix Paediatric is three doses with a gap of one month between the first two doses and a gap of five months between the second and third.
Priporočena shema cepljenja z zdravilom Twinrix Paediatric vključuje tri odmerke, dane v presledku enega meseca med prvima dvema odmerkoma, in presledku petih mesecev med drugim in tretjim odmerkom.
Levels of antibodies to both hepatitis A and B increased after the third dose of the vaccine.
Ravni protiteles proti hepatitisu A in hepatitisu B so se povečale po tretjemu odmerku cepiva.
It should be given by injection into the muscle of the upper arm or the thigh.
Zdravilo se daje z injekcijsko brizgo v mišico nadlakti ali stegno.
The studies showed that Twinrix Paediatric produced an immune response that was at least as good as that seen during studies of Twinrix Adult.
Študije so pokazale, da je zdravilo Twinrix Paediatric povzročilo imunski odziv, ki je bil vsaj tako dober kot tisti, ki so ga opazili pri uporabi zdravila Twinrix Adult.
The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Paediatric's benefits are greater than its risks for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Twinrix Paediatric za uporabo pri neimunih dojenčkih, otrocih in mladostnikih, starih od enega leta do vključno 15 let, pri katerih obstaja tveganje za okužbo s hepatitisom A in hepatitisom B, večje od z njim povezanih tveganj.
Twinrix Paediatric should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic).
Zdravila Twinrix Paediatric ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) katero koli od zdravilnih učinkovin, katero koli od drugih sestavin zdravila ali neomicin (antibiotik).
Twinrix Paediatric should be postponed in patients with a severe sudden fever.
Dajanje zdravila Twinrix Paediatric je treba pri bolnikih s hudo nenadno vročino odložiti na pozneje.
Because Twinrix Paediatric and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Twinrix Paediatric.
Ker vsebujeta zdravili Twinrix Paediatric in Twinrix Adult iste sestavine, so nekatere podatke v podporo zdravilu Twinrix Adult uporabili za zdravilo Twinrix Paediatric.
Twinrix Paediatric is a vaccine, which is available as a suspension for injection.
Zdravilo Twinrix Paediatric je cepivo, ki je na voljo v obliki suspenzije za injiciranje.