FrancophonIA/ELRC3.0 huggingface dataset:
English: In comparative clinical studies, similar rates of symptoms were observed in preterm and full-term infants (refer to section 4.4 for information on apnoea).
Romanian: În studiile clinice comparative, a fost obsevată o rată similară a simptomelor la sugarii prematuri şi la cei născuţi la termen (vezi pct.
English: Multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles 50 x 1 dose (0.5 ml)
Romanian: Ambalaj colectiv compus din 5 ambalaje, fiecare conţinând 10 flacoane şi 10 seringi preumplute fără ace 50 x 1 doză (0, 5 ml)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 VIAL AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 VIALS AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
Romanian: INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR AMBALAJ CU 1 FLACON ŞI 1 SERINGĂ PREUMPLUTĂ FĂRĂ AC AMBALAJ CU 10 FLACOANE ŞI 10 SERINGI PREUMPLUTE FĂRĂ ACE AMBALAJ CU 1 FLACON ŞI O SERINGĂ PREUMPLUTĂ CU 2 ACE
English: BATCH NUMBER LOT:
Romanian: SERIA DE FABRICAŢIE LOT:
English: One month after primary vaccination at least 98.7% of subjects were seroprotected against diphtheria, tetanus and poliovirus types 1 and 2; at least 90.9% had seroprotective antibody levels against the hepatitis B, PRP and poliovirus type 3 antigens; and all subjects were seropositive for antibodies against FHA and PRN while 94.9% were seropositive for anti-PT antibodies.
Romanian: tetanosului şi poliovirusului de tip 1 şi 2; cel puţin 90,9% au avut titruri de anticorpi seroprotectivi împotriva hepatitei B, PRP şi poliovirusului de tip 3 şi toţi subiecţii au fost seropozitivi pentru anticorpi împotriva HAF
English: This can cause nerve damage, heart problems, and even death.
Romanian: probleme cardiace şi chiar moarte.
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity after primary and booster vaccination with Infanrix hexa
Romanian: Procentul de subiecţi cu titruri de anticorpi indicând seroprotecţie/seropozitivitate după vaccinarea primară şi vaccinarea de rapel cu Infanrix hexa Anticorp
English: redness
Romanian: Somnolenţă
English: Filamentous Haemagglutinin (FHA)1
Romanian: Hemaglutinină filamentoasă (HAF) 1
English: Store in a refrigerator (2°C - 8°C).
Romanian: 6.4 Precauţii speciale pentru păstrare A se păstra la frigider (2°C - 8°C)
English: • Infanrix hexa is available in packs of 1 and 10 with or without needles, and a multipack of 5 packs,
Romanian: • Infanrix hexa este disponibil în ambalaje de 1 şi 10 doze cu sau fără ace şi un ambalaj colectiv compus din 5 ambalaje, fiecare conţinând 10 flacoane şi 10 seringi preumplute, fără ace.
English: Pack sizes of 1 and 10 with or without needles and a multipack of 5 packs, each containing 10 vials and 10 pre-filled syringes, without needles.
Romanian: Ambalaje conţinând 1 şi 10 doze cu sau fără ace şi un ambalaj colectiv compus din 5 ambalaje, fiecare conţinând 10 flacoane şi 10 seringi preumplute, fără ace.
English: In extremely rare cases, allergic reactions mimicking serum sickness, paralysis, neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis, muscular weakness, GuillainBarré syndrome, encephalopathy, encephalitis and meningitis have been reported.
Romanian: nevrită, hipotensiune arterială, vasculită, lichen plan, eritem polimorf, artrită, slăbiciune musculară, sindrom Guillain-Barre, encefalopatie, encefalită si meniningită.
English: • There should be an interval of at least 2 months between primary doses.
Romanian: • Trebuie respectat un interval de cel puţin 2 luni între dozele administrate în cadrul vaccinării primare.
English: The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Romanian: La pacienţii imunodeprimaţi este posibil să nu se obţină răspunsul imun aşteptat.
English: Poliovirus (inactivated) type 1 (Mahoney strain)4
Romanian: Virusuri poliomielitice (inactivate) tip 1 (tulpina Mahoney)4
English: 2-dose
Romanian: 2-doze
English: Component of a multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles
Romanian: Component al unui ambalaj colectiv compus din 5 ambalaje, fiecare conţinând 10 flacoane şi 10 seringi preumplute fără ace
English: Tetanus toxoid1
Romanian: Anatoxină tetanică1
English: Bordetella pertussis antigens (Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1)
Romanian: (Anatoxină pertussis1, Hemaglutinină filamentoasă1, Pertactină1)
English: Protective immunity against the three poliovirus types and PRP was observed in at least 91.0% of children and against diphtheria and tetanus in at least 64.7% of children.
Romanian: 91% dintre copii şi împotriva difteriei şi tetanosului la cel puţin 64,7% dintre copii.
English: months N= 1693 (6 studies)
Romanian: 2-4-6 luni N= 1693 (6 studii)
English: Poliovirus (inactivated) (IPV) type 1 (Mahoney strain)4
Romanian: Virusuri poliomielitice (inactivate) (VPI) tip 1 (tulpina Mahoney)4
English: What you need to know before your child receives Infanrix hexa
Romanian: Ce trebuie să ştiţi înainte să i se administreze Infanrix hexa copilului dumneavoastră Infanrix hexa nu trebuie administrat:
English: Diarrhoea, vomiting
Romanian: Diaree, vărsături
English: • If your child gets any side effects, talk to your doctor or pharmacist.
Romanian: • Dacă orice reacţii adverse sunt manifestate de către copilul dumneavoastră, adresaţi-vă medicului dumneavoastră sau farmacistului.
English: • There should be an interval of at least 1 month between primary doses.
Romanian: • Trebuie respectat un interval de cel puţin o lună între dozele administrate în cadrul vaccinării primare.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 50 (5 X 10) (OUTER WRAPPER LABEL TO BE APPLIED ON TRANSPARENT FOIL, INCLUDING BLUE BOX)
Romanian: INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR AMBALAJ COLECTIV DE 50 (5 X 10) (ETICHETĂ EXTERIOARĂ PENTRU APLICARE PE
English: Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines.
Romanian: Hipersensibilitate după o administrare precedentă de vaccinuri difteric, tetanic, pertussis, hepatitic B,
English: How Infanrix hexa works
Romanian: Cum acţionează Infanrix hexa
English: Post-dose 2
Romanian: După-doza 2
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Hib powder:
Romanian: PROPRIETĂŢI FARMACEUTICE 6.1 Lista excipienţilor
English: • The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV
Romanian: • Componenta difteric, tetanic, pertussis acelular, hepatitic B, poliomielitic inactivat (DTPa-VHB-VPI)
English: Powder and suspension for suspension for injection.
Romanian: Pulbere şi suspensie pentru suspensie injectabilă
English: In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar (PCV7) as a booster (4th) dose of both vaccines, fever ≥ 38.0°C was reported in 43.4% of infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of infants receiving the hexavalent vaccine alone.
Romanian: Prevenar (PCV7), ca doză de rapel (a 4 a) din ambele vaccinuri, a fost raportată febră > 38°C la 43,4% din doze la sugarii la care s-au utilizat concomitent dozele de Prevenar şi Infanrix hexa, comparativ cu 30,5% din sugarii la care s-a administrat vaccinul hexavalent în monoterapie.
English: • rashes that may be itchy or blistering
Romanian: • erupţie pe piele care poate fi însoţită de mâncărime sau vezicule
English: Infanrix hexa contains neomycin and polymyxin This vaccine contains neomycin and polymyxin (antibiotics).
Romanian: Infanrix hexa conţine neomicină şi polimixină
English: Hepatitis B surface antigen2,3
Romanian: Antigen de suprafaţă al virusului hepatitic B2,3
English: 10 vials and 10 pre-filled syringes 10 x 1 dose (0.5 ml)
Romanian: 10 flacoane şi 10 seringi preumplute 10 x 1 doză (0,5 ml)
English: Infanrix hexa, Powder and suspension for suspension for injection.
Romanian: Infanrix hexa - Pulbere şi suspensie pentru suspensie injectabilă în seringă preumplută
English: Fever of greater than 39.5°C was reported in 18% of children receiving Infanrix hexa with MMRV vaccine, as compared to 3.3% of children receiving Infanrix hexa alone and 19.3% of children receiving MMRV alone (see sections 4.4 and 4.5).
Romanian: Hexa şi vaccin ROR-V, comparativ cu 3,3% la copii la care s-a administrat numai Infanrix Hexa şi 19,3% la copii la care s-a administrat numai ROR-V (vezi pct. 4.4 şi 4.5).
English: 1 dose (0.5 ml)
Romanian: 10 x 1 doză (0,5 ml)
English: Filamentous Haemagglutinin1
Romanian: Hemaglutinină filamentoasă1
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hib for Infanrix hexa
Romanian: ADMINISTRARE Hib pentru Infanrix hexa
English: months N= 1055 (6 studies)
Romanian: 3-4-5 luni N= 1055 (6 studii)
English: 8 D-antigen unit type 3 (Saukett strain)4
Romanian: tip 3 (tulpina Saukett)4
English: Anti-Polio type 3 (1/8 dilution) †
Romanian: Anti-Polio tip 3 (diluţie1/8) † Anti-PRP (0,15 µg/ml) †
English: After a complete vaccination according to a 2-dose primary and booster schedule with Infanrix hexa, at least 97.9% of the subjects had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Romanian: Infanrix Hexa conform schemei de vaccinare primară cu 2 doze şi rapel, cel puţin 97,9% din subiecţi au dezvoltat anticorpi seroprotectivi sau seropozitivi pentru fiecare dintre antigenele vaccinului.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES FOR MULTIPACK OF 50 (5 X 10) (WITHOUT BLUE BOX)
Romanian: AMBALAJ CU 10 FLACOANE ŞI 10 SERINGI PREUMPLUTE FĂRĂ ACE, COMPONENT AL AMBALAJULUI COLECTIV DE 50 (5 X 10) (FĂRĂ CHENAR ALBASTRU)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DTPa HBV IPV for Infanrix hexa
Romanian: ADMINISTRARE DTPa VHB VPI pentru Infanrix hexa
English: After control of the disease the vaccine can be given.
Romanian: Vaccinul poate fi administrat după obţinerea controlului terapeutic al afecţiunii
English: • if after previously having Infanrix hexa or another vaccine against whooping cough, 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 - fits with or without a high temperature within 3 days of vaccination
Romanian: - colaps sau o stare asemănătoare şocului în primele 48 ore de la vaccinare - plâns persistent cel puţin 3 ore în primele 48 ore de la vaccinare - convulsii/ crize convulsive însoţite sau nu de creşterea temperaturii în primele 3 zile de la vaccinare
English: Hepatitis B surface antigen2
Romanian: Antigen de suprafaţă al virusului hepatitic B2
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 2-dose primary and booster vaccination with Infanrix hexa
Romanian: Procentul de subiecţi cu titruri de anticorpi indicând seroprotecţia/seropozitivitatea la o lună după administrarea schemei de vaccinare primară cu 2 doze şi a dozei de rapel cu Infanrix hexa
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very preterm infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Romanian: În cazul administrării schemelor de vaccinare primară la sugarii născuţi prematur (născuţi la ≤28 săptămâni de sarcină) şi în special în cazul celor cu antecendente de imaturitate respiratorie, trebuie luate în considerare riscul potenţial de apariţie a apneei şi necesitatea monitorizării funcţiei respiratorii timp de 48-72 ore.
English: After booster vaccination (post-dose 4), at least 98.4% of children had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Romanian: După administrarea rapelului (după doza 4), cel puţin 98,4 % dintre copii au dezvoltat titruri de anticorpi seroprotectivi sau seropozitivi pentru fiecare dintre antigenele vaccinului.
English: After a 2-dose primary vaccination schedule, at least 84.3% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Romanian: După schema de vaccinare primară cu 2 doze, cel puţin 84,3% dintre sugari au dezvoltat anticorpi seroprotectivi sau seropozitivi pentru fiecare dintre antigenele vaccinului.
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 3-dose primary and booster vaccination with Infanrix hexa
Romanian: Procentul de subiecţi cu titruri de anticorpi indicând seroprotecţia/seropozitivitatea la o lună după administrarea schemei de vaccinare primară cu 3 doze şi a dozei de rapel cu Infanrix hexa
English: The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a turbid white suspension.
Romanian: Componenta difteric, tetanic, pertussis, hepatitic B, poliomielitic inactivat (DTPa-HBV-VPI) se prezintă sub formă de suspensie albă, tulbure.
English: Belgique/ België /Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
Romanian: Belgique/België/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00
English: Booster doses should be given in accordance with the official recommendations, but, as a minimum, a dose of Hib conjugate vaccine must be administered.
Romanian: Administrarea unor doze de rapel se va face în conformitate cu recomandările oficiale, dar, ca un minim,
English: How Infanrix hexa is given
Romanian: Cum se administrează Infanrix hexa
English: STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml): Diphtheria toxoid1
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE După reconstituire, 1 doză (0,5ml) conţine:
English: (polyribosylribitol phosphate) 2 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Romanian: conjugat cu anatoxină tetanică cu rol de proteină purtător aproximativ 25 micrograme
English: 2-4-12 months of age N=196 (1 study)
Romanian: 2-3-4 luni N= 196 (2 studii)
English: The virus is found in body fluids such as in the vagina, blood, semen or spit (saliva) of infected people.
Romanian: Virusul se regăseşte în lichidele organismului persoanelor infectate, ca de exemplu în secreţii vaginale,
English: • if your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping cough, hepatitis B, polio or Haemophilus influenzae type b.
Romanian: • în cazul în care copilul dumneavoastră a manifestat anterior reacţii alergice la vreunul din vaccinurile difteric, tetanic, pertussis, hepatitic B, poliomielitic sau Haemophilus influenzae tip b. • în cazul în care copilul dumneavoastră a avut probleme ale sistemului nervos în decurs de 7 zile de la vaccinarea precedentă cu vaccin pertussis
English: When Infanrix hexa was co-administered with MenB and pneumococcal conjugate vaccines, inconsistent results were seen across studies for responses to inactivated poliovirus type 2, pneumococcal conjugate serotype 6B antigen and to the pertussis pertactin antigen but these data do not suggest clinically significant interference.
Romanian: antigenul pneumococic conjugat serotip 6B şi antigenul pertactina pertussis, însă aceste date nu sugerează interacţiuni clinice semnificative.
English: Lymphadenopathy2, thrombocytopenia2
Romanian: Limfadenopatie2, trombocitopenie2
English: 40 D-antigen unit type 2 (MEF-1 strain)4
Romanian: tip 2 (tulpina MEF-1)4
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH DTPA HBV IPV SUSPENSION
Romanian: SERINGĂ PREUMPLUTĂ CU SUSPENSIE DTPA VHB VPI
English: 1 vial and 1 pre-filled syringe 1 dose (0.5 ml)
Romanian: 1 flacon şi o seringă preumplută + 2 ace 1 doză (0,5 ml)
English: Anti-PRN (5 EL.U/ml)
Romanian: Anti-PRN (5 EL.U/ml) Anti-HBs (10 mUI/ml) † Anti-Polio tip 1
English: Bordetella pertussis antigens Pertussis toxoid1
Romanian: Antigene Bordetella pertussis
English: Very common Fever ≥ 38°C, local swelling at the injection site (≤ 50 mm), fatigue, pain,
Romanian: pierderea poftei de mâncare, febră mai mare sau egală cu 38°C, umflare, durere, roşeaţă la locul injectării,
English: Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Romanian: Vaccin adsorbit difteric (D), tetanic (T), pertussis (acelular, componente) (Pa), hepatitic B (VHB) (ADNr), poliomielitic (inactivat) (VPI) şi Haemophilus influenzae tip b (Hib) conjugat.
English: Powder and suspension for suspension for injection in a pre-filled syringe Vial: powder
Romanian: Pulbere şi suspensie pentru suspensie injectabilă în seringă preumplută
English: • Keep this vaccine out of the sight and reach of children.
Romanian: Cum se păstrează Infanrix hexa • A nu se lăsa acest vaccin la vederea şi îndemâna copiilor.
English: After a 3-dose primary vaccination schedule, at least 95.7% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Romanian: După administrarea vaccinului în schema de vaccinare primară cu 3 doze, cel puţin 95,7% dintre sugari au dezvoltat titruri de anticorpi seroprotectivi sau seropozitivi pentru fiecare dintre antigenele vaccinului.
English: If your child misses a dose
Romanian: În cazul în care copilului dumneavoastră nu i s-a administrat una dintre injecţiile programate
English: Hib powder: lactose anhydrous
Romanian: FLACON CU PULBERE HIB
English: Full-term infants 3-dose
Romanian: Sugari născuţi la termen
English: Swelling of the entire injected limb1, 2, extensive swelling reactions2, injection site mass2, injection site vesicles2 1 Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines.
Romanian: 1Copiii primovaccinaţi cu vaccinuri pertussis de tip acelular au o probabilitate mai mare de a prezenta reacţii de tip edem după administrarea rapelului în comparaţie cu copiii primovaccinaţi cu vaccinuri pertussis de tip celular.
English: • if your child has had problems of the nervous system within 7 days after previous vaccination with a vaccine against whooping cough
Romanian: • în cazul în care la o vaccinare anterioară cu Infanrix hexa sau cu un vaccin contra tusei măgăreşti,
English: Suspension for suspension for injection
Romanian: Suspensie pentru suspensie injectabilă i.m.
English: months N= 196 (2 studies)
Romanian: N=196 (1 studiu)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Romanian: Medicamentului http://www.ema.europa.eu/.
English: Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Infanrix hexa and Prevenar 13 (see section
Romanian: În cazul administrării concomitente de Infanrix Hexa şi Prevenar 13 s-au observat creşterea frecvenţei convulsiilor (însoţite sau nu de febră) şi episoade de hipotonie-hiporeactivitate (EHH) (vezi pct. 4.8).
English: N = number of subjects † cut-off accepted as indicative of protection * Post booster, 94.4% of subjects in the 2-4-12 months schedule and 97.0% of subjects in the 3-5-11 months schedule had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection.
Romanian: 97,0% dintre subiecţi incluşi în schema de vaccinare la 3-5-11 luni au avut o concentraţie anti-PRP ≥ 1 µg/ml, indicând o protecţie pe termen lung..
English: GlaxoSmithKline Lietuva UAB Tel. +370 5 264 90 00 info.lt@gsk.com
Romanian: +370 5 264 90 00 info.lt@gsk.com
English: Infanrix hexa, Powder and suspension for suspension for injection in a pre-filled syringe Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)
Romanian: Vaccin adsorbit difteric (D), tetanic (T), pertussis (acelular, componente) (Pa), hepatitic B (VHB) (ADNr), poliomielitic (inactivat) (VPI) şi Haemophilus influenzae tip b (Hib) conjugat
English: Syringe plunger
Romanian: Flacon: pulbere
English: 3-5-11 months of age N=530 (4 studies)
Romanian: N=530 (4 studii)
English: Anti-Polio type 1 (1/8 dilution) †
Romanian: (diluţie 1/8) †
English: Powder for suspension for injection
Romanian: Pulbere pentru suspensie injectabilă i.m.
English: 10 vials and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
Romanian: 10 flacoane şi 10 seringi preumplute + 20 ace
English: Anti-diphtheria (0.1 IU/ml)
Romanian: Anti-difterie (0,1 UI/ml) † Anti-tetanos (0,1 UI/ml) † Anti-AP (5 EL.U/ml) Anti-HAF (5 EL.U/ml)
English: Infanrix hexa is indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b.
Romanian: tetanosului, tusei convulsive, hepatitei B, poliomielitei şi a bolii determinate de Haemophilus influenzae tip b.
English: 3-5-11 months of age N=532 (3 studies)
Romanian: N=532 (3 studii)
English: Interference with laboratory testing
Romanian: Studiu în care au fost incluşi contacţii familiali
English: each containing 10 vials and 10 pre-filled syringes, without needles.
Romanian: AMBALAJ CU 10 FLACOANE ŞI 10 SERINGI PREUMPLUTE CU 20 ACE
English: Anti-Polio type 1 (1/8 dilution)
Romanian: (diluţie 1/8)
English: Slovenská republika GlaxoSmithKline Slovakia s.r.o.
Romanian: GlaxoSmithKline Lietuva UAB Tel.
English: Needle
Romanian: Anticorp
English: Oral Drops, Solution Oral Use
Romanian: Picături orale, soluție
English: Film-Coated Tablet Oral Use
Romanian: Comprimat filmat Administrare orală
English: These changes usually resolve over time.
Romanian: Aceste modificări se rezolvă de obicei în timp.
English: Nevertheless the leaflet will refer to ‘you' throughout.
Romanian: Cu toate acestea, întregul prospect se va referi la „dumneavoastră“.
English: It belongs to a group of medicines called ‘monoclonal antibodies'.
Romanian: Aceasta aparţine unui grup de medicamente numite „anticorpi monoclonali“.
English: The study protocol should be submitted within 3 months of the EC decision.
Romanian: Protocolul studiului clinic trebuie depus în decurs de trei luni de la decizia CE.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Romanian: Dacă nu este utilizat imediat, condiţiile şi perioada de păstrare în timpul utilizării sunt responsabilitatea utilizatorului.
English: Dilution must be carried out under aseptic conditions.
Romanian: Diluţia trebuie efectuată în condiţii aseptice.
English: Non-clinical data reveal no special hazard for humans based on conventional studies conducted to date.
Romanian: Datele non-clinice nu au evidenţiat niciun risc special pentru om pe baza studiilor convenţionale efectuate până în prezent.
English: There was no apparent correlation between the development of these antibodies and allergic reactions.
Romanian: Nu a existat o corelaţie evidentă între dezvoltarea acestor anticorpi şi reacţiile alergice.
English: No direct effects on electrocardiogram parameters or on the respiratory system were observed.
Romanian: Nu s-au observat efecte directe asupra parametrilor electrocardiogramei sau asupra sistemului respirator.
English: Each course lasts one month.
Romanian: Fiecare ciclu de tratament durează o lună.
English: Polysorbate 20 (E 432)
Romanian: Polisorbat 20 (E 432)
English: The doctor or nurse will throw away medicines you no longer use.
Romanian: Medicul sau asistenta medicală vor elimina medicamentele care nu vă mai sunt necesare.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Romanian: Acest medicament conţine mai puţin de 1 mmol sodiu (23 mg) per doză.