FrancophonIA/ELRC3.0 huggingface dataset:
English: 8 D-antigen unit type 3 (Saukett strain)4
Latvian: 3.tipa (Saukett celms) 4
English: It makes the liver swollen.
Latvian: Tas rada aknu palielināšanos.
English: Bordetella pertussis antigens Pertussis toxoid1
Latvian: Bordetella pertussis antigēnus
English: The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a turbid white suspension.
Latvian: Difterijas, stingumkrampju, acelulārs garā klepus, B hepatīta, inaktivētā poliomielīta (DTPa-HBVIPV) komponents ir duļķaina, balta suspensija.
English: GlaxoSmithKline Biologicals s.a. 10, Tuas South Avenue 8 Singapore 637421
Latvian: GlaxoSmithKline Biologicals s.a. 10, Tuas South Avenue 8
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Latvian: BIOLOĢISKI AKTĪVĀS (-O) VIELAS (-U) RAŽOTĀJS (-I) UN RAŽOTĀJS (-I), KAS ATBILD PAR SĒRIJAS IZLAIDI
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 2-dose primary and booster vaccination with Infanrix hexa
Latvian: Personu procentuālais skaits, kurām antivielu titri liecina par seroprotekciju/seropozitivitāti vienu mēnesi pēc primārās vakcinācijas ar 2 devām un revakcinācijas ar Infanrix hexa
English: including induration, local swelling at the injection site (> 50 mm)1
Latvian: Drudzis >39,5°C, reakcijas injekcijas vietā, tai skaitā sacietējums, vietējs pietūkums injekcijas vietā (> 50 mm)1
English: (polyribosylribitol phosphate)3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Latvian: (poliribozilribitola fosfātu, PRP) 3, kas konjugēts ar tetanusa toksoīdu kā nesējproteīnu apmēram 25 mikrogramiem
English: Anti-PRP (0.15 µg/ml) †
Latvian: Antivielas pret PRP (0,15 µg/ml) † N = personu skaits
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)
Latvian: Infanrix hexa, pulveris un suspensija injekciju suspensijas pagatavošanai pilnšļircē Difterijas (D), stingumkrampju (T), garā klepus (acelulārs komponents) (Pa), B hepatīta (rDNS) (HBV), poliomielīta (inaktivēta)
English: months N= 1693 (6 studies)
Latvian: 2-4-6 mēneši N= 1693
English: If your child gets any side effects, talk to your doctor or pharmacist.
Latvian: Ja Jums rodas jebkādas blakusparādības, konsultējieties ar ārstu vai farmaceitu.
English: 40, 8, 32 DU
Latvian: Itālija 2., 4., 6.
English: Anti-diphtheria (0.1 IU/ml)
Latvian: Antivielas pret difteriju (0,1 SV/ml)
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.
Latvian: Pēc 2 devu primārās vakcinācijas shēmas vismaz 84,3% zīdaiņu attīstījās seroprotektīvs vai seropozitīvs antivielu līmenis pret katru no vakcīnas antigēniem.
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.
Latvian: Pēc revakcinācijas (pēc 4. devas) vismaz 98,4% bērnu attīstījās seroprotektīvs vai seropozitīvs antivielu līmenis pret katru no vakcīnas antigēniem.
English: Haemophilus influenzae type b polysaccharide
Latvian: 32 D-antigēna vienības b tipa Haemophilus influenzae polisaharīds
English: 3-5-11 months of age N=530 (4 studies)
Latvian: 3-4-5 mēneši N= 1055
English: 40 D-antigen unit type 2 (MEF-1 strain)4
Latvian: 2.tipa (MEF-1 celms) 4
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Hib powder:
Latvian: FARMACEITISKĀ INFORMĀCIJA 6.1. Palīgvielu saraksts
English: months N= 196 (2 studies)
Latvian: vecums N=196
English: Upon storage, a clear liquid and white deposit may be observed in the pre-filled syringe containing the DTPa-HBV-IPV suspension.
Latvian: Īpaši norādījumi atkritumu likvidēšanai un citi norādījumi par rīkošanos Uzglabāšanas laikā pilnšļircē, kas satur DTPa-HBV-IPV suspensiju, var novērot dzidru šķidrumu un baltas nogulsnes.
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.
Latvian: Pēc 3 devu primārās vakcinācijas shēmas vismaz 95,7% zīdaiņu attīstījās seroprotektīvs vai seropozitīvs antivielu līmenis pret katru no vakcīnas antigēniem.
English: • There should be an interval of at least 1 month between primary doses.
Latvian: • Primārās vakcinācijas devas jāievada ar vismaz 1 mēneša intervālu.
English: This suggests that a second booster dose of pertussis vaccine is warranted in children aged 5-7 years who have previously been vaccinated following this particular schedule.
Latvian: Tādēļ bērniem 5-7 gadu vecumā, kas iepriekš vakcinēti atbilstoši šim grafikam, jāsaņem otra garā klepus vakcīnas revakcinācija.
English: 3-5-11 months of age N=532 (3 studies)
Latvian: vecums N=532
English: N = number of subjects * in a subgroup of infants not administered hepatitis B vaccine at birth, 77.7% of subjects had anti-HBs titres ≥ 10 mIU/ml ** Post booster, 98.4% of subjects had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection † cut-off accepted as indicative of protection
Latvian: * zīdaiņu apakšgrupā, kam uzreiz pēc dzimšanas netika ievadīta B hepatīta vakcīna, 77,7% pacientu antivielu pret HBs titri bija ≥ 10 mSV/ml
English: Anti-PRP (0.15 µg/ml)
Latvian: Antivielas pret PRP (0,15 µg/ml) N = personu skaits
English: I.M.
Latvian: A.
English: Clinical data indicate that Infanrix hexa can be given to preterm infants, however, as expected in this population, a lower immune response has been observed for some antigens (see section 4.8 and section
Latvian: Tomēr, kā sagaidāms, šai pacientu grupā, novērota vājāka imūnreakcija pret dažiem antigēniem (skatīt 4.8. un 5.1.
English: each containing 10 vials and 10 pre-filled syringes, without needles.
Latvian: 10 FLAKONI UN 10 PILNŠĻIRCES BEZ ADATĀM
English: MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Latvian: GlaxoSmithKline Biologicals s.a.
English: In a clinical study in which some of the vaccinees received a booster dose of Infanrix hexa concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine, fever ≥ 38.0°C was reported in 76.6% of children receiving MMRV vaccine and Infanrix hexa at the same time, as compared to 48% of children receiving Infanrix hexa alone and 74.7% of children receiving MMRV vaccine alone.
Latvian: 38,0°C tika ziņots 76,6% bērnu, kas vienlaikus saņēma MMRV vakcīnu un Infanrix hexa, salīdzinot ar 48% bērnu, kas saņēma tikai Infanrix hexa, un 74,7% bērnu, kas saņēma tikai MMRV vakcīnu.
English: What Infanrix hexa looks like and contents of the pack
Latvian: Infanrix hexa ārējais izskats un iepakojums
English: B. PACKAGE LEAFLET
Latvian: Blakusparādību kopsavilkums tabulā
English: GSK Vaccines GmbH Emil-von-Behring-Str. 76, D-35041 Marburg Germany
Latvian: GSK Vaccines GmbH Emil-von-Behring-Str.
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).
Latvian: Difterijas (D), stingumkrampju (T), garā klepus (acelulārs komponents) (Pa), B hepatīta (rDNS) (HBV), poliomielīta (inaktivēta)
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.
Latvian: Primārai imunizēšanai ordinējot vakcīnas ļoti neiznēsātiem (priekšlaicīgi dzimušiem) zīdaiņiem (kas dzimuši ≤28 grūtniecības nedēļās), it īpaši tiem, kuriem anamnēzē ir elpošanas sistēmas nepietiekama brieduma pazīmes, jāapsver iespējamais apnojas risks un nepieciešamība uzraudzīt zīdaiņa elpošanu 48 - 72 stundas pēc vakcīnas ievadīšanas.
English: This can cause death by suffocation.
Latvian: Tas var radīt arī rīkles pietūkumu, kas var izraisīt nāvi nosmokot.
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
Latvian: Vienlaikus lietojot Infanrix hexa un Prevenar 13, biežāk ziņots par krampjiem (ar drudzi vai bez tā) un hipotonisku-hiporeaktīvu epizodi (HHE) (skatīt 4.8. apakšpunktu).
English: GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5000
Latvian: Ltd Tel: + 353 (0)1 4955000
English: • fits - this may be when they have a fever These side effects have happened very rarely with Infanrix hexa as with other vaccines against whooping cough.
Latvian: Šīs blakusparādības bijušas ļoti reti, lietojot Infanrix hexa, tāpat kā citas vakcīnas pret garo klepu.
English: redness
Latvian: Miegainība
English: Post-dose 3
Latvian: 3. deva
English: Anti-PRN (5 EL.U/ml)
Latvian: Antivielas pret PRN (5 EL.V/ml) Antivielas pret HBs (10 mSV/ml) Antivielas pret 1.
English: Bordetella pertussis antigens Pertussis toxoid (PT)1
Latvian: garā klepus toksoīdu (PT)1
English: 2-4-12 months of age N=223 (1 study)
Latvian: vecums N=223
English: Infanrix hexa contains neomycin and polymyxin This vaccine contains neomycin and polymyxin (antibiotics).
Latvian: Infanrix hexa satur neomicīnu un polimiksīnu
English: The physician should be aware that the rate of febrile reactions is higher when Infanrix hexa is coadministered with a pneumococcal conjugate vaccine (PCV7, PCV10, PCV13), or with a measlesmumps-rubella-varicella (MMRV) vaccine, compared to that occurring following the administration of Infanrix hexa alone.
Latvian: Ārstam jāzina, ka, Infanrix hexa lietojot vienlaikus ar konjugētu pneimokoku vakcīnu (PCV7, PCV10,
English: • if your child tends to have fits when they have a fever, or if there is a history of this in the family.
Latvian: • ja Jūsu bērnam vai ģimenes anamnēzē ir bijusi nosliece uz krampjiem paaugstinātas temperatūras gadījumā;
English: Syringe
Latvian: Klepus
English: Poliovirus (inactivated) type 1 (Mahoney strain)4
Latvian: 1.tipa (Mahoney celms) 4
English: If you are not sure, talk to your doctor or pharmacist before your child is given Infanrix hexa.
Latvian: Neskaidrību gadījumā, pirms bērnam tiek ievadīts Infanrix hexa, jautājiet ārstam vai farmaceitam.
English: 10 vials and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
Latvian: 10 flakoni un 10 pilnšļirces + 20 adatas
English: Lymphadenopathy2, thrombocytopenia2
Latvian: Limfadenopātija2, trombocitopēnija2
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
Latvian: 1 FLAKONS UN 1 PILNŠĻIRCE AR 2 ADATĀM 10 FLAKONI UN 10 PILNŠĻIRCES AR 20 ADATĀM
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)
Latvian: KASTĪŠU IEPAKOJUMAM PA 50 (5 X 10) (BEZ BLUE BOX)
English: 10 vials and 10 pre-filled syringes 10 x 1 dose (0.5 ml)
Latvian: 10 x 1 deva (0,5 ml)
English: Talk to your doctor or pharmacist before your child is given Infanrix hexa:
Latvian: Pirms Jūsu bērnam tiek ievadīta Infanrix hexa, konsultējieties ar ārstu vai farmaceitu:
English: Powder for suspension for injection
Latvian: Pulveris injekciju suspensijas pagatavošanai i.m.
English: Syringe plunger
Latvian: Flakons: pulveris
English: Filamentous Haemagglutinin1
Latvian: 25 mikrogrami filamentais hemaglutinīns1
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DTPa HBV IPV for Infanrix hexa
Latvian: DPTa HBV IPV - Infanrix hexa Suspensija injekciju suspensijas pagatavošanai i.m.
English: Pertactin1
Latvian: I PIELIKUMS
English: Antibody (cut-off)
Latvian: Poliovīrusu (inaktivētu)
English: • rashes that may be itchy or blistering
Latvian: • krampji; tie var būt drudža laikā.
English: STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml): Diphtheria toxoid1
Latvian: Antivielas pret difteriju (0,1 SV/ml) † Antivielas pret stingumkrampjiem (0,1 SV/ml) † Antivielas pret garā klepus toksoīdu
English: Needle
Latvian: Šļirce
English: Name and address of the manufacturer responsible for batch release
Latvian: Ungārija Ražotāja(-u), kas atbild par sērijas izlaidi, nosaukums un adrese
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hib for Infanrix hexa
Latvian: Hib - Infanrix hexa
English: These changes usually resolve over time.
Latvian: Parasti šīs izmaiņas laika gaitā izzūd.
English: The study protocol should be submitted within 3 months of the EC decision.
Latvian: Pētījuma protokols jāiesniedz 3 mēnešu laikā pēc EK lēmuma.
English: 18 months
Latvian: 18 mēneši
English: 14 days.
Latvian: 14 dienas.
English: The doctor or nurse will throw away medicines you no longer use.
Latvian: Ārsts vai medmāsa izmetīs zāles, kuras vairs nelietojat.
English: Dilution must be carried out under aseptic conditions.
Latvian: Atšķaidīšana jāveic aseptiskos apstākļos.
English: A risk for interactions with concomitantly used medicinal products cannot be excluded.
Latvian: Mijiedarbības risku ar vienlaicīgi lietotām zālēm nevar izslēgt.
English: The clinical study report should be submitted by
Latvian: Klīniskā pētījuma ziņojums jāiesniedz līdz
English: United Kingdom Tel: +44 (0)1932 664884 Fax: +44 (0)1932 573800 E-mail: druginfo@unither.com
Latvian: Lielbritānija tel.: +44 (0)1932 664884 fakss: +44 (0)1932 573800 e-pasts: druginfo@unither.com
English: United Therapeutics Corporation 1040 Spring Street Silver Spring, Maryland 20910 USA
Latvian: United Therapeutics Corporation 1040 Spring Street Silver Spring, Maryland 20910 ASV
English: Polysorbate 20 (E 432)
Latvian: Polisorbāts 20 (E 432)
English: The terminal halflife was estimated at 10 (+ 6) days.
Latvian: Sagaidāmais konstatētais terminālais eliminācijas pusperiods bija 10 (+ 6) dienas.
English: Unituxin will be given to you in five of the six courses.
Latvian: Unituxin Jums ievadīs piecos no sešiem kursiem.
English: Classical biotransformation studies have not been performed.
Latvian: Klasiski biotransformācijas pētījumi nav veikti.
English: Grade 3 (sensory changes for more than 2 weeks, objective motor weakness) or Grade 4
Latvian: 3. pakāpe (izmainīta jutība vairāk nekā 2 nedēļas, objektīvs motorais vājums) vai 4. pakāpe
English: Nevertheless the leaflet will refer to ‘you' throughout.
Latvian: Jebkurā gadījumā visā lietošanas instrukcijā izmantota uzrunas forma „Jūs”.
English: Other medicines and Unituxin
Latvian: Citas zāles un Unituxin
English: They help the immune system to target certain cells, such as cancer cells, by ‘sticking' to them.
Latvian: Tās palīdz imūnai sistēmai iedarboties uz noteiktām šūnām, piemēram, vēža šūnām, „pielīpot” viņām.
English: The complete dosing regimen is outlined in Table 1 and Table 2.
Latvian: Pilna devu lietošanas shēma ir attēlota 1. tabulā un 2. tabulā.
English: Your doctor or nurse will check you during and after the infusion.
Latvian: Ārsts vai medmāsa Jūs uzraudzīs infūzijas ievadīšanas laikā un pēc tās.
English: You will be given pain relieving medicines (such as paracetamol, ibuprofen and morphine) to help prevent and reduce the pain.
Latvian: Jums ordinēs pretsāpju līdzekļus (piemēram, paracetamolu, ibuprofēnu un morfiju), lai novērstu un mazinātu sāpes.
English: Central nervous system (CNS) toxicity
Latvian: Centrālās nervu sistēmas (CNS) toksicitāte
English: In addition to the above criteria, clinician judgement must be exercised in the evaluation of the patient's cardiovascular functions.
Latvian: Papildus iepriekš minētajiem kritērijiem, ārstam pēc saviem ieskatiem jāizvērtē pacienta kardiovaskulārās funkcijas.
English: You will be given an anti-histamine medicine which helps to prevent allergic reactions.
Latvian: Jums ordinēs antihistamīna līdzekli, kas palīdz novērst alerģiskas reakcijas;
English: There was no apparent correlation between the development of these antibodies and allergic reactions.
Latvian: Acīmredzamas saistības starp šo antivielu veidošanos un alerģiskām reakcijām nebija.
English: Tests and checks
Latvian: Analīzes un pārbaudes
English: • It is recommended to use contraception for 6 months after discontinuation of this medicine.
Latvian: • Ieteicams lietot kontracepciju 6 mēnešus pēc šo zāļu lietošanas pārtraukšanas.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1022/001
Latvian: EU/1/15/1022/001
English: Some neuroblastomas are classed as ‘high risk' if the cancer has spread to various parts of the body and contains certain types of cells.
Latvian: Dažas neiroblastomas tiek klasificētas kā augsta riska, ja vēzis izplatās dažādās organisma daļās un satur noteikta tipa šūnas.
English: High-risk neuroblastomas are more likely to come back again after treatment.
Latvian: Augsta riska neiroblastomas biežāk pēc ārstēšanas var atkārtoties.
English: The recommended interval time between treatment discontinuation and breastfeeding is 6 months.
Latvian: Ieteicamais laika posms starp ārstēšanas pārtraukšanu un barošanu ar krūti ir 6 mēneši.
English: This is because it is not known if the medicine can pass into breast-milk.
Latvian: Tas ir tādēļ, ka nav zināms, vai šīs zāles izdalās cilvēka pienā.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Latvian: Ja tās netiek izlietotas nekavējoties pēc iepakojuma atvēršanas, tad par uzglabāšanas laiku un apstākļiem pirms ievadīšanas atbild lietotājs.
English: Additional adverse reactions characteristic of an allergic response were also reported - including anaphylactic reaction (18 %) and bronchospasm (4 %).
Latvian: Ziņoja arī par nevēlamām blakusparādībām, kas raksturīgas alerģiskai atbildes reakcijai, tai skaitā anafilaktisku reakciju (18%) un bronhospazmām (4%).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Latvian: MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ MAZA IZMĒRA TIEŠĀ IEPAKOJUMA
English: Your doctor will work out your dose based on your body surface area.
Latvian: Ārsts aprēķinās Jums nepieciešamo devu, ņemot vērā Jūsu ķermeņa virsmas laukumu.
English: However, the presence of HACA appears to increase the clearance of dinutuximab by approximately 60%.
Latvian: Tomēr cilvēka antihimērisko antivielu (HACA) klātbūtne acīmredzami palielina dinutuksimaba klīrensu par aptuveni 60%.
English: You will not be given all of the medicines in every course.
Latvian: Ne visas no šīm zālēm Jums ievadīs katra ārstēšanas kursa laikā.
English: The safety and efficacy of Unituxin in children aged less than 12 months have not yet been established.
Latvian: Pediatriskā populācija Unituxin drošums un efektivitāte, lietojot bērniem vecumā līdz 12 mēnešiem, līdz šim nav pierādīta.
English: It belongs to a group of medicines called ‘monoclonal antibodies'.
Latvian: Tas pieder zāļu grupai, ko sauc par monoklonālām antivielām.
English: To reduce the risk of side effects, your doctor may increase the time allowed for the Unituxin infusion up to 20 hours.
Latvian: Lai samazinātu blakusparādību risku, ārsts var pagarināt Unituxin infūzijas laiku līdz 20 stundām.
English: Occasionally a young person who is taking this medicne may be reading the package leaflet, but usually it will be a parent/carer.
Latvian: Šo lietošanas instrukciju reizēm var lasīt bērns vai pusaudzis, kas lieto šīs zāles, bet parasti to lasa kāds no vecākiem/aprūpētājs.
English: High-risk neuroblastoma was based on the patient age (greater than 12 months) and tumour stage at diagnosis and / or the presence of biological risk factors, such as MYCN amplification.
Latvian: Augsta riska neiroblastomas klasifikācijai par pamatu izmantoja pacienta vecumu (vairāk nekā 12 mēneši) un audzēja stadiju diagnozes noteikšanas brīdī, un/vai bioloģisko riska faktoru, piemēram, MYCN amplifikāciju.
English: As with all therapeutic proteins, there is potential for immunogenicity.
Latvian: Tāpat kā lietojot citas olbaltumvielas terapeitiskos nolūkos, pastāv imunogenitātes risks.
English: Systemic infections
Latvian: Sistēmiskas infekcijas
English: Unituxin has been shown to delay the progression or relapse of the disease and to increase survival.
Latvian: Pierādīts, ka Unituxin aizkavē slimības progresēšanu vai atkārtošanos un pagarina dzīvildzi.
English: If patients meet criteria for discontinuation of these medications, treatment may continue with isotretinoin as clinically indicated.
Latvian: Ja pacients atbilst šo zāļu lietošanas pārtraukšanas kritērijiem, ārstēšanu var turpināt ar izotretinoīnu atbilstoši klīniskajām indikācijām.
English: When Unituxin attaches to the GD2 on the cancer cells, the patient's immune system starts to attack these cells and kill them.
Latvian: Tiklīdz Unituxin piestiprinās vēža šūnām ar GD2, pacienta imūnā sistēma sāk uzbrukumu šīm šūnām un šo šūnu iznīcināšanu.
English: Depending on the severity of the allergic reaction, the rate of infusion should be reduced or treatment discontinued.
Latvian: Atkarībā no alerģisko reakciju smaguma, infūzijas ātrums jāsamazina vai ārstēšana jāpārtrauc.
English: Keep the vial in the outer carton in order to protect from light.
Latvian: Flakons jāuzglabā ārējā kartona iepakojumā, lai pasargātu to no gaismas.
English: - The other ingredients are histidine, polysorbate 20 (E 432), sodium chloride and water for injection.
Latvian: - Citas sastāvdaļas ir histidīns, polisorbāts 20 (E 432), nātrija hlorīds un injekciju ūdens.
English: Severe pain (Grade 3 or 4) occurs most frequently during the first 4-day course of dinutuximab, often subsiding over time with subsequent courses.
Latvian: Stipras sāpes (3. vai 4. pakāpe) visbiežāk parādās pirmā 4 dienu dinutuksimaba kursa laikā, laika gaitā nākamajos kursos tās bieži mazinās.
English: It must be administered by a healthcare professional prepared to manage severe allergic reactions including anaphylaxis in an environment where full resuscitation services are immediately available.
Latvian: Tas jāievada veselības aprūpes speciālistam, kurš ir gatavs smagu alerģisku reakciju, tai skaitā anafilakses, ārstēšanai, vietā, kur nekavējoties ir pieejams viss reanimācijas pakalpojumu spektrs.
English: Isotretinoin3
Latvian: Izotretinoīns3
English: Pregnancy There are no data from the use of dinutuximab in pregnant women.
Latvian: Grūtniecība Dati par dinutuksimaba lietošanu grūtniecības laikā nav pieejami.
English: Immunoglobulin must not be given within two weeks before and one week after completing each course of Unituxin.
Latvian: Imūnglobulīnu nedrīkst ievadīt divas nedēļas pirms un vienu nedēļu pēc Unituxin kursa pabeigšanas.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Latvian: Katrā sastopamības biežuma grupā nevēlamās blakusparādības sagrupētas to nopietnības samazinājuma secībā.
English: The dose may be subsequently increased (up to a maximum of 60 mg/kg/day or 3600 mg/day) as needed for pain management.
Latvian: Devu vēlāk var palielināt (līdz maksimāli 60 mg/kg/dienā vai 3 600 mg/dienā), ja tas nepieciešams sāpju mazināšanai.
English: Prior to starting each treatment course, refer to Table 3 for a list of criteria that must be evaluated.
Latvian: Pirms katra ārstēšanas kursa uzsākšanas skatīt 3. tabulu, kurā attēlots izvērtējamo kritēriju saraksts.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ ĀRĒJĀ IEPAKOJUMA KARTONA KĀRBA
English: Each course lasts one month.
Latvian: Viena ārstēšanas kursa ilgums ir viens mēnesis.
English: Hence, this medicinal product is not recommended during pregnancy and in women of childbearing potential not using contraception.
Latvian: Tāpēc šīs zāles grūtniecības laikā un sievietēm reproduktīvā vecumā, neizmantojot kontracepcijas līdzekļus, lietot nav ieteicams.
English: Intravenous use after dilution
Latvian: Intravenozai lietošanai pēc atšķaidīšanas