natgillin/translations-raw huggingface dataset:
In two additional studies, liquid palivizumab was used as an active control (3918 pediatric subjects) to evaluate an investigational monoclonal antibody for prophylaxis of serious RSV disease in premature infants or children with BPD or hemodynamically significant CHD (see below for further details of these two studies).
V dveh dodatnih študijah so palivizumab v tekoči obliki uporabili kot aktivno primerjavo (3918 pediatričnih bolnikov) za oceno preiskovanega monoklonskega protitelesa za profilakso resnih okužb z RSV pri nedonošenčkih ali otrocih z bronhopulmonalno displazijo ali hemodinamično pomembno prirojeno srčno boleznijo (dodatne podrobnosti o teh dveh študijah so navedene v nadaljevanju).
Palivizumab serum concentrations of approximately 30 g/ml have been shown to produce a 99% reduction in pulmonary RSV replication in the cotton rat model.
V serumski koncentraciji približno 30 g/ml je palivizumab v modelu z bombažno podgano zmanjšal replikacijo RSV v pljučih za 99%.
Synagis Water for injections ampoule label
Synagis voda za injekcije - nalepka na ampuli
(3 x 0.15) ml = 0.45 ml palivizumab per month.
(3 x 0,15) ml = 0,45 ml palivizumaba na mesec.
• Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.
• pri otrocih, ki so se rodili z največ 35 gestacijskimi tedni in so na začetku sezone RSV mlajši od 6 mesecev,
In addition, palivizumab inhibits virus replication in cell culture and, therefore, may also interfere with viral culture assays.
Poleg tega palivizumab zavira replikacijo virusov v celičnih kulturah in zato lahko moti nekatere teste na virusnih kulturah.
Subsequent doses should resume monthly through the remainder of the RSV season for children that continue to be at high risk of RSV disease (see section 5.2).
Otroci, ki jih bolezen RSV še naprej zelo ogroža, morajo nadaljnje odmerke dobivati vsak mesec med preostalo sezono RSV (glejte poglavje 5.2).
The recommended dose of palivizumab is 15 mg/kg of body weight, given once a month during anticipated periods of RSV risk in the community.
Priporočeni odmerek palivizumaba je 15 mg/kg telesne mase enkrat na mesec med predvidenimi obdobji tveganja za RSV v otrokovem okolju.
What Synagis looks like and contents of the pack
Izgled zdravila Synagis in vsebina pakiranja
Synagis is a medicine to help protect your child from getting severe RSV illness.
Zdravilo Synagis je zdravilo, ki otroka pomaga zaščititi pred hudo obliko bolezni RSV.
Synagis solution for injection is a clear or slightly opalescent solution and is available in vials of either 0.5 ml or 1 ml.
Zdravilo Synagis raztopina za injiciranje je bistra do rahlo opalescentna raztopina in je na voljo v vialah z 0,5 ml ali 1 ml raztopine.
Synagis solution for injection is a ready to use formulation.
Zdravilo Synagis raztopina za injiciranje je pripravljeno za uporabo.
However, as the efficacy of palivizumab when administered to patients as a second course of treatment during an ensuing RSV season has not been formally investigated in a study performed with this objective, the relevance of these data in terms of efficacy is unknown.
Ker pa učinkovitost palivizumaba, uporabljenega kot drugi ciklus zdravljenja med naslednjo sezono RSV, ni bila formalno raziskana v kakšni raziskavi, opravljeni v ta namen, ni znano, kaj ti podatki pomenijo glede učinkovitosti.
For children undergoing cardiac bypass, it is recommended that a 15 mg/kg of body weight injection of palivizumab be administered as soon as stable after surgery to ensure adequate palivizumab serum levels.
Otroci, operirani na srcu z zunajtelesnim obtokom, naj injekcijo palivizumaba 15 mg/kg telesne teže dobijo, čim se jim stanje po operaciji stabilizira; tako je zagotovljena ustrezna koncentracija palivizumaba v serumu.
1ml of water for injections in an ampoule (type I glass).
1 ml vode za injekcije v ampuli (steklo tipa I).
The incidences of these reactions in these studies showed no difference between the palivizumab and placebo groups and the reactions were not drug related.
V pogostnosti teh dogodkov v teh študijah med skupinama na palivizumabu in placebu ni bilo razlik in dogodki niso bili povezani z zdravilom.
When reconstituted as recommended, the final concentration is 100 mg/ml.
Če je raztopina pripravljena po navodilu, je končna koncentracija 100 mg/ml.
Single-use vials: 3 ml capacity, clear, colourless type I glass vial with a chlorobutyl stopper and flipoff seal containing either 0.5 ml or 1 ml of solution for injection.
Viale za enkratno uporabo: 3 ml viala iz prozornega, brezbarvnega stekla tipa I s klorobutilnim zamaškom in pretržno zaporko, ki vsebuje 0,5 ml ali 1 ml raztopine za injiciranje.
Signs and symptoms of a severe allergic reaction include: severe rash, hives, or itching skin swelling of the lips, tongue, or face closing of the throat, difficulty swallowing difficult, rapid, or irregular breathing bluish colour of skin, lips, or under fingernails muscle weakness or floppiness a drop in blood pressure unresponsiveness
- hud izpuščaj, koprivnico ali srbečo kožo - otekanje ustnic, jezika ali obraza - zamašitev grla, težave s požiranjem - težko, hitro ali neredno dihanje - modrikasta barva kože, ustnic ali pod nohti - šibkost ali ohlapnost mišic - padec krvnega tlaka - neodzivnost
This medicinal product should not be mixed with other medicinal products or diluents other than water for injections.
Tega zdravila se ne sme mešati z drugimi zdravili ali vehikli razen z vodo za injekcije.
Pre-term infants and children with Chronic Lung Disease of Prematurity (CLDP): this trial, conducted at 347 centers in the North America, European Union and 10 other countries, studied patients less than or equal to 24 months of age with CLDP and patients with premature birth (less than or equal to 35 weeks gestation) who were less than or equal to 6 months of age at study entry.
Nedonošenčki in otroci s kronično pljučno boleznijo nedonošenčkov (CLDP): v tem preskušanju, izvedenem na 347 centrih v Severni Ameriki, Evropski Uniji in 10 drugih državah, so proučevali bolnike s CLDP, stare 24 mesecev ali manj in prezgodaj rojene bolnike (v 35. tednu nosečnosti ali prej), ki so bili ob vključitvi v študijo stari 6 mesecev ali manj.
Also contains: histidine, glycine and water for injections.
Vsebuje tudi: histidin, glicin in vodo za injekcije.
In an observational, post-marketing, database study, a small increase in the frequency of asthma was observed among preterm palivizumab recipients; however, the causal relationship is uncertain.
V obdobju trženja zdravila so v opazovalni študiji po zbirkah podatkov opazili majhen porast v pogostnosti astme pri nedonošenčkih, ki so prejemali palivizumab, vendar vzročna povezava ni gotova.
Immune system disorders Not known
Bolezni imunskega sistema Neznana pogostnost
Palivizumab is a humanised IgG1 monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV).
Palivizumab je humanizirano monoklonsko protitelo IgG1, usmerjeno na epitop antigenskega mesta A fuzijske beljakovine respiratornega sincicijskega virusa (RSV).
Palivizumab binds a highly conserved region on the extracellular domain of mature RSV F protein, referred to as antigenic site II or A antigenic site, which encompasses amino acids 262 to 275.
Palivizumab se veže na dobro ohranjeno območje na zunajcelični domeni zrelega RSV F proteina, znanega kot antigensko mesto II ali A antigensko mesto, ki obsega aminokisline 262 do 275.
Secondary efficacy endpoints showed significant reductions in the Synagis group compared to placebo in total days of RSV hospitalisation (56% reduction, p = 0.003) and total RSV days with increased supplemental oxygen (73% reduction, p = 0.014) per 100 children.
Sekundarne končne točke učinkovitosti so pokazale, da je bilo v skupini, ki je dobivala zdravilo Synagis, v primerjavi s skupino, ki je dobivala placebo, na 100 otrok značilno manjše celotno število dni hospitalizacije zaradi RSV (56% zmanjšanje, p = 0,003) in celotno število dni RSV z zvečanim dodajanjem kisika (73% zmanjšanje, p
- The other ingredients are histidine, glycine and water for injections.
- Druge sestavine zdravila so histidin, glicin in voda za injekcije.
If you are not sure about how this product will be given to your child, ask your doctor or pharmacist.
Če ste negotovi glede uporabe zdravila pri vašem otroku, se posvetujte z zdravnikom ali s farmacevtom.
In the congenital heart disease study, monthly intramuscular doses of 15 mg/kg achieved mean 30 day trough serum active substance concentrations of approximately 55 µg/ml after the first injection and approximately 90 µg/ml after the fourth injection.
V raziskavi prirojenih bolezni srca je bila z mesečnimi intramuskularnimi odmerki 15 mg/kg dosežena povprečna 30-dnevna najmanjša koncentracija zdravilne učinkovine v serumu približno 55 µg/ml po prvi injekciji in približno 90 µg/ml po četrti injekciji.
If your child gets any side effects, talk to your doctor.
Če se otroku pojavijo kateri koli neželeni učinki, se posvetujte z zdravnikom.
Please tell your doctor if your child is unwell, as the use of Synagis may need to be delayed.
Če vaš otrok ni povsem zdrav, morate to povedati zdravniku; morda bo treba uporabo zdravila Synagis odložiti.
Detailed information on this product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
The pharmacokinetics and safety of palivizumab liquid formulation and palivizumab lyophilised formulation, following 15 mg/kg intramuscular administration, were compared in a cross-over trial of 153 infants less than or equal to 6 months of age with a history of prematurity (less than or equal to 35 weeks gestational age).
Farmakokinetiko in varnost palivizumaba v tekoči obliki in palivizumaba v obliki liofilizata, po intramuskularni aplikaciji 15 mg/kg, so primerjali v navskrižnem preskušanju pri 153 dojenčkih, starih 6 mesecev ali manj, ki so bili rojeni prezgodaj (v 35 mesecu nosečnosti ali manj).
In this trial, patients were randomized to receive 5 monthly injections of 15mg/kg of liquid palivizumab (N=3306) used as active control for an investigational monoclonal antibody (N=3329).
V tem preskušanju so bili bolniki randomizirani za prejemanje 5 mesečnih injekcij palivizumaba v tekoči obliki po 15 mg/kg (N=3306), ki so ga uporabili kot aktivno primerjavo za preiskovano monoklonsko protitelo (N=3329).
Palivizumab may interfere with immune-based RSV diagnostic tests, such as some antigen detection based assays.
Palivizumab lahko moti nekatere imunsko osnovane RSV diagnostične teste, kot so nekateri testi, ki temeljijo na detekciji antigenov.
In prophylactic studies in premature and bronchopulmonary dysplasia paediatric populations, the mean half-life of palivizumab was 20 days and monthly intramuscular doses of 15 mg/kg achieved mean 30 day trough serum active substance concentrations of approximately 40 g/ml after the first injection, approximately 60 g/ml after the second injection, approximately 70 g/ml after the third injection and fourth injection.
V profilaktičnih raziskavah pri nedonošenčkih in otrocih z bronhopulmonalno displazijo je bil povprečni razpolovni čas palivizumaba 20 dni, z mesečnimi intramuskularnimi odmerki 15 mg/kg pa je bila dosežena povprečna 30-dnevna najmanjša koncentracija zdravilne učinkovine v serumu približno 40 g/ml po prvi injekciji, približno 60 g/ml po drugi injekciji in približno 70 g/ml po tretji in četrti injekciji.
Transient, low levels of antipalivizumab antibody were observed in one child after the second dose of palivizumab that dropped to undetectable levels at the fifth and seventh dose.
Pri enem otroku so po drugem odmerku palivizumaba ugotovili prehodno, nizko raven protiteles proti palivizumabu; raven teh protiteles je ob petem in sedmem odmerku padla na nemerljivo.
Single-use vial.
Vial aza enkratno uporabo.
Your child should not be given Synagis
Otrok ne sme dobiti zdravila Synagis
In this trial, patients were randomized to receive 5 monthly injections of 15mg/kg of liquid palivizumab (N=612) used as active control for an investigational monoclonal antibody (N=624).
V preskušanju so bili bolniki naključno izbrani za prejemanje 5 mesečnih injekcij palivizumaba v tekoči obliki po 15 mg/kg (N=612), ki so ga uporabili kot aktivno primerjavo za preiskovano monoklonsko protitelo (N=624).
How often will Synagis be given to my child?
Kako pogosto bo otrok dobil zdravilo Synagis?
Other medicines and Synagis
Druga zdravila in zdravilo Synagis
100 mg of powder in a 10 ml vial (type I glass) with a stopper (butyl rubber) and a flip-off seal (aluminium).
100 mg praška v 10 ml viali (steklo tipa I) z zamaškom (butil) in pretržno zaporko (aluminij).
Children who are more likely to get severe RSV disease (high risk children) include babies born prematurely (35 weeks or less) or babies born with certain heart or lung problems.
Otroci, pri katerih je večja verjetnost, da bodo dobili resno okužbo z RSV (npr: otroci z velikim tveganjem) so nedonošenčki (stari 35 tednov ali manj) ali dojenčki, rojeni z nekaterimi srčnimi in pljučnimi težavami.
A review of clinical findings did not reveal an association between A antigenic site sequence changes and RSV disease severity among children receiving palivizumab immunoprophylaxis who develop RSV lower respiratory tract disease.
Pregled kliničnih odkritij ni odkril povezave med sekvenčnimi spremembami v A antigenskem mestu in stopnjo RSV bolezni med otroki, ki so prejemali profilakso s palivizumabom in pri katerih se je razvila RSV bolezen spodnjih dihal.
*Palivizumab is a recombinant humanised monoclonal antibody produced by DNA technology in mouse myeloma host cells.
* Palivizumab je rekombinantno humanizirano monoklonsko protitelo, pridobljeno z DNA tehnologijo v mielomskih celicah miši.
50 mg of powder in a 4 ml vial (type I glass) with a stopper (butyl rubber) and a flip-off seal (aluminium).
50 mg praška v 4 ml viali (steklo tipa I) z zamaškom (butil) in pretržno zaporko (aluminij).
- for the solvent: water for injections.
- v vehiklu: voda za injekcije.
Reconstitute slowly with 0.6 ml water for injections.
Počasi pripravite z 0,6 ml vode za injekcije.
Slowly add 1.0 ml of water for injections along the inside wall of the vial to minimise foaming.
Počasi dodajte 1,0 ml vode za injekcije, in sicer vzdolž notranje stene viale, da boste čim bolj omejili penjenje.
Palivizumab should not be mixed with any medicinal products or diluents other than water for injections.
Palivizumaba se ne sme mešati z nobenim drugim zdravilom in nobenim drugim vehiklom kot z vodo za injekcije.
Both the 0.5 ml and 1 ml vials contain an overfill to allow the withdrawal of 50 mg or 100 mg, respectively.
Obe viali, 0,5 ml in 1 ml, vsebujeta presežek za zagotovitev odvzema 50 mg ali 100 mg.
Slowly add 0.6 ml of water for injections along the inside wall of the vial to minimise foaming.
Počasi dodajte 0,6 ml vode za injekcije, in sicer vzdolž notranje stene viale, da boste čim bolj omejili penjenje.
Two clinical studies were conducted to directly compare liquid and lyophilised formulations of palivizumab.
Študije, v katerih so uporabljali palivizumab v tekoči obliki Dve klinični študiji sta bili izvedeni za neposredno primerjavo palivizumaba v tekoči in liofilizirani obliki.
In studies in adult volunteers, palivizumab had a pharmacokinetic profile similar to a human IgG1 antibody with regard to volume of distribution (mean 57 ml/kg) and half-life (mean 18 days).
V raziskavah odraslih prostovoljcev so bile farmakokinetične lastnosti palivizumaba glede volumna distribucije (povprečno 57 ml/kg) in razpolovnega časa (povprečno 18 dni) podobne kot pri človeških protitelesih IgG1.
If he/she is allergic to palivizumab or any of the other ingredients of this medicine(listed in section 6).
Če je alergičen na palivizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Palivizumab should not be mixed with any medicinal products or diluents.
Palivizumaba se ne sme mešati z drugimi zdravili ali topili.
What do you need to know before Synagis is given to your child
Kaj morate vedeti, preden bo vaš otrok dobil zdravilo Synagis
The RSV hospitalisation rate was 10.6% in the placebo group.
V placebni skupini je bil delež hospitalizacij zaradi RSV 10,6%.
- The other ingredients are, - for the powder: histidine, glycine and mannitol.
- Druge sestavine so - v prašku: histidin, glicin in manitol.
What Synagis contains
Kaj vsebuje zdravilo Synagis
How will my child receive Synagis?
Kako bo otrok dobival zdravilo Synagis?
Boehringer Ingelheim Pharma GmbH & Co. KG D-88397 Biberach an der Riss Germany
KG D-88397 Biberach an der Riss Nemčija
Concentration of 100 mg/ml solution for injection.
Koncentracija 100 mg/ml raztopine za injiciranje.
At least one of the palivizumab resistance-associated substitutions, N262D, K272E/Q, or S275F/L was identified in these 8 clinical RSV isolates resulting in a combined resistance-associated mutation frequency of 6.3% in these patients.
V teh 8 kliničnih izolatih RSV so identificirali vsaj eno od substitucij, ki so povezane z odpornostjo na palivizumab, N262D, K272E/Q ali S275F/L, skupna pogostnost z odpornostjo povezanih mutacij pri teh bolnikih je bila 6,3%.
In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.
V raziskavi III. faze IMpactRSV pri nedonošenčkih in otrocih z bronhopulmonalno displazijo so bili deleži prejemnikov rednih otroških cepiv, cepiva proti gripi, bronhodilatatorjev ali kortikosteroidov podobni med otroki, ki so dobili placebo, in tistimi, ki so dobili palivizumab.
Synagis may cause serious side effects including: severe allergic reactions, such reactions may be life threatening or fatal (see "Your child should not be given Synagis" for a list of signs and symptoms).
• hudo alergijsko reakcijo; take reakcije lahko ogrozijo življenje ali so smrtne (glejte ''Otrok ne sme dobiti zdravila Synagis'' za seznam znakov in simptomov).
Additional side effects Very common (affects at least 1 user in 10): rash fever
Zelo pogosti (pojavijo se pri vsaj 1 bolniku od 10 bolnikov):
Antibody to palivizumab was evaluated in four additional studies in 4337 patients (children born at 35 weeks of gestation or less and 6 months of age or less, or 24 months of age or less with bronchopulmonary dysplasia, or with haemodynamically significant congenital heart disease were included in these studies) and was observed in 0% - 1.5% of patients at different study timepoints.
Protitelesa proti palivizumabu so bila ocenjena v štirih dodatnih študijah pri 4337 bolnikih (v to študijo so bili vključeni otroci, rojeni v 35. tednu gestacije ali manj in stari 6 mesecev ali manj ali otroci, stari 24 mesecev ali manj, z bronhopulmonalno displazijo ali s hemodinamično pomembno prirojeno boleznijo srca).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or other humanised monoclonal antibodies.
Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na katero od humaniziranih monoklonskih protiteles.
Reconstitute slowly with 1.0 ml water for injections.
Počasi pripravite z 1,0 ml vode za injekcije.
Powder and solvent for solution for injection Contents:
Prašek in vehikel za raztopino za injiciranje Vsebina:
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to other humanised monoclonal antibodies.
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na katero od humaniziranih monoklonskih protiteles.
In a placebo-controlled trial in 1,287 patients  24 months of age with haemodynamically significant congenital heart disease (639 Synagis; 648 placebo), 5 monthly doses of 15 mg/kg Synagis reduced the incidence of RSV hospitalisations by 45% (p = 0.003) (congenital heart disease study).
V preskušanju, ki je bilo kontrolirano s placebom in je zajelo 1.287 bolnikov, starih  24 mesecev in s hemodinamično pomembno prirojeno boleznijo srca (639 jih je dobivalo zdravilo Synagis, 648 placebo), je 5 mesečnih odmerkov zdravila Synagis 15 mg/kg zmanjšalo incidenco hospitalizacij zaradi RSV za 45% (p = 0,003) (raziskava prirojenih bolezni srca).
Swirl gently.
Obzirno vrtite.
How will my child receive Synagis
Kako bo otrok dobival zdravilo Synagis
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja Zelo pogosti
The 100 mg vial contains an overfill to allow the withdrawal of 100 mg when reconstituted if following the directions described below.
100 mg viala vsebuje presežek za zagotovitev odvzema 100 mg pri rekonstituciji, če se sledi spodnjim navodilom.
A total of 222 children were enrolled in two separate studies to examine the safety of palivizumab when it is administered for a second RSV season.
Dve ločeni raziskavi varnosti palivizumaba, uporabljenega v drugi sezoni RSV, sta zajeli skupno 222 otrok.
Palivizumab is administered once a month intramuscularly, preferably in the anterolateral aspect of the thigh.
Palivizumab se aplicira enkrat na mesec intramuskularno, po možnosti v anterolateralni predel stegna.
The efficacy of palivizumab when administered to patients as a second course of treatment during an ensuing RSV season has not been formally investigated in a study performed with this objective.
Učinkovitost palivizumaba pri bolnikih, ki ga dobijo v ponovnem ciklusu naslednjo sezono RSV, ni bila formalno raziskana v kakšni študiji, opravljeni s tem namenom.
The 50 mg vial contains an overfill to allow the withdrawal of 50 mg when reconstituted if following the directions described below.
50 ml viala vsebuje presežek za zagotovitev odvzema 50 mg pri rekonstituciji, če se sledi spodnjim navodilom.
Also contains histidine, glycine and mannitol.
Vsebuje tudi histidin, glicin in manitol.
- The active substance is palivizumab.
- Zdravilna učinkovina je palivizumab.
It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains.
Palivizumab močno nevtralizira seve RSV podtipov A in B in zavira njihovo fuzijsko aktivnost.
Label of 0.5 ml vial
Nalepka na 0,5 ml viali
Label of 1.0 ml vial
Nalepka na 1,0 ml viali
However, you should inform your doctor of all medicines your child is currently taking before starting Synagis.
Ni znano, da bi imelo zdravilo Synagis medsebojne učinke z drugimi zdravili, vendar morate zdravniku pred začetkom uporabe zdravila Synagis povedati za vsa zdravila, ki jih vaš otrok trenutno dobiva.
Synagis 100 mg vial label
Synagis 100 mg - nalepka na viali
One ml of Synagis solution for injection contains 100 mg of palivizumab.
1 ml zdravila Synagis raztopina za injiciranje vsebuje 100 mg palivizumaba.
Studies carried out in rodents gave no indication of enhancement of RSV replication, or RSV-induced pathology or generation of virus escape mutants in the presence of palivizumab under the chosen experimental conditions.
Raziskave na glodalcih v izbranih eksperimentalnih pogojih in v navzočnosti palivizumaba niso odkrile zvečane replikacije RSV, z RSV izzvane patologije ali nastanka ubežnih virusnih mutantov.
Synagis is presented as a powder and solvent for solution for injection (100 mg of powder in vial) + 1 ml of solvent in ampoule - Pack size of 1.
Zdravilo Synagis sestavljata prašek in vehikel za raztopino za injiciranje (100 mg praška v viali) + 1 ml vehikla v ampuli - pakiranje vsebuje 1 vialo in 1 ampulo.
100 mg Outer Carton
100 mg - zunanja škatla
50 mg Outer Carton
50 mg - zunanja škatla