natgillin/translations-raw huggingface dataset:
Common side effects, seen in more than 1 in 100 patients but less than 1in 10, include apathia muscle cramps, tiredness, a general feeling of being unwell or weakness, headache, sleepiness, problems with focussing your eyes, palpitations, chest pain, giddiness, dizziness, swelling, faintness or dizziness when standing up from a sitting or lying position (orthostatic dysregulation), shortness of breath, runny nose (rhinitis), constipation, indigestion, an increased desire or need to urinate and delayed ejaculation weakness (asthenia).
Med pogostimi neželenimi učinki, ki so jih opazili pri več kot 1 bolniku od 100, vendar manj kot 1 bolniku od 10, so apatija, mišični krči, utrujenost, splošno slabo počutje ali šibkost, glavobol, zaspanost, težave z ostrino vida, razbijanje srca, bolečine v prsnem košu, vrtoglavica, omotica, otekanje, omedlevica ali vrtoglavica pri vstajanju iz sedečega ali ležečega položaja (ortostatska disregulacija), zasoplost, izcedek iz nosu (rinitis), zaprtje, prebavne motnje, povečana želja ali potreba po uriniranju in zapoznela ejakulacija, oslabelost (astenija).
- The active substance is doxazosin mesilate.
- Zdravilna učinkovina je doksazosinijev mesilat.
Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]should not be used during pregnancy unless clearly needed.
Zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
At steady-state, the relative bioavailability of doxazosin from Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets compared to immediate release form was 54% at the 4 mg dose and 59% at the 8 mg dose.
V stanju dinamičnega ravnovesja je relativna biološka uporabnost doksazosina v zdravilu Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena 54 % relativne biološke uporabnosti doksazosina v tabletah s takojšnjim sproščanjem, pri odmerku 8 mg pa 59 %.
The pharmacokinetic properties of doxazosin in Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets lead to a minor variation in plasma levels.
Farmakokinetične lastnosti doksazosina v zdravilu Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena so vzrok za manjše razlike pri koncentracijah v plazmi.
After oral administration of therapeutic doses, doxazosin in Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets is well absorbed with peak blood levels gradually reached at 6 to 8 hours after dosing.
Po peroralnem jemanju terapevtskih odmerkov se doksazosin v zdravilu Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena dobro absorbira, najvišje koncentracije v plazmi pa so postopoma dosežene v 6 do 8 urah po odmerjanju.
Each prolonged-release tablet contains 4 mg doxazosin (as mesilate).
2 KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta s podaljšanim sproščanjem vsebuje 4 mg doksazosina (v obliki mesilata).
Throughout the recommended dosage range, Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]has only a minor or no effect on blood pressure in normotensive benign prostatic hyperplasia (BPH) patients.
Znotraj priporočenega intervala odmerkov ima zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena pri normotenzivnih bolnikih z benigno hiperplazijo prostate (BPH) le manjši učinek na krvni tlak ali pa ga sploh nima.
Overflow bladder, anuria or progressive renal insufficiency History of oesophageal or gastrointestinal obstruction or decreased lumen diameter of the gastrointestinal tract
• ezofagealna ali gastrointestinalna obstrukcija v anamnezi ali zmanjšan premer lumna prebavil.
PVC/PVDC/aluminium blister pack.
6.5 Vrsta ovojnine in vsebina Pretisni omot iz PVC/PVDC/aluminija.
Do not take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]if you are pregnant or breast-feeding.
Zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena ne jemljite, če ste noseči ali če dojite.
Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: [To be completed nationally]
Imetnik dovoljenja za promet z zdravilom in izdelovalec: Imetnik dovoljenja za promet z zdravilom: [Izpolni država članica]
In patients with hypertension, the decrease in blood pressure during treatment with Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]was similar in both the sitting and standing position.
Pri bolnikih s hipertenzijo je bilo med zdravljenjem z zdravilom Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena znižanje krvnega tlaka v sedečem in stoječem položaju podobno.
Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]work by relaxing the muscle around the bladder exit and prostate gland, which allows the urine to pass more easily.
Zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena deluje tako, da sprošča mišice okoli izvodila mehurja in prostate, kar olajša uriniranje.
Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is not recommended for use in children and adolescents due to a lack of clinical experience.
Uporaba zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena pri otrocih zaradi pomanjkanja kliničnih izkušenj ni priporočena.
Lactation.
• dojenje.
Peak/trough ratio of Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets is less than half that of immediate release doxazosin tablets.
Razmerje najvišjih koncentracij in koncentracij pred naslednjim odmerkom pri zdravilu Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena je manjše kot polovica razmerja pri tabletah doksazosina s takojšnjim sproščanjem.
Patients treated with immediate release doxazosin tablets against hypertension can be transferred to Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets and the dose titrated upwards as needed, while maintaining effect and tolerability.
Bolniki, ki jemljejo tablete doksazosina s takojšnjim sproščanjem lahko preidejo na zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena.
Taking Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]with food and drink
Jemanje zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena skupaj s hrano in pijačo
Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]can be taken at any time of day, during or after meals.
Zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena lahko jemljete kadar koli čez dan, s hrano ali po obroku.
Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]can be taken with or without food.
Zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena se lahko jemlje s hrano ali brez nje.
the CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names (see Annex I).
je CHMP za Doksazosin “Winthrop” 4 mg tablete s podaljšanim sproščanjem in z njim povezana imena (glejte Dodatek I) priporočil odobritev dovoljenj za promet z zdravilom, za katere so Povzetki glavnih značilnosti zdravila, označevanje in Navodila za uporabo opredeljeni v Dodatku III.
Patients with hepatic impairment: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]should be given with particular caution to patients with evidence of impaired liver function.
Bolniki z jetrno okvaro: Bolnikom z jetrno okvaro je treba zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena dajati posebno previdno.
Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena [glejte Dodatek I] doksazosin
Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]has moderate influence on the ability to drive and use machines, especially at the beginning of therapy.
Zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
If you take more Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]than you should:
Če ste vzeli večji odmerek zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena, kot bi smeli.
This is the maximum dose of Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I].
To je največji odmerek zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena.
NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] Doxazosin STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 4 mg of doxazosin (as mesilate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta s podaljšanim sproščanjem vsebuje 4 mg doksazosina (v obliki mesilata).
1 WHAT DOXAZOSIN WINTHROP 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES [SEE ANNEX I]IS AND WHAT IT IS USED FOR
1 KAJ JE ZDRAVILO DOXAZOSIN WINTHROP 4 MG TABLETE S PODALJŠANIM SPROŠČANJEM IN POVEZANA IMENA IN ZA KAJ GA UPORABLJAMO
Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]can be taken with or after food.
Zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena lahko jemljete s hrano ali po obroku.
Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]should be administered with caution in patients with signs of mild to moderate hepatic impairment (see section 5.2).
Pri bolnikih z manjšo do zmerno jetrno okvaro je treba zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena odmerjati previdno (glejte poglavje 5.2).
• if you have ever suffered an allergic reaction (e.g. itching, reddening of the skin or difficulty breathing)
• če ste kdaj imeli alergijsko reakcijo (npr. srbenje, rdečico kože ali težave pri dihanju) na zdravilno učinkovino doksazosin ali katero koli zgoraj navedeno sestavino zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena;
What Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is and what it is used for
Kaj je zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena in za kaj ga uporabljamo
3 HOW TO TAKE DOXAZOSIN WINTHROP 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES [SEE ANNEX I]
3 KAKO JEMATI ZDRAVILO DOXAZOSIN WINTHROP 4 MG TABLETE S PODALJŠANIM SPROŠČANJEM IN POVEZANA IMENA
Alternatively, breast-feeding must be stopped, if treatment with Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is unavoidable.
Če je zdravljenje z zdravilom Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena neizogibno, je treba dojenje prekiniti.
2 BEFORE YOU TAKE DOXAZOSIN WINTHROP 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES [SEE ANNEX I]
1 IME ZDRAVILA Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena [glejte Dodatek I]
Always take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]exactly as your doctor has told you.
Pri jemanju zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena natančno upoštevajte zdravnikova navodila.
Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]may be used in benign prostatic hyperplasia (BPH) patients who are either hypertensive or normotensive, as the blood pressure changes in normotensive patients are clinically insignificant.
Spremembe krvnega tlaka pri normotenzivnih bolnikih so klinično nepomembne, zato se lahko zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena uporablja pri hipertenzivnih in tudi pri normotenzivnih bolnikih z benigno hiperplazijo prostate (BPH - benign prostatic hyperplasia).
Take special care with Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Bodite posebno pozorni pri jemanju zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena:
Do not take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Ne jemljite zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena:
How to take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I] 4.
NAVODILO ZA UPORABO Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena [glejte Dodatek I] (doksazosin)
8 MARKETING AUTHORISATION NUMBER
8 ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolni država članica]
The procedure started on 18 October 2007.
Postopek se je začel dne 18. oktobra 2007.
Ref. EMEA/CHMP/541853/2008
EMEA/CHMP/541636/2008
London, 6 October 2008 Doc.
London, 6. oktober 2008 Sklic na dok.
A Decision was issued by the European Commission on 6 October 2008.
Evropska komisija je odločbo izdala dne 6. oktobra 2008.
The Marketing Authorisation Holder provided supplementary information on 28 January 2008.
Imetnik dovoljenja za promet z zdravilom je dne 28.januarja 2008 priskrbel dodatne informacije.
Zyrtec and associated names, 10 mg film coated tablets, 10 mg/ml oral drops, 1 mg/ml oral solution, is an anti-allergic drug indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the relief of chronic idiopathic urticaria.
Zyrtec in z njim povezana imena, 10-miligramske filmsko obložene tablete, 10 mg/ml peroralne kapljice, 1 mg/ml peroralna raztopina, je protialergijsko zdravilo, namenjeno za lajšanje nosnih in očesnih simptomov sezonskega in celoletnega alergijskega rinitisa ter lajšanje simptomov kronične idiopatske utikarije (bolezni kože, ki jo povzroča alergija in katere simptomi vključujejo srbenje in izpuščaje).
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Zyrtec and associated names approved across EU Member States, in particular with respect to the indications, the posology, the contra-indications and the special warnings.
Podlaga za napotitev so bila razhajanja med povzetki glavnih značilnosti zdravila (SPC) Zyrtec in z njim povezana imena, ki so bili odobreni v vseh državah članicah EU, zlasti v zvezi z indikacijami, odmerjanjem, kontraindikacijami in posebnimi opozorili.
On 9 October 2007 the Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Zyrtec and associated names.
Komisija je dne 9. oktobra 2007 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi uskladila na nacionalni ravni odobrene povzetke glavnih značilnosti zdravila (SPC), označevanja in navodila za uporabo zdravila Zyrtec in z njim povezana imena.
During its May 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Med svojim zasedanjem maja 2008 je CHMP na osnovi vseh predloženih podatkov in znanstvene razprave v Odboru menil, da je predlog za uskladitev povzetkov glavnih značilnosti zdravila, označevanj in navodil za uporabo sprejemljiv in da bi bilo treba navedene dokumente dopolniti.
The CHMP gave a positive opinion on 30 May 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Zyrtec and associated names.
CHMP je dne 30. maja 2008 izdal pozitivno mnenje, s katerim priporoča uskladitev povzetkov glavnih značilnosti zdravila, označevanj in navodil za uporabo za zdravilo Zyrtec in z njim povezana imena.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Zyrtec and associated names International Non-Proprietary Name (INN): cetirizine
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA zdravilo Zyrtec in z njim povezana imena
Let stand for 20 minutes.
Pustite stati 20 minut.
Date of first authorisation: 13 August 1999 Date of latest renewal: 27 July 2009
Datum pridobitve dovoljenja za promet: 13. avgust 1999 Datum zadnjega podaljšanja dovoljenja za promet: 27. julij 2009
Subjects were followed for safety and efficacy for 150 days.
Bolnike so spremljali glede varnosti in učinkovitosti 150 dni.
However in-use stability has been demonstrated for 3 hours at 20 - 24oC.
Stabilnost po pripravi je sicer dokazana za 3 ure pri 20 - 24°C.
On this basis, the absolute risk reduction is 5.8% which means the number needed to treat is 17 to prevent one hospitalisation.
Glede na to je absolutno zmanjšanje tveganja 5,8%, kar pomeni, da je število potrebnih zdravljenj za preprečitev ene hospitalizacije 17.
In vitro studies of antiviral activity
In vitro študije protivirusne aktivnosti
unusual bruising or groups of tiny red spots on the skin.
• nenavadne modrice ali skupine majhnih rdečih pik na koži.
These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg.
Ti odmerki so bili 20,25 mg/kg, 21,1 mg/kg in 22,27 mg/kg.
AstraZeneca Pharmaceuticals Limited Partnership (AZPLP) 660 MedImmune Court / 633 Research Court, Frederick, Maryland, USA
AstraZeneca Pharmaceuticals Limited Partnership (AZPLP) 660 MedImmune Court / 633 Research Court, Frederick, Maryland, ZDA
In some cases, fatalities have been reported (see section 4.8).
V nekaj primerih so poročali o smrtnih primerih (glejte poglavje 4.8).
Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki za ‘EXP'.
Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child.
Pred uporabo tega zdravila pri vašem otroku natančno preberite navodilo, ker vsebuje za vas in vašega otroka pomembne podatke.
Where possible, the first dose should be administered prior to commencement of the RSV season.
Prvi odmerek je treba po možnosti uporabiti pred začetkom sezone RSV.
The majority of clinical RSV isolates tested (n=96) were collected from subjects in the United States.
Večina testiranih kliničnih RSV izolatov (n=96) je bilo zbranih od osebkov v Združenih državah Amerike.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
V primeru prevelikega odmerjanja je priporočljivo bolnika nadzorovati zaradi kakršnih koli znakov in simptomov neželenih reakcij ali učinkov in nemudoma uvesti ustrezno simptomatsko zdravljenje.
In clinical studies, three children received an overdose of more than 15 mg/kg.
V kliničnih raziskavah so trije otroci dobili prevelike odmerke, večje od 15 mg/kg.
In the first study, all 153 premature infants received both formulations in different sequences.
V prvi študiji je vseh 153 nedonošenčkov prejelo obe obliki v različnih zaporedjih.
For example, for a baby with a body weight of 3 kg, the calculation becomes:
Na primer za dojenčka s telesno maso 3 kg velja naslednji izračun:
Anaphylaxis, anaphylactic shock (in some cases, fatalities have been reported.)
Anafilaksija, anafilaktični šok (v nekaterih primerih so poročali o smrtih)
Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies.
Raztopina palivizumaba mora stati na sobni temperaturi vsaj 20 minut, dokler se ne zbistri.
Store in a refrigerator (2ºC to 8ºC).
Shranjujte v hladilniku (2°C - 8°C).
Groups were equally balanced between cyanotic and acyanotic patients.
Skupini sta bila uravnoteženi glede cianotičnih in necianotičnih bolnikov.
This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences.
To humanizirano monoklonsko protitelo je sestavljeno iz človeških (95%) in murinih (5%) protitelesnih zaporedij.
One hundred and three (103) children received monthly palivizumab injections for the first time, and 119 children received palivizumab for two consecutive seasons.
Sto trije (103) otroci so mesečne injekcije palivizumaba dobili prvič, 119 otrok pa je dobivalo palivizumab dve sezoni zapored.
If your child misses an injection, you should contact your doctor as soon as possible.
Če otrok zamudi injekcijo, se čim prej obrnite na zdravnika.
To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Če želite poslušati ali prejeti kopijo teh Navodil za uporabo v <Braillovi pisavi>, <v večjem tisku> ali <zvočni obliki>, se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Of this group 1,250 enrolled infants had 6 injections, 183 infants had 7 injections, and 27 infants had either 8 or 9 injections.
V tej skupini je 1.250 vključenih dojenčkov dobilo 6 injekcij, 183 dojenčkov 7 injekcij in 27 dojenčkov 8 ali 9 injekcij.
Insert the needle into the vial and withdraw into the syringe an appropriate volume of solution.
Vstavite iglo v vialo in v brizgo odvzemite ustrezen volumen raztopine.
No medical consequences were identified in these instances.
V nobenem od teh primerov niso ugotovili zdravstvenih posledic.
Patients with hemodynamically significant congenital heart disease were excluded from enrollment in this study and were studied in a separate study.
Bolniki s hemodinamično pomembno prirojeno boleznijo srca so bili izključeni iz postopka vključevanja v to študijo in so jih proučevali v ločeni študiji.
The neutralization titre (50% effective concentration [EC50]) is expressed as the antibody concentration required to reduce detection of RSV antigen by 50% compared with untreated virus-infected cells.
Nevtralizacijski titer (50 odstotno učinkovita koncentracija [EC50]) je izražen kot koncentracija protiteles, ki je potrebna za zmanjšanje detekcije RSV protiteles za 50% v primerjavi z nezdravljenimi, z virusom okuženimi celicami.
Data on fertility, pregnancy and lactation are not available.
Podatkov o vplivu na plodnost, nosečnost in dojenje ni na voljo.
• Children less than 2 years of age and with haemodynamically significant congenital heart disease.
• pri otrocih, mlajših od 2 let, ki imajo hemodinamično pomembno prirojeno bolezen srca.
The majority of experience including the pivotal phase III clinical trials with palivizumab has been gained with 5 injections during one season (see section 5.1).
Večina izkušenj s palivizumabom, tudi tistih v ključnih kliničnih preskušanjih III. faze, je bila pridobljena s 5 injekcijami v eni sezoni (glejte poglavje 5.1).
Undesirable effects in clinical studies* and post-marketing reports in paediatric patients MedDRA system organ class
Neželeni učinki v kliničnih študijah* in poročila iz obdobja trženja zdravila pri pediatričnih bolnikih
For your child's best protection, it is necessary to take the doctor's advice about when to return for additional doses of Synagis.
Za najboljšo zaščito vašega otroka upoštevajte zdravnikova navodila o tem, kdaj je treba priti po dodatne odmerke zdravila Synagis.
After reconstitution, the product should be used immediately.
Po rekonstituciji morate zdravilo uporabiti takoj.
If your child is to have a heart operation (cardiac bypass surgery), he or she may be given an extra dose of Synagis after the operation.
Če bo vaš otrok imel operacijo na srcu (operacija na srcu z zunajtelesnim obtokom), bo po operaciji morda dobil dodaten odmerek zdravila Synagis.