natgillin/translations-raw huggingface dataset:
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity to reproduction and development.
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Flucelvax Tetra was non-inferior to TIVc.
Cepivo Flucelvax Tetra je bilo neinferiorno cepivu TIVc.
Flucelvax Tetra was noninferior to TIVc in children 4 to less than 18 years of age.
Cepivo Flucelvax Tetra je bilo neinferiorno cepivu TIVc pri otrocih, starih od 4 leta do manj kot 18 let.
The safety of Flucelvax Tetra in adults 18 years and older was evaluated in a randomised, controlled study (V130_01), in which 1334 subjects received Flucelvax Tetra.
Varnost cepiva Flucelvax Tetra pri odraslih, starih 18 let ali več, so ocenili v randomizirani nadzorovani študiji (V130_01), v kateri je 1.334 oseb prejelo cepivo Flucelvax Tetra.
Based on clinical experience with cell-based trivalent influenza vaccine (TIVc), Flucelvax Tetra can be given at the same time as other vaccines.
Podatkov o sočasnem dajanju cepiva Flucelvax Tetra z drugimi cepivi ni. Na osnovi kliničnih izkušenj s trivalentnim cepivom proti gripi na celični osnovi (TIVc) se cepivo Flucelvax Tetra lahko daje sočasno z drugimi cepivi.
Attack Rate
Stopnja obolevnosti
Individual strains
Skupaj Individualni sevi
Flucelvax Tetra suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 2019/2020 season
Flucelvax Tetra suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti gripi iz kulture celic, s površinskimi antigeni, inaktivirano sezona 2019/2020
• Fever (> 38°C)
• zvišana telesna temperatura (≥ 38 °C).
The safety of Flucelvax Tetra in children 4 to less than 18 years of age was evaluated in a randomised, controlled study (V130_03).
Varnost cepiva Flucelvax Tetra pri otrocih, starih od 4 leta do manj kot 18 let, je bila ocenjena v randomizirani nadzorovani študiji (V130_03).
Table 1: Adverse reactions reported following vaccination in adults 18 years and older in clinical trials and post-marketing surveilance.
Preglednica 1: Neželeni učinki, o katerih so poročali v kliničnih preskušanjih in v obdobju po prihodu zdravila na trg pri odraslih, starih 18 let ali več
Allergic or immediate hypersensitivity reactions, including anaphylactic shock
Bolezni imunskega sistema alergijske ali takojšnje preobčutljivostn e reakcije,
Pre-filled syringe label
Nalepka napolnjene injekcijske brizge
Carton box for syringe(s) with needle: - 1 pre-filled syringe (0.5 ml) with needle - 10 pre-filled syringes (0.5 ml) with needle Carton box for syringe(s) without needle: - 10 pre-filled syringes (0.5 ml) without needle
Kartonska škatla za injekcijsko brizgo/injekcijske brizge brez igle: - 10 napolnjenih injekcijskih brizg (0,5 ml) brez igle Kartonska škatla za injekcijsko brizgo/injekcijske brizge z iglo: - 1 napolnjena injekcijska brizga (0,5 ml) z iglo - 10 napolnjenih injekcijskih brizg (0,5 ml) z iglo
Antigenically Matched Strains Overall
Antigensko ujemajoči se sevi
• Nausea, vomiting, diarrhoea
• siljenje na bruhanje, bruhanje, driska,
Use of Flucelvax Tetra during breast-feeding has not been studied.
Uporabe cepiva Flucelvax Tetra pri doječih materah niso proučili.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija1
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja generalizirane kožne reakcije,
Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Flucelvax Tetra - suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti gripi iz kulture celic, s površinskimi antigeni, inaktivirano
or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 677) or TIV2c (N = 669)].
V tej študiji so osebe prejele cepivo Flucelvax Tetra (N = 1.334) ali eno od dveh formulacij primerjalnega trivalentnega cepiva proti gripi na celični osnovi (TIVc) [TIV1c (N = 677) ali TIV2c (N = 669)].
No interaction studies have been performed with Flucelvax Tetra.
Študij medsebojnega delovanja s cepivom Flucelvax Tetra niso izvedli.
There are no data for overdose with Flucelvax Tetra.
Podatkov o prevelikem odmerjanju cepiva Flucelvax Tetra ni.
Read the package leaflet before use.
intramuskularna uporaba Pred uporabo preberite priloženo navodilo!
What Flucelvax Tetra looks like and contents of the pack
Izgled cepiva Flucelvax Tetra in vsebina pakiranja
For egg-derived influenza vaccines larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.
Za cepiva proti gripi na jajčni osnovi so za drugi in tretji trimester na voljo večji nabori podatkov o varnosti kot za prvi trimester.
1 Reported as Common in the elderly population 65 years of age and older 2 Reported as Uncommon in the elderly population 65 years of age and older 3 Adverse reactions reported from post-marketing surveillance
1 Poročana kot pogosta pri populaciji oseb, starih 65 let ali več.
GMT (95% CI) Seroconversion Rateb
GMT (95-% IZ) Stopnja serokonverzijeb
Vaccine Group Ratio (95% CI)
Razmerje med skupinami cepljenja (95-% IZ)
Vaccine Efficacy = (1 - Relative Risk) x 100%; ** There were too few cases of influenza due to vaccine-matched influenza A/H3N2 or B to adequately assess vaccine efficacy.
** Ni bilo dovolj primerov gripe, ki jo povzroča s cepivom ujemajoči se podtip A/H3N2 ali B, za ustrezno oceno učinkovitosti cepiva.
In the event of any foreign particulate matter and/or variation of physical aspect is observed, do not administer the vaccine.
Ne dajajte tega cepiva, če opazite kakršne koli trdne delce in/ali spremembo videza cepiva.
How Flucelvax Tetra is given
Kako se cepivo Flucelvax Tetra daje
Generalised skin reactions including pruritus, urticaria or non-specific rash
vključno s pruritusom, urtikarijo ali neznačilnim izpuščajem
Loss of appetite
Presnovne in prehranske motnje izguba apetita
TIVc = cell-based trivalent influenza vaccine; TIVeA = egg-based trivalent influenza vaccine (Agrippal); TIVeF = egg-based trivalent influenza vaccine (Fluvirin) a Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre.
(Agrippal); TIVeF = trivalentno cepivo proti gripi na jajčni osnovi (Fluvirin) a Stopnja serokonverzije = odstotek oseb s titrom HI < 1 : 10 pred cepljenjem in titrom HI ≥ 1 : 40 po cepljenju ali titrom HI ≥ 1 : 10 pred cepljenjem in najmanj 4-kratnim zvišanjem titra protiteles HI po cepljenju.
Sodium chloride Potassium chloride Magnesium chloride hexahydrate Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid kalijev klorid magnezijev klorid heksahidrat natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
GMT (95% CI) Seroconversion Rateb (95% CI)
GMT (95-% IZ) Stopnja serokonverzijeb (95-% IZ)
Flucelvax Tetra is not indicated for use in children less than 9 years of age, see section 4.2.
Pediatrična populacija (od 4 leta do manj kot 9 let) Cepivo Flucelvax Tetra ni indicirano za uporabo pri otrocih, mlajših od 9 let; glejte poglavje 4.2.
Non-inferiority was established for all 4 influenza strains included in Flucelvax Tetra, as assessed by ratios of GMTs and the differences in the percentages of subjects achieving seroconversion at 3 weeks following vaccination.
Neinferiornost, ki so jo ocenili na osnovi razmerij GMT in razlik v odstotkih oseb, ki so dosegle serokonverzijo 3 tedne po cepljenju, je bila dokazana za vse 4 seve virusa gripe, vključene v cepivo Flucelvax Tetra.
The immunogenicity endpoints were geometric mean antibody titres (GMTs) of haemagglutination inhibition (HI) antibodies response and percentage of subjects who achieved seroconversions, defined as a pre-vaccination HI titre of <1:10 with a post vaccination titre ≥1:40 or with a prevaccination HI titre of ≥10 and a minimum 4-fold increase in serum HI antibody titre.
Opazovana dogodka imunogenosti sta bila geometrična sredina titrov protiteles (GMT - geometric mean antibody titers) odziva protiteles za inhibicijo hemaglutinacije (HI) in odstotek oseb, ki so dosegle serokonverzije, opredeljene kot titer HI pred cepljenjem < 1 : 10 in titer po cepljenju ≥ 1 : 40 ali kot titer HI pred cepljenjem ≥ 1 : 10 in najmanj 4-kratno zvišanje titra protiteles HI v serumu.
The European Medicines Agency has deferred the obligation to submit the results of studies with Flucelvax Tetra in children 6 months to 4 years of age in the prevention of influenza.
Flucelvax Tetra za otroke, stare od 6 mesecev do 4 leta, za preprečevanje gripe.
• Extensive swelling of injected limb
• obsežno otekanje okončine, v katero je bilo injicirano cepivo.
Nervous system disorders
Bolezni živčevja glavobol1
The immunogenicity endpoints were GMTs of HI antibodies response and percentage of subjects who achieved seroconversions (seroconversion rate), defined as a pre-vaccination HI titre of <1:10 with a post-vaccination titre ≥1:40 or with a pre-vaccination HI titre ≥ 1:10 and a minimum 4-fold increase in serum HI antibody titre.
Opazovana dogodka imunogenosti sta bila GMT odziva protiteles HI in odstotek oseb, ki so dosegle serokonverzije (stopnja serokonverzije), opredeljene kot titer HI pred cepljenjem < 1 : 10 in titer po cepljenju ≥ 1 : 40 ali kot titer HI pred cepljenjem ≥ 1 : 10 in najmanj 4-kratno zvišanje titra protiteles HI v serumu.
Injection site pain, Fatigue1,
Splošne težave in spremembe na mestu aplikacije bolečina na mestu injiciranja, utrujenost1, eritem, induracija1
Immunogenicity of Flucelvax Tetra was evaluated in children 9 to less than 18 years of age as part of a randomised, double-blind, controlled study (V130_03) that was performed in the paediatric population 4 to less than 18 years of age.
Imunogenost cepiva Flucelvax Tetra pri otrocih in mladostnikih, starih od 9 let do manj kot 18 let V okviru randomizirane, dvojno slepe, nadzorovane študije (V130_03), ki je bila izvedena pri pediatrični populaciji starosti od 4 leta do manj kot 18 let, so ocenili imunogenost cepiva Flucelvax Tetra pri otrocih, starih od 9 let do manj kot 18 let.
b Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre.
b Stopnja serokonverzije = odstotek oseb s titrom HI < 1 : 10 pred cepljenjem in titrom HI ≥ 1 : 40 po cepljenju ali titrom HI ≥ 1 : 10 pred cepljenjem in najmanj 4-kratnim zvišanjem titra protiteles HI po cepljenju.
There are no reproductive and developmental toxicology studies with Flucelvax Tetra.
Študij vpliva na sposobnost razmnoževanja in razvoj s cepivom Flucelvax Tetra niso izvedli.
Extensive swelling of injected limb
obsežna oteklina okončine, v katero je bilo injicirano cepivo
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) This medicine is subject to additional monitoring.
Navodilo za uporabo Flucelvax Tetra, suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti gripi iz kulture celic, s površinskimi antigeni, inaktivirano Za to zdravilo se izvaja dodatno spremljanje varnosti.
Mild side effects
Blagi neželeni učinki
Name and address of the manufacturer(s) responsible for batch release Seqirus Vaccines Ltd
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
How to store Flucelvax Tetra
Shranjevanje cepiva Flucelvax Tetra
Name and address of the manufacturer(s) of the biological active substance(s) Seqirus Inc.
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
• Muscle pain
• bolečine v mišicah,
HI data, egg-derived assay
Podatki za HI, analiza na osnovi jajčnih celic.
Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra.
Preden prejmete cepivo Flucelvax Tetra, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Immunogenicity of TIVc in children 9 to less than 18 years of age was evaluated as part of a randomised, double-blind, controlled study (V58P12) that was performed in the paediatric population 3 to less than 18 years of age.
nadzorovane študije (V58P12), ki je bila izvedena pri pediatrični populaciji starosti od 3 leta do manj kot 18 let, so ocenili imunogenost cepiva TIVc pri otrocih, starih od 9 let do manj kot 18 let.
Studies 301 and 202
Študiji 301 in 202
What is MPS VII
Kaj je MPS VII
Compatibility with other medicinal products has not been evaluated.
Združljivosti z drugimi zdravili niso ocenili.
Currently available data are described in section 4.8 and section 5.1.
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8 in 5.1.
Appropriate clinical treatment should be immediately sought.
Nemudoma je treba uvesti ustrezno klinično zdravljenje.
Reports to be submitted as part of the annual reassessment
Poročila je treba predložiti kot del letne ponovne ocene.
- These sugars are re-cycled all the time - new ones are made and old ones are broken down.
- Ti sladkorji se ves čas reciklirajo - nastajajo novi, medtem ko se stari razgrajujejo.
The posology in the paediatric population is the same as in adults.
Pediatrična populacija Pri pediatrični populaciji je odmerjanje enako kot pri odraslih.
Dilution preparation should be done at room temperature.
Raztopino je treba pripraviti pri sobni temperaturi.
From a microbiological safety point of view, the diluted product should be used immediately.
Z vidika mikrobiološke varnosti je treba razredčeno zdravilo uporabiti takoj.
- Do not use this medicine if you notice particles.
- Ne uporabljajte tega zdravila, če opazite prisotnost delcev.
Other symptoms to look out for
Drugi simptomi, na katere morate biti pozorni
He or she will check that the correct dose has been given and take action as needed.
Prepričal se bo, da ste dobili pravilen odmerek, in po potrebi ukrepal.
Tell your doctor if you are using, have recently used or might use any other medicines.
Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Colourless glass vial (Ph. Eur.
Viala iz brezbarvnega stekla (Ph. Eur.
Nine patients were younger than 18 years of age.
Devet bolnikov je bilo mlajših od 18 let.
They may include an allergic reaction (see section 4).
Učinki lahko vključujejo alergijsko reakcijo (glejte poglavje 4).
Nineteen patients were younger than 18 years of age.
Devetnajst bolnikov je bilo mlajših od 18 let.
These problems can be signs of the illness and may be caused by pressure on your spinal cord.
Te težave so lahko znaki bolezni in so lahko posledica pritiska na hrbtenjačo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
In addition, uGAG response (% change from study week 0) shows a similar magnitude of reduction in uGAG in all groups after crossover to active treatment.
Poleg tega odziv uGAG (% spremembe od študijskega tedna 0) kaže podoben obseg zmanjšanja ravni uGAG v vseh skupinah po prehodu na aktivno zdravljenje.
- The medicine has to be diluted before being given.
- Zdravilo je treba pred dajanjem razredčiti.
- If you have ever had a severe allergic reaction to vestronidase alfa or any of the other ingredients of this medicine (listed in section 6).
- če ste kdaj imeli hudo alergijsko reakcijo na vestronidazo alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica doseženja pomembnega mejnika (farmakovigilančnega ali povezanega z zmanjševanjem tveganja).
Side effects were mainly seen while patients were being given the medicine or within a day after the infusion (infusion reactions).
Neželene učinke so v glavnem opažali, medtem ko so bolniki dobivali zdravilo ali v enem dnevu po infuziji (infuzijske reakcije).
Treatment with Mepsevii should be started and monitored by your doctor.
Zdravljenje z zdravilom Mepsevii mora začeti in nadzorovati vaš zdravnik.
Take this into account if you are on a controlled sodium diet.
To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
Starting treatment early in children may stop the illness getting worse and reduce permanent damage.
Pri otrocih lahko zgodnji začetek zdravljenja ustavi napredovanje bolezni in zmanjša trajno škodo.
No alternative dose regimen is recommended in these patients (see section 5.1).
Pri teh bolnikih se ne priporoča drugačen režim odmerjanja (glejte poglavje 5.1).
- This enzyme helps to break down sugars in the body called mucopolysaccharides.
- Ta encim pomaga razgraditi sladkorje v telesu, ki se imenujejo mukopolisaharidi.
- Treatment may improve various signs and symptoms of illness, like walking difficulties and tiredness.
- Zdravljenje lahko izboljša različne znake in simptome bolezni, denimo oteženo hojo in utrujenost.
All 12 patients were responders, pre-specified as ≥ 50% reduction in uGAG on at least one visit during the first 24 weeks of treatment.
Vseh 12 bolnikov je doseglo odziv, vnaprej določen kot ≥ 50-odstotno zmanjšanje uGAG ob najmanj enem obisku v prvih 24 tednih zdravljenja.
The extremely small population of patients with MPS VII globally necessitated the enrolment of all patients able to participate in this clinical trial, resulting in a highly variable group.
Ker je populacija bolnikov z MPS VII po vsem svetu izjemno majhna, je bilo treba v to klinično preskušanje sprejeti vse bolnike, ki so bili zmožni sodelovati; to je povzročilo visoko variabilno skupino.
Patients should be informed of the signs and symptoms of hypersensitivity reactions and instructed to seek immediate medical care should such signs and symptoms occur.
Bolnike seznanite z znaki in simptomi preobčutljivostnih reakcij in jim naročite, naj ob morebitnem pojavu takšnih znakov in simptomov takoj poiščejo zdravniško pomoč.
What you need to know before you are given Mepsevii 3.
Kaj morate vedeti, preden boste dobili zdravilo Mepsevii 3.
Total Infusion Volume (infused over 4 hours) (mL)
Celotni volumen infuzije (infundiran v 4 urah) (ml)
If you have an infusion reaction, tell your doctor straight away.
Če imate infuzijsko reakcijo, o tem takoj obvestite svojega zdravnika.
Do not infuse Mepsevii with other medicinal products in the infusion tubing.
Ne mešajte zdravila Mepsevii z drugimi zdravili v istih infuzijskih cevkah.
The effects of treatment with vestronidase alfa should be periodically evaluated and discontinuation of treatment should be considered in cases where clear benefits (including stabilisation of disease manifestations) are not observed.
Učinke zdravljenja z vestronidazo alfa je treba občasno oceniti in razmisliti o prekinitvi zdravljenja v primerih, ko ni videti jasnih koristi (vključno s stabilizacijo manifestacij bolezni).
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnje sprejetih posodobitvah RMP.
The safety and efficacy of vestronidase alfa in patients older than 65 years have not been established.
Varnost in učinkovitost vestronidaze alfa pri bolnikih, starejših od 65 let, nista dokazani.
It is not known whether Mepsevii passes into breast milk, but transfer of the medication to your baby is not expected.
Ni znano, ali zdravilo Mepsevii prehaja v materino mleko, vendar ni pričakovati, da se bo zdravilo preneslo na vašega otroka.
In order to obtain long-term data on effectiveness and safety of treatment with Mepsevii and to characterize the entire mucopolysaccharidosis VII, including variability of clinical manifestation, progression and natural history, the MAH is requested to submit the results of a study based on adequate source of data deriving from a Disease Monitoring Program of patients with mucopolysaccharidosis VII.
Za pridobitev dolgoročnih podatkov o učinkovitosti in varnosti zdravljenja z zdravilom Mepsevii in za določitev značilnosti celotne mukopolisaharidoze tipa VII, vključno z razlikami v klinični izraženosti, napredovanju in naravni zgodovini, mora imetnik z dovoljenjem za promet predložiti rezultate študije na podlagi ustreznih virov podatkov, pridobljenih iz programa spremljanja bolezni pri bolnikih z mukopolisaharidozo tipa VII.
These side effects are called infusion reactions because they are caused by the infusion (drip) of the medicine.
Ti neželeni učinki se imenujejo »infuzijske reakcije«, ker jih povzroča infuzija zdravila.
Each vial of Mepsevii is intended for single use only.
Vsaka viala zdravila Mepsevii je samo za enkratno uporabo.
**One adverse reaction of Peripheral swelling is included within the frequency of Infusion site swelling as the event is classified as intravenous catheter issue.
** Neželeni učinek »periferna oteklina« je vključen v pogostnost »otekline na mestu infundiranja«, ker je dogodek razvrščen med težave, povezane z intravenskim katetrom.
What Mepsevii is and what it is used for 2.
Kaj je zdravilo Mepsevii in za kaj ga uporabljamo 2.
- If you have an allergic reaction during your infusion your doctor may slow down, or stop your infusion.
- Če se med infundiranjem pri vas pojavi alergijska reakcija, lahko zdravnik upočasni ali ustavi infuzijo.
For each vial dosed, including the corresponding diluent volume, the sodium intake is 35.5 mg sodium.
Pri vsaki odmerjeni viali, vključno z ustreznim volumnom razredčila, je vnos natrija 35,5 mg.
- The recommended dose is 4 mg for each kg of body weight.
- Priporočeni odmerek je 4 mg na vsak kg telesne mase.
Administration of vestronidase alfa should be carried out by an appropriately trained healthcare professional with the ability to manage medical emergencies.
Vestronidazo alfa smejo dajati samo ustrezno usposobljeni zdravstveni delavci z zmožnostjo obvladovanja nujnih zdravstvenih primerov.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB18
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi; oznaka ATC: A16AB18
The dose you will receive is based on how much you weigh.
Odmerek, ki ga boste dobili, bo izračunan na podlagi vaše telesne mase.
You will not be given Mepsevii if you are pregnant unless treatment is clearly necessary.
Če ste noseči, ne boste dobili zdravila Mepsevii, razen če je zdravljenje nedvomno nujno.
Treatment should be supervised by a healthcare professional experienced in the management of patients with MPS VII or other inherited metabolic disorders.
Zdravljenje mora nadzorovati zdravnik z izkušnjami z zdravljenjem bolnikov z MPS VII ali drugimi dednimi presnovnimi boleznimi.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
(od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).