natgillin/translations-raw huggingface dataset:
Growth should be monitored in paediatric and adolescent patients during treatment with Miglustat Gen.Orph; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Med zdravljenjem z zdravilom Miglustat Gen.Orph je treba spremljati rast pediatričnih bolnikov in mladostnikov; razmerje med koristmi in tveganji je treba ponovno oceniti posamično za vsakega bolnika pred nadaljevanjem zdravljenja.
Common effects may affect up to 1 in 10 people.
Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov.
NAME OF THE MARKETING AUTHORISATION HOLDER Gen.Orph (logo)
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Gen.Orph (logo)
Miglustat Gen.Orph works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Zdravilo Miglustat Gen.Orph deluje tako, da zavira delovanje encima, ki se imenuje 'glukozilceramid sintaza', ki je odgovoren za prvi korak sinteze večine glikosfingolipidov.
Miglustat Gen.Orph should not be taken during breast-feeding.
Zdravilo Miglustat Gen.Orph se ne sme jemati v času dojenja.
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Tremor
What Miglustat Gen.Orph is and what it is used for
Kaj je zdravilo Miglustat Gen.Orph in za kaj ga uporabljamo
There was no drug-related increase in tumor incidence in male or female rats in any other organ.
Drugih z zdravilom povezanih povišanj incidenc tumorjev katerega koli drugega organa pri samcih ali samicah podgan ni bilo.
The benefit of treatment with Miglustat Gen.Orph for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with Miglustat Gen.Orph.
Koristi zdravljenja z zdravilom Miglustat Gen.Orph pri nevroloških manifestacijah pri bolnikih z Niemann- Pickovo boleznijo tipa C je treba redno preverjati, npr. vsakih 6 mesecev; za nadaljevanje terapije se je treba ponovno odločiti po vsaj 1-letnem zdravljenju z zdravilom Miglustat Gen.Orph.
Miglustat Gen.Orph is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Miglustat Gen.Orph se jemlje le, kadar bolnik za encimsko nadomestno zdravljenje ni primeren.
What Miglustat Gen.Orph contains - The active substance is miglustat 100 mg. - The other ingredients are sodium starch glycolate (type A), povidone (K30), magnesium stearate, gelatin, titanium dioxide (E171).
- Druge sestavine zdravila so natrijev karboksimetilškrob (tip A), povidon (K30), magnezijev stearat, želatina, titanov dioksid (E171).
Miglustat Gen.Orph is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Zdravilo Miglustat Gen.Orph je indicirano za zdravljenje progresivne nevrološke manifestacije pri odraslih bolnikih in pediatričnih bolnikih z Niemann-Pickovo boleznijo vrste C (glejte poglavji 4.4, in
INFORMATION IN BRAILLE Miglustat Gen.Orph
PODATKI V BRAILLOVI PISAVI Miglustat Gen.Orph
The benefit to the patient of treatment with Miglustat Gen.Orph should be evaluated on a regular basis (see section 4.4).
Koristi zdravljenja z zdravilom Miglustat Gen.Orph je treba pri bolnikih redno preverjati (glejte poglavje 4.4).
Miglustat Gen.Orph contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Zdravilo Miglustat Gen.Orph vsebuje učinkovino miglustat, ki spada v skupino zdravil, ki vplivajo na presnovo.
Studies in the rat have shown that miglustat adversely affects sperm parameters (motility and morphology) thereby reducing fertility (see sections 4.4 and 5.3).
Plodnost Študije na podganah so pokazale, da miglustat negativno vpliva na parametre spermijev (gibljivost in obliko), s čimer zmanjša plodnost (glejte poglavji 4.4 in 5.3).
The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.
Najbolj pogosti neželeni učinki so driska, flatulenca (vetrovi), bolečine v trebuhu, izguba telesne mase in zmanjšanje apetita.
Other possible side effects are muscular spasms or weakness, fatigue, chills and malaise, depression, difficulty sleeping, forgetfulness and less libido.
Drugi možni neželeni učinki so mišični krči ali slabost, utrujenost, mrzlice in splošno slabo počutje,
The benefit of treatment with Miglustat Gen.Orph for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with Miglustat Gen.Orph, (see section 4.4).
Koristi zdravljenja z zdravilom Miglustat Gen.Orph pri nevroloških manifestacijah pri bolnikih z Niemann- Pickovo boleznijo tipa C je treba redno preverjati, npr. vsakih 6 mesecev; za nadaljevanje terapije se je treba ponovno odločiti po vsaj 1-letnem zdravljenju z zdravilom Miglustat Gen.Orph (glejte poglavje 4.4).
If you stop taking Miglustat Gen.Orph
Če ste prenehali jemati zdravilo Miglustat Gen.Orph
Male patients should maintain reliable contraceptive methods while taking Miglustat Gen.Orph (see sections 4.4 and 5.3).
Moški morajo ves čas uporabe zdravila Miglustat Gen.Orph uporabljati zanesljiv način kontracepcije (glejte poglavji 4.4 in 5.3).
The pharmacokinetics of miglustat is similar in adult type 1 Gaucher disease patients and NiemannPick type C disease patients when compared to healthy subjects.
Farmakokinetika miglustata je podobna pri odraslih bolnikih z Gaucherjevo boleznijo tipa 1 in bolenikih z Niemann-Pickovo boleznijo tipa C, primerjano pri odraslih osebah.
Talk to your doctor or pharmacist before taking Miglustat Gen.Orph if you suffer from kidney disease if you suffer from liver disease
Pred začetkom jemanja zdravila Miglustat Gen.Orph se posvetujte z zdravnikom ali farmacevtom če imate ledvično bolezen če imate jetrno bolezen.
Other medicines and Miglustat Gen.Orph
Druga zdravila in zdravilo Miglustat Gen.Orph
Due to limited experience, Miglustat Gen.Orph should be used with caution in patients with renal or hepatic impairment.
Posebne populacije Zaradi malo izkušenj moramo zdravilo Miglustat Gen.Orph pri bolnikih z okvarjenim delovanjem ledvic ali jeter uporabljati previdno.
Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of miglustat having an efficacy or safety advantage over ERT. ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
niso bile opravljene, ni dokazov, da bi bil miglustat učinkovitejši ali varnejši kot ERT. ERT je standardna oskrba za bolnike, ki potrebujejo zdravljenje Gaucherjeve bolezni tipa 1 (glejte poglavje
Miglustat Gen.Orph is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Zdravilo Miglustat Gen.Orph je indicirano za peroralno zdravljenje odraslih bolnikov z blago do zmerno obliko Gaucherjeve bolezni tipa 1.
If you do lose some weight when you start treatment with Miglustat Gen.Orph don't worry.
Če po začetku zdravljenja z zdravilom Miglustat Gen.Orph izgubite nekaj telesne mase, to ni razlog za zaskrbljenost.
Hepatic impairment Miglustat Gen.Orph has not been evaluated in patients with hepatic impairment.
Okvarjeno delovanje jeter Zdravila Miglustat Gen.Orph pri bolnikih z okvarjenim delovanjem jeter niso ovrednotili.
Until further information is available, it is advised that before seeking to conceive, male patients should cease Miglustat Gen.Orph and maintain reliable contraceptive methods for 3 months thereafter.
Dokler ne bo na voljo več informacij, je treba moškim svetovati, da pred poskusi zaploditve prenehajo uporabljati zdravilo Miglustat Gen.Orph in še 3 mesece potem uporabljajo zanesljivo metodo kontracepcije.
Miglustat Gen.Orph 100 mg hard capsules miglustat
Miglustat Gen.Orph 100 mg trde kapsule miglustat
• Miglustat Gen.Orph is used to treat mild to moderate type 1 Gaucher disease in adults.
• Zdravilo Miglustat Gen.Orph se uporablja za zdravljenje blage do zmerne Gaucherjeve bolezni tipa 1 pri odraslih.
Your doctor will perform the following tests before treatment and during treatment with Miglustat Gen.Orph: - an examination to check the nerves in your arms and legs - measurement of vitamin B12 levels - monitoring growth if you are a child or adolescent with Niemann-Pick type C disease - monitoring of blood platelet counts
Pred in med zdravljenjem z zdravilom Miglustat Gen.Orph bo vaš zdravnik opravil naslednje preiskave: pregled živcev v vaših rokah in nogah meritev ravni vitamina B12
There is limited experience with the use of Miglustat Gen.Orph in Niemann-Pick type C disease patients under the age of 4 years.
Izkušenj z zdravljenjem z zdravilom Miglustat Gen.Orph pri bolnikih z Niemann-Pickovo boleznijo tipa C, starih pod 4 leta, je malo.
Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas, cataracts, nephropathy and myocardial changes in rats.
spremembe v limfoidnih organih pri vseh testiranih vrstah, spremembe vrednosti transaminaz, vakuolizacija ščitnice in trebušne slinavke, katarakte, nefropatija ter spremembe miokarda pri podganah.
Sometimes your doctor will need to reduce the dose or stop Miglustat Gen.Orph treatment to stop the tremor.
Lahko se zgodi, da bo moral vaš zdravnik, da bi odpravil tremor, znižati vaš odmerek zdravila Miglustat Gen.Orph ali prekiniti zdravljenje z njim.
Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d.
Manifestacije Gaucherjeve bolezni tipa 1 na kosteh so bile ocenjene v 3 odprtih kliničnih študijah pri bolnikih, zdravljenih z miglustatom 100 mg trikrat dnevno do 2 leti (n = 72).
NAME OF THE MEDICINAL PRODUCT Miglustat Gen.Orph 100 mg hard capsules
IME ZDRAVILA Miglustat Gen.Orph 100 mg trde kapsule
Elderly There is no experience with the use of Miglustat Gen.Orph in patients over the age of 70.
Ni izkušenj z zdravljenjem bolnikov, starih več kot 70 let, z zdravilom Miglustat Gen.Orph.
How to store Miglustat Gen.Orph 6.
Shranjevanje zdravila Miglustat Gen.Orph 6.
The tremor often disappears without needing to stop the treatment.
Tremor pogosto izgine brez potrebe prekinitve zdravljenja z zdravilom Miglustat Gen.Orph.
Miglustat Gen.Orph may make you feel dizzy.
Zaradi zdravila Miglustat Gen.Orph ste lahko omotični.
Miglustat Gen.Orph 100 mg hard capsules are white opaque cap and body, hard gelatin capsules size 4 of 14.0 mm length.
Izgled zdravila Miglustat Gen.Orph in vsebina pakiranja Miglustat Gen.Orph 100 mg trde kapsule so trde želatinske kapsule z neprozornima belima pokrovčkom in telesom, velikosti 4, dolžine 14,0 mm.
What you need to know before you take Miglustat Gen.Orph Do not take Miglustat Gen.Orph - if you are allergic to miglustat or any of the other ingredients of this medicine
Kaj morate vedeti, preden boste vzeli zdravilo Miglustat Gen.Orph Ne jemljite zdravila Miglustat Gen.Orph:
The efficacy of Miglustat Gen.Orph in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Pediatrična populacija Učinkovitost zdravila Miglustat Gen.Orph pri otrocih in mladostnikih, starih od 0 do 17 let, z
Male patients should maintain reliable contraceptive methods while taking Miglustat Gen.Orph.
Učinek na spermatogenezo Bolniki moškega spola naj v času jemanja zdravila Miglustat Gen.Orph uporabljajo zanesljive kontracepcijske metode.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg miglustat
Ena kapsula vsebuje 100 mg miglustata.
White opaque cap and body, hard gelatin capsules size 4 of about 14.0 mm length.
Trde želatinske kapsule z neprozornima belima pokrovčkom in telesom, velikosti 4, dolžine približno
If you get a slight tremor, usually trembling hands, seek medical advice from your doctor as soon as possible.
Če med zdravljenjem z zdravilom Miglustat Gen.Orph izkusite blag tremor, običajno tresenje rok, to čim prej sporočite zdravniku.
Male patients should use reliable birth control methods during their treatment with Miglustat Gen.Orph, and for 3 months after finishing treatment.
Moški bolniki morajo med jemanjem zdravila Miglustat Gen.Orph in 3 mesece po končanju zdravljenja uporabljati zanesljivo obliko kontracepcije.
How to take Miglustat Gen.Orph
Kako jemati zdravilo Miglustat Gen.Orph
Marketing Authorisation Holder Gen.Orph
Imetnik dovoljenja za promet z zdravilom Gen.Orph
Symptoms
Zdravilo
Do not breastfeed while you are taking Miglustat Gen.Orph.
V času jemanja zdravila Miglustat Gen.Orph ne smete dojiti.
Miglustat has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.
To je povzročilo zmanjšanje števila belih krvničk in druge neželene učinke, ki so bili podobni opisanim v poglavju 4.
How to store Miglustat Gen.Orph
Shranjevanje zdravila Miglustat Gen.Orph
He or she may reduce the dose of Miglustat Gen.Orph or recommend other medicines to help control side effects.
Kadar neželeni učinki povzročajo skrbi ali neprijetnosti, se posvetujte s svojim zdravnikom, ki vam bo morda znižal odmerek zdravila Miglustat Gen.Orph ali, za nadzor nad neželenimi učinki, priporočil druga zdravila.
in type 1 Gaucher disease patients, consistent with the doselinear pharmacokinetics of miglustat.
ki so bile približno dvakratne od tistih, pridobljenih po odmerku 100 mg trikrat dnevno pri bolnikih z Gaucherjevo boleznijo tipa 1, kar je skladno z farmakokinetiko miglustata, linearno z odmerkom.
adjusted for body surface area resulted in Cmax and AUCτ values which were approximately twofold those attained after 100 mg t.i.d.
200 mg trikrat dnevno pri otrocih, prilagojeno na površino telesa, je povzročilo vrednosti Cmax in AUCτ,
Tremor
Dojenje
Of these patients, 132 had type 1 Gaucher disease, and 40 had Niemann-Pick type C disease.
132 Gaucherjevo bolezen tipa 1 in 40 Niemann-Pickovo bolezen tipa C. Neželeni učinki so bili v glavnem blagi do zmerni in so se pojavljali s podobno pogostnostjo za vse preskušane indikacije in odmerke.
You must use effective birth control while taking Miglustat Gen.Orph.
V času jemanja zdravila Miglustat Gen.Orph morate uporabljati učinkovite metode preprečitve zanositve.
• There is insufficient data on Binocrit to know the size of any increased immunogenicity risk with sc use
• Podatkov o zdravilu Binocrit je premalo, da bi vedeli, za koliko se poveča tveganje za pojav imunogenosti pri subkutani uporabi zdravila.
Adopted at the 5-8 March 2018 PRAC
Sprejeto na seji odbora PRAC med 5. in 8. marcem 2018
Most of these reactions occurred most likely in the first week during treatment.
Večina teh reakcij se je najverjetneje pojavila v prvem tednu zdravljenja.
The highest risk for occurrence of this serious skin reaction is within the first week of treatment.
Največje tveganje za pojav te hude kožne reakcije je v prvem tednu zdravljenja.
What do you need to know before you use cefalexin
Kaj morate vedeti, preden boste vzeli cefaleksin
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
V času, ko je bolnikom zdravilo predpisano, jim je treba svetovati glede znakov in simptomov ter jih skrbno spremljati glede kožnih reakcij.
Warnings and precautions - Take special care with cefalexin:
Opozorila in previdnostni ukrepi - Pri uporabi cefaleksina bodite posebno previdni:
The most common location: mainly localized on the skin folds, trunk, and upper extremities.
Najpogostejše mesto: v glavnem se pojavlja v kožnih gubah, na trupu in zgornjih okončinah.
Frequency ‘not known': Stress cardiomyopathy
Pogostnost neznana: stresna kardiomiopatija
AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever.
AGEP se pojavi na začetku zdravljenja v obliki rdečega, luskastega razširjenega izpuščaja s podkožnimi bulicami in mehurji, ki jih spremlja povišana telesna temperatura.
Cefalexin - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 18911)
Cefaleksin - akutna generalizirana eksantemska pustuloza (AGEP)(št. EPITT 18911)
Skin and subcutaneous tissue disorders (frequency: not known) Acute generalised exanthematous pustulosis (AGEP)
Bolezni kože in podkožja (pogostnost: neznana) akutna generalizirana eksantemska pustuloza (AGEP)
If signs and symptoms suggestive of these reactions appear, cefalexin should be withdrawn immediately and an alternative treatment considered.
Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravljenje s cefaleksinom takoj prekiniti in razmisliti o drugi vrsti zdravljenja.
A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
Pogostnost neznana: rdeč, luskast razširjen izpuščaj s podkožnimi bulicami in mehurji, ki jih spremlja povišana telesna temperatura, na začetku zdravljenja (akutna generalizirana eksantemska pustuloza).
If you develop a serious rash or another of these skin symptoms, stop taking cefalexin and contact your doctor or seek medical attention immediately.
Če se je pri vas pojavil hud izpuščaj ali eden od teh kožnih simptomov, prenehajte z jemanjem cefaleksina in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefalexin or other antibacterials
• če so se vam po jemanju cefaleksina ali drugih antibiotikov kdaj pojavili hudi kožni izpuščaji ali luščenje kože, mehurji na koži in/ali razjede v ustih.
TELL YOUR DOCTOR BEFORE TAKING CEFALEXIN:
PRED ZAČETKOM JEMANJA CEFALEKSINA ZDRAVNIKA OBVESTITE:
Stop using cefalexin if you develop these symptoms and contact your doctor or seek medical attention immediately.
Če se pri vas pojavijo ti simptomi, prenehajte jemati cefaleksin in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
Norepinephrine - Stress cardiomyopathy (EPITT no
Noradrenalin - stresna kardiomiopatija (št. EPITT 19172)
Undesirable effects Cardiac disorders
Srčne bolezni
Acute generalised exanthematous pustulosis (AGEP) has been reported with the use of cefalexin.
V povezavi z uporabo cefaleksina so poročali o akutni generalizirani eksantemski pustulozi (AGEP).
Acute generalised exanthematous pustulosis (AGEP) has been reported in association with cefalexin treatment.
V povezavi z zdravljenjem s cefaleksinom so poročali o akutni generalizirani eksantemski pustulozi (AGEP).
Frequency not known:
Preglednica neželenih učinkov:
The date for last use corresponds to the last day of the month mentioned.
Datum zadnje uporabe ustreza zadnjemu dnevu navedenega meseca.
The cough may last for 1-2 months or longer.
Kašelj lahko traja 1 - 2 meseca ali dlje.
Most adults fully recover from the disease.
Večina odraslih popolnoma ozdravi.
(<1/10,000) including isolated reports
(<1/10.000), vključno s posameznimi primeri
1 Vial: Suspension
1 viala: suspenzija
It occasionally causes death by suffocation.
Občasno pride do smrti zaradi zadušitve.
The vaccine should never be given into a vein.
Cepiva se ne sme nikoli dati v žilo.
• Collapse (floppiness) or periods of unconsciousness or lack of awareness
• kolaps (ohlapnost) ali obdobja nezavesti ali pomanjkanja zavesti
Such reactions may occur before leaving the doctor's surgery.
Takšne reakcije se lahko pojavijo še preden zapustite ordinacijo.
- This medicine has been prescribed for your child and should not be passed on to others.
- To cepivo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
Official batch release: in accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: v skladu s členom 114 Direktive 2001/83/ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
The 3-5-12 month schedule was not evaluated.
Shema 3., 5., 12. mesec ni bila ovrednotena.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Vsako neuporabljeno cepivo ali odpadni material je potrebno zavreči v skladu z lokalnimi predpisi.
For this reason, the vaccinee should remain under medical supervision for at least 30 minutes.
Zaradi tega mora biti otrok po cepljenju še vsaj 30 minut pod zdravniškim nadzorom.
The reconstituted vaccine is a homogeneous turbid white suspension.
Rekonstituirano cepivo je homogena motna bela suspenzija.
• if your child has a severe infection with a high temperature (over 38°C).
• če ima vaš otrok hudo okužbo z zvišano telesno temperaturo (nad 38 ºC).
In these cases, the vaccination will be postponed until your child has recovered.
V takšnih primerih se bo cepljenje odložilo dokler vaš otrok ne bo ozdravel.
Frequencies are reported as: Very common:
Pogostnost je prikazana kot: Zelo pogosti:
Signs of the disease may not be seen for 6 weeks to 6 months after infection.
Bolezenski znaki se lahko pojavijo šele 6 tednov do 6 mesecev po okužbi.
However the stability has been demonstrated for 8 hours at 25°C after reconstitution.
Po rekonstituciji je bila sicer dokazana 8-urna stabilnost pri temperaturi 25 ºC.
HIB infection also causes inflammation of the throat.
Okužba s HIB povzroči tudi vnetje grla.
The vaccine works by causing the body to produce its own protection (antibodies) against these infectious diseases.
Cepivo deluje tako, da v telesu spodbudi ustvarjanje lastne zaščite (protiteles) proti tem nalezljivim boleznim.
Other tests should be performed in order to confirm HIB infection during this period.
V tem času je za potrditev okužbe s HIB potrebno uporabiti druge teste.
In the following cases, your doctor can determine the right time and scheme of vaccination for your child. Tell your doctor:
V naslednjih primerih lahko vaš zdravnik določi ustrezen čas in shemo cepljenja za vašega otroka.
However, you should seek immediate treatment in any event.
V katerem koli primeru morate nemudoma poiskati zdravniško pomoč.
4.7 Effects on ability to drive and use machines Not relevant.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Navedba smiselno ni potrebna.
If your child misses the visit scheduled for the second or third injection, talk to your doctor and arrange another visit as soon as possible.
Če vaš otrok ni prejel drugega ali tretjega odmerka po načrtovani shemi, se pogovorite z zdravnikom in dogovorite za drug obisk takoj, ko je to možno.
• Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause.
• Zvišana telesna temperatura ≥ 40,0 ºC v 48 urah, ki ji ni možno pripisati drugega vzroka.
• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
• Kolaps ali šoku podobno stanje (hipotonična-hiporesponzivna epizoda) v 48 urah.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
But some people, particularly children, who may not have shown signs of the disease can remain infected.
Vendar pa posamezniki, predvsem otroci, lahko ne kažejo bolezenskih znakov, ostanejo pa okuženi.
Adverse reactions are listed below.
Neželene reakcije so navedene v nadaljevanju.
• if your child is taking any other medicine or has recently received any other vaccine.
• če vaš otrok dobiva katero koli drugo zdravilo ali pa je pred kratkim prejel katero koli drugo cepivo.
You will be informed by the doctor or nurse when you should come back for subsequent injections.
Zdravnik ali sestra vam bosta naročila, kdaj morate priti po naslednje odmerke.
• Induration (hard lump)
• induracija (čvrsta oteklina)