natgillin/translations-raw huggingface dataset:
The excretion of Twinrix Paediatric in milk has not been studied in animals.
Študije izločanja cepiva Twinrix za otroke v mleko pri živalih niso bile izvedene.
Swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise, fever (≥ 37.5°C)
utrujenost, občutek slabosti, zvišana telesna temperatura (≥ 37.5°C)
However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres.
ali hepatitisu B aplicirani sočasno s specifičnimi imunoglobulini, ni bilo opaziti vpliva na serokonverzijo, čeprav so titri protiteles lahko nižji.
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Virus hepatitisa B je prisoten v telesnih tekočinah, kot so kri, sperma, vaginalni izločki ali slina (izpljunek)
Twinrix Paediatric is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Twinrix za otroke je kombinirano cepivo, pripravljeno iz posameznih pripravkov prečiščenega, inaktiviranega virusa hepatitisa A (HA) in prečiščenega površinskega antigena virusa hepatitisa B (HBsAg), ki sta ločeno adsorbirana na aluminijev hidroksid in aluminijev fosfat.
• Diarrhoea, vomiting, stomach pain
• driska, bruhanje, bolečine v trebuhu,
It is unknown whether Twinrix Paediatric is excreted in human breast milk.
Ni znano, če se cepivo Twinrix za otroke izloča v materino mleko.
Twinrix Paediatric confers immunity against HAV and HBV infection by inducing specific anti-HA and anti-HBs antibodies.
Twinrix za otroke omogoča imunost proti virusu hepatitisa A in hepatitisa B z indukcijo specifičnih anti-HAV in anti-HBs protiteles.
• Swelling or infection of the brain (encephalitis)
• oteklost ali okužba možganov (encefalitis);
Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens.
Med uporabo cepiva Twinrix za otroke hkrati s cepivom Cervarix (cepivo proti HPV) ni bilo klinično pomembnih medsebojnih vplivov na odziv protiteles proti antigenoma HPV in hepatitisa A.
Twinrix Paediatric can be given with a Human Papillomavirus (HPV) vaccine at a separate injection site (another part of your body, e.g. the other arm) during the same visit.
Cepivo Twinrix za otroke je mogoče dati na istem pregledu kot cepivo proti humanemu papilomavirusu (HPV), vendar mesto injiciranja mora biti drugo (drug del telesa, npr. druga roka).
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in pre-filled syringe 1 pre-filled syringe
FARMACEVTSKA OBLIKA IN VSEBINA Suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga 1 odmerek (0,5 ml)
Other medicines and Twinrix Paediatric
Druga zdravila in cepivo Twinrix za otroke
Alternatively, subjects primed with Twinrix Paediatric may be administered a booster dose of either of the monovalent vaccines.
Osebe, cepljene s cepivom Twinrix za otroke, lahko prejmejo obnovitveni odmerek posameznega monovalentnega cepiva.
Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the adult formulation
*se nanaša na splošne reakcije, ki se lahko pojavijo v kliničnih preskusih z cepivom za odrasle
Twinrix Paediatric can be given concomitantly with Human Papillomavirus (HPV) vaccine.
Cepivo Twinrix za otroke je mogoče uporabiti sočasno s cepivom proti humanemu papilomavirusu
Twinrix Paediatric contains neomycin Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
Obvestite zdravnika, če ste kdaj imeli alergijsko reakcijo na neomicin (antibiotik).
Only the concomitant administration of Twinrix Paediatric with Cervarix has been specifically studied.
Posebej je bila raziskana samo sočasna uporaba cepiva Twinrix za otroke s cepivom Cervarix.
• Abnormal laboratory liver test results
• nenormalne vrednosti preiskav jetrne funkcije;
• Aching muscles
• boleče mišice,
It is advised that vaccines other than Cervarix should not be administered at the same time as Twinrix Paediatric.
Drugih cepiv ni priporočljivo uporabljati sočasno s cepivom Twinrix za otroke.
• Numbness or weakness of the arms and legs (neuropathy), paralysis
• otrplost ali šibkost rok in nog (nevropatija), paraliza;
Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus.
6 tednov po stiku z virusom.
• Joint swelling, muscular weakness
• oteklost sklepov, mišična oslabelost;
Talk to you doctor or pharmacist before you receive Twinrix Paediatric if:
Preden prejmete cepivo Twinrix za otroke se posvetujte z zdravnikom ali farmacevtom, če:
Specific humoral antibodies against hepatitis B were observed in approximately 67% of the subjects after the first dose and 100% after the third dose.
Specifična humoralna protitelesa proti hepatitisu B so bila opažena pri 67 %
• Multiple sclerosis, swelling of the spinal cord (myelitis)
• multipla skleroza, oteklost hrbtenjače (mielitis);
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Twinrix za otroke se lahko izjemoma aplicira podkožno pri osebah s trombocitopenijo ali motnjami strjevanja krvi.
• Fits or seizures
• krči ali napadi krčev;
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, težave z dihanjem (zasoplost)
In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric can be given.
V okoliščinah, ko je zaželen obnovitveni odmerek proti hepatitisu A in tudi proti hepatitisu B, se lahko uporabi cepivo Twinrix za otroke.
• Fever equal to or greater than 37.5°C
• zvišana telesna temperatura do 37.5°C ali višja, • razdražljivost.
At 10 years following the initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged
Deset let po začetku cepljenja otrok, starih od 12 do 15 let, s cepivom Twinrix za otroke po shemi 0.,
PHARMACEUTICAL FORM Suspension for injection.
FARMACEVTSKA OBLIKA Suspenzija za injiciranje Motna bela suspenzija
• Drowsiness, headache
• zaspanost, glavobol,
Uncommon Upper respiratory tract infection*
Infekcijske in parazitske bolezni občasni okužba zgornjih dihalnih poti *
Twinrix Paediatric is a white, slightly milky liquid presented in a glass pre-filled syringe (0.5 ml).
Cepivo Twinrix za otroke je bela, rahlo mlečna tekočina v stekleni napolnjeni injekcijski brizgi
(meningitis)
(zlatenica).
Urticaria, pruritus*
• koprivnica, srbečica,
Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix.
Twinrix za otroke ali posameznim cepivom proti hepatitisu A in hepatitisu B ali s cepivom Twinrix za odrasle.
The effect of Twinrix Paediatric on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials.
V kliničnih preskušanjih vpliva cepiva Twinrix za otroke na embriofetalno, perinatalno in postnatalno preživetje ter razvoj prospektivno niso ovrednotili.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Twinrix Paediatric, suspension for injection
IME ZDRAVILA IN POT(I) UPORABE Twinrix za otroke, suspenzija za injiciranje HAB cepivo i.m.
Hypotension*
redki artralgija*
Side effects that may occur are the following:
- Zdravilni učinkovini sta:
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Zelo redki (ki se lahko pojavijo pri največ 1 od 10.000 odmerkov cepiva):
How to store Twinrix Paediatric
Kako uporabljati cepivo Twinrix za otroke
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
4.4 Posebna opozorila in previdnostni ukrepi Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa (omedlevica), zlasti pri mladostnikih,
What you need to know before you receive Twinrix Paediatric
Kaj morate vedeti, preden boste prejeli cepivo Twinrix za otroke Cepiva Twinrix za otroke ne smete prejeti, če:
Uncommon Myalgia* Rare
Žilne bolezni redki hipotenzija*
Irritability
Pogostnost
Very common Pain and redness at the injection site Common
Splošne težave in spremembe na mestu aplikacije takojšnja bolečina na mestu vboda
10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 napolnjenih injekcijskih brizg + 20 igel 10 x 1 odmerek (0,5 ml)
At 5 years following initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged 1-11
Pet let po začetku cepljenja otrok, starih od 1 do 11 let, s cepivom Twinrix za otroke po shemi 0., 1., 6. mesec so se protitelesa anti-HAV vsem spremljanim preiskovancem ohranila na ≥ 15 mIE/ml in 97 %
No data on concomitant administration of Twinrix Paediatric with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Ni zbranih podatkov o sočasni aplikaciji cepiva Twinrix za otroke in specifičnih imunoglobulinov proti hepatitisu A ali hepatitisu B. Vsekakor pa, kadar sta bili monovalentni cepivi proti hepatitisu A
Frequency Adverse reactions
- Obnovitveni odmerek
1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
1 napolnjena injekcijska brizga + 1 igla 1 odmerek (0,5 ml)
Twinrix Paediatric, Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Twinrix za otroke - suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Redki (ki se lahko pojavijo pri največ 1 od 1000 odmerkov cepiva):
50 x 1 dose (0.5 ml)
50 napolnjenih injekcijskih brizg 50 x 1 odmerek (0,5 ml)
1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
1 napolnjena injekcijska brizga + 2 igli 1 odmerek (0,5 ml)
Contents of the pack and other information What Twinrix Paediatric contains - The active substances are: Hepatitis A virus (inactivated)1,2
1 odmerek (0,5 ml) vsebuje: Virus hepatitisa A (inaktivirani)1,2
The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age.
Za dojenčke, otroke in mladostnike stare od 1 leta do vključno 15 let je priporočljiv odmerek 0,5 ml
Cases of overdose have been reported during post-marketing surveillance.
4.9 Preveliko odmerjanje Med spremljanjem cepiva po pridobitvi dovoljenja za promet so poročali o primerih prevelikega odmerjanja.
It is not known whether Twinrix Paediatric will prevent HA and HB in such cases.
Obstaja možnost, da so osebe v času cepljenja v inkubacijski dobi za hepatitis A ali hepatitis B. Ni znano, če Twinrix za otroke v teh primerih prepreči bolezni.
10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
10 napolnjenih injekcijskih brizg + 10 igel 10 x 1 odmerek (0,5 ml)
Hypoaesthesia*, paraesthesia*, dizziness
Bolezni živčevja pogosti zaspanost, glavobol redki hipestezija*, parestezija*, omotica
• Dizziness
• izpuščaj,
NAME OF THE MEDICINAL PRODUCT Twinrix Paediatric - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Navodilo za uporabo Twinrix za otroke, suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Občasni (ki se lahko pojavijo pri največ 1 od 100 odmerkov cepiva):
Gastrointestinal symptoms, nausea Uncommon Diarrhoea, vomiting, abdominal pain
Bolezni prebavil pogosti gastrointestinalni simptomi, navzea.
Common (these may occur with up to 1 in 10 doses of the vaccine)
Pogosti (ki se lahko pojavijo pri največ 1 od 10 odmerkov cepiva):
- If you get / your child gets any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
10 x 1 dose (0.5 ml)
10 napolnjenih injekcijskih brizg 10 x 1 odmerek (0,5 ml)
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFATURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Uncommon Rash Rare
Pshiatrične motnje pogosti razdražljivost
years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 97% had anti-HBs antibody ≥10 mIU/ml.
jih je imelo protitelesa anti-HBs ≥ 10 mi.e./ml.
I.M.
(HPV).
The full EPAR for Zoledronic acid Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Actavis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Zoledronic acid Actavis.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Actavis.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Actavis on 20 April 2012.
Evropska komisija je dovoljenje za promet z zdravilom Zoledronska kislina Actavis, veljavno po vsej Evropski uniji, izdala 20. aprila 2012.
For more information about treatment with Zoledronic acid Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zoledronska kislina Actavis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
In addition, the company that markets Zoledronic acid Actavis will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
Poleg tega bo družba, ki trži zdravilo Zoledronska kislina Actavis, pripravila kartico, s katero bo bolnike seznanila s tveganji osteonekroze čeljustnice (poškodbe čeljustne kosti, ki lahko povzroči bolečine, oteklost v ustih ali majanje zob) in jih pozvala, naj v primeru pojava simptomov poiščejo zdravniško pomoč.
Because Zoledronic acid Actavis is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Zoledronska kislina Actavis generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Actavis, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
This means that Zoledronic acid Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Zometa.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Actavis.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Pri uporabi zdravila za preprečevanje z okostjem povezanih zapletov se infundiranje lahko ponovi vsake tri do štiri tedne, bolniki pa morajo prejemati tudi dodatek kalcija in vitamina D. Pri bolnikih s kostnimi metastazami (rakom, ki se je razširil na kost), ki imajo blage do zmerne težave z ledvicami, je priporočljiv manjši odmerek zdravila.
The usual dose of Zoledronic acid Actavis is one infusion of 4 mg over at least 15 minutes.
Običajni odmerek zdravila Zoledronska kislina Actavis je ena 4-miligramska infuzija v trajanju vsaj 15 minut.
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Actavis has been shown to be comparable to Zometa.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Zoledronska kislina Actavis primerljivo z zdravilom Zometa.
What measures are being taken to ensure the safe and effective use of Zoledronic acid Actavis?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zoledronska kislina Actavis?
A risk management plan has been developed to ensure that Zoledronic acid Actavis is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Zoledronska kislina Actavis je bil pripravljen načrt obvladovanja tveganj.
Zoledronic acid Actavis can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Zdravilo Zoledronska kislina Actavis se lahko uporablja za preprečevanje zapletov, povezanih z okostjem, pri odraslih z napredovalim rakom, ki vpliva na kosti.
Zoledronic acid Actavis is a medicine that contains the active substance zoledronic acid (4 mg).
Zoledronska kislina Actavis je zdravilo, ki vsebuje zdravilno učinkovino zoledronsko kislino (4 mg).
Zoledronic acid Actavis can also be used to treat the hypercalcaemia caused by tumours.
Zdravilo Zoledronska kislina Actavis se lahko uporablja tudi za zdravljenje hiperkalcemije, ki jo povzročajo tumorji.
What are the benefits and risks of Zoledronic acid Actavis?
Kakšne so koristi in tveganja, povezani z zdravilom Zoledronska kislina Actavis?
Zoledronic acid Actavis must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Zdravilo Zoledronska kislina Actavis smejo uporabljati le zdravniki z izkušnjami z uporabo te vrste zdravil za intravensko uporabo.
The Committee recommended that Zoledronic acid Actavis be given marketing authorisation.
Priporočil je, da se za zdravilo Zoledronska kislina Actavis izda dovoljenje za promet.
Zoledronic acid Actavis is a ‘generic medicine'.
Zdravilo Zoledronska kislina Actavis je „generično zdravilo“.
By preventing the breakdown of bones, Zoledronic acid Actavis also helps to reduce the amount of calcium released into the blood.
Zdravilo Zoledronska kislina Actavis s preprečevanjem razgradnje kosti pripomore tudi k znižanju ravni kalcija, ki se sprosti v kri.
Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Zometa odtehtajo znana tveganja.
Other information about Zoledronic acid Actavis
Druge informacije o zdravilu Zoledronska kislina Actavis
Zoledronic acid Actavis zoledronic acid
Zoledronska kislina Actavis zoledronska kislina
The active substance in Zoledronic acid Actavis, zoledronic acid, is a bisphosphonate.
Zdravilna učinkovina zdravila Zoledronska kislina Actavis, zoledronska kislina, je difosfonat.
No additional studies were needed as Zoledronic acid Actavis is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Ker je zdravilo Zoledronska kislina Actavis generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Zometa, niso bile potrebne nobene dodatne študije.
Why has Zoledronic acid Actavis been approved?
Zakaj je bilo zdravilo Zoledronska kislina Actavis odobreno?
How has Zoledronic acid Actavis been studied?
Kako je bilo zdravilo Zoledronska kislina Actavis raziskano?
What is Zoledronic acid Actavis used for?
Za kaj se zdravilo Zoledronska kislina Actavis uporablja?
How is Zoledronic acid Actavis used?
Kako se zdravilo Zoledronska kislina Actavis uporablja?
What is Zoledronic acid Actavis?
Kaj je zdravilo Zoledronska kislina Actavis?
How does Zoledronic acid Actavis work?
Kako zdravilo Zoledronska kislina Actavis deluje?
It is particularly important that you mention any of the following medicines.
Zlasti je pomembno, da omenite katero koli izmed naslednjih zdravil.
if you are pregnant.
- če ste noseči.
In men, no data are available.
Podatki za moške niso na voljo.
Do not give this medicine to children and adolescents from birth up to age of 18 years as safety and efficacy in children and adolescents have not been established.
Ne dajajte tega zdravila otrokom in mladostnikom od rojstva do 18. leta starosti, saj varnost in učinkovitost pri otrocih in mladostnikih nista bili dokazani.
Distribution into testes is relatively low.
Distribucija v testise je relativno nizka.
Time to recovery
Čas do okrevanja
The dosage of the medicine will be adjusted in accordance with the results of these tests.
Odmerek zdravila se prilagodi v skladu z rezultati teh testov.
Therefore you should talk to your doctor if you are planning to become pregnant in the future; your eggs may need to be frozen.
Zato morate pogovoriti s svojim zdravnikom, če nameravate zanositi v prihodnosti; morda bo treba vaša jajčeca zamrzniti.
The usual dose is:
Običajni odmerek:
Plasma concentrations decrease rapidly during the first two hours and slowly thereafter.
Plazemske koncentracije se hitro zmanjšujejo v prvih dveh urah, potem pa se zmanjšujejo počasi.
Contraception in men and women
Kontracepcija pri moških in ženskah
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Pristojne oblasti države članice lahko informacije o zdravilu pozneje posodobijo ob sodelovanju referenčne države članice, če je to potrebno, skladno s postopki, določenimi v 4. poglavju naslova III Direktive 2001/83/ES.
There are insufficient data that allows for dose adjustment recommendations.
Ni dovolj podatkov, da bi bilo mogoče podati priporočila za prilagajanje odmerkov.
{MM/YYYY} {DD/MM/YYYY} {DD month YYYY}
{Ime in naslov} {Tel.} {Faks} {E-pošta}
Most complete remissions will occur following the initial course of induction therapy.
Večina popolnih remisij se bo zgodila po prvem krogu indukcijskega zdravljenja.
If you suffer from these side effects, do not drive any vehicles and/or use any machines.
Če trpite zaradi teh neželenih učinkov, ne vozite vozil in/ali ne upravljajte s stroji.
In cases of overdosage patients should be monitored closely.
V primerih prevelikega odmerka je treba bolnike skrbno spremljati.
Safety and efficacy have not been established.
Varnost in učinkovitost nista bili dokazani.
The individual dose of Novantrone is calculated by your doctor.
Posamezni odmerek zdravila Novantrone izračuna vaš zdravnik.
Its presumed mechanism of action in MS is immunosuppression.
Njegov domnevni mehanizem delovanja pri MS je imunosupresija.
- Blood poisoning (sepsis).
- zastrupitev krvi (sepsa),
Recovery > 21 days
Izboljšanje > 21 dni
To date, only isolated cases of severe local reactions (necroses) have been described due to extravasation.
Do danes so znani le posamezni primeri hude lokalne reakcije (nekroza) zaradi ekstravazacije.
Infection (including fatal outcome)
Okužba (vključno s smrtnim izidom)
Any duration
Ne glede na trajanje
Recovery ≤ 21 days
Izboljšanje ≤ 21 dni