natgillin/translations-raw huggingface dataset:
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Pharma (4 tablets of 75 mg) once at the start of treatment.
Če ste imeli hudo bolečino v prsih (nestabilna angina pektoris ali srčna kap), vam lahko zdravnik na začetku zdravljenja da enkrat 300 mg zdravila Klopidogrel Teva Pharma (štiri 75 mg tablete).
- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
- akutni miokardni infarkt z elevacijo ST spojnice v kombinaciji z ASA pri bolnikih, ki se zdravijo z zdravili in so primerni za trombolitično zdravljenje.
INFORMATION IN BRAILLE Clopidogrel Teva Pharma 75 mg
PODATKI V BRAILLOVI PISAVI Klopidogrel Teva Pharma 75 mg
Clopidogrel Teva Pharma contains hydrogenated castor oil This may cause stomach upset or diarrhoea.
Zdravilo Klopidogrel Teva Pharma vsebuje hidrogenirano ricinusovo olje To lahko povzroči želodčne motnje ali drisko.
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Bolezni kože in podkožja bulozni dermatitis (toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem), akutna generalizirana eksantemska pustuloza (AGEP), angioedem, z zdravili povzročen sindrom preobčutljivosti (sindrom DIHS, Drug-Induced Hypersensitivity Syndrome), kožni izpuščaj z eozinofilijo in sistemskimi simptomi, kot posledica zdravljenja z zdravilom (sindrom DRESS, Drug Rash with Eosinophilia and Systemic Symptoms), eritematozni ali eksfoliativen izpuščaj, urtikarija, ekcem, lihen planus
As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Tako kot druge antitrombotike tudi klopidogrel previdno uporabljamo pri bolnikih, pri katerih zaradi poškodbe, kirurškega posega ali drugih patoloških stanj obstaja tveganje za povečano krvavitev, in pri bolnikih, ki so na zdravljenju z ASA, s heparinom, z zaviralci glikoproteina IIb/IIIa ali z nesteroidnimi protivnetnimi zdravili (NSAID), vključno z zaviralci ciklooksigenaze-2 (COX-2) ali s selektivnimi zaviralci privzema serotonina (SSRI), ali z drugimi zdravili, ki so povezana s tveganjem za krvavitve, kot je pentoksifilin (glejte poglavje 4.5).
Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Eliminacija Po peroralnem odmerku s 14C označenega klopidogrela pri človeku se ga je v 120-urnem intervalu po odmerjanju približno 50 % izločilo s sečem in približno 46 % z blatom.
• You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
• morate zdravniku takoj povedati, če se pri vas pojavi bolezensko stanje (znano kot tombotična trombocitopenična purpura ali TTP), ki vključuje zvišano telesno temperaturo in modrice pod kožo (pojavijo se kot drobne rdeče pike), nerazložljiva huda utrujenost, zmedenost ter porumenelost kože ali oči (zlatenica) (glejte poglavje 4 »Možni neželeni učinki«);
Boxes of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters or boxes of 28x1 and 50x1 film-coated tablets in perforated unit dose blisters are available.
Na voljo so v pretisnih omotih po 7, 13, 28, 30, 50, 56, 84, 90 in 100 filmsko obloženih tablet v škatli ali v škatli z 28x1 in 50x1 filmsko obloženo tableto v preforiranih, enoodmernih pretisnih omotih.
Rare side effect (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): Vrtoglavica, , povečanje prsi pri moških.
• Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000 and hydrogenated castor oil
Jedro tablete: celuloza, mikrokristalna brezvodni koloidni silicijev dioksid krospovidon (vrsta A) makrogol 6000 hidrogenirano ricinusovo olje
You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach,
Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete - zdravila, ki lahko povečajo tveganje za krvavitve, kot so: o peroralni antikoagulanti, zdravila, ki se uporabljajo za preprečevanje strjevanja krvi, o nesteroidna protivnetna zdravila, običajno za lajšanje bolečih in/ali vnetih sklepov ali mišic, o heparin ali katero koli drugo zdravilo za preprečevanje strjevanja krvi, o tiklopidin, druga antiagregacijska zdravila, o selektivni zaviralci privzema serotonina (na primer fluoksetin ali fluvoksamin, a ne le tadva), ki se po navadi uporabljajo za zdravljenje depresije, - omeprazol ali esomeprazol, zdravila za zdravljenje težav z želodcem, - flukonazol ali vorikonazol, zdravila za zdravljenje glivičnih okužb, - efavirenz, zdravilo za zdravljenje infekcij z virusom HIV (virus humane imunske pomanjkljivosti),
The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Koristi, ki so jih opazili s klopidogrelom, so bile neodvisne od drugih akutnih in dolgotrajnih srčnožilnih terapij (kot je heparin /nizkomolekularni heparin, antagonisti glikoproteina IIb/IIIa, učinkovine za zniževanje lipidov, zaviralci adrenergičnih receptorjev beta in zaviralci angiotenzinske konvertaze (ACEI)).
In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR = 23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]).
Pri analizi podskupin glede na vključitveni pogoj (MI, ishemična kap in PAD) je bila korist (doseganje statistične značilnosti pri p = 0,003) največja pri bolnikih, vključenih zaradi PAD (zlasti pri tistih, ki so doživeli tudi MI) (zmanjšanje RT: =23,7 %; IZ: 8,9 do 36,2), in manjša (ni bila pomembno drugačna kot pri ASA) pri bolnikih s kapjo (zmanjšanje RT: 7,3 %; IZ: -5,7 do 18,7 /p = 0,258/).
• Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
- Ledvična okvara Terapevtske izkušnje pri bolnikih z ledvično okvaro so omejene (glejte poglavje 4.4).
Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*
Bolezni imunskega sistema serumska bolezen, anafilaktoidne reakcije, navzkrižna preobčutljivost med tienopiridini (kot sta tiklopidin in prasugrel) (glejte poglavje 4.4)*
Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia, dizziness
Bolezni živčevja intrakranialna krvavitev (opisani so primeri s smrtnim izidom), glavobol, parestezije, omotica motnje okusa
Pharmacogenetics: In patients who are poor CYP2C19 metabolisers, clopidogrel at recommended doses forms less of the active metabolite of clopidogrel and has a smaller effect on platelet function.
Citokrom P450 2C19 (CYP2C19) Farmakogenetika: Pri bolnikih, ki so slabi metabolizatorji CYP2C19, med uporabo priporočenih odmerkov klopidogrela nastane manj aktivnega presnovka klopidogrela in ima manjši učinek na delovanje trombocitov.
- fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections, - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer.
- karbamazepin, zdravilo za zdravljenje nekaterih oblik epilepsije, - moklobemid, zdravilo za zdravljenje depresije, - repaglinid, zdravilo za zdravljenje sladkorne bolezni, - paklitaksel, zdravilo za zdravljenje raka.
Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of phenobarbital or oestrogen.
Na farmakodinamiko klopidogrela tudi ni pomembno vplivalo sočasno jemanje fenobarbitala ali estrogena.
Clopidogrel Teva Pharma 75 mg film-coated tablets Clopidogrel
Klopidogrel Teva Pharma 75 mg filmsko obložene tablete klopidogrel
Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Pri bolnikih z akutnim koronarnim sindromom: - Akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca): zdravljenje moramo začeti z enkratnim udarnim odmerkom 300 mg klopidogrela in nadaljevati s 75 mg enkrat na dan (s 75 mg do 325 mg acetilsalicilne kisline (ASA) dnevno).
Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste of food.
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): zlatenica, huda bolečina v trebuhu z bolečino v hrbtu ali brez nje, zvišana telesna temperatura, težave pri dihanju, ki so včasih povezane s kašljem, splošne alergijske reakcije na primer, splošni občutek toplote z nenadnim nelagodjem do nezavesti), oteklina v ustih, mehurji na koži, kožna alergija, vnetje v ustih (stomatitis), znižanje krvnega tlaka, zmedenost, halucinacije, bolečine v sklepih, bolečine v mišicah, motnje v okušanju hrane.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (7, 14, 28, 30, 50, 56, 84, 90, 100, 50x1 film-coated tablets)
PRETISNI OMOT (7, 14, 28, 30 50, 56, 84, 90, 100, 50x1 filmsko obloženih tablet)
Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Če bolnik izpusti odmerek: - če je zamuda manj kot 12 ur po pravem času: bolnik naj odmerek vzame takoj, potem pa naslednji odmerek ob pravem času.
The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Število bolnikov s primarnim opazovanim dogodkom (srčno-žilna smrt, MI, kap ali neodzivna ishemija) je bilo 1.035 (16,5 %) v skupini zdravljeni s klopidogrelom in 1.187 (18,8 %) v skupini s placebom, to je 14 % zmanjšanje relativnega tveganja (95 % IZ od 6 % -21 %, p=0,0005) za skupino, zdravljeno s klopidogrelom.
While you are taking Clopidogrel Teva Pharma:
Ko jemljete zdravilo Klopidogrel Teva Pharma:
The Cmax of the active metabolite is twice as high following a single 300-mg clopidogrel loading dose as it is after four days of 75-mg maintenance dose.
Cmax aktivnega presnovka je po enem 300 mg polnilnem odmerku klopidogrela dvakrat večja kot po štirih dneh uporabe vzdrževalnega odmerka 75 mg. Cmax je dosežena približno 30 do 60 minut po uporabi zdravila.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28x1 film-coated tablets)
PRETISNI OMOT (28x1 filmsko obložena tableta)
NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Pharma 75 mg film-coated tablets
IME ZDRAVILA Klopidogrel Teva Pharma 75 mg filmsko obložene tablete
Do not take Clopidogrel Teva Pharma
Ne jemljite zdravila Klopidogrel Teva Pharma:
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Pri analizi vključenih bolnikov (intention to treat analysis) so v skupini, ki je jemala klopidogrel, opazili 939 dogodkov, v skupini, ki je jemala ASA, pa 1.020 dogodkov (zmanjšanje relativnega tveganja /RT/: 8,7 %, 95-odstotni interval zaupanja /IZ/: 0,2 do 16,4; p = 0,045), kar ustreza preprečevanju pojava novega ishemičnega dogodka na vsakih 1.000 bolnikov, zdravljenih 2 leti, dodatnim 10 (IZ: 0 do 20) bolnikom.
Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Bolniki so dobivali klopidogrel (300 mg udarni odmerek, nato pa 75 mg na dan, n=1.752) ali placebo (n=1.739), oboje v kombinaciji z ASA (150 mg do 325 mg kot udarni odmerek, nato 75 mg do 162 mg na dan),
However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents
Vendar pa so bolniki, ki so bili vključeni v klinično preizkušanje klopidogrela, brez dokazov o klinično pomembnih neželenih interakcijah sočasno jemali različna zdravila, tudi diuretike, zaviralce adrenergičnih receptorjev beta, zaviralce angiotenzinske konvertaze (ACE), kalcijeve antagoniste, učinkovine za zniževanje holesterola,
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
Bolezni krvi in limfatičnega sistema trombocitopen nevtropenija, vključno s hudo nevtropenijo trombotična trombocitopenična purpura (TTP) (glejte poglavje 4.4), aplastična anemija, pancitopenija, agranulocitoza, huda trombocitopenija, pridobljena hemofilija A, granulocitopenija, anemija
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
V študiji CAPRIE so primerjali klopidogrel in ASA, v študijah CURE, CLARITY, COMMIT in ACTIVE-A pa klopidogrel in placebo; bolniki so oboje dobivali v kombinaciji z ASA in drugo standardno terapijo.
Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Absorpcija na podlagi presnovkov klopidrogela, izločenih s sečem, je najmanj 50-odstotna.
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Teva Pharma.
Iz varnostnih razlogov naj matere, ki se zdravijo z zdravilom Klopidogrel Teva Pharma, ne dojijo.
Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information related to clopidogrel with frequency “not known”.
* Podatki se nanašajo na klopidogrel s pogostnostjo “neznani”.
The active substance is clopidogrel.
• Zdravilna učinkovina je klopidogrel.
If you forget to take a dose of Clopidogrel Teva Pharma, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Če ste pozabili vzeti zdravilo Klopidogrel Teva Pharma Če ste pozabili vzeti odmerek in od tega ni minilo več kot 12 ur, ga vzemite takoj, ko se spomnite.
The major exclusion criteria for patients were documented peptic ulcer disease within the previous 6 months; prior intracerebral hemorrhage; significant thrombocytopenia (platelet count < 50 x 109/l); requirement for clopidogrel or oral anticoagulants (OAC); or intolerance to any of the two compounds.
Glavna merila za nevključitev bolnikov so bila potrjena peptična ulkusna bolezen v preteklih 6 mesecih, predhodna intracerebralna krvavitev, pomembna trombocitopenija (število trombocitov
Do not stop the treatment unless your doctor tells you so.
Če ste prenehali jemati zdravilo Klopidogrel Teva Pharma Ne prekinite zdravljenja razen, če tako določi zdravnik.
• Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
• Pomožne snovi so (glejte poglavje 2 »Zdravilo Klopidogrel Teva Pharma vsebuje hidrogenirano ricinusovo olje«): - Jedro tablete: mikrokristalna celuloza, brezvodni koloidni silicijev dioksid, krospovidon (vrsta A), makrogol 6000 in hidrogenirano ricinusovo olje - Obloga tablete: polivinilalkohol, titanov dioksid (E171), rdeči železov oksid (E172), rumeni železov oksid (E172), smukec in makrogol 3000.
EU/1/09/561/011 Cartons of 50x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
EU/1/09/561/011 škatla z 50x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih,
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
želodčna razjeda in razjeda na retroperitonealna krvavitev krvavitev v prebavila in retroperitonealna krvavitev s smrtnim izidom, pankreatitis, kolitis (vključno z ulceroznim ali limfocitnim kolitisom), stomatitis
EU/1/09/561/010 Cartons of 28x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose
EU/1/09/561/010 škatla z 28x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih,
Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Po enkratnem in večkratnih peroralnih odmerkih po 75 mg na dan se klopidogrel hitro absorbira Povprečna največja koncentracija nespremenjenega klopidogrela v plazmi (približno 2,2-2,5 ng/ml po enem 75-mg peroralnem odmerku) se je pojavila približno 45 minut po odmerjanju.
How to take Clopidogrel Teva Pharma
Kako jemati zdravilo Klopidogrel Teva Phrama
What Clopidogrel Teva Pharma contains
Kaj vsebuje zdravilo Klopidogrel Teva Pharma
For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
- če je zamuda več kot 12 ur: bolnik naj naslednji odmerek vzame ob pravem času;
Clopidogrel Teva Pharma is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Zdravilo Klopidogrel Teva Pharma jemljejo odrasli za preprečevanje nastanka krvnih strdkov (trombov) v otrdelih krvnih žilah (arterijah).
A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
Študija je ocenila farmakokinetiko in antiagregacijski odziv po uporabi odmerka 300 mg in potem 75 mg/dan ter 600 mg in potem 15 mg/dan, vsako od obeh shem skupaj 5 dni (stanje dinamičnega ravnovesja).
(including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
koronarne vazodilatatorje, antidiabetike (tudi insulin), antiepileptične učinkovine in antagoniste glikoproteinov IIb/IIIa.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects').
Pri manjših urezninah ali poškodbah, npr. pri britju, navadno ni razloga za skrb, če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte poglavje 4»Možni neželeni učinki«);
You should not breast-feed while taking this medicine.
Med jemanjem zdravila Klopidogrel Teva Pharma ne smete dojiti.
- If you have any of the side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Clopidogrel should be given as a single daily dose of 75 mg.
Klopidogrel dajemo kot enkratni dnevni odmerek po 75 mg, s hrano ali brez nje.
Batch
Heparin.
Powder: 220 mg Solvent:5 ml
prašek: 220 mg vehikel: 5 ml
4 vials powder+ 4 vials solvent + 8 disposable 3 ml syringes + 8 disposable 27-gauge, ½ inch needles
4 viale praška + 4 viale vehikla + 8 3-mililitrskih brizg za enkratno uporabo + 8 polpalčnih igel kalibra 27 za enkratno uporabo
Strength Pharmaceutical Form Route of Administration
Izmišljeno ime jakost farmacevtska oblika pot uporabe pakiranje vsebina velikost pakiranja
Subcutaneous use Powder: vial (glass) Solvent: LDPE vial
80 mg/ml prašek in vehikel za raztopino za injiciranje subkutana uporaba prašek: viala (steklo) vehikel: viala iz LDPE
The following age groups will be used: < 2 years, 2-8 years, ≥ 9 years.
Uporabljene bodo naslednje starostne skupine: < 2 leti, 2-8 let, > 9 let.
The frequency cannot be estimated from the available data.
Pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world.
Pandemska gripa je vrsta gripe, ki se pojavi vsakih nekaj desetletij in se zelo hitro širi, prizadene pa večino držav in regij po svetu.
• if you have a severe infection with a high temperature (over 38°C).
• če imate hudo okužbo in povišano temperaturo (nad 38°C).
For further information, see section 5.1.
Za dodatne informacije glejte poglavje 5.1.
- First data-lock point is 30 days later.
- Prvo zaključno obdobje zbiranja podatkov nastopi 30 dni pozneje.
The following principles should be followed when compiling the data:
Pri zbiranju podatkov je treba upoštevati naslednja načela:
All control animals succumbed to the infection.
Vse živali iz kontrolne skupine so podlegle okužbi.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji z zdravilom.
• A protective response may not be induced in all vaccinees (see section 5.1).
• Zaščitni odziv morda ne bo dosežen pri vseh cepljenih osebah (glejte poglavje 5.1).
- A line listing of fatal cases will be provided in an Annex.
- V prilogi bo podan še vrstični seznam smrtnih primerov.
Read all of this leaflet carefully, before you are vaccinated because it contains important information for you.
Pred cepljenjem natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 October 2009
Datum prve odobritve: 16. oktober 2009