natgillin/translations-raw huggingface dataset:
Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.
Zaščita proti gripi pri odraslih starejših od 60 let, še zlasti tistih, pri katerih obstaja povečano tveganje
MARKETING AUTHORISATION HOLDER Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
IMETNIK DOVOLJENJA ZA PROMET Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, Francija.
• The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
• Sistem za mikro-injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro-iglo (1,5 mm) in s sistemom za zaščito igle.
Reactions of not known frequency (frequency cannot be estimated from the available data) - Allergic reactions including skin reactions that may spread throughout the body such as hives, severe allergic reactions (anaphylactic reactions), swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe (angioedema), failure of the circulatory system
- Alergijske reakcije, vključno kožne reakcije, ki se lahko razširijo po vsem telesu kot izpuščaji, hude alergijske reakcije (anafilaktične reakcije) otekel obraz, jezik ali žrelo, težave pri požiranju, koprivnica in oteženo dihanje (angioedem), okvare obtočil (šok ), zaradi katerih je
In some cases, redness at the injection site lasted up to 7 days.
V posameznih primerih lahko ostane rdečina na mestu vboda do 7 dni.
In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of IDflu by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
V randomiziranem primerjalnem preskušanju faze III je 398 oseb, starih 65 in več let, prejelo 0,1 ml cepiva IDflu intradermalno, 397 oseb, starih 65 let in več, pa je prejelo 0,5 ml trivalentnega inaktiviranega cepiva proti gripi z adjuvansom (ki vsebuje MF-59) v enakem odmerku
• The vaccine should be allowed to reach room temperature before use.
• Pred uporabo počakajte, da doseže cepivo sobno temperaturo.
This vaccine has no or negligible influence on the ability to drive and use machines.
Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo IDflu nima oziroma zanemarljivo vpliva na sposobnost vožnje in upravljanja s stroji.
• Pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord or Guillain-Barré syndrome which causes
• bolečine na živčnih poteh, konvulzije, povezane s povišano telesno temperaturo, bolezni živčevja, vključno z vnetjem možganov ali hrbtenjače, vnetjem živcev ali Guillain-Barréjev sindrom, ki povzroča izjemno utrujenost in paralizo.
Across all three influenza strains, for the comparator intramuscular vaccine GMTs ranged between 34.8 (1/dil) and 181.0 (1/dil), seroprotection rates ranged between 48.9% and 87.9%, seroconversion or significant increase rates ranged between 30.0% and 46.9% and GMTRs ranged between 3.04 and 5.35-fold over baseline HI titres.
), stopnje serozaščite med 48,9% in 87,9%, serokonverzija ali značilne stopnje povečanja med 30,0% in 46,9% in GMTR med 3,04 in 5,35 krat nad izhodiščem
- Tell your doctor if you have been treated with medicines that may reduce your immune response such as corticosteroids (for example cortisone), medicines against cancer (chemotherapy), radiotherapy or other medicines affecting the immune system.
kot so kortikosteroidi (na primer kortizon), zdravila proti raku (kemoterapija), radioterapija ali druga zdravila, ki vplivajo na imunski sistem.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, Francija.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System
PODATKI NA ZUNANJI OVOJNINI Pakiranje z 1 ali 10 ali 20 napolnjenimi brizgami s sistemom za mikro-injiciranje
Common reactions (may affect up to 1 in 10 people) - Bruising at the injection site.
Pogosti (lahko prizadanejo do 1 med 10 cepljenimi) - Modrica na mestu injiciranja
IDflu will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them.
Po injiciranju cepiva IDflu razvije imunski sistem (naravna obramba telesa) zaščito proti okužbi z Cepivo IDflu pomaga pri zaščiti pred tremi sevi virusov, ki so zajeti v cepivu, in drugimi sevi, ki so tesno povezani z njimi.
• The vaccine should not be used if foreign particles are present in the suspension.
• Če so v suspenziji prisotni tujki, cepiva ne smete uporabiti.
4.5 Interaction with other medicinal products and other forms of interaction IDflu may be given at the same time as other vaccines.
Zdravilo IDflu se lahko daje sočasno z drugimi cepivi.
The immunological response may be diminished if the patient is undergoing immunosuppressant
Če se bolnik zdravi z imunosupresivnimi zdravili, je imunski odziv lahko manjši.
The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Pomožne snovi so: natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen
Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain-Barré
Bolezni živčevja nevralgija, febrilne konvulzije, nevrološke motnje kot je encefalomielitis in Guillain-Barréjev sindrom Žilne bolezni vaskulitis, v zelo redkih primerih povezan s prehodno prizadetostjo ledvic
The following side effects have been reported with other vaccines given to prevent flu.
V povezavi z drugimi cepivi proti gripi so poročali o naslednjih neželenih učinkih Neželeni učinki, ki
The recommended dose is 0.1 ml for individuals 60 years of age and over.
Priporočeni odmerek za drasle, starejše od 60 let je 0,1 ml.
IDflu 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
IDflu 15 mikrogramov/sev suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
Transient thrombocytopenia, transient lymphadenopathy
Bolezni krvi in limfatičnega sistema prehodna trombocitopenija, prehodna limfadenopatija
- You should tell your doctor before vaccination if you have a poor immune response
- Obvestite svojega zdravnika, če ste se zdravili z zdravili, ki lahko zmanjšajo vaš imunski odziv,
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom s farmacevtom ali z
- If you have any further questions, ask your doctor, pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom ali z
0.1 ml of suspension in a pre-filled syringe (glass) with a Micro-Injection System, with attached micro-needle, equipped with an elastomer plunger stopper (chlorobutyl), a tip cap (thermoplastic elastomer and polypropylene) and a needle shielding system.
opremljeno z batom iz elastomera (klorobutil), s pokrovom konice (termoplastični elastomer in polipropilen) in sistemom za zaščito igle.
Always use this vaccine exactly as your doctor or pharmacist has told you.
Pri uporabi tega cepiva natančno upoštevajte napotke v tem navodilu ali navodila svojega zdravnika ali farmacevta.
Influenza virus (inactivated, split) of the following strains: A/California/7/2009 (H1N1)pdm09 - like strain A/Hong Kong/4801/2014 (H3N2) - like strain
A/California/7/2009, NYMC X-179A, ki je podoben sevu A/California/7/2009 (H1N1)pdm09
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine (see
4.4 Posebna opozorila in previdnostni ukrepi Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju (glejte poglavje 4.8).
• Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
(ovalbumin, piščančje beljakovine), neomicin, formaldehid in oktoksinol 9.
• As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic event following the administration of the vaccine.
Naslednje informacije so namenjene samo zdravstvenemu osebju: • Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju
5/ ACTIVATE NEEDLE SHIELD BY PUSHING FIRMLY ON PLUNGER
5/ S ČVRSTIM PRITISKOM NA BAT AKTIVIRAJTE ZAŠČITO IGLE
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label text
OVOJNINAH Besedilo na nalepki za napolnjeno brizgo
NAME OF THE MEDICINAL PRODUCT IDflu 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
Navodilo za uporabo: informacije za uporabnika IDflu 15 mikrogramov/sev suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
IDflu is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection System in
Zdravilo IDflu je suspenzija za injiciranje v napolnjenih injekcijskih brizgah z 0,1 ml s sistemom za mikro-injiciranje, pakirana po 1, 10 ali 20 enot.
Therefore, this information is not
Navedba zato smiselno ni potrebna.
Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen
6.1 Seznam pomožnih snovi natrijev klorid kalijev klorid natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
The vaccine should not be used if foreign particles are present in the suspension.
Če so v raztopini prisotni tujki, cepiva ne smete uporabiti.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
(UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI)
Talk to your doctor, pharmacist or nurse before using IDflu.
Pred začetkom uporabe cepiva IDflu se posvetujte s svojim zdravnikom, farmacevtom ali z medicinsko sestro.
Common Uncommon Rare
Prirobni ca
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
C. RUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Paediatric population
Otroci in mladostniki
NAME OF THE MEDICINAL PRODUCT IDflu 15 microgram/strain, suspension for injection Influenza vaccine (split virion, inactivated) Strains 2016/2017
IDflu 15 mikrogramov/sev, suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
Injection is considered successful whether or not the presence of a wheal is In case of presence of liquid at the injection site after vaccine administration, re
Injekcija je uspešna ne glede na prisotnost izpuščaja.
The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Sistem za mikro-injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro-iglo
15 µg haemagglutinin per strain per 0.1 ml dose
15 mikrogramov hemaglutinina na sev na 0,1 ml odmerek natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen fosfat, voda za
IDflu is administered to you by your doctor or nurse.
Cepivom IDflu vam bo dal vaš zdravnik.
Cattle and Sheep
Govedo in ovce
* Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.
* Relativna potenca (test potence na miših) v primerjavi z referenčnim cepivom, ki je bilo dokazano učinkovito pri ciljnih živalskih vrstah.
Vial (HDPE) 50 ml
Viala (HDPE) 50 ml
Inactivated Schmallenberg virus, strain BH80/11-4: ≥ 1 RP*/2 ml (for cows) or ≥ 1 RP*/ml (for sheep).
Inaktivirani virus Scmallenberg, sev BH80/11-4: ≥ 1 RP*/2 ml (za krave) ali ≥ 1 RP* /ml (za ovce).
Intramuscular use or subcutaneous use.
Intramuskularna uporaba ali subkutana uporaba
Zero days
1 viala 0 dni
The Agency issued its opinion on 17 October 2019.
Agencija je mnenje izdala 17. oktobra 2019.
The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.
Podjetje, ki je zaprosilo za dovoljenje, Daiichi Sankyo Europe GmbH, lahko v 15 dneh od prejema mnenja zahteva ponovni pregled mnenja.
18 October 2019 EMA/559309/2019 EMEA/H/C/004468
18. oktober 2019 EMA/559309/2019 EMEA/H/C/004468
Further information on the orphan designation can be found on the Agency's website: ema.europa.eu/medicines/human/orphan-designations/eu309622.
Več informacij o določitvi zdravila sirote je voljo na spletišču agencije: ema.europa.eu/medicines/human/orphan-designations/eu309622.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, speak with your clinical trial doctor.
Če ste vključeni v klinično preskušanje ali program sočutne uporabe in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki sodeluje v kliničnem preskušanju.
What were the main reasons for refusing the marketing authorisation?
Kateri so bili glavni razlogi za zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom?
Does this refusal affect patients in clinical trials or compassionate use programmes?
Ali ta zavrnitev vpliva na bolnike v kliničnih preskušanjih ali programih sočutne uporabe?
What is Vanflyta and what was it intended to be used for?
Kaj je zdravilo Vanflyta in za kaj naj bi se uporabljalo?
How does Vanflyta work?
Kako zdravilo Vanflyta deluje?
It works by blocking FLT3, a protein involved in cell growth and proliferation.
Deluje z zaviranjem FLT3, beljakovine, ki sodeluje pri celični rasti in proliferaciji.
Refusal of the marketing authorisation for Vanflyta (quizartinib) EMA/559309/2019
Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Vanflyta (kvizartinib) EMA/559309/2019
Although the results from the main study indicated a marginal improvement in overall survival for patients given Vanflyta, the study had important limitations which meant that the effectiveness of Vanflyta could not be sufficiently demonstrated.
Čeprav rezultati glavne študije kažejo rahlo izboljšanje celokupnega preživetja pri bolnikih, ki so prejemali zdravilo Vanflyta, je imela študija večje omejitve, kar pomeni, da učinkovitosti zdravila Vanflyta ni bilo mogoče zadostno dokazati.
The company presented the results of a study in 367 patients with FLT3-ITD positive AML whose disease did not respond to treatment or came back after treatment.
Podjetje je predložilo rezultate študije s 367 bolniki s FLT3-ITD pozitivno akutno mieloično levkemijo, pri katerih se bolezen ni odzvala na predhodno zdravljenje ali se je po zdravljenju ponovila.
Therefore, the Agency's opinion was that the benefits of Vanflyta did not outweigh its risks and it recommended refusing marketing authorisation.
Zato je agencija menila, da koristi zdravila Vanflyta ne odtehtajo z njim povezanih tveganj, in priporočila zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom.
Vanflyta contains the active substance quizartinib and was to be available as tablets.
Zdravilo Vanflyta vsebuje učinkovino kvizartinib in naj bi bilo na voljo v obliki tablet.
Vanflyta was to be used in adult patients whose disease had come back or did not respond to previous treatments and for continuation of treatment after the patient had undergone a haematopoietic stem cell transplant (HSCT, a transplant of cells that can develop into different types of blood cells).
Uporabljalo naj bi se pri odraslih bolnikih, pri katerih se je bolezen ponovila ali se ni odzvala na predhodno zdravljenje, ter za nadaljevanje zdravljenja pri bolnikih, ki so prestali transplantacijo krvotvornih matičnih celic (HSCT, presaditev celic, ki se lahko razvijejo v različne vrste krvnih celic).
cancer medicines and the main measure of effectiveness was overall survival (how long patients lived) after being given Vanflyta or the comparator medicines.
Vanflyta so primerjali z drugimi zdravili za zdravljenje raka, glavno merilo učinkovitosti pa je bilo celokupno preživetje (kako dolgo so bolniki živeli) po dajanju zdravila Vanflyta ali primerjalnih zdravil.
The active substance in Vanflyta, quizartinib, is a ‘receptor tyrosine kinase inhibitor'.
Učinkovina v zdravilu Vanflyta, kvizartinib, je „zaviralec tirozin-kinaze“.
Vanflyta was developed as a cancer medicine for the treatment of a type of AML called ‘FLT3-ITD positive' (when the cancer cells have a certain change in the gene for a protein called FLT3).
Zdravilo Vanflyta je bilo razvito kot zdravilo proti raku za zdravljenje vrste akutne mieloične levkemije, imenovane „FLT3-ITD pozitivna“ (rakave celice imajo določeno spremembo v genu za beljakovino, imenovano FLT3).
By blocking FLT3, quizartinib is expected to stop cancer cells from multiplying and thus slow down the progression of the disease.
Kvizartinib naj bi z zaviranjem FLT3 ustavil razmnoževanje rakavih celic in tako upočasnil napredovanje bolezni.
Refusal of the marketing authorisation for Vanflyta (quizartinib)
Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Vanflyta (kvizartinib)
The European Medicines Agency has recommended the refusal of the marketing authorisation for Vanflyta, a medicine intended for the treatment of adults with acute myeloid leukaemia (AML) (a cancer of the white blood cells).
Evropska agencija za zdravila je priporočila zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Vanflyta, namenjenim zdravljenju odraslih z akutno mieloično levkemijo (AML) (vrsto raka belih krvnih celic).
The company informed the Agency that there are no consequences for patients in clinical trials or in compassionate use programmes with Vanflyta.
Podjetje je obvestilo agencijo, da zavrnitev nima posledic za bolnike, ki so vključeni v klinična preskušanja ali programe sočutne uporabe zdravila Vanflyta.
Vanflyta was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 March 2009 for the treatment of AML.
Zdravilo Vanflyta je bilo 23. marca 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje akutne mieloične levkemije.
The most common side effect (affects 1 to 10 patients in 100) reported with clopidogrel is bleeding.
Najpogostejši neželeni učinek (pojavi se pri 1 do 10 od 100 bolnikov), o katerem so poročali s klopidogrelom, je krvavitev.
• Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg with or without food.
• Odrasli in starostniki Klopidogrel se mora dajati kot enkratni dnevni odmerek 75 mg, z ali brez hrane.
• Paediatric patients The safety and efficacy of clopidogrel in children and adolescents have not yet been
• Pediatrični bolniki Varnost in učinkovitost klopidogrela pri otrocih in mladostnikih še nista ugotovljeni.
Some other medicines may influence the use of Clopidogrel Sandoz or vice versa.
Nekatera druga zdravila lahko vplivajo na uporabo zdravila Klopidogrel Sandoz in obratno.
Children and adolescents Clopidogrel Sandoz is not intended for use in children or adolescents.
Otroci in mladostniki Zdravilo Klopidogrel Sandoz ni namenjeno za uporabo pri otrocih ali mladostnikih.
Detailed information is available on the European Medicines Agency website: http://www.ema.europa.eu/
Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila : http://www.ema.europa.eu/.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/547/001-007
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/547/001-007
Do not use Clopidogrel Sandoz if you notice any visible sign of damage of blister or film-coated tablets.
Ne uporabljajte zdravila Klopidogrel Sandoz, če ste opazili vidne znake poškodovanja pretisnega omota ali filmsko obloženih tablet.
Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with clopidogrel.
Podatki študije CAPRIE kažejo, da se lahko fenitoin in tolbutamid sočasno s klopidogrelom varno uporabljata.
If you stop taking Clopidogrel Sandoz Do not stop the treatment.
Če ste prenehali jemati zdravilo Klopidogrel Sandoz Ne prekinite zdravljenja.
The association between CYP2C19 genotype and clopidogrel treatment outcome was evaluated in 2 post hoc clinical trial analyses (substudies of CLARITY [n = 465] and TRITON-TIMI 38 [n = 1,477]) and 5 cohort studies (total n = 6,489).
Povezavo med genotipom CYP2C19 in izidom zdravljenja s klopidogrelom so ocenili v 2 post hoc analizah kliničnih preskušanj (podštudiji CLARITY [n = 465] in TRITON-TIMI 38 [n = 1.477]) ter 5 kohortnih študijah (celotni n = 6.489).
Other side effects reported with clopidogrel are: -Common side effects:
Drugi neželeni učinki, o katerih so poročali s klopidogrelom, so: - Pogosti neželeni učinki:
You should take Clopidogrel Sandoz for as long as your doctor continues to prescribe it.
Zdravilo Klopidogrel Sandoz morate jemati, vse dokler vam ga vaš zdravnik predpisuje.
The usual dose is one 75 mg tablet of Clopidogrel Sandoz per day to be taken orally with or without food, and at the same time each day.
Običajni odmerek je ena 75-mg tableta zdravila Klopidogrel Sandoz na dan, ki jo lahko vzamete s hrano ali brez nje; odmerek morate jemati vsak dan ob istem času.
Taking Clopidogrel Sandoz with food and drink Clopidogrel Sandoz may be taken with or without food.
Jemanje zdravila Klopidogrel Sandoz skupaj s hrano in pijačo Zdravilo Klopidogrel Sandoz lahko jemljete s hrano ali brez nje.
If you forget to take a dose of Clopidogrel Sandoz, but remember within 12 hours of your usual time, take your tablet straight away and then take your next tablet at the usual time.
Če ste pozabili vzeti zdravilo Klopidogrel Sandoz Če pozabite vzeti odmerek zdravila Klopidogrel Sandoz in se nanj spomnite do 12 ur po ustaljenem času, takoj vzemite tableto in nato vzemite naslednjo tableto spet ob ustaljenem času jemanja.
Clopidogrel has been evaluated for safety for 1 year or more.
4.8 Neželeni učinki Varnost klopidogrela so vrednotili v obdobju 1 leta ali več.
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Sandoz.
Če menite, da se karkoli od navedenega nanaša na vas, ali če ste kakorkoli v dvomih, se posvetujte s svojim zdravnikom, preden boste vzeli Klopidogrel Sandoz.
Like all medicines, Clopidogrel Sandoz can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Klopidogrel Sandoz neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you experience prolonged bleeding when taking Clopidogrel Sandoz.
Če doživite podaljšanje krvavitve v času jemanja zdravila Klopidogrel Sandoz.
If you take more Clopidogrel Sandoz than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Če ste vzeli večji odmerek zdravila Klopidogrel Sandoz, kot bi smeli Zaradi povečanega tveganja krvavitve se posvetujte s svojim zdravnikom ali oddelkom najbližje bolnišnične nujne zdravniške pomoči.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Sandoz.
Če ste noseči ali mislite, da ste noseči, morate o tem obvestiti svojega zdravnika ali farmacevta, preden vzamete zdravilo Klopidogrel Sandoz.
In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p = 0.639]).
Pri bolnikih, ki so bili vključeni v preskušanje samo na podlagi nedavnega miokardnega infarkta, je bil klopidogrel numerično inferioren, vendar se statistično ni razlikoval od ASA (zmanjšanje RT= -4,0 %; IZ: -22,5 do 11,7 [p=0,639]).