FrancophonIA/ELRC3.0 huggingface dataset:
English: Between November 2004 and June 2005, the MAH made oral explanations to the CHMP on cardiovascular and skin safety aspects for Dynastat on 18 January, 20 April and 25 May 2005.
Slovenian: Med novembrom 2004 in junijem 2005 je imetnik dovoljenja za promet 18. januarja, 20. aprila in 25. maja 2005 pred CHMP ustno obrazložil kardiovaskularne in kožne varnostne vidike zdravila Dynastat.
English: Whereas, the CHMP - is of the Opinion that the benefit/risk balance of Dynastat in the short-term treatment of postoperative pain remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics and Package Leaflet (attached in Annex I and IIIB, respectively of the CHMP Opinion), - concluded that the cardiovascular safety and serious skin reactions should be continuously and carefully monitored and assessed, - recommended follow-up measures to further investigate the safety of parecoxib.
Slovenian: Ob upoštevanju, da je CHMP - mnenja, da razmerje med koristjo in tveganjem za zdravilo Dynastat pri kratkotrajnem zdravljenju pooperacijske bolečine ostaja ugodno in da se dovoljenja za promet ohranijo v skladu s popravljenimi Povzetki glavnih značilnosti zdravil (priloženih mnenju CHMP v Dodatku III), - zaključil, da je treba kardiovaskularno varnost in hude kožne reakcije neprekinjeno in natančno spremljati in vrednotiti, - priporočil nadaljnje ukrepe za dodatno raziskovanje varnosti parekoksiba.
English: The changes of the Product Information related to the SCAR can be summarised as follows: - Addition of a contra-indication for patients with a history of any drug allergy, - Addition of a warning to report that the onset of skin reactions occur in the majority of cases within the first month of treatment, - Addition of a warning for prescribers to monitor any serious skin reactions, which could occur during the treatment, - Addition of a warning for patients to immediately report any emergent skin condition to their physician.
Slovenian: Spremembe informacij o zdravilu, povezanih s hudimi kožnimi neželenimi reakcijami (Severe Cutaneous Adverse Reaction, SCAR), lahko povzamemo, kot sledi: - dodana je kontraindikacija za bolnike z anamnezo alergije na katerokoli zdravilo, - dodano je opozorilo k poročilu, da se kožne reakcije v večini primerov pojavijo v prvem mesecu zdravljenja, - dodano je opozorilo za zdravnike, naj spremljajo vse hude kožne reakcije, ki se utegnejo pojaviti med zdravljenjem, - dodano je opozorilo za bolnike, da morajo zdravnika takoj obvestiti o vsaki novonastali kožni spremembi.
English: The changes of the Product Information related to the CV can be summarised as follows: - Addition of a statement that decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks, - Addition of the contraindications Established ischaemic heart disease and/or cerebrovascular disease and Peripheral arterial disease, - Addition of a warning for patients with risk factors for heart disease, such as hypertension, hyperlipidaemia (high cholesterol levels), diabetes and smoking, - Addition of a warning for prescribers to consider discontinuation of therapy if during treatment, patients deteriorate in any of the organ system functions described, - Addition of a warning for prescribers not to discontinue antiplatelet therapies,
Slovenian: Spremembe informacij o zdravilu v zvezi s kardiovaskularnim sistemom lahko povzamemo kot sledi: - dodana je izjava, da mora odločitev o uvedbi selektivnega zaviralca COX-2 temeljiti na vrednotenju celotnega tveganja za posameznega bolnika, - dodani sta kontraindikaciji Potrjena ishemična srčna bolezen in/ali cerebrovaskularno obolenje ter Periferna arterijska bolezen, - dodano je opozorilo za bolnike z dejavniki tveganja za srčne bolezni, kot so hipertenzija, hiperlipidemija (visoke ravni holesterola), sladkorna bolezen in kajenje, - dodano je opozorilo za predpisovalce zdravila, naj preučijo možnost prekinitve zdravljenja, če se med zdravljenjem bolniku poslabša katerakoli opisana funkcija organskih sistemov, - dodano je opozorilo za zdravnike, da se ne sme prekiniti antiagregacijsko zdravljenje.
English: Further to the assessment of: - the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk of thrombotic CV events, - the data on celecoxib presented in the APC study, which suggested a dose-related increased risk of serious CV events, - the data on valdecoxib and parecoxib presented in the CABG (Coronary Artery Bypass Graft) and in the CABG II studies, which showed a higher rate of serious CV thromboembolic events in the parecoxib/valdecoxib treatment arm compared to the group of patients receiving placebo, - the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials, which suggested an association with a higher thrombotic risk than naproxen, - the data on lumiracoxib in the Target study, which suggested a small increase in thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
Slovenian: po vrednotenju: - novih podatkov, ki jih je za rofekoksib prispevala klinična raziskava APPROVe in ki kažejo tveganje za trombotične kardiovaskularne dogodke, - podatkov za celekoksib iz raziskave APC, ki so nakazali povečanje tveganja hudih kardiovaskularnih dogodkov, ki so odvisni od odmerka, - podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft) in CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo, - podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih kliničnih preizkušanj, ki nakazujejo povezavo z večjim tveganjem za trombotične dogodke v primerjavi z naproksenom, - podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povečanje trombotičnih dogodkov (zlasti miokardnega infarkta) v primerjavi z naproksenom,
English: ATC code: A10AB01.
Slovenian: Oznaka ATC: A10AB01.
English: At the request of the European Medicines Agency.
Slovenian: • na zahtevo Evropske agencije za zdravila;
English: Date of latest renewal: 18 September 2007
Slovenian: Datum prve odobritve: 7. oktober 2002 Datum zadnjega podaljšanja: 18. september 2007
English: If not, change the needle and repeat the procedure no more than 6 times.
Slovenian: Če se ne, zamenjajte iglo in ponovite postopek, vendar ne več kot 6 krat.
English: The data are limited but suggest that the pharmacokinetic profile in children and adolescents may be similar to that in adults.
Slovenian: Podatkov je malo, vendar nakazujejo, da utegne biti farmakokinetični profil pri otrocih in mladostnikih podoben kot pri odraslih.
English: Actrapid which has been frozen must not be used.
Slovenian: Zdravila Actrapid, ki je bilo zamrznjeno, ne smete uporabiti.
English: Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to low blood sugar.
Slovenian: Ustreznim osebam povejte, da imate sladkorno bolezen in kakšne so lahko posledice, vključno s tveganjem, da se onesvestite (izgubite zavest) zaradi nizkega krvnega sladkorja.
English: Onset of action is within ½ hour, reaches a maximum effect within 1.5-3.5 hours and the entire duration of action is approximately 7-8 hours.
Slovenian: Delovati začne v ½ ure, največji učinek doseže v 1,5-3,5 urah, celotni čas delovanja pa je približno 78 ur.
English: • Drink alcohol, see Actrapid with alcohol in section 2.
Slovenian: • pijete alkohol, glejte podpoglavje Zdravilo Actrapid skupaj z alkoholom v poglavju 2.
English: The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
Slovenian: Absorpcija Največja koncentracija v plazmi je dosežena v 1,5 do 2,5 urah po subkutani aplikaciji.
English: It is therefore recommended that the diabetic patient always carries sugar-containing products.
Slovenian: Zato je priporočljivo, da bolniki s sladkorno boleznijo vedno nosijo pri sebi živila, ki vsebujejo sladkor.
English: Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters.
Slovenian: Potreba po insulinu se v prvem trimesečju ponavadi zmanjša, nato pa se v drugem in tretjem trimesečju zveča.
English: The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
Slovenian: Farmakokinetični profil zdravila Actrapid je bil raziskan pri majhnem številu (n = 18) otrok (starost 612 let) in mladostnikov (starost 13-17 let) s sladkorno boleznijo.
English: Trials have indicated a t½ of about 2-5 hours.
Slovenian: Preskušanja so pokazala, da t1/2 znaša približno 2-5 ur.
English: Although stable over time, a certain amount of insulin will initially be adsorbed to the material of the infusion bag.
Slovenian: Kljub časovni stabilnosti se določena količina insulina na začetku adsorbira na material infuzijske vrečke.
English: Name and address of the manufacturers of the biological active substance Novo Nordisk A/S
Slovenian: Ime in naslov izdelovalcev biološke zdravilne učinkovine Novo Nordisk A/S
English: If not, talk to your doctor.
Slovenian: Če ne mine, se pogovorite z zdravnikom.
English: Actrapid dosing is individual and determined in accordance with the needs of the patient.
Slovenian: Odmerjanje zdravila Actrapid je individualno in določeno skladno z bolnikovimi potrebami.
English: Withdraw the needle from the skin, then release the pressure on the push-button.
Slovenian: Izvlecite iglo iz kože in nato spustite potisni gumb.
English: Subcutaneous injection into the abdominal wall ensures a faster absorption than other injection sites.
Slovenian: Subkutano injiciranje v trebušno steno zagotovi hitrejšo absorpcijo kot injiciranje na drugih mestih.
English: However, there were differences between age groups in Cmax, stressing the importance of individual dose titration.
Slovenian: Cmax pa se je med starostnima skupinama razlikovala, kar poudarja pomembnost individualnega titriranja odmerka.
English: • Forget to inject your insulin or stop taking insulin.
Slovenian: • si pozabite injicirati insulin ali ga nehate uporabljati,
English: Actrapid will start to lower your blood sugar about half an hour after you inject it, and the effect will last for approximately 8 hours.
Slovenian: Zdravilo Actrapid začne krvni sladkor zniževati približno pol ure po injiciranju, njegov učinek pa traja približno 8 ur.
English: When two types of insulin are mixed always mix the insulin medicinal products in the same sequence.
Slovenian: V primeru mešanja dveh vrst insulinov je treba insulinska zdravila vedno zmešati v enakem zaporedju.
English: Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.
Slovenian: Oktreotid in lanreotid (uporabljata se za zdravljenje akromegalije, redke hormonske motnje, ki se ponavadi pojavi pri odraslih osebah srednjih let in je posledica čezmernega nastajanja rastnega hormona v žlezi hipofizi) lahko zvišata ali znižata vaš krvni sladkor.
English: If necessary Actrapid can be given directly into a vein, but this must only be done by healthcare professionals.
Slovenian: Če je potrebno, je mogoče zdravilo Actrapid injicirati neposredno v veno, vendar smejo to narediti le zdravstveni delavci.
English: Actrapid is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).
Slovenian: Zdravilo Actrapid se uporablja za znižanje visokega krvnega sladkorja pri bolnikih s sladkorno boleznijo (diabetesom).
English: If you suspect that the cartridge is damaged, take it back to your supplier.
Slovenian: Če sumite, da je vložek poškodovan, ga vrnite v lekarno.
English: The manufacturer can be identified by the batch number printed on the slip of the carton and on the label: - If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo
Slovenian: Izdelovalca je mogoče ugotoviti po serijski številki, natisnjeni na etiketi škatle in na nalepki: - Če sta drugi in tretji znak S6, P5, K7, R7, VG, FG ali ZF, je izdelovalec Novo Nordisk A/S,
English: Actrapid can be used during pregnancy.
Slovenian: Zdravilo Actrapid lahko uporabljate med nosečnostjo.
English: A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
Slovenian: Predlagali so številna mesta razcepa (hidrolize) na molekuli humanega insulina, nobeden od presnovkov, nastalih po razcepu, pa ni aktiven.
English: Actrapid can be used in elderly patients.
Slovenian: Zdravilo Actrapid se lahko uporablja pri starejših bolnikih.
English: ► If you are treated with Actrapid Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Slovenian: ► Če se zdravite z zdravilom Actrapid Penfill in še drugim insulinom v vložkih Penfill, morate uporabljati dva sistema za dajanje insulina, enega za vsako vrsto insulina.
English: This should be kept in mind if treatment with the combination of pioglitazone and Actrapid is considered.
Slovenian: To je treba upoštevati pri načrtovanju zdravljenja s kombinacijo pioglitazona in zdravila Actrapid.
English: An injection should be followed within 30 minutes by a meal or snack containing carbohydrates.
Slovenian: V 30 minutah po injiciranju zdravila je treba zaužiti obrok ali prigrizek, ki vsebuje ogljikove hidrate.
English: • Screw the needle straight and tightly onto your InnoLet (picture 1A).
Slovenian: • Iglo naravnost in trdno privijte na injekcijski peresnik InnoLet (slika 1A).
English: If administration by syringe or intravenous injection is necessary, a vial should be used.
Slovenian: Če je potrebno dajanje z injekcijsko brizgo ali intravensko injekcijo, je treba uporabiti vialo.
English: Serious allergic reaction to Actrapid or one of its ingredients (called a systemic allergic reaction) is a very rare side effect, but it can potentially be life threatening.
Slovenian: Resna alergijska reakcija na zdravilo Actrapid ali katero od njegovih sestavin (to imenujemo sistemska alergijska reakcija) je zelo redek, a potencialno smrtno nevaren neželeni učinek.
English: When transferring from other insulin medicinal products, adjustment of the Actrapid dose and the dose of the basal insulin may be necessary.
Slovenian: Pri prehodu z drugih insulinskih zdravil je lahko potrebna prilagoditev odmerka zdravila Actrapid in odmerka bazalnega insulina.
English: A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/l) in 204 diabetic and 1344 non-diabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 - 6.1 mmol/l) induced by intravenous Actrapid reduced mortality by 42% (8% versus 4.6%).
Slovenian: Klinično preskušanje zdravljenja hiperglikemije (koncentracija glukoze v krvi nad 10 mmol/l) v eni sami intenzivni enoti pri 204 bolnikih s sladkorno boleznijo in 1.344 bolnikih brez sladkorne bolezni po večji operaciji je pokazala, da je normoglikemija (koncentracija glukoze v krvi 4,4-6,1 mmol/l), dosežena z intravensko aplikacijo zdravila Actrapid, zmanjšala umrljivost za 42 % (8 % v primerjavi s
English: ► Always carry a spare Penfill cartridge in case the one in use is lost or damaged.
Slovenian: ► Vedno imejte s seboj še dodaten vložek Penfill, za primer, če vložek, ki ga uporabljate izgubite ali se poškoduje.
English: Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible.
Slovenian: Hitro izboljšanje urejenosti glikemije je lahko povezano z akutno bolečo nevropatijo, ki je običajno reverzibilna.
English: Pull off the big outer needle cap and keep it for later.
Slovenian: Snemite veliki zunanji pokrovček igle in ga shranite za pozneje.
English: Keep the push-button fully depressed until the needle has been withdrawn from the skin.
Slovenian: Držite potisni gumb povsem pritisnjen, dokler igle ne izvlečete iz kože.
English: Medicinal products added to the insulin solution may cause degradation of the insulin, e.g. if the medicinal products contain thiols or sulfites.
Slovenian: Zdravila, dodana raztopini insulina, lahko povzročijo razgradnjo insulina, npr. če zdravilo vsebuje tiole ali sulfite.
English: Due to the risk of precipitation in pump catheters, Actrapid should not be used in insulin pumps for continuous subcutaneous insulin infusion.
Slovenian: Zaradi tveganja obarjanja insulina v katetrih črpalke se zdravila Actrapid ne sme uporabljati za kontinuirano subkutano infundiranje insulina v sistemih z insulinsko črpalko.
English: Patients transferred to Actrapid from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products.
Slovenian: Bolniki, ki preidejo na zdravilo Actrapid z druge vrste insulina, utegnejo potrebovati večje število dnevnih injekcij ali drugačen odmerek kot med uporabo svojih običajnih insulinskih zdravil.
English: The solution is clear, colourless and aqueous.
Slovenian: Raztopina je bistra, brezbarvna in vodna.
English: Other medicines and Actrapid
Slovenian: Druga zdravila in zdravilo Actrapid
English: On rare occasions, injection site reactions may require discontinuation of Actrapid.
Slovenian: V redkih primerih je lahko zaradi reakcij na mestu injiciranja potrebna prekinitev zdravljenja z zdravilom Actrapid.
English: • Hold your InnoLet with the needle upwards and tap the cartridge gently with your finger a few times (picture 1B) to make any air bubbles collect at the top of the cartridge.
Slovenian: • Držite injekcijski peresnik InnoLet tako, da je igla obrnjena navzgor, in s prstom nekajkrat rahlo potrkajte po vložku (slika 1B), da se bodo zračni mehurčki zbrali na vrhu vložka.
English: Treatment with Actrapid helps to prevent complications from your diabetes.
Slovenian: Zdravljenje z zdravilom Actrapid pomaga preprečiti zaplete sladkorne bolezni.
English: • Have not injected enough insulin.
Slovenian: • si niste injicirali dovolj insulina,
English: In case of hypoglycaemia or if hypoglycaemia is suspected, Actrapid must not be injected.
Slovenian: V primeru hipoglikemije ali suma na hipoglikemijo se zdravila Actrapid ne sme injicirati.
English: Paediatric population Actrapid can be used in children and adolescents.
Slovenian: Pediatrična populacija Zdravilo Actrapid se lahko uporablja pri otrocih in mladostnikih.
English: For intravenous use, infusion systems with Actrapid at concentrations from 0.05 international unit/ml to 1.0 international unit/ml human insulin in the infusion fluids 0.9% sodium chloride, 5% dextrose and 10% dextrose with 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at room temperature for 24 hours.
Slovenian: Pri intravenski uporabi so infuzijski sistemi iz polipropilenskih vrečk, ki vsebujejo zdravilo Actrapid v koncentraciji od 0,05 mednarodne enote/ml do 1,0 mednarodne enote/ml humanega insulina v infuzijskih tekočinah z 0,9 % natrijevega klorida, s 5 % glukoze ali z 10 % glukoze ter s koncentracijo kalijevega klorida 40 mmol/l, pri sobni temperaturi stabilni 24 ur.
English: The following substances may increase the patient's insulin requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Slovenian: Bolnikovo potrebo po insulinu lahko zvečajo naslednje snovi: peroralni kontraceptivi, tiazidi, glukokortikoidi, ščitnični hormoni, simpatikomimetiki, rastni hormon in danazol.
English: Actrapid is a fast-acting human insulin and may be used in combination with intermediate or longacting insulin medicinal products.
Slovenian: Zdravilo Actrapid je hitrodelujoči humani insulin in se lahko uporablja v kombinaciji s srednjedolgodelujočimi ali z dolgodelujočimi insulinskimi zdravili.
English: If necessary, Actrapid can be administered intravenously.
Slovenian: Če je potrebno, je mogoče zdravilo Actrapid aplicirati tudi intravensko.
English: Insert the needle into your skin.
Slovenian: Zabodite iglo v kožo.
English: What Actrapid is and what it is used for
Slovenian: Kaj je zdravilo Actrapid in za kaj ga uporabljamo
English: Actrapid vial, Penfill and FlexPen:
Slovenian: Actrapid viala, Penfill in FlexPen:
English: Actrapid is human insulin with a fast-acting effect.
Slovenian: Zdravilo Actrapid je humani insulin s hitrodelujočim učinkom.
English: Actrapid contains less than 1 mmol sodium (23 mg) per dose, i.e. Actrapid is essentially ‘sodiumfree'.
Slovenian: Zdravilo Actrapid vsebuje natrij Zdravilo Actrapid vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni “brez natrija”.
English: What Actrapid is and what it is used for What you need to know before you use Actrapid How to use Actrapid
Slovenian: Kaj je zdravilo Actrapid in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Actrapid
English: • Always make sure that a drop appears at the needle tip before injection (picture 1B).
Slovenian: • Pred injiciranjem vedno preverite, da se je na konici igle pojavila kapljica (slika 1B).
English: How to use Actrapid Dose and when to take your insulin
Slovenian: Odmerek in kdaj uporabiti insulin
English: Checking the insulin flow
Slovenian: Preverjanje pretoka insulina
English: Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ne uporabite zdravila, če opazite, da raztopina ni bistra, brezbarvna in vodna.
English: ► Actrapid Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Slovenian: ► Vložki Actrapid Penfill so namenjeni za uporabo s sistemi za dajanje insulina Novo Nordisk in iglami NovoFine ali NovoTwist.
English: Uncommon - Peripheral neuropathy (painful neuropathy)
Slovenian: Bolezni živčevja občasni - periferna nevropatija (boleča nevropatija)
English: Just before use, roll the vial of intermediate- or long-acting (cloudy) insulin between your hands until the liquid is uniformly white and cloudy.
Slovenian: Vialo srednjedolgodelujočega ali dolgodelujočega (motnega) insulina tik pred uporabo zavrtite med dlanmi, dokler tekočina ni enakomerno bela in motna.
English: • Glucocorticoids (such as ‘cortisone' used to treat inflammation)
Slovenian: • glukokortikoide (na primer “kortizon”; uporabljajo se za zdravljenje vnetja),
English: Actrapid can be used in children and adolescents.
Slovenian: Uporaba pri otrocih in mladostnikih Zdravilo Actrapid se lahko uporablja pri otrocih in mladostnikih.
English: Actrapid is a fast-acting insulin.
Slovenian: Zdravilo Actrapid je hitrodelujoči insulin.
English: Inject the air into the vial containing Actrapid.
Slovenian: Injicirajte zrak v vialo z zdravilom Actrapid.
English: Draw into the syringe the same amount of air as the dose of Actrapid.
Slovenian: Potegnite v brizgo enako količino zraka, kot je odmerek zdravila Actrapid.
English: They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentrating, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Slovenian: Obsegajo lahko hladno znojenje, hladno bledo kožo, utrujenost, živčnost ali tremor, tesnobnost, nenavadno izčrpanost ali šibkost, zmedenost, težave s koncentracijo, zaspanost, čezmerno lakoto, motnje vida, glavobol, navzejo in palpitacije.
English: High blood sugar may occur if you:
Slovenian: Visok krvni sladkor se lahko pojavi, če: