natgillin/translations-raw huggingface dataset:
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Potreben je strokoven, TAKOJŠEN, kirurški poseg, ter morda tudi takojšnja incizija in izpiranje injiciranega mesta, zlasti če so prizadete tudi kite ali mehka tkiva prsta.
For whole herd vaccination, an injection of one dose may be administered per gilt, sow and boar every 4 months.
Za cepljenje cele črede se priporoča injicirati po en odmerek na mladico, svinjo in merjasca vsake 4
To reconstitute the vaccine, inject 3 ml of solvent into the small vial with the powder.
Za rekonstitucijo cepiva injicirajte 3 ml vehikla v vialo s praškom.
Basic vaccination of fattening pigs and breeding pigs (gilts, sows and boars):
Osnovno cepljenje prašičev pitancev in plemenskih prašičev (mladic, svinj in merjascev):
SPECIAL WARNING(S) Accidental injection is dangerous - see package insert before use.
POSEBNO(A) OPOZORILO(A) Nenamerno injiciranje je nevarno - pred uporabo preberite priložena navodila.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER SUBSTANCE(S)
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SESTAVIN
The vials are closed with a butyl rubber stopper and sealed with an aluminium cap.
Viale so zaprte z gumijastim zamaškom iz butila, zaščitenim z aluminijasto kapico.
• Inject one dose per fattening pig from the age of 10 weeks.
• Z enim odmerkom cepiva cepite prašiče pitance pri starosti 10 tednov.
46 µl,
46 μl
Any person intending to manufacture, import, possess, sell, supply and use Suvaxyn Aujeszky 783 + O/W must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati Suvaxyn Aujeszky 783 + O/W, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Live attenuated Aujeszky's disease virus
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Živ, atenuiran virus Aujeszkyjeve bolezni
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 ºC - 8 ºC).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
Shake gently to dissolve the vaccine and transfer the dissolved vaccine into the vial with the solvent.
Nežno pretresite, da se cepivo raztopi in prenesite raztopljeno cepivo nazaj v stekleničko z vehiklom.
Progeny of vaccinated gilts and sows derive a passive immunity via the colostrum and milk.
Potomci cepljenih svinj razvijejo pasivno imunost preko kolostruma in mleka.
BATCH NUMBER Lot {number}
ŠTEVILKA SERIJE Lot {številka}:
Cardboard box with 1 vial of powder and 1 bottle of solvent or 10 vials of powder and 10 bottles of solvent for injection.
Kartonska škatla z 1 vialo praška in 1 stekleničko vehikla ali z 10 vialami s praškom in 10 stekleničkami vehikla.
For intramuscular use.
Za intramuskularno dajanje.
Shelf-life of the veterinary medicinal product as packaged for sale (powder): 2 years.
Rok uporabnosti zdravila v pakiranju za prodajo (prašek): 2 leti.
INDICATION(S) Active and passive immunisation of pigs against Aujeszky's disease.
INDIKACIJE Aktivna in pasivna imunizacija prašičev proti Aujeszkyjevi bolezni.
Lot: {number} for the solvent:
Lot:{številka} za vehikel:
20 ml, 100 ml or 200 ml bottles of Type I hydrolytic glass containing solvent for the 10-doses, 50doses or 100-doses presentation or Type II glass rinsed with WFI containing solvent for the 50-doses and 100-doses presentation.
20 ml, 100 ml ali 200 ml stekleničke iz hidrolitičnega stekla (tip I), ki vsebujejo vehikel za 10, 50 ali 100 odmerkov cepiva ali iz stekla (tip II), ki so sprane z vodo za injekcije in vsebujejo vehikel za 50 in 100 odmerkov cepiva .
The manufacture, import, possession, sale, supply and/or use of Suvaxyn Aujeszky 783 + O/W may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba Suvaxyn Aujeszky 783 + O/W je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
Aluminium hydroxide Mineral oil (Marcol 52) Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80) Thiomersal
Mineralno olje (Marcol 52) Manidijev monooleat (Arlacel A) Polisorbat 80 (Tween 80) Tiomersal
Manufacturer responsible for the batch release: Zoetis Manufacturing & Research Spain, S.L.
Izdelovalec, odgovoren za sproščanje serij: Zoetis Manufacturing & Research Spain, S.L.
Shelf-life of the veterinary medicinal product as packaged for sale (solvent): 2 years.
Rok uporabnosti zdravila v pakiranju za prodajo (vehikel): 2 leti.
Administer by intramuscular injection of 1 dose (2 ml) per pig in the neck in the area behind the ear.
En odmerek (2 ml) na prašiča aplicirajte intramuskularno v vratni predel za ušesom.
METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use of 1 dose (2 ml) per pig.
NAČIN IN POT UPORABE 1 odmerek (2 ml) na prašiča apliciramo intramuskularno.
100 doses
100 odmerkov
EXPIRY DATE EXP {month/year}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP{ mesec/leto}
By reconstitution of the immunogen in the oil emulsion, the stimulation of immunity after injection is prolonged.
Po predhodni rekonstituciji zdravilne učinkovine v oljno emulzijo, se po injiciranju prolongira stimulacija imunosti.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
The active substance stimulates active immunity against Aujeszky's disease in pigs.
Zdravilna učinkovina povzroči nastanek aktivne imunosti proti Aujeszkyjevi bolezni pri prašičih.
Slight, transient and local reactions up to 2 cm in diameter after first vaccination and up to 5 cm after second vaccination may occur up to 50 % of the pigs.
Pri približno 50 % živali se lahko po cepljenju pokaže škodljiva reakcija v obliki 2 cm velike otekline po prvem cepljenju in 5 cm velike otekline po drugem cepljenju.
Use within one hour after reconstitution.
Po rekonstituciji je uporabno 1 uro.
• Inject one dose per gilt or sow during each gestation at 3-6 weeks before the expected date of farrowing.
• Injicirajte en odmerek na mladico ali svinjo v obdobju 3-6 tednov pred pričakovano gonitvijo • Injicirajte en odmerek na merjasca najmanj vsakih 6 mesecev.
Name and address of the manufacturers of the biological active substances Zoetis Manufacturing & Research Spain, S.L.
Ime in naslov izdelovalca biološke zdravilne učinkovine (zdravilnih učinkovin): Zoetis Manufacturing & Research Spain, S.L.
Powder for emulsion for injection:
Prašek za pripravo emulzije za injiciranje:
4.2 Indications for use, specifying the target species Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija prašičev, starih 10 tednov z namenom zmanjšanja pogina in klinične manifestacije zaradi Aujeszkyjeve bolezni ter za redukcijo prisotnosti virusa Aujeszkyjeve bolezni v okolju.
- Active immunity: The onset of immunity is from 3 weeks after basic vaccination.
- Aktivna imunost: Razvije se v 3 tednih po cepljenju.
The gE- (glycoprotein E negative) characteristic of the vaccine virus makes it possible to distinguish between antibodies induced by vaccination with this product and those induced by field infection with Aujeszky's disease virus, if the vaccine is used in association with an appropriate diagnostic test.
gE- (Glikoprotein E negativen) je značilen za cepivo in se odlikuje ravno v tem, da omogoča s specifičnim diagnostičnim testom potrditev prisotnosti protiteles, nastalih zaradi cepljenja in izključitev protiteles, pridobljenih z okužbo virusov Aujeszkyjeve bolezni iz okolja.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Name and address of the manufacturers responsible for batch release Zoetis Manufacturing & Research Spain, S.L.
Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije: Zoetis Manufacturing & Research Spain, S.L.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št. Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1.
ANNEX III LABELLING AND PACKAGE INSERT
OZNAČEVANJE IN NAVODILO ZA UPORABO
Solvent for emulsion for injection:
Vehikel za pripravo emulzije za injiciranje:
ATCvet code: QI09 AD01.
Farmakoterapevtska skupina: Oznaka ATCvet: QI 09 AD 01
1 vial with powder for injection (10 doses) and 1 bottle of solvent for injection (20 ml).
1 prebodna viala s praškom (10 odmerkov) in 1 prebodna steklenička z vehiklom (20 ml).
A transient increase in body temperature, up to about 40,5 oC and lasting for up to 2 days, may occur in a small number of pigs after vaccination.
Pri manjšem številu cepljenih živali lahko naraste telesna temperatura do 40,5 ˚C.
Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Aktivna imunizacija prašičev, starih 10 tednov z namenom zmanjšanja pogina in klinične manifestacije zaradi Aujeszkyjeve bolezni ter za redukcijo prisotnosti virusa Aujeszkyjeve bolezni v okolju.
ROUTE OF ADMINISTRATION For intramuscular use.
POT UPORABE ZDRAVILA Za intramuskularno dajanje.
PHARMACEUTICAL FORM Powder and solvent for emulsion for injection
Prašek in vehikel za pripravo emulzije za injiciranje
20 ml 100 ml 200 ml
200 ml
10 vials with powder for injection (each containing 100 doses) and 10 bottles of solvent for injection (each containing 200 ml).
10 prebodnih vial s praškom (v vsaki je 100 odmerkov) in 10 prebodnih stekleničk z vehiklom (vsaka vsebuje 200 ml)
10 vials with powder for injection (each containing 50 doses) and 10 bottles of solvent for injection (each containing 100 ml).
10 prebodnih vial s praškom (v vsaki je 50 odmerkov) in 10 prebodnih stekleničk z vehiklom (vsaka vsebuje 100 ml)
Live attenuated Aujeszky's disease virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion.
Živ, atenuiran virus Aujeszkyjeve bolezni, sev NIA3-783: ≥105.2.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Po dajanju si operite in razkužite roke in opremo.
Shelf life after reconstitution: Use within one hour.
Rok uporabe po rekonstituciji: 1 ura.
Passive immunisation of piglets from vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Pasivna imunizacija pujskov, katerih matere so bile cepljene, z namenom zmanjšanja pogina in manifestacije kliničnih znakov zaradi Aujeszkyjeve bolezni in za zmanjšanje prisotnosti virusa v okolju.
To avoid foaming, shake gently the vial after reconstitution of the freeze-dried component in the liquid component.
Da preprečite penjenje, pretresite raztopljeni prašek v vehiklu zelo nežno.
NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Aujeszky 783 + O/W, solvent for injection for pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Suvaxyn Aujeszky 783 + O/W, vehikel za pripravo emulzije za injiciranje Za prašiče.
PACKAGE LEAFLET Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection for pigs
Suvaxyn Aujeszky 783 + O/W, prašek in vehikel za pripravo emulzije za injiciranje za prašiče
SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Shranjujte nedosegljivo otrokom.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials for the powder: 10 doses, 50 doses, 100 doses
Viala za prašek: 10 odmerkov, 50 odmerkov, 100 odmerkov 1.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles for the solvent: 10 doses, 50 doses, 100 doses
Steklenička z vehiklom: 10 odmerkov, 50 odmerkov, 100 odmerkov 1.
One dose (2 ml) of reconstituted emulsion containing ≥ 105.2 CCID50 of live attenuated Aujeszky's disease virus strain NIA3-783 for each pig.
Živ, atenuiran virus Aujeszkyjeve bolezni, sev NIA3-783: 105.2.
SCIENTIFIC CONCLUSIONS FOR AMENDMENT OF PRODUCT INFORMATION
ZNANSTVENI ZAKLJUČKI ZA DOPOLNILO DOVOLJENJA ZA PROMET
The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in April 2005 further to the February USR and requested further changes.
CHMP je potrdil spremembe informacij o zdravilu, že vnešene z variacijo tipa II, sprejeto aprila 2005, po februarskem nujnem varnostnem ukrepu in zahteval še nadaljnje spremembe.
Further to the assessment of the data on serious skin reactions, parecoxib is associated with very rare occurrence of serious skin reactions, as evidenced in post-marketing surveillance.
Po vrednotenju podatkov o hudih kožnih reakcijah je parekoksib povezan z zelo redkim pojavljanjem hudih kožnih reakcij, kakor je razvidno iz postmarketinškega nadzora.
Further to a request from the European Commission, the scope of the ongoing class review was broadened to include the assessment of serious skin reactions in addition to the cardiovascular safety aspects.
Na zahtevo Evropske komisije se je obseg revizije skupine zdravil v teku še razširil, tako da poleg vidikov kardiovaskularne varnosti zajema tudi vrednotenje hudih kožnih reakcij.
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.
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.
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.
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.
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.
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.
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,
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.
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.
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,
ATC code: A10AB01.
Oznaka ATC: A10AB01.
At the request of the European Medicines Agency.
• na zahtevo Evropske agencije za zdravila;
Date of latest renewal: 18 September 2007
Datum prve odobritve: 7. oktober 2002 Datum zadnjega podaljšanja: 18. september 2007
If not, change the needle and repeat the procedure no more than 6 times.
Če se ne, zamenjajte iglo in ponovite postopek, vendar ne več kot 6 krat.
The data are limited but suggest that the pharmacokinetic profile in children and adolescents may be similar to that in adults.
Podatkov je malo, vendar nakazujejo, da utegne biti farmakokinetični profil pri otrocih in mladostnikih podoben kot pri odraslih.
Actrapid which has been frozen must not be used.
Zdravila Actrapid, ki je bilo zamrznjeno, ne smete uporabiti.
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.
Ustreznim osebam povejte, da imate sladkorno bolezen in kakšne so lahko posledice, vključno s tveganjem, da se onesvestite (izgubite zavest) zaradi nizkega krvnega sladkorja.
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.
Delovati začne v ½ ure, največji učinek doseže v 1,5-3,5 urah, celotni čas delovanja pa je približno 78 ur.
• Drink alcohol, see Actrapid with alcohol in section 2.
• pijete alkohol, glejte podpoglavje Zdravilo Actrapid skupaj z alkoholom v poglavju 2.
The maximum plasma concentration is reached within 1.5-2.5 hours after subcutaneous administration.
Absorpcija Največja koncentracija v plazmi je dosežena v 1,5 do 2,5 urah po subkutani aplikaciji.
It is therefore recommended that the diabetic patient always carries sugar-containing products.
Zato je priporočljivo, da bolniki s sladkorno boleznijo vedno nosijo pri sebi živila, ki vsebujejo sladkor.
Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters.
Potreba po insulinu se v prvem trimesečju ponavadi zmanjša, nato pa se v drugem in tretjem trimesečju zveča.
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).
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.
Trials have indicated a t½ of about 2-5 hours.
Preskušanja so pokazala, da t1/2 znaša približno 2-5 ur.
Although stable over time, a certain amount of insulin will initially be adsorbed to the material of the infusion bag.
Kljub časovni stabilnosti se določena količina insulina na začetku adsorbira na material infuzijske vrečke.
Name and address of the manufacturers of the biological active substance Novo Nordisk A/S
Ime in naslov izdelovalcev biološke zdravilne učinkovine Novo Nordisk A/S
If not, talk to your doctor.
Če ne mine, se pogovorite z zdravnikom.
Actrapid dosing is individual and determined in accordance with the needs of the patient.
Odmerjanje zdravila Actrapid je individualno in določeno skladno z bolnikovimi potrebami.
Withdraw the needle from the skin, then release the pressure on the push-button.
Izvlecite iglo iz kože in nato spustite potisni gumb.
Subcutaneous injection into the abdominal wall ensures a faster absorption than other injection sites.
Subkutano injiciranje v trebušno steno zagotovi hitrejšo absorpcijo kot injiciranje na drugih mestih.
However, there were differences between age groups in Cmax, stressing the importance of individual dose titration.
Cmax pa se je med starostnima skupinama razlikovala, kar poudarja pomembnost individualnega titriranja odmerka.
• Forget to inject your insulin or stop taking insulin.
• si pozabite injicirati insulin ali ga nehate uporabljati,