natgillin/translations-raw huggingface dataset:
In all of the studies, IDflu was compared with another flu vaccine given by injection into a muscle.
V vseh študijah so zdravilo IDflu primerjali z drugim cepivom proti gripi, ki je bilo injicirano v mišico.
The studies compared the ability of the two vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before injection and three weeks afterwards.
V študiji so primerjali učinkovitost obeh cepiv pri sprožanju nastanka protiteles (imunogenosti), tako da so primerjali ravni protiteles pred injiciranjem in tri tedne po njem.
In all studies, both IDflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
V vseh študijah so bile pri zdravilu IDflu in primerjalnem cepivu koncentracije protiteles ustrezne za zaščito proti vsem trem sevom gripe.
In adults below 60 years, the 9-microgram strength provided as good a level of protection as the intramuscular vaccine.
Pri odraslih, mlajših od 60 let, je 9- mikrogramski odmerek zagotovil tako dobro zaščito kot intramuskularno cepivo.
In people aged 60 years and over, the 15-microgram strength provided as good a level of protection as the intramuscular vaccine.
Pri odraslih, mlajših od 60 let, je 15 - mikrogramski odmerek zagotovil tako dobro zaščito kot intramuskularno cepivo.
The most common side effects with IDflu (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), malaise (feeling unwell) and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching).
Najpogostejši neželeni učinki zdravila IDflu (opaženi pri več kot 1 bolniku izmed 10) so glavobol, mialgija (bolečine v mišicah), slabo počutje in lokalne reakcije na mestu cepljenja (pordelost, oteklost, otrdelost kože, bolečina in srbenje).
For the full list of all side effects reported with IDflu, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila IDflu, glejte navodilo za uporabo.
IDflu should not be used in people who may be hypersensitive to the active substances, any of the other ingredients, egg, chicken protein, neomycin (an antibiotic), formaldehyde (a preservative) or octoxinol 9 (a detergent).
Zdravila IDflu ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilno učinkovino, katero koli drugo sestavino zdravila, jajca, kokošje beljakovine, neomicin (antibiotik), formaldehid (konzervans) ali oktoksinol 9 (detergent).
People who have a fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.
Osebe z vročino ali akutno (kratkotrajno) okužbo ne smejo prejeti cepiva, dokler ne ozdravijo.
The Committee for Medicinal Products for Human Use (CHMP) decided that IDflu’ s benefits are greater than its risks for the prophylaxis of influenza in adults up to 59 years of age and in individuals 60 years of age and over, especially those who run an increased risk of associated complications.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila IDflu pri zaščiti proti gripi pri odraslih, mlajših od 59 let, in posameznikih, starih 60 let ali več, zlasti tistih, pri katerih obstaja povečano tveganje za zaplete, povezane z gripo, večje od z njim povezanih tveganj.
The Committee recommended that IDflu be given marketing authorisation.
Odbor je priporočil, da se za zdravilo IDflu odobri dovoljenje za promet.
Other information about IDflu:
Druge informacije o zdravilu IDflu:
The European Commission granted a marketing authorisation valid throughout the EU for IDflu to Sanofi Pasteur SA on 24 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom IDflu, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pasteur MSD SNC dne 24. februarja 2009.
The full EPAR for IDflu can be found here.
Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo IDflu je na voljo tukaj.
Pharmaceutica l Form
Izmišljeno ime Jakost
9 microgram/ strain
9 mikrogramov/ sev
15 microgram/ strain
15 mikrogramov/ sev
IDflu 9 microgram/ strain suspension for injection Influenza vaccine (split virion, inactivated)
Zdravilo IDflu 9 mikrogramov/ sev suspenzija za injiciranje Cepivo proti gripi (razgrajen virion, inaktiviran)
Split Influenza virus*, inactivated, containing antigens equivalent to the following strains:
Razgrajen virus gripe *, inaktiviran z antigeni, ki ustrezajo naslednjim sevom:
A/ New Caledonia/ 20/ 99 (H1N1) like strain (A/ New Caledonia/ 20/ 99 (IVR-116)) 9 micrograms HA**
A/ New Caledonia/ 20/ 99 (H1N1), podoben sevu (A/ New Caledonia/ 20/ 99 (IVR- 116)) 9 mikrogramov HA **
A/ Wisconsin/ 67/ 2005 (H3N2) like strain (A/ Wisconsin/ 67/ 2005 (NYMC X-161)) 9 micrograms HA**
A/ Wisconsin/ 67/ 2005 (H3N2), podoben sevu (A/ Wisconsin/ 67/ 2005 (NYMC X- 161)) 9 mikrogramov HA **
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004) 9 micrograms HA**
B / Malaysia/ 2506/ 2004, podoben sevu (B/ Malaysia/ 2506/ 2004) 9 mikrogramov HA **
Per 0.1 ml dose
na 0, 1 ml odmerka
* propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin
* razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat ** hemaglutinin
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2006/ 2007 season.
Cepivo ustreza priporočilom Svetovne zdravstvene organizacije (severna polobla) in Odločbi EU za sezono 2006/ 2007.
Prophylaxis of influenza in adults up to 59 years of age, especially in those who run an increased risk of associated complications.
Zaščita proti gripi pri odraslih, starih do 59 let, še zlasti tistih, pri katerih obstaja povečano tveganje za z gripo povezane zaplete.
The use of IDflu should be based on official recommendations.
Uporaba zdravila IDflu mora temeljiti na uradnih priporočilih.
Adults up to 59 years of age:
Odrasli stari do 59 let:
For instructions for use, see section 6.6.
Za navodila za uporabo glejte poglavje 6. 6.
Hypersensitivity to the active substances, to any of the excipients, to egg, chicken proteins, neomycin, formaldehyde and octoxinol 9.
Preobčutljivost na zdravilno učinkovino, na katero koli pomožno snov, na jajca, piščančje beljakovine, neomicin, formaldehid in oktoksinol 9.
IDflu does not contain more than 0.05 microgram ovalbumin per dose.
Zdravilo IDflu ne vsebuje več kot 0, 05 mikrograma ovalbumina na odmerek.
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.
Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju.
IDflu should under no circumstances be administered intravascularly.
Zdravilo IDflu se pod nobenim pogojem ne sme dajati intravaskularno.
For IDflu no clinical data on exposed pregnancies are available.
Za zdravilo IDflu ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
In general data from intramuscular influenza vaccinations in pregnant women do not indicate adverse fetal and maternal outcomes attributable to the vaccine.
Na splošno podatki o intramuskularnih cepivih proti gripi pri nosečnicah ne kažejo neželenih učinkov na plod in mater, ki bi se jih lahko pripisalo cepivu.
One animal study with IDflu did not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/ fetal development, parturition or postnatal development.
Ena študija na živalih z zdravilom IDflu ni kazala neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj embria/ fetusa, kotitev ali razvoj po skotitvi.
The use of IDflu may be considered from the second trimester of pregnancy.
Zdravilo IDflu se lahko uporablja od drugega trimesečja nosečnosti dalje.
For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
Pri nosečnicah z zdravstvenimi stanji, ki povečajo tveganje za zaplete zaradi gripe, se priporoča cepljenje s cepivom ne glede na stopnjo nosečnosti.
The vaccine IDflu may be used during breast-feeding.
Cepivo IDflu se lahko uporablja med dojenjem.
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
Cepivo najverjetneje ne vpliva na sposobnost vožnje ali uporabe strojev.
Adverse reactions observed from clinical trials
Neželeni učinki, ki so jih opazili v kliničnih preskušanjih
The safety of IDflu has been assessed in 2 open-label randomised clinical trials in which 2,384 vaccinees received an injection of IDflu.
Varnost zdravila IDflu je bila ocenjena v 2 odprtih, randomiziranih kliničnih preskušanjih, v katerih je bilo 2384 oseb cepljenih z zdravilom IDflu.
3 Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up.
3 Ocena varnosti se je izvajala za vse osebe v prvih 3 tednih po cepljenju, resne neželene reakcije pa so se beležili v šestmesečnem obdobju spremljanja.
Apparent local reactions after intradermal administration were more frequent than after the comparator vaccine administered intramuscularly.
Očitne lokalne reakcije so bile po tem, ko je bilo cepivo odmerjeno intradermalno, bolj pogoste kot pri primerjanem cepivu, odmerjenem intramuskularno.
Systemic safety profile of IDflu is similar to the comparator vaccine administered intramuscularly.
Sistemski profil varnosti zdravila IDflu je podoben primerjanemu cepivu, ki se daje intramuskularno.
After repetitive yearly injections the safety profile of IDflu is similar to the previous injections.
Po ponovnem vsakoletnem cepljenju je bil profil varnosti zdravila IDflu podoben prejšnjim injekcijam.
The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination, using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from available data).
Spodnji podatki so povzetek pogostnosti neželenih učinkov, ki so jih zabeležili po cepljenju po naslednjem dogovoru: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥1/ 1000 do < 1/ 100); redki (≥ 1/ 10000 do < 1/ 1000); zelo redki (< 1/ 10000); neznani (se jih ne da oceniti na podlagi razpoložljivih podatkov).
Very common
Zelo pogosti,
Common
Pogosti,
Uncommon
Občasni,
Rare
Redki,
Very rare
Zelo redki,
Lymphadenopath y
Limfadenopatija
Nervous system disorders
Bolezni živčevja Bolezni kože in podkožja
Paresthesia
Znojenje
Skin and subcutaneous tissue disorders
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Pruritus, rash
Mialgija
Sweating
Artralgija
Musculoskeletal and connective tissue disorders
Splošne težave in spremembe na mestu aplikacije
Myalgia
Slabo počutje
Arthralgia
Mrzlica, povišana telesna temperatura,
General disorders and
Astenija
Malaise,
Lokalne
Shivering, fever,
reakcije:
Asthenia
Lokalne
administration site conditions
pordelost *, reakcije:
Local reactions: redness*, swelling, induration pain, pruritus
oteklost, induracija, bolečina, pruritus
Local reactions: ecchymosis
ehimoza
* In some cases, local redness lasted up to 7 days
* V nekaterih primerih je lokalna pordelost trajala do 7 dni
Adverse reactions from Post-Marketing surveillance
Neželene reakcije iz opazovanega obdobja po začetku trženja
There is no safety data from post-marketing experience with IDflu.
Podatkov o varnosti iz izkušenj po začetku trženja z zdravilom IDflu ni.
However, based on the experience with trivalent inactivated influenza vaccines administered by intramuscular or deep subcutaneous injection, systemic reactions, not listed above, may be reported:
Vendar pa lahko na podlagi izkušenj s trivalentnimi inaktiviranimi cepivi proti gripi, ki se dajejo v obliki intramuskularne ali globoke subkutane injekcije, poročajo o sistemskih reakcijah, ki niso opisane zgoraj:
Blood and lymphatic system disorders Transient thrombocytopenia
Bolezni krvi in limfatičnega sistema prehodna trombocitopenija
Immune system disorders Allergic reactions, in rare cases leading to shock, angioedema
Bolezni imunskega sistema alergijske reakcije, ki so v redkih primerih povzročile šok, angioedem
4 Nervous system disorders Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
4 Bolezni živčevja nevralgija, febrilne konvulzije, nevrološke motnje kot je encefalomielitis, nevritis in Guillain- Barréjev sindrom
Vascular disorders Vasculitis associated in very rare cases with transient renal involvement
Žilne bolezni vaskulitis, v zelo redkih primerih povezan s prehodno prizadetostjo ledvic
Skin and subcutaneous tissue disorders Generalised skin reactions including urticaria
Bolezni kože in podkožja generalizirane kožne reakcije, vključno z urtikarijo
Influenza vaccines, ATC code:
Cepiva proti gripi, oznaka ATC:
J07BB02
J07BB02.
The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6- 12 months.
Po cepljenju se trajanje imunosti na homologne seve ali na seve, ki so tesno povezani s sevi cepiva, razlikuje, običajno pa traja od 6 do 12 mesecev.
In a randomised comparative phase III trial, 1,796 subjects from 18 to 59 years of age received 0.1 ml of IDflu by intradermal route and 453 subjects from 18 to 59 years of age received 0.5 ml of trivalent inactivated influenza vaccine administered by intramuscular route.
V randomiziranih primerjalnih preskušanjih faze III je 1796 oseb, starih od 18 do 59 let, prejelo 0, 1 ml zdravila IDflu intradermalno, 453 oseb, starih od 18 do 59 let, pa je prejelo 0, 5 ml trivalentno inaktiviranega cepiva gripe po intramuskularni poti.
In this comparative trial the seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
V tem primerjalnem preskušanju so ocenili stopnjo serozaščite *, serokonverzijo ali značilne stopnje povečanja ** in razmerje geometričnega povprečja titrov (GMTR) za protitelesa anti- HA (izmerjeno z uporabo metode HI) v skladu s predhodno opredeljenimi kriteriji.
Data were as follows (values in brackets show the 95% confidence intervals):
Pridobili so naslednje podatke (vrednosti v oklepajih kažejo 95% intervale zaupanja):
Strain specific anti-HA
Za sev specifično protitelo anti -
antibody
HA Stopnja serozaščite
A/ New Caledonia/ 20/ 99 N=1,296
A/ New Caledonia / 20/ 99 N = 1296 87, 2%
A/ Wisconsin/ 67/ 2005 N=1,297
A/ Wisconsin / 67/ 2005 N = 1297 93, 5%
B/ Malaysia/ 2506/ 2004 N=1,294
B/ Malaysia / 2506/ 2004 N = 1294 72, 9%
Seroprotection rate
(85, 2; 89, 0) 57, 5%
87.2% (85.2, 89.0)
(92, 0; 94, 8) 66, 5%
93.5% (92.0, 94.8)
(70, 4; 75, 3) 56, 7%
72.9% (70.4, 75.3)
(63, 8; 69, 0)
Seroconversion/ Significant increase rate GMTR
(54, 0; 59, 4)
57.5% (54.7, 60.2) 9.17 (8.33, 10.1)
(8, 33; 10, 1)
66.5% (63.8, 69.0) 11.5 (10.4, 12.7)
(10, 4; 12, 7)
56.7% (54.0, 59.4) 6.39 (5.96, 6.84)
(5, 96; 6, 84)
Geometric mean titre ratio of individual (post-/ pre-vaccination titre).
* Serozaščita = HI titri ≥ 40 ** Serokonverzija = negativni titer HI pred cepljenjem in titer po cepljenju ≥ 40, značilno povečanje = pozitivni titri HI pred cepljenjem in vsaj 4- povečanje titra HI po cepljenju GMTR (geometric mean titer ratio): razmerje geometričnega povprečja titra posameznika (titri pred cepljenjem in po njem).
IDflu is as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 18 to 59 years of age.
Zdravilo IDflu je enako imunogeno kot primerjano trivalentno inaktivirano cepivo gripe, ki se daje intramuskularno, za vse 3 seve gripe pri osebah, starih od 18 do 59 let.
5 Across all three influenza strains, for the comparator intramuscular vaccine seroprotection rates ranged between 74.8% and 95.4%, seroconversion or significant increase rates ranged between 56.4% and 69.3% and GMTRs ranged between 6.63 and 11.2-fold over baseline HI titres.
5 Za vse tri seve gripe so se stopnje serozaščite primerjanega intramuskularnega cepiva gibale med 74, 8% in 95, 4%, serokonverzija ali značilne stopnje povečanja so se gibale med 56, 4% in 69, 3% in GMTR med 6, 63 in 11, 2- krat nad izhodiščem titrov HI.
Nevertheless, single and repeated administration led to transient local erythema and oedema.
Vendar pa je enkratno in večkratno dajanje povzročilo prehodni lokali eritem in edem.
Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
natrijev klorid kalijev klorid natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
0.1 ml of suspension in a pre-filled syringe (type I 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.
0, 1 ml suspenzije v napolnjeni brizgi (steklo tipa I) s sistemom za mikro- injiciranje, s pritrjeno mikro - iglo, opremljeno z batom iz elastomera (klorobutil), s pokrovom konice (termoplastični elastomer in polipropilen) in sistemom za zaščito igle.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Kakršno koli neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi zahtevami
6 It is not necessary to shake the vaccine before use.
6 Cepiva pred uporabo ni potrebno pretresati.
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.
The needle shielding system is designed to cover the micro-needle after use.
Sistem za zaščito igle je zasnovan tako, da po uporabi mikro- iglo pokrije.
Finger pads
Okence
Plunger
Prstne blazinice
Window
Bat
Needle shield
Zaščita igle
Needle cap
Pokrov
Flange
Prirobni
7 INSTRUCTIONS FOR USE
7 NAVODILA ZA UPORABO
Please read the instruction before use
Pred uporabo preberite navodila 2 / SISTEM ZA MIKROINJICIRANJE DRŽITE 1 / ODSTRANITE POKROV IGLE
Remove the needle
Pokrov igle odstranite s sistema za mikroinjiciranje.
2/ HOLD MICRO-INJECTION SYSTEM BETWEEN THUMB & MIDDLE FINGER
Ne spuščajte
cap from the Micro-Injection System.
MED PALCEM IN SREDINCEM
Hold the system by placing the thumb and middle finger only on the finger pads; the
Sistem držite tako, da ga nastavite med palec in sredinec samo na blazinice za prste; kazalec ostane prost.
Do not purge air through the needle.
zraka skozi iglo.
index finger remains free.
Pazite, da okenc ne zakrijete s prsti.
3/ INSERT NEEDLE RAPIDLY PERPENDICULAR TO THE SKIN
3 / IGLO HITRO PRAVOKOTNO VSTAVITE SKOZI KOŽO
4/ INJECT USING THE INDEX FINGER Once the micro-needle
4 / INJICIRAJTE S KAZALCEM
has been inserted, maintain a light pressure on the surface of the skin and inject using the index finger to push on the plunger.
Ko mikroiglo vstavite, vzdržujte rahel pritisk na površini kože in injicirajte cepivo s kazalcem, s katerim pritiskate na bat.
5/ ACTIVATE NEEDLE SHIELD BY PUSHING FIRMLY ON PLUNGER Remove the needle from the skin.
5 / S ČVRSTIM PRITISKOM NA BAT AKTIVIRAJTE ZAŠČITO IGLE
Orient the needle away from you and others.
Iglo odstranite s kože.
With the same hand, push very firmly with the thumb on the plunger to activate the needle shield.
Iglo obrnite proč od sebe in drugih.
You hear a click and a shield comes out to cover the needle.
Z isto roko čvrsto pritisnite palec na bat, da aktivirate zaščito igle.
Immediately dispose of the system in the nearest sharps collector.
Ko bo zaščita izskočila in pokrila iglo, boste zaslišali klik.
Click Injection is considered successful whether or not the presence of a wheal is observed.
Nemudoma odstranite sistem v najbližji koš za ostre predmete.
Activated needle shield
Aktivirajte zaščito igle
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F- 69007 Lyon, Francija.
IDflu 15 microgram/ strain suspension for injection Influenza vaccine (split virion, inactivated)
Zdravilo IDflu 15 mikrogramov/ sev, suspenzija za injiciranje Cepivo proti gripi (razgrajen virion, inaktiviran)
A/ New Caledonia/ 20/ 99 (H1N1) like strain (A/ New Caledonia/ 20/ 99 (IVR-116)) 15 micrograms HA**
A/ New Caledonia/ 20/ 99 (H1N1), podoben sevu (A/ New Caledonia/ 20/ 99 (IVR- 116)) 15 mikrogramov HA **
A/ Wisconsin/ 67/ 2005 (H3N2) like strain (A/ Wisconsin/ 67/ 2005 (NYMC X-161)) 15 micrograms HA**
A/ Wisconsin/ 67/ 2005 (H3N2), podoben sevu (A/ Wisconsin/ 67/ 2005 (NYMC X- 161)) 15 mikrogramov HA **
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004) 15 micrograms HA**
B / Malaysia/ 2506/ 2004, podoben sevu (B/ Malaysia/ 2506/ 2004) 15 mikrogramov HA **
Individuals 60 years of age and over:
Odrasli starejši od 60 let:
10 4.3 Contraindications
10 4. 3 Kontraindikacije
The safety of IDflu has been assessed in 2 open-label randomised clinical trials, 2,974 vaccinees received an injection of IDflu.
Varnost zdravila IDflu je bila ocenjena v 2 odprtih, randomiziranih kliničnih preskušanjih, v katerih je bilo 2974 oseb cepljenih z zdravilom IDflu.
Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and serious adverse reactions were collected during six months of follow-up.
Ocena varnosti se je izvajala za vse osebe v prvih 3 tednih po cepljenju, resne neželene reakcije pa so se beležili v šestmesečnem obdobju spremljanja.
11 Systemic safety profile of IDflu is similar to the comparator vaccine administered intramuscularly.
Sistemski profil varnosti zdravila IDflu je podoben primerjanemu cepivu, ki se daje intramuskularno.
After repetitive yearly injections the safety profile of IDflu is similar to the previous injections.
11 Po ponovnem vsakoletnem cepljenju je bil profil varnosti zdravila IDflu podoben prejšnjim injekcijam.
The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination, using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1000); very rare (< 1/ 10,000), not known (cannot be estimated from available data).
Spodnji podatki so povzetek pogostnosti neželenih učinkov, ki so jih zabeležili po cepljenju po naslednjem dogovoru: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥1/ 1000 do < 1/ 100); redki (≥ 1/ 10000 do < 1/ 1000); zelo redki (< 1/ 10000); neznani (se jih ne da oceniti na podlagi razpoložljivih podatkov).
Pruritus, rash
Pruritus, izpuščaj
Local reactions: redness*, induration swelling, pruritus, pain
Mrzlica, povišana telesna
Malaise, shivering, fever, Local reactions: ecchymosis
pordelost *, induracija, oteklost, pruritus, bolečina,
Fatigue
Lokalne reakcije: ehimoza
*In some cases, local redness lasted up to 7 days.
* V nekaterih primerih je lokalna pordelost trajala do 7 dni
Blood and lymphatic system disorders Transient thrombocytopenia, transient lymphadenopathy
Bolezni krvi in limfatičnega sistema prehodna trombocitopenija, prehodna limfadenopatija
Nervous system disorders Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain Barré syndrome
Bolezni živčevja nevralgija, febrilne konvulzije, nevrološke motnje kot je encefalomielitis in Guillain- Barréjev sindrom
12 4.9 Overdose
12 4. 9 Preveliko odmerjanje