natgillin/translations-raw huggingface dataset:
The tablets should be taken with water.
Tablete pogoltnite z vodo.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Noseč in dojenje nost Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
Tell your doctor if you are pregnant, think you might be pregnant or if you intend to become pregnant.
Povejte zdravniku, č ste noseč č menite, da bi lahko bili noseč ali č nameravate zanositi.
Your doctor will then discuss with you if you should continue to take Oprymea.
Zdravnik se bo z vami pogovoril o tem, ali naj zdravljenje z zdravilom Oprymea nadaljujete.
The effect of Oprymea on the unborn child is not known.
Uč zdravila Oprymea na nerojenega otroka ni znan.
Therefore, do not take Oprymea if you are pregnant unless your doctor tells you to do so.
Č ste noseč ne jemljite zdravila Oprymea,
Oprymea is not recommended during breast-feeding.
razen č vam je tako svetoval zdravnik. e
Oprymea can reduce the production of breast milk.
Č dojite, zdravila Oprymea ne smete jemati, saj lahko zavira nastajanje mleka.
Also, it can pass into the breast milk and can reach your baby.
Poleg tega se lahko e izloč v mleko in ga skupaj z njim zauž tudi otrok.
If treatment with Oprymea is unavoidable, breast-feeding must be stopped.
Č se jemanju ne morete izogniti, morate
If affected, do not drive or use machines.
prenehati dojiti.
Oprymea has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’ s disease.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Oprymea lahko povzročhalucinacije (pojav, pri katerem vidite, sliš ali č nekaj, č
If you experience these side effects, you must not drive or operate machinery.
Č se pojavijo pri vas, ne vozite in ne upravljajte strojev. e Pramipeksol so zlasti pri bolnikih s Parkinsonovo boleznijo povezovali z zaspanostjo in epizodami nepremagljivega spanca.
Please tell your doctor if this occurs.
Č te než morate obvestiti zdravnika.
HOW TO TAKE OPRYMEA
elene uč
Always take Oprymea exactly as your doctor has told you.
opazite, ne smete voziti ali upravljati strojev.
You should check with your doctor or pharmacist if you are not sure.
O njih inke
Parkinson’ s disease The daily dose is to be taken divided into 3 equal doses.
KAKO JEMATI ZDRAVILO OPRYMEA
103 During the first week, the usual dose is 1 tablet Oprymea 0.088 mg three times a day (equivalent to 0.264 mg daily):
103 1. teden Število tablet Skupni dnevni odmerek
1 tablet Oprymea 0.088 mg three times a day 0.264
1 tableta zdravila Oprymea po 0, 088 mg 3- krat na dan 0, 264 mg
This will be increased every 5 – 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
Odmerek boste po zdravnikovih navodilih vsakih 5 do 7 dni poveč evali, dokler ne bodo simptomi minili (vzdrž evalni odmerek).
1 tablet Oprymea 0.18 mg three times a day OR 2 tablets Oprymea 0.088 mg three times a day
1 tableta zdravila Oprymea po 0, 18 mg 3- krat na dan ALI 2 tableti zdravila Oprymea po 0, 088 mg 3- krat na dan
1 tablet Oprymea 0.35 mg three times a day OR 2 tablets Oprymea 0.18 mg three times a day
1 tableta zdravila Oprymea po 0, 35 mg 3- krat na dan ALI 2 tableti zdravila Oprymea po 0, 18 mg 3- krat na dan
Total daily dose (mg)
0, 54 mg
0.54
1, 1 mg
1.1
ajni
The usual maintenance dose is 1.1 mg per day.
evalni odmerek je 1, 1 mg na dan.
However, your dose may have to be increased even further.
Vč je treba odmerek š poveč Zdravnik vam asih e ati.
If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day.
Mož je tudi zdravljenje z manjš
A lower maintenance dose of three Oprymea 0.088 mg tablets a day is also possible.
vzdrževalnim odmerkom, in sicer s tremi tabletami zdravila Oprymea po 0, 088 mg na dan.
Lowest maintenance dose
Najmanjšvzdrž
Highest maintenance dose
Največ vzdrž ji
1 tablet Oprymea 0.088 mg three times a day
1 tableta zdravila Oprymea po 0, 088 mg 3- krat na dan
1 tablet Oprymea 1.1 mg three times a day
1 tableta zdravila Oprymea po 1, 1 mg 3- krat na dan
0.264
0, 264 mg
3.3
3, 3 mg
Patients with kidney disease If you have moderate or severe kidney disease, your doctor will prescribe a lower dose.
V tem
In this case, you will have to take the tablets only once or twice a day.
primeru boste tablete jemali samo 1- krat ali 2- krat na dan.
If you have moderate kidney disease, the usual starting dose is 1 tablet Oprymea 0.088 mg twice a day.
Pri hudi ledvič bolezni
In severe kidney disease, the usual starting dose is just 1 tablet Oprymea 0.088 mg a day.
je obič odmerek 1 tableta zdravila Oprymea po 0, 088 mg na dan. ajni
If you take more Oprymea than you should If you accidentally took too many tablets:
Č ste vzeli več odmerek zdravila Oprymea, kot bi smeli e ji Č ste nenamerno vzeli več e tablet, kot bi smeli:
- Contact your doctor or nearest hospital casualty department immediately for advice.
- nemudoma vpraš za nasvet svojega zdravnika ali v najbliž bolniš
- You may experience vomiting, restlessness, or any of the side effects as described in section 4.
- boste morda bruhali, obč nemir ali pa se bo pojavil kateri od než
"Possible side effects".
inki ".
If you forget to take Oprymea Do not worry.
Č ste pozabili vzeti zdravilo Oprymea e Naj vas ne skrbi.
Do not take a double dose to make up for a forgotten tablet.
Odmerek izpustite in naslednjega vzemite ob predvidenem č Ne vzemite asu. dvojnega odmerka, č ste pozabili vzeti prejš odmerek.
If you stop taking Oprymea Do not stop taking Oprymea without first talking to your doctor.
Č ste prenehali jemati zdravilo Oprymea e Zdravilo Oprymea ne prenehajte jemati brez posveta s svojim zdravnikom.
If you have to stop taking this medicine, your doctor will reduce the dose gradually.
Č ga morate prenehati e jemati, vam bo zdravnik postopno zmanjš odmerek.
This reduces the risk of worsening symptoms.
Tako prepreč nevarnost, da bi se simptomi poslabš ali.
If you suffer from Parkinson’ s disease you should not stop treatment with Oprymea abruptly.
Č imate Parkinsonovo bolezen, zdravljenja z zdravilom Oprymea ne smete nenadoma prekiniti. e Nenadna prekinitev lahko povzročrazvoj bolezenskega stanja, imenovanega nevroleptič
A sudden stop could cause you to develop a medicinal condition called neuroleptic malignant syndrome which may represent a major health risk.
maligni sindrom, ki lahko predstavlja več nevarnost za zdravje.
The symptoms include:
Simptomi so: jo
- akinesia (loss of muscle movement),
- akinezija (nezmož gibanja),
- rigid muscles,
- zmedenost,
- fever,
- zmanjš zavest (npr. koma).
- unstable blood pressure,
ana
- tachycardia (increased heart rate),
Č imate dodatna vpraš o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom. e anja
- confusion,
MOŽ NEŽ NI ELENI UČINKI
- depressed level of consciousness (e. g. coma).
Než eleni uč so navedeni v skupinah po pogostosti: inki
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Pojavijo se pri več 1 od 10 bolnikov kot Pojavijo se pri 1 do 10 bolnikih od 100 bolnikov
POSSIBLE SIDE EFFECTS
asni Redki
Like all medicines, Oprymea can cause side effects, although not everybody gets them.
Pojavijo se pri 1 do 10 bolnikih od 1. 000 bolnikov Pojavijo se pri 1 do 10 bolnikih od 10. 000 bolnikov
Uncommon:
Zelo redki Neznani:
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from available data
Pojavijo se pri manj kot 1 bolniku od 10. 000 bolnikov pogostosti iz razpolož ljivih podatkov ni mogoč oceniti e
You may experience the following side effects (regardless of indication):
eleni uč ki bi se lahko pojavili (ne glede na indikacijo): inki,
- Hallucinations (seeing, hearing or feeling things that are not there)
- halucinacije (pojav, pri katerem vidite, sliš ali č nekaj, č ni),
- Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
- sprememba vzorca spanja (npr. nespeč ali zaspanost),
- Excess of fluid, usually in the legs (peripheral oedema)
- preveč tekoč obič v nogah (periferni edem),
- Constipation
- zaprtje.
Uncommon:
Obč asni:
- Paranoia (e. g. excessive fear for one’ s own well-being)
- paranoja (npr. prevelik strah za lastno blaginjo),
- Hyperkinesia (increased movements and inability to keep still)
- hiperkinezija (č ezmerni gibi in nezmož mirovanja),
- Weight increase
- poveč spolno pož
- Increased sexual desire (e. g. increased libido)
elenje (npr. poveč libido), an
- Allergic reactions (e. g. rash, itching, hypersensitivity)
- alergijske reakcije (npr. izpušaj, srbenje, preobč
Unknown frequency:
Redki:
- Pathological gambling, especially in patients with Parkinson’ s disease taking high doses of
- patološ hazardiranje, zlasti pri bolnikih s Parkinsonovo boleznijo, ki jemljejo velike odmerke
Oprymea
ko zdravila Oprymea,
- Abnormal behaviour
- nenormalno vedenje,
- Increased eating (binge eating, hyperphagia)
ano ivanje hrane (prenajedanje, hiperfagija).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE OPRYMEA
SHRANJEVANJE ZDRAVILA OPRYMEA
Do not use Oprymea after the expiry date which is stated on the packaging.
Oprymeo ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
The expiry date refers to the last day of that month.
Datum izteka roka uporabnosti se nanaš na zadnji dan navedenega meseca. a
Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvrečv odpadne vode ali med gospodinjske odpadke.
Ask your pharmacist how to dispose of medicines no longer required.
zdravila, ki ga ne potrebujete večse posvetujte s farmacevtom.
These measures will help to protect the environment.
Takš ukrepi pomagajo varovati okolje.
- The active substance is pramipexole.
- Zdravilna uč inkovina je pramipeksol.
Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg
1 tableta vsebuje 0, 088 mg, 0, 18 mg, 0, 35 mg, 0, 7 mg ali
or 1.1 mg pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 1.5 mg pramipexole dihydrochloride monohydrate, respectively.
1, 1 mg pramipeksola v obliki 0, 125 mg, 0, 25 mg, 0, 5 mg, 1 mg oziroma 1, 5 mg pramipeksolijevega dihidroklorid monohidrata.
- The other ingredients are mannitol, maize starch, pregelatinised maize starch, povidone K25,
krob, predgelirani koruzni škrob, povidon K25, brezvodni
colloidal anhydrous silica and magnesium stearate.
koloidni silicijev dioksid in magnezijev stearat.
What Oprymea looks like and contents of the pack Tablets of 0.088 mg are white, round, with bevelled edges and imprint "P6" on one side of the tablet.
Izgled zdravila Oprymea in vsebina pakiranja Tablete po 0, 088 mg so bele, okrogle, s posnetimi robovi in oznako P6 na eni strani tablete.
Tablets of 0.18 mg are white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
Tablete po 0, 18 mg so bele, ovalne, s posnetimi robovi in z zarezo na obeh straneh ter oznako P7 na obeh polovicah ene strani tablete.
Tablets of 0.35 mg are white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
Tablete po 0, 35 mg so bele, ovalne, s posnetimi robovi in z zarezo na obeh straneh ter oznako P8 na obeh polovicah ene strani tablete.
Tablets of 0.70 mg are white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
Tablete po 0, 70 mg so bele, okrogle, s posnetimi robovi in z zarezo na obeh straneh ter oznako P9 na obeh polovicah ene strani tablete.
Tablets of 1.1 mg are white, round, with bevelled edges, both sides scored.
Tablete po 1, 1 mg so bele, okrogle, s posnetimi robovi in z zarezo na obeh straneh.
Boxes of 20, 30, 60, 90 and 100 tablets in blisters of 10 tablets are available.
Na voljo so š katle z 20, s 30, 60, z 90 in s 100 tabletami v pretisnih omotih po 10 tablet.
Marketing Authorisation Holder and Manufacturer KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Imetnik dovoljenja za promet z zdravilom in izdelovalec KRKA, tovarna zdravil, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenija ka
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavniš imetnika tvo dovoljenja za promet z zdravilom:
Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 6060
106 Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 6060
The vaccine contains the inactivated ‘ surface antigen ’ from three different strains (types) of influenza (flu) virus as active substances (A/ Solomon Islands/ 3/ 2006, A/ Wisconsin/ 67/ 2005 and B/ Malaysia/ 2506/ 2004).
Cepivo vsebuje kot zdravilno učinkovino inaktiviran „ površinski antigen “ treh različnih sevov (tipov) virusa gripe (A/ Salomonovi otoki/ 3/ 2006, A/ Wisconsin/ 67/ 2005 in B/ Malezija/ 2506/ 2004).
Optaflu is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications of the disease.
Zdravilo Optaflu se uporablja za cepljenje odraslih proti gripi, zlasti tistih, pri katerih obstaja povečano tveganje za nastanek zapletov pri bolezni.
Optaflu is given as one injection of 0.5 ml into the muscle at the top of the arm.
Zdravilo Optaflu se daje v obliki ene 0, 5- mililitrske injekcije v mišico nadlahti.
Optaflu contains fragments from the surface of three different strains of flu virus.
Zdravilo Optaflu vsebuje delce s površine treh različnih sevov virusa gripe.
Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season, and these virus strains need to be included in Optaflu before the vaccine can be used.
Svetovna zdravstvena organizacija (SZO) vsako leto pripravi priporočila o tem, kateri sevi gripe naj bodo vključeni v cepiva za prihajajočo sezono gripe, te virusne seve pa je treba vključiti v zdravilo Optaflu, preden se cepivo lahko uporabi.
Optaflu currently contains fragments of the virus strains that are expected to cause flu in the 2007/ 2008 season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU).
Zdravilo Optaflu trenutno vsebuje delce virusnih sevov, za katere se glede na priporočila SZO za severno poloblo in priporočila Evropske unije (EU) predvideva, da bodo povzročali gripo v sezoni 2007/ 2008.
The virus strains in Optaflu will be need to be replaced again before the vaccine can be used in subsequent seasons.
Virusne seve v zdravilu Optaflu bo treba ponovno zamenjati, preden bo cepivo mogoče uporabljati v naslednjih sezonah.
The viruses used in Optaflu are grown in mammal cells, unlike those in other flu vaccines, which are grown in hen’ s eggs.
Viruse, ki so uporabljeni v zdravilu Optaflu, gojijo v celicah sesalcev, medtem ko viruse, uporabljene v drugih cepivih proti gripi, gojijo v kokošjih jajcih.
The effects of Optaflu were first tested in experimental models before being studied in humans.
Učinki zdravila Optaflu so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The effectiveness of Optaflu was first assessed using a formulation of the vaccine that included the virus strains expected to cause flu in the 2004/ 2005 season.
Učinkovitost zdravila Optaflu so najprej ocenili z uporabo pripravka cepiva, ki je vključeval virusne seve, ki naj bi povzročili gripo v sezoni 2004/ 2005.
The vaccine’ s effectiveness was assessed in one main study involving 2,654 adults, around half of whom were elderly (over 60 years of age).
Učinkovitost cepiva so preučevali v eni glavni študiji z 2. 654 bolniki, od katerih jih je bilo približno polovica starejših (starih več kot 60 let).
The effects of Optaflu were compared to those of a similar flu vaccine that was made in eggs.
Učinke zdravila Optaflu so primerjali z učinki podobnega cepiva proti gripi, ki je bilo izdelano v jajcih.
The study 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 (imunogenost), tako da so primerjali ravni protiteles pred injiciranjem in tri tedne po njem.
The immunogenicity of the current formulation of the vaccine has been confirmed in 135 adults, around half of whom were elderly.
Imunogenost trenutnega pripravka cepiva so potrdili pri 135 bolnikih, od katerih jih je bila približno polovica starejših.
What benefit has Optaflu shown during the studies?
Kakšne koristi je zdravilo Optaflu izkazalo med raziskavami?
In the original main study, both Optaflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains, as defined in criteria laid down by the Committee for Medicinal Products for Human Use (CHMP) for flu vaccines produced in cell culture.
V prvotni glavni študiji sta zdravilo Optaflu in primerjalno cepivo spodbudila nastanek zadostnih ravni protiteles za zaščito pred vsemi tremi sevi gripe v skladu z merili Odbora za zdravila za uporabo v humani medicini (CHMP) za cepiva proti gripi, proizvedena v celični kulturi.
The two vaccines were similar in triggering the production of antibodies, both in adults 60 years of age and below, and in the elderly.
Cepivi imata podoben učinek pri sprožanju nastanka protiteles pri odraslih, starih 60 let ali manj, ter pri starejših.
The current formulation of Optaflu for the 2007/ 2008 season brought about similar antibody responses against the three flu strains included in the vaccine to those seen in the main study.
Trenutni pripravek zdravila Optaflu za sezono 2007/ 2008 je povzročil podobne odzive protiteles proti trem sevom gripe, vključenim v cepivo, kot so bili tisti v glavni študiji.
The most common side effects with Optaflu (seen in more than 1 patient in 10) are headache, erythema (reddening of the skin), pain, malaise (feeling unwell) and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Optaflu (opaženi pri več kot 1 od 10 bolnikov) so glavobol, eritemi (pordelost kože), bolečina, občutek slabosti (slabo počutje) in utrujenost.
These side effects usually disappear within one to two days without treatment.
Ti neželeni učinki običajno izginejo brez zdravljenja v enem do dveh dneh.
For the full list of all side effects reported with Optaflu, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Optaflu, glejte Navodilo za uporabo.
Optaflu should not be used in people who may be hypersensitive to the active substances or any of the other ingredients.
Zdravila Optaflu ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilne učinkovine ali katero koli drugo sestavino zdravila.
People who have a fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.
Ljudje, ki imajo vročino ali akutno (kratkotrajno) okužbo, ne smejo prejeti cepiva, dokler ne ozdravijo.
The CHMP decided that Optaflu’ s benefits are greater than its risks for the prophylaxis of influenza for adults, especially those who run an increased risk of associated complications.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Optaflu pri preprečevanju gripe pri odraslih, zlasti pri tistih s povečanim tveganjem za povezane zaplete, večje od z njim povezanih tveganj.
The Committee recommended that Optaflu be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Optaflu odobri dovoljenje za promet.
Other information about Optaflu:
Druge informacije o zdravilu Optaflu:
The European Commission granted a marketing authorisation valid throughout the EU for Optaflu to Novartis Vaccines and Diagnostics GmbH & Co.
Evropska komisija je dovoljenje za promet z zdravilom Optaflu, veljavno po vsej Evropski uniji, odobrila družbi Novartis Vaccines and Diagnostics GmbH & Co.
KG on 1 June 2007.
KG dne 1. junija 2007.
The full EPAR for Optaflu can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Optaflu je na voljo tukaj.
Suspension for injection in pre- filled syringe
Suspenzija za injiciranje v napolnjeni injekcijski brizgi
1/ 2 1 Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
1 Površinski antigeni virusa gripe (hemaglutinin in nevraminidaza) *, inaktivirani, naslednjih sevov:
A/ Solomon Islands/ 3/ 2006 (H1N1) like strain (A/ Solomon Islands/ 3/ 2006, IVR-145) A/ Wisconsin/ 67/ 2005 (H3N2) like strain (A/ Wisconsin/ 67/ 2005, NYMC X161B) B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004)
Sev, podoben A/ Solomon Islands/ 3/ 2006 (H1N1) (A/ Solomon Islands/ 3/ 2006, IVR- 145) Sev, podoben A/ Wisconsin/ 67/ 2005 (H3N2) (A/ Wisconsin/ 67/ 2005, NYMC X161B) Sev, podoben B/ Malaysia/ 2506/ 2004 (B/ Malaysia/ 2506/ 2004)
15 micrograms HA** 15 micrograms HA** 15 micrograms HA** per 0.5 ml dose
15 mikrogramov HA ** 15 mikrogramov HA ** 15 mikrogramov HA ** na 0, 5- mililitrski odmerek
* propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
* razmnoženi v celicah pasjih ledvic Madin Darby (MDCK)
Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Optaflu suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti gripi (površinski antigen, inaktiviran, pripravljen na celičnih kulturah)
(2007/ 2008 season)
(sezona 2007/ 2008)
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
Površinski antigeni virusa gripe (hemaglutinin in nevraminidaza) *, inaktivirani, naslednjih sevov:
A/ Solomon Islands/ 3/ 2006 (H1N1) like strain (A/ Solomon Islands/ 3/ 2006, IVR-145)
Sev, podoben A/ Solomon Islands/ 3/ 2006 (H1N1) (A/ Solomon Islands/ 3/ 2006, IVR- 145)
A/ Wisconsin/ 67/ 2005 (H3N2) like strain
Sev, podoben A/ Wisconsin/ 67/ 2005 (H3N2)
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004) ………………………………………. * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
Sev, podoben B/ Malaysia/ 2506/ 2004 (B/ Malaysia/ 2506/ 2004)
15
15 mikrogramov HA ** na 0, 5- mililitrski odmerek
micrograms HA** per 0.5 ml dose
…………………………………………………………………………………. * razmnoženi v celicah pasjih ledvic Madin Darby (MDCK) ** hemaglutinin
The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2007/ 2008 season.
Cepivo je v skladu s priporočili SZO (za severno poloblo) in z odločbo EU za sezono 2007/ 2008.
Suspension for injection in pre-filled syringe Clear to slightly opalescent.
Bistra do rahlo opalescenčna.
The use of Optaflu should be based on official recommendations.
Cepivo Optaflu je treba uporabljati na podlagi uradnih priporočil.
Immunisation should be carried out by intramuscular (into the deltoid muscle) injection.
Imunizacijo je treba opraviti z intramuskularnim injiciranjem (v deltoidno mišico).
Children and adolescents (< 18 years of age):
Otroci in mladostniki (stari < 18 let):
Optaflu is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy (see section 5.1).
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba cepiva Optaflu pri otrocih in mladostnikih pod 18 let ni priporočljiva (glejte poglavje 5. 1).
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV-1, Hepatitis C and especially HTLV-1 have been observed.
Po cepljenju proti gripi so opazili lažne pozitivne rezultate pri seroloških preizkusih z metodo ELISA za odkrivanje protiteles proti virusu HIV- 1, virusu hepatitisa C in zlasti proti virusu HTLV- 1.
The transient false positive reactions may be due to the IgM response to the vaccine.
Prehodni lažno pozitivni rezultati so lahko posledica odziva protiteles IgM na cepivo.