natgillin/translations-raw huggingface dataset:
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs
NAVODILO ZA UPORABO Versican Plus DHPPi/L4 liofilizat in suspenzija za suspenzijo za injiciranje za pse
− to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,
- za preprečevanje kliničnih znakov (izcedek iz smrčka in oči) in zmanjšanje izločanja virusa, ki jih povzroča virus pasje parainfluence, - za preprečevanje kliničnih znakov, okužbe in izločanja virusa z urinom, ki jih povzroča L.
No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been observed after administration of a 10-fold overdose of the vaccine.
Po dajanju 10-krat prevelikega odmerka cepiva ni bilo opaziti drugih neželenih učinkov, razen tistih, navedenih v poglavju »Neželeni učinki«.
Suspension (inactivated): L. interrogans serovar Icterohaemorrhagiae
L. interrogans serovar Icterohaemorrhagiae titer ALR ≥ 1:51
No other adverse reactions other than those mentioned in section 4.6 were observed after administration of a 10-fold overdose of the vaccine.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Po dajanju 10- krat prevelikega odmerka cepiva ni bilo opaziti neželenih učinkov, razen tistih, navedenih v poglavju 4.6.
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 103.1 TCID50* 105.1 TCID50 Suspension (inactivated):
Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 suspension for dogs
Versican Plus DHPPi/L4 suspenzijaza pse
EXPIRY DATE
EXP{ mesec/leto }
VIALS (1 DOSE LYOPHILISATE)
VIALA (1 ODMEREK LIOFILIZATA) IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
The company withdrew before the European Commission had issued a decision on this opinion.
Družba je umaknila vlogo še preden je Evropska komisija izdala odločbo o mnenju.
The summary of opinion of the Committee for Orphan Medicinal Products for Oncophage is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Oncophage je na voljo na tukaj.
What documentation did the company present to support its application to the Agency?
Katero dokumentacijo je družba predložila Agenciji v podporo svoji vlogi?
The Commitee also noted that the company had provided insufficient information on the contents of the medicine and on the manufacturing process.
Odbor je menil tudi, da družba ni predložila zadostnih informacij o vsebnosti zdravila in proizvodnem postopku.
The effects of Oncophage were first tested in experimental models before being studied in humans.
Učinki zdravila Oncophage so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Autologous means that it is derived from the cells in the patient's own body.
Avtologni pomeni, da je izdelano iz celic iz bolnikovega telesa.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Oncophage?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Oncophage?
The company presented results of a study involving 818 adults with localised renal cell carcinoma that had been surgically removed and who had a high risk of the cancer coming back.
Družba je predstavila rezultate študije, ki je zajela 818 odraslih bolnikov z lokaliziranim karcinomom ledvičnih celic, ki je bil kirurško odstranjen, in so imeli veliko tveganje ponovitve raka.
Since the proteins in vitespen are similar to proteins on the cancer cells, it was expected that the immune system would also attack the cancer cells, preventing the recurrence or the spread of the original tumour.
Ker so beljakovine v vitespenu podobne beljakovinam na rakavih celicah, so pričakovali, da bo imunski sistem napadel tudi rakave celice, kar bi preprečilo pojav ali širjenje prvotnega tumorja.
The main measure of effectiveness was how long the patients lived without the cancer coming back.
Glavno merilo učinkovitosti je bilo trajanje preživetja bolnikov brez ponovitve raka.
There was also not enough information to clarify the way Oncophage works in renal cell carcinoma and to determine the appropriate dose of the medicine.
Predloženih tudi ni bilo zadosti informacij za razjasnitev, kako zdravilo Oncophage deluje v primeru karcinoma ledvičnih celic, in za določitev primernega odmerka zdravila.
Oncophage was expected to be used in patients with renal cell carcinoma (a type of kidney cancer) that had not yet spread to other parts of the body (localised).
Zdravilo Oncophage naj bi se uporabljalo pri bolnikih s karcinomom ledvičnih celic (vrsto ledvičnega raka), ki se še ni razširil na druge dele telesa (lokaliziran).
The company informed the CHMP that there are no patients in the European Union currently receiving Oncophage as part of a clinical trial or a formal compassionate use or named patient programme.
Družba je obvestila CHMP, da v Evropski uniji ni bolnikov, ki bi trenutno prejemali zdravilo Oncophage v okviru kliničnega preskušanja ali uradnega programa sočutne uporabe ali poimenskega programa.
The letter from the company notifying the CHMP of the withdrawal of the application is available here.
Dopis, s katerim družba agencijo EMEA obvešča o umiku vloge, je na voljo na tukaj.
When Oncophage is given to the patient, the body's defence system (immune system) learns to recognize the proteins in vitespen as foreign and triggers an immune response.
Ko bolnik prejme zdravilo Oncophage, se obrambni sistem telesa (imunski sistem) nauči prepoznavati beljakovine vitespena kot „tuje“ in sproži imunski odziv.
Oncophage is a solution for injection that contains the active substance vitespen (20 micrograms).
Zdravilo Oncophage je raztopina za injiciranje, ki vsebuje zdravilno učinkovino vitespen (20 mikrogramov).
The CHMP was of the opinion that the main study did not show that Oncophage was effective at prolonging the length patients lived without the cancer coming back.
CHMP je menil, da v glavni študiji niso dokazali, da je zdravilo Oncophage učinkovito pri podaljšanju preživetja bolnikov brez ponovitve raka.
The active substance in oncophage, vitespen, is made up of proteins (‘heat shock protein-peptide complex-96') that have been extracted from the patient's cancer cells.
Zdravilna učinkovina v zdravilu Oncophage, vitespen, je izdelana iz beljakovin („kompleks beljakovina toplotnega šoka-peptid 96“), ki so pridobljene iz bolnikovih rakavih celic.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Oncophage did not outweigh its risks.
CHMP je takrat menil, da koristi zdravila Oncophage ne odtehtajo z njim povezanih tveganj.
It was to be used when there is a high risk of the cancer coming back after the patient has had surgery to remove the tumour.
Uporabljalo naj bi se v primerih velikega tveganja ponovitve raka po kirurškem posegu za odstranitev tumorja.
The study compared the patients who were given Oncophage with those who were not.
V študiji so primerjali bolnike, ki so prejeli zdravilo Oncophage, in bolnike, ki ga niso prejeli.
Oncophage was designated as an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 April 2005 for renal cell carcinoma.
Zdravilo Oncophage je bilo dne 11. aprila 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje karcinoma ledvičnih celic.
On 23 November 2009, Antigenics Therapeutics Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Oncophage, intended as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.
Družba Antigenics Therapeutics Limited je dne 23. novembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Oncophage, namenjenim kot dodatno zdravljenje po kirurškem posegu za lokaliziran karcinom ledvičnih celic z velikim tveganjem ponovitve.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Oncophage for use as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet z zdravilom Oncophage, namenjenim kot dodatno zdravljenje po kirurškem posegu za lokaliziran karcinom ledvičnih celic z velikim tveganjem ponovitve.
What is Oncophage?
Kaj je zdravilo Oncophage?
Oncophage is an autologous immunotherapy product.
Zdravilo Oncophage je avtologni imunoterapevtik.
What was Oncophage expected to be used for?
Za kaj naj bi se zdravilo Oncophage uporabljalo?
How was Oncophage expected to work?
Kako naj bi zdravilo Oncophage delovalo?
Content (concentration)
Številka EU ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
Further information on Prolia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Nadaljnje informacije o zdravilu Prolia so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Prolia?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Prolia?
Prolia received a marketing authorisation valid throughout the EU on 26 May 2010.
Za zdravilo Prolia je bilo 26. maja 2010 izdano dovoljenje za promet, veljavno po vsej EU.
Prolia is a medicine used to treat the following conditions:
Prolia je zdravilo, ki se uporablja za zdravljenje naslednjih bolezni:
The European Medicines Agency decided that Prolia's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Prolia večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Prolia must not be used in people with hypocalcaemia (low blood calcium levels).
Zdravilo Prolia se ne sme uporabljati pri ljudeh s hipokalciemijo (nizko ravnijo kalcija v krvi).
Other information about Prolia
Druge informacije o zdravilu Prolia
Osteoporosis in women
Osteoporoza pri ženskah
As for all medicines, data on the use of Prolia are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Prolia stalno spremljajo.
What is Prolia and what is it used for?
Kaj je zdravilo Prolia in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prolia have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Prolia upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The medicine contains the active substance denosumab.
Zdravilo vsebuje učinkovino denosumab.
What benefits of Prolia have been shown in studies?
Kakšne koristi zdravila Prolia so se pokazale v študijah?
RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue.
RANKL sodeluje pri aktiviranju osteoklastov, tj. celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
What are the risks associated with Prolia?
Kakšna tveganja so povezana z zdravilom Prolia?
Why is Prolia authorised in the EU?
Zakaj je bilo zdravilo Prolia odobreno v EU?
This reduces the loss of bone and maintains bone strength, making fractures less likely to happen.
S tem se zmanjša izguba kostne mase in ohrani jakost kosti, zaradi tega pa so zlomi manj verjetni.
Side effects reported with Prolia are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Prolia, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
An overview of Prolia and why it is authorised in the EU
Pregled zdravila Prolia in zakaj je odobreno v EU
Osteoporosis in men
Osteoporoza pri moških
The active substance in Prolia, denosumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific structure in the body called RANKL.
Učinkovina v zdravilu Prolia, denosumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo v telesu, imenovano RANKL, in se veže nanjo.
For more information about using Prolia, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Prolia glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Prolia (seen in more than 1 patient in 10) are pain in the arms or legs, and bone, joint and muscle pain.
Najpogostejši neželeni učinek zdravila Prolia (opažen pri več kot 1 bolniku od 10) so bolečine v rokah ali nogah ter kosteh, sklepih in mišicah.
Prolia is available as a solution for injection in prefilled syringes, each containing 60 mg denosumab.
Zdravilo Prolia je na voljo v obliki raztopine za injiciranje v napolnjenih injekcijskih brizgah, ki vsebujejo 60 mg denosumaba.
In addition, after 3 years the risk of new spine fractures was lower in patients who received Prolia.
Prav tako je bilo po treh letih tveganje za nove zlome hrbtenice manjše pri bolnikih, ki so jemali zdravilo Prolia.
• osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones).
• osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi in moških, pri katerih obstaja povečano tveganje za zlome kosti.
The company that markets Prolia will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Podjetje, ki trži zdravilo Prolia, bo pripravilo kartico, s katero bo bolnike seznanilo s tveganjem pojava osteonekroze čeljusti in jih pozvalo, naj v primeru pojava simptomov poiščejo zdravniško pomoč.
Uncommon or rare cases of cellulitis (inflammation of deep skin tissue), hypocalcaemia (low blood calcium), hypersensitivity (allergy), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and unusual fractures of the thigh bone have been seen in patients taking Prolia.
Pri bolnikih, ki so jemali zdravilo Prolia, so občasno ali redko opazili tudi celulit (vnetje globokega podkožnega tkiva), hipokalciemijo (nizko raven kalcija), preobčutljivost (alergijo), osteonekrozo čeljusti (poškodbe čeljustnice, kar lahko povzroči bolečine, oteklost v ustih ali majanje zob) in nenavadne zlome stegnenice.
Prolia has been compared with placebo in one main study involving 242 men with osteoporosis.
Zdravilo Prolia so primerjali s placebom v eni glavni študiji, v katero je bilo vključenih 242 moških z osteoporozo.
In the second study, the women were receiving treatment for breast cancer and were considered to be at high risk of fracture.
V drugi študiji so proučevali ženske, ki so se zdravile zaradi raka dojke, zato je bilo pri njih tveganje za zlome večje.
• bone loss in adults at increased risk of fractures who are treated long term with corticosteroid medicines given by mouth or injection.
• izgube kostne mase pri odraslih s povečanim tveganjem za zlome, dolgotrajno zdravljenih s kortikosteroidnimi zdravili, ki se dajejo peroralno ali z injiciranjem.
Prolia was also more effective at reducing the number of women who had fractures elsewhere in the body, including in the hip.
Zdravilo Prolia je bilo učinkovitejše tudi z vidika manjšega števila žensk, pri katerih je prišlo do zloma drugih kosti v telesu, vključno s kolkom.
By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
Denosumab z vezavo na beljakovino RANKL in njenim zaviranjem zmanjšuje nastajanje in delovanje osteoklastov.
Prolia reduces the risk of fractures in the spine;
Zdravilo Prolia zmanjšuje tveganje za zlome hrbtenice;
How is Prolia used?
Kako se zdravilo Prolia uporablja?
For the full list of side effects and restrictions with Prolia, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Prolia glejte navodilo za uporabo.
Bone loss in men receiving treatment for prostate cancer
Izguba kostne mase pri moških, ki se zdravijo zaradi raka prostate
Prolia has been shown to be more effective than placebo at treating bone loss in one main study involving 1,468 men receiving treatment for prostate cancer who were at an increased risk of fracture.
Zdravilo Prolia se je pokazalo kot učinkovitejše od placeba pri zdravljenju izgube kostne mase v eni glavni študiji, v katero je bilo vključenih 1 468 moških, ki so se zdravili zaradi raka prostate in pri katerih je bilo tveganje za zlom večje.
• bone loss in men receiving treatment for prostate cancer that increases their risk of fracture.
• izgube kostne mase pri moških, ki se zdravijo zaradi raka prostate, kar povečuje tveganje za zlome.
Prolia has been shown to be more effective than risedronate (a bisphosphonate medicine) at increasing bone density in one main study involving 795 adults treated with corticosteroid medicines.
Zdravilo Prolia se je pri povečevanju kostne gostote pokazalo kot učinkovitejše od risedronata (difosfonatnega zdravila) v eni glavni študiji, v katero je bilo vključenih 795 odraslih, zdravljenih s kortikosteroidnimi zdravili.
In women who have been through the menopause Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip;
Zdravilo Prolia pri ženskah po menopavzi zmanjšuje tveganje za zlome hrbtenice in drugih kosti v telesu, vključno s kolkom;
Bone loss in adults receiving long-term corticosteroid therapy
Izguba kostne mase pri odraslih, ki se dolgotrajno zdravijo s kortikosteroidi
In men who took Prolia bone density increased by 5.7% after 1 year of treatment compared with a 0.9% increase in men who took placebo.
Pri moških, ki so jemali zdravilo Prolia, se je kostna gostota po enem letu zdravljenja povečala za 5,7 %, pri moških, ki so jemali placebo, pa za 0,9 %.
How does Prolia work?
Kako zdravilo Prolia deluje?
In patients who had been treated with corticosteroids for more than 3 months before the study, lumbar spine bone density increased by 3.6% after 1 year of treatment with Prolia compared with a 2.0% increase with risedronate.
Pri bolnikih, ki so se pred študijo s kortikosteroidi zdravili več kot tri mesece, se je gostota kosti v ledvenem delu hrbtenice po enem letu zdravljenja z zdravilom Prolia povečala za 3,6 %, pri bolnikih, zdravljenih z risedronatom, pa za 2,0 %.
In the first of these studies, 2% of the women receiving Prolia had a new spine fracture after 3 years of treatment compared with 7% of the women receiving placebo.
V prvi študiji je po treh letih zdravljenja do novega zloma prišlo pri 2 % žensk, ki so jemale zdravilo Prolia, in pri 7 % žensk, ki so jemale placebo.
After 2 years, men who received Prolia had an increase in bone density in the lumbar spine that was 7% higher than in those who received placebo.
Po dveh letih se je pri moških, ki so jemali zdravilo Prolia, povečala gostota kosti v ledvenem delu hrbtenice in je bila za 7 % večja kot pri tistih, ki so jemali placebo.
In patients who had been treated with corticosteroids for up to 3 months before the study, bone density in the lumbar spine increased by 3.1% after 1 year of treatment with Prolia compared with a 0.8% increase with risedronate.
Pri bolnikih, ki so se pred študijo s kortikosteroidi zdravili največ tri mesece, se je gostota kosti v ledvenem delu hrbtenice po enem letu zdravljenja z zdravilom Prolia povečala za 3,1 %, pri bolnikih, zdravljenih z risedronatom, pa za 0,8 %.
Women who took Prolia had higher bone density (a measure of how strong the bones are) in the lumbar (lower) spine after 1 year of treatment than women on placebo.
Ženske, ki so jemale zdravilo Prolia, so imele po enem letu zdravljenja večjo kostno gostoto (merilo jakosti kosti) v ledvenem delu hrbtenice kot ženske, ki so jemale placebo.
Prolia is given once every 6 months as a 60 mg injection under the skin in the thigh, abdomen (belly) or back of the arm. During treatment with Prolia, the doctor should ensure that the patient is receiving calcium and vitamin D supplements.
Zdravilo Prolia se daje enkrat na šest mesecev v obliki 60-miligramske injekcije v podkožje stegna, trebuha ali zgornjega dela roke.
Prolia has been shown to be more effective than placebo (a dummy treatment) at reducing fractures in two main studies involving a total of over 8,000 women with osteoporosis who had been through the menopause.
V dveh glavnih študijah, v katere je bilo skupno vključenih več kot 8 000 žensk po menopavzi z osteoporozo, se je pokazalo, da je zdravilo Prolia pri zmanjševanju zlomov učinkovitejše od placeba (zdravila brez učinkovine).
None
Nobenih.
This summary was last updated in December 2018.
Ta povzetek je bil nazadnje posodobljen decembra 2018.
The local reactions lasted up to 25 days.
Lokalne reakcije so trajale do 25 dni.
Further information on Zulvac BTV can be found on the Agency's website: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
Nadaljnje informacije o zdravilu Zulvac BTV so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
The vaccine also contains ‘adjuvants' (aluminium hydroxide and Quil-A) that enhance the response of the immune system.
Cepivo vsebuje tudi „adjuvansa“ (aluminijev hidroksid in Quil-A) za povečanje imunskega odziva.
The serotype to be used in the vaccine is selected before manufacture depending on which type is circulating and causing disease at the time.
Serotip za uporabo v cepivu se izbere pred proizvodnjo, odvisno od vrste virusa, ki takrat kroži in povzroča bolezen.
A booster is required after 12 months.
Obnovitveno cepljenje je potrebno po 12 mesecih.
They may also be nodules that can be felt under the skin of up to 60 cm2 in size which reduce with time but may persist for more than 50 days.
Pojavijo se lahko tudi otipljivi podkožni noduli v velikosti 60 cm2, ki se sčasoma zmanjšajo in lahko trajajo tudi več kot 50 dni.
Zulvac BTV received a marketing authorisation valid throughout the EU on 25 April 2017.
Zdravilo Zulvac BTV je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 25. aprila 2017.
The vaccine can prevent the presence of serotypes 1 or 8 in the blood and reduce levels of serotype 4.
Cepivo lahko prepreči prisotnost serotipov 1 ali 8 v krvi in zmanjša ravni serotipa 4.
The European Medicines Agency decided that Zulvac BTV' benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Zulvac BTV večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The name of the medicine was changed to Zulvac BTV on 21 February 2019.
Ime zdravila je bilo 21. februarja 2019 spremenjeno v Zulvac BTV.
Data on the effectiveness under field conditions of other bluetongue virus vaccines containing the individual serotypes or a combination of two serotypes were also taken into account.
Upoštevali so tudi terenske podatke o učinkovitosti drugih cepiv proti okužbi z virusom bolezni modrikastega jezika, ki so vsebovala posamezne serotipe ali kombinacijo dveh serotipov.
The withdrawal period for meat and milk from sheep and cattle treated with Zulvac BTV is ‘zero' days, which means there is no mandatory waiting time.
Karenca za meso in mleko ovac in goveda, cepljenih s cepivom Zulvac BTV, je „nič“ dni, kar pomeni, da ni obvezne čakalne dobe.
The vaccine is available as a suspension for injection and can only be obtained with a prescription.
Cepivo je na voljo v obliki suspenzije za injiciranje, njegovo predpisovanje in izdaja pa je le na recept.