natgillin/translations-raw huggingface dataset:
The company informed the CHMP that there are no patients in clinical trials or compassionate use programmes using Gemesis.
Družba je obvestila CHMP, da klinična preskušanja ali programi sočutne uporabe z zdravilom Gemesis ne potekajo.
Platelet-derived growth factors act on cells that are involved in wound repair.
Rastni faktorji iz trombocitov delujejo na celice, ki sodelujejo pri celjenju ran.
Gemesis was expected to be used to regenerate tissue in adults with defects around the teeth, including defects within the surrounding bone and receding gums.
Zdravilo Gemesis naj bi se uporabljalo pri odraslih za regeneracijo obolelega tkiva z nepravilnostmi okrog zob, vključno s težavami na bližnjih kosteh in umikajočimi se dlesnimi.
Gemesis is a kit for implant.
Zdravilo Gemesis je komplet za vsaditev.
Gemesis was to be prepared by mixing the solution containing becaplermin with the matrix, which was then to be placed into the defect around the teeth to promote healing.
Zdravilo Gemesis naj bi se pripravilo tako, da se zmešata raztopina, ki vsebuje bekaplermin, in matrica, kar naj bi se položilo na težavno mesto okoli zoba in tako pospešilo celjenje.
How was Gemesis expected to work?
Kako naj bi zdravilo Gemesis delovalo?
The CHMP noted that the company did not at this time have sufficient information on how strongly becaplermin binds to PDGF receptors and did not sufficiently demonstrate that Gemesis used in clinical studies was comparable to the product intended to be placed on the market.
CHMP je ugotovil tudi, da družba v danem trenutku ni imela dovolj informacij o tem, kako močno se bekaplermin veže na receptorje rekombinantnega človeškega rastnega faktorja iz trombocitov, ter da ni v zadostni meri prikazala, da je zdravilo Gemesis,
300 mg Powder for concentrate for solution for infusion
300 mg prašek za koncentrat za raztopino za infundiranje
Vial (glass)
Intravenska uporaba viala (steklo)
Immediate Packaging
Sitčna ovojnina Velikost pakiranja
Do not freeze.
Ne zamrznite.
MARKETING AUTHORISATION NUMBER(S) EU/1/98/093/002
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/98/093/002
Boonton, New Jersey 07005 USA
Boonton, New Jersey 07005 ZDA
Very common ( >1/10); common (>1/100, <1/10); uncommon (>1/1,000, < 1/100); rare (>1/10,000, < 1/1,000); very rare (<1/10,000), including isolated reports.
Zelo pogosti (>1/10); pogosti (>1/100, <1/10); občasni (>1/1.000, <1/100); redki (>1/10.000, <1/1.000); zelo redki (<1/10.000), vključno s posameznimi primeri.
Each pack contains 10 ampoules.
Vsaka škatla vsebuje 10 ampul.
The injection will be given to you by a doctor or a nurse.
Injekcijo vam bo dal zdravnik ali medicinska sestra.
Date of last renewal:
Datum zadnjega podaljšanja:
The same applies to patients with altered hepatic function.
Isto velja tudi za bolnike s spremenjeno jetrno funkcijo.
Other possible but less frequent undesirable effects are:
Drugi možni, vendar manj pogosti, neželeni učinki so:
However, the clinical relevance of this finding is not known.
Vendar pa klinična pomembnost te ugotovitve ni znana.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 11-01-1999
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve: 11. 1. 1999
• swelling of the tongue or throat
• otekanje jezika ali grla,
• metallic taste in the mouth
• kovinski okus v ustih,
These are not allergic reactions but are due to a pharmacological effect, and are usually observed 10 to 20 minutes after administration.
Ne gre za alergične reakcije, temveč za farmakološke učinke, ki se običajno vidijo 10 do 20 minut po uporabi zdravila.
Please ask him to explain the reasons for any changes in your treatment schedule.
Prosite ga, naj vam razloži, kaj je vzrok za morebitne spremembe v vašem načrtu zdravljenja.
Again, this effect disappears with time, usually during the first or second week of treatment.
Tudi ta učinek sčasoma izgine, ponavadi v prvem ali drugem tednu zdravljenja.
Any unused product or waste material should be disposed of in accordance with local requirements.
Neporabljena zdravila ali odpadne snovi je treba zavreči v skladu z lokalnimi zahtevami.
If you forget to inject your medicine at the correct time, inject it as soon as you remember unless it is almost time for the next dose.
Če si pozabite injicirati zdravilo ob pravem času, storite to takoj, ko se na to spomnite, razen če ni že skoraj čas za naslednji odmerek.
Salmon calcitonin is rapidly absorbed and eliminated.
Lososov kalcitonin se hitro absorbira in izloči.
Plasma protein binding is 30 to 40%.
Vezava kalcitonina na plazemske proteine je 30 %-40 %.
Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively).
Biorazpoložljivost po subkutanem in intramuskularnem injiciranju pri ljudeh je visoka in podobna pri obeh načinih dajanja (71 % pri prvem in 66 % pri drugem).
Using FORCALTONIN with other medicines:
Uporaba FORCALTONINA skupaj z drugimi zdravili:
• anaphylactic shock (a very severe type of allergic response)
• anafilaktični šok (zelo hud tip alergijske reakcije).
If you are pregnant, please tell your doctor.
Če ste noseči, seznanite s tem svojega zdravnika.
All of these undesirable effects are mild and occur in isolated cases only.
Vsi ti neželeni učinki so blagi in se pojavljajo samo v nekaterih primerih.
The only serious undesirable effect which has been reported in patients treated with salmon calcitonin is an allergic reaction.
Edini resni neželeni učinek, o katerem so poročali pri bolnikih, zdravljenih z lososovim kalcitoninom, je alergijska reakcija.
You should discuss the possible undesirable effects with your doctor who will be able to advise you on the risks and benefits of your treatment.
O morebitnih neželenih učinkih se pogovorite z zdravnikom, ki vam bo znal svetovati glede tveganj in prednosti zdravljenja.
Conventional long-term toxicity, reproduction, mutagenicity, and carcinogenicity studies have been performed in laboratory animals.
Običajne študije dolgoročne toksičnosti, reprodukcije, mutagenosti in karcinogenosti so bile opravljene na laboratorijskih živalih.
The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent.
Farmakološke lastnosti sintetičnih in rekombinantnih peptidov so se izkazale za kvalitativno in kvantitativno enakovredne.
This is considered a species-specific effect and of no clinical relevance.
Gre za vrstno specifični učinek brez klinične pomembnosti.
• difficulties in breathing (bronchospasm)
• težave z dihanjem (bronhospazem),
Dosage is to be adjusted to the individual patient's needs.
Odmerke moramo prilagajati individualnim potrebam bolnikov.
This medicine has been prescribed for you personally and you should not pass it on to others.
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
The metabolites lack the specific biological activity of calcitonin.
Metaboliti nimajo specifične biološke aktivnosti kalcitonina.
The presence of antibodies appears to bear no relationship to allergic reactions, which are rare.
Kaže, da prisotnost protiteles ni povezana z alergijskimi reakcijami, ki so redke.
Never change the dose yourself or stop injecting the medicine without consulting your doctor first.
Sami nikoli ne smete spreminjati odmerkov ali nehati jemati zdravilo, ne da bi se prej posvetovali z zdravnikom.
Your body's response to treatment will be tested at regular intervals and your doctor will decide whether your treatment needs to be continued and which dose should be used.
Odziv vašega telesa na zdravilo bodo ugotavljali v rednih časovnih presledkih in vaš zdravnik bo odločil, ali je treba zdravljenje nadaljevati ter s kolikšnim odmerkom.
Calcitonin is indicated for:
Kalcitonin je indiciran:
Such reactions should be differentiated from generalised or local flushing, which are common non-allergic effects of calcitonin (see 4.8).
Take reakcije moramo razlikovati od splošnih ali lokalnih rdečic, ki so običajni nealergijski učinek kalcitonina (glejte poglavje 4.8).
In this case, you should wait until it is time to inject the next dose and then continue as before.
V tem primeru svetujemo, da počakate do injiciranja naslednjega odmerka, potem pa nadaljujte kot običajno.
This effect is diminished as osteoclastic activity is reduced.
Ta učinek se zmanjša z zmanjšanjem aktivnosti osteoklastov.
You should also talk to your doctor if you feel that the effect of FORCALTONIN is decreasing or that you are no longer benefiting from treatment.
Zdravniku morate prav tako povedati, če se vam zdi, da se učinek FORCALTONINA zmanjšuje ali da vam zdravljenje ne koristi več.
The effect may also disappear if the dose is reduced.
Učinek lahko izgine tudi z zmanjšanjem odmerka.
Some of the undesirable effects will disappear without being treated but others may need medical attention.
Nekateri neželeni učinki bodo izginili, ne da bi jih skušali odpraviti, pri drugih bo morda potrebna zdravniška pomoč.
• diuresis (increase in urination)
• diureza (povečano izločanje urina),
Flushing of the face and hands has been noted.
Opažena je bila rdečica na obrazu in dlaneh.
The duration of treatment depends on the indication for treatment and the patient´s response.
Trajanje jemanja je odvisno od indikacije za zdravljenje in od bolnikovega odziva.
WHAT FORCALTONIN IS AND WHAT IT IS USED FOR
KAJ JE FORCALTONIN IN ZA KAJ GA UPORABLJAMO
If you notice any unwanted effects not mentioned in this leaflet or any change in your health while receiving this medicine, or afterwards, please inform your doctor, nurse or pharmacist (chemist).
Če opazite katerikoli neželen učinek, ki ni omenjen v tem navodilu, ali kakršnokoli spremembo v svojem zdravju med prejemanjem zdravila ali po njem, vas prosimo, da o tem obvestite svojega zdravnika, medicinsko sestro ali farmacevta (lekarnarja).
Use in elderly, hepatic and renal impairment patients Experience with the use of calcitonin in the elderly has shown no evidence of reduced tolerability or altered dosage requirements.
Uporaba pri starejših bolnikih in bolnikih z okvaro jeter in ledvic Izkušnje z uporabo kalcitonina pri starejših niso pokazale znakov zmanjšane tolerance ali potreb po spreminjanju odmerkov.
Higher blood levels may be associated with increased incidence of nausea and vomiting.
Višje koncentracije v krvi so lahko povezane s povečano pogostnostjo slabosti in bruhanja.
What FORCALTONIN is and what it is used for Before you use FORCALTONIN How to use FORCALTONIN Possible side effects
Kaj je FORCALTONIN in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili FORCALTONIN Kako uporabljati FORCALTONIN Možni neželeni učinki
The dose may be reduced after the condition of the patient has improved.
Odmerek lahko zmanjšamo, ko se bolnikovo stanje izboljša.
Dosages of these drugs may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations.
Odmerke teh zdravil bomo morda morali prilagoditi, ker na njihove učinke lahko vplivajo spremembe v koncentracijah celičnih elektrolitov.
Salmon calcitonin is devoid of embryotoxic, teratogenic and mutagenic potential.
Lososov kalcitonin nima potencialno embriotoksičnih, teratogenih in mutagenih učinkov.
Such allergic reactions have only been seen in a very few cases and the most extreme form, anaphylactic shock, is very rare.
Takšne alergijske reakcije so se pojavile samo v nekaterih primerih, najekstremnejša oblika, anafilaktični šok, pa je izredno redka.
If you have the impression that the effect of FORCALTONIN is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek FORCALTONINa premočan ali prešibak, se o tem pogovorite s svojim zdravnikom ali farmacevtom.
Rare: Neutralising antibodies to calcitonin rarely develop.
Redki: nevtralizirajoča protitelesa za kalcitonin se razvijejo le redko.
If you forget to take FORCALTONIN:
Če ste pozabili vzeti FORCALTONIN:
For subcutaneous, intramuscular or intravenous infusion (product specific) use in individuals aged 18 years or more.
Za subkutano in intramuskularno uporabo ali intravensko infuzijo (specifično za zdravilo) pri osebah, starejših od 18 let.
In some cases, however, your doctor may decide to use another dose or another frequency of dosing.
Zdravnik se v nekaterih primerih lahko odloči za drugačen odmerek ali drugačno razporeditev odmerkov.
Calcitonin should be used during pregnancy only under exceptional circumstances appreciated by the physician.
Kalcitonin se sme uporabljati med nosečnostjo le v posebnih okoliščinah, ki jih ugotovi zdravnik.
If you use more FORCALTONIN than you should:
Če ste vzeli večji odmerek FORCALTONINa, kot bi smeli:
It is recommended to store the ampoule in the lower part or the door of the refrigerator to protect the solution from freezing.
Priporočamo, da ampule shranjujete v spodnjem delu ali predalu na vratih hladilnika, da raztopina ne zamrzne.
Any product where such defects are observed should be discarded.
Zdravilo, kjer opazite takšne napake, je treba zavreči.
Prevention of bone loss due to sudden immobilisation.
Preprečevanje izgubljanja kostnine zaradi nenadne nepokretnosti.
Forcaltonin should be used immediately after the single-use ampoule is opened.
Forcaltonin morate uporabiti takoj, ko je ampula za enkratno uporabo odprta.
Calcitonin is also contraindicated in patients with hypocalcaemia.
Kalcitonin je kontraindiciran tudi pri bolnikih s hipokalciemijo.
Should symptoms of overdose appear, treatment should be symptomatic.
Če se pojavijo simptomi prevelikega odmerjanja, jih zdravimo simptomatsko.
Rare: In case of patients with high bone remodelling (Paget's disease and young patients) a transient decrease of calcaemia may occur between the 4th and the 6th hour after administration, usually asymptomatic
Redki: pri bolnikih z visoko stopnjo preoblikovanja kostnine (Pagetova bolezen in mladi bolniki) se lahko pojavi prehodno zmanjšanje kalciemije med 4. in 6. uro po danem zdravilu, ponavadi asimptomatsko.
Do not use FORCALTONIN: if you are hypersensitive (allergic) to salmon calcitonin or any of the other ingredients of FORCALTONIN.
Ne uporabljajte zdravila FORCALTONIN: - Če ste preobčutljivi za (alergični na) lososov kalcitonin ali katerokoli sestavino zdravila FORCALCITONIN.
Nausea/vomiting are less frequent when the injection is done in the evening and after meals.
Slabost in bruhanje sta manj pogosta, če zdravilo injiciramo zvečer in po zaužitem obroku.
The salmon calcitonin contained in Forcaltonin is not made by a conventional, chemical method but by genetic engineering.
Lososov kalcitonin v zdravilu Forcaltonin ni izdelan na klasičen kemijski način, temveč z genskim inženirstvom.
The length of time over which you will receive FORCALTONIN will depend on the way you respond to the treatment.
Koliko časa boste prejemali FORCALTONIN, je odvisno od tega, kako se odzivate na zdravljenje.
Store in a refrigerator (2°C - 8°C) .
Shranjujte v hladilniku (2ºC - 8°C).
Like all medicines, FORCALTONIN may have undesirable effects which are very rare.
Kot vsa zdravila ima lahko tudi FORCALTONIN neželene učinke, ki so zelo redki.
If the response to treatment is not satisfactory after one or two days, the dose may be increased to 400 International Units every 6 to 8 hours.
Če odziv na zdravljenje po enem do dveh dnevih ni zadovoljiv, se odmerek lahko poveča na 400 mednarodnih enot na vsakih 6 do 8 ur.
An antiemetic may be administered, if required.
Bolniku lahko po potrebi damo antiemetik.
6.6 Instructions for use and handling <and disposal> For subcutaneous, intramuscular or intravenous use.
6.6 Navodila za pripravo in ravnanje z zdravilom <in odlaganje> Za subkutano, intramuskularno ali intravensko dajanje.
BATCH NUMBER <Batch> <Lot> <BN> {number}
ŠTEVILKA SERIJE <Serija> <Lot> <BN> {številka}
Serious allergic reactions will need emergency treatment.
Hude alergijske reakcije je treba takoj zdraviti.
Extreme sensitivity to salmon calcitonin may cause difficulties in breathing (bronchospasm), swelling of the tongue or throat, or even an anaphylactic shock (a very severe type of allergic response).
Pretirana občutljivost na lososov kalcitonin lahko povzroči težave z dihanjem (bronhospazem), otekanje jezika ali grla ali celo anafilaktični šok (ki je zelo hud tip alergijske reakcije).
Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule.
Lososov kalcitonin se primarno in skoraj izključno razgrajuje v ledvicah, kjer se tvorijo farmakološko neaktivni delci molekule.
Pharmacotherapeutic group: antiparathyroid hormone, ATC code: H05BA01 (calcitonin, salmon).
Farmakoterapevtska skupina: paratiroideo zavirajoči hormoni, oznaka ATC: H05BA01 (lososov kalcitonin).
If the response is not satisfactory after one or two days, the dose may be increased to a maximum of 400 IU every 6 to 8 hours.
Če odziv po enem ali dveh dnevih ni zadovoljiv, lahko odmerek povečamo na največ 400 IE vsakih 6 do 8 ur.
However, FORCALTONIN might influence the effects of certain drugs given to treat heart complaints.
Vendar pa FORCALTONIN lahko vpliva na učinkovanje nekaterih zdravil za zdravljenje težav s srcem.
Examples of serious allergic reactions to salmon calcitonin are:
Znaki resne alergijske reakcije na lososov kalcitonin so:
It is contained in a glass ampoule.
Na voljo je v stekleni ampuli.
Calcitonin has short absorption and elimination half-lives of 10-15 minutes and 50-80 minutes, respectively.
Kalcitonin ima kratek absorpcijski čas od 10 do 15 minut in razpolovni čas izločanja od 50 do 80 minut.
Approximately 10% of patients treated with salmon calcitonin suffer from nausea, sometimes with vomiting.
Približno 10 % bolnikov, zdravljenih z lososovim kalcitoninom, muči občutek slabosti, ki ga včasih spremlja bruhanje.
The manufacturer is FAMAR S.A., 7 P. Marinopoulou Str., 174 56 Alimos, Athens, Greece.
Izdelovalec je FAMAR S.A., 7 P. Marinopoulou Str., 174 56 Alimos, Atene, Grčija.
Calcitonin is secreted into the milk.
Kalcitonin se izloča v mleko.
HOW TO USE FORCALTONIN
KAKO UPORABLJATI FORCALTONIN
FORCALTONIN is only available from your doctor.
FORCALTONIN vam lahko predpiše le zdravnik.
The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lowering effect.
Uporaba kalcitonina v kombinaciji z bifosfonati ima lahko za posledico aditiven učinek na zmanjševanja kalcija.
The effect disappears without the need for special treatment.
Učinek je izginil, ne da bi ga bilo treba posebej zdraviti.
The development of these antibodies is not usually related to loss of clinical efficacy, although their presence in a small percentage of patients following long-term therapy with calcitonin may result in a reduced response to the product.
Njihov nastanek ponavadi ni povezan z zmanjšanjem klinične učinkovitosti, čeprav njihova prisotnost pri majhnem odstotku bolnikov po daljšem zdravljenju s kalcitoninom lahko zmanjša odziv na zdravilo.
By inhibiting osteoclast activity via its specific receptors, salmon calcitonin decreases bone resorption.
Z zaviranjem delovanja osteoklastov prek svojih specifičnih receptorjev lososov kalcitonin zmanjšuje resorpcijo kosti.
Should the solution become frozen, the ampoule must be discarded.
Če raztopina zamrzne, morate ampulo zavreči.
In addition, salmon calcitonin could be administered by intravenous injection after previous rehydration.
Lososov kalcitonin lahko dajemo tudi z intravenskim injiciranjem po predhodni rehidraciji.
• Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures
• za preprečevanje akutnega izgubljanja kostnine zaradi nenadne nepokretnosti, na primer pri bolnikih z nedavnim osteoporoznim zlomom;
The solution is clear, colourless and sterile.
Raztopina je prozorna, brezbarvna in sterilna.
Your doctor may then decide that it is not safe for you to receive this medicine.
Vaš zdravnik potem lahko odloči, ali je jemanje tega zdravila za vas varno - če imate hipokalciemijo
If you or your doctor accidentally inject more than the recommended dose of FORCALTONIN, it is extremely unlikely to have any serious effects.
Če si nehote injicirate večji odmerek FORCALTONINa od priporočenega ali če vam ga nehote injicira zdravnik, je zelo malo verjetno, da bi to lahko imelo kakršnokoli resno posledico.
It is also used to treat Paget's disease (a chronic disease of the bones characterised by inflammation and deformation), and hypercalcaemia of malignancy (increased calcium blood levels due to tumours).
Uporabljamo ga tudi za zdravljenje Pagetove bolezni (kronične bolezni kosti, za katero sta značilna vnetje in deformiranje kosti) in hiperkalciemije zaradi malignih obolenj (povečane ravni kalcija v krvi zaradi tumorjev).
Nervous system disorders: Uncommon: metallic taste in the mouth; dizziness
Bolezni živčevja Občasni: kovinski okus v ustih; omotičnost
The effect of calcitonin may be monitored by measurement of suitable markers of bone remodeling, such as serum alkaline phosphatase or urinary hydroxyproline or deoxypyridinoline.
Učinek kalcitonina lahko spremljamo z merjenjem ustreznih markerjev preoblikovanja kosti, npr. serumske alkalne fosfataze ali hidroksiprolina ali dezoksipiridinolina v urinu.
Paget's disease of bone.
Pagetova bolezen kosti.
There is a relationship between the subcutaneous dose of calcitonin and peak plasma concentrations.
Obstaja povezava med subkutanim odmerkom kalcitonina in maksimalnimi koncentracijami v plazmi.
However, care should be exercised in patients receiving concurrent treatment with cardiac glycosides or calcium channel blocking agents.
Vseeno pa moramo biti previdni pri bolnikih, ki hkrati prejemajo tudi srčne glikozide ali blokatorje kalcijevih kanalčkov.
Prevention of acute bone loss:
Preprečevanje akutnega izgubljanja kostnine
It is not known if the substance is excreted in human milk.
Ni znano, ali se učinkovina izloča v materino mleko.
Very common: Nausea with or without vomiting is noted in approximately 10% of patients treated with calcitonin.
Zelo pogosti: slabost, ki jo lahko spremlja bruhanje, so opazili pri približno 10 % bolnikov, zdravljenih s kalcitoninom.
Patients must therefore be warned that transient dizziness may occur, in which case they should not drive or use machines.
Bolnike moramo zato opozoriti, da se lahko pojavi prehodna omotičnost in da v tem primeru ne smejo voziti ali upravljati strojev.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zdravilo se ne sme mešati z drugimi zdravili, ker ni na voljo študij o kompatibilnosti.
Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician.
Med nosečnostjo naj se kalcitonin uporablja le, če zdravnik meni, da je terapija nujno potrebna.
The recommended dosage is 100 IU per day administered subcutaneously or intramuscularly, however, a minimum dosage regimen of 50 IU three times a week has achieved clinical and biochemical improvement.
Priporočeni odmerek je 100 IE na dan subkutano ali intramuskularno, vendar lahko z minimalnimi odmerki 50 IE trikrat na teden dosežemo klinično in biokemično izboljšanje.
General disorders and administration site conditions Uncommon: local inflammatory reactions at the site of subcutaneous or intramuscular injection
Splošne težave in spremembe na mestu aplikacije Občasni: lokalne vnetne reakcije na mestu subkutanega ali intramuskularnega injiciranja
No data exist on the effects of injectable calcitonin on the ability to drive and use machines.
O vplivu kalcitonina za injiciranje na sposobnost vožnje in upravljanja strojev ni podatkov.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Very rare: serious allergic-type reactions, such as bronchospasm, swelling of the tongue and throat, and in isolated cases, anaphylaxis.
Zelo redki: hude reakcije alergijskega tipa, kot so bronhospazem, zatekanje jezika in grla ter v nekaterih primerih anafilaksa.