natgillin/translations-raw huggingface dataset:
The marketing authorisation holder shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
• Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
There are no fertility data in humans.
Podatki o plodnosti pri ljudeh niso na voljo.
Evaluation of the need to continue treatment is recommended regularly thereafter.
Po tem se priporoča redna ocena potrebe po zdravljenju.
AJOVY should not be used if the solution has been frozen.
Zdravila AJOVY ne smete uporabiti, če je bila raztopina zamrznjena.
− Clean the chosen injection area using a new alcohol swab.
− Očistite izbrani predel injiciranja z novo alkoholno blazinico.
It is preferable to avoid the use of AJOVY during pregnancy as the effects of this medicine in pregnant women are not known.
Uporabi zdravila AJOVY med nosečnostjo se je bolje izogniti, saj učinki zdravila pri nosečnicah niso znani.
The European Medicines Agency has deferred the obligation to submit the results of studies with AJOVY in one or more subsets of the paediatric population in prevention of migraine headaches (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom AJOVY za eno ali več podskupin pediatrične populacije za preprečevanje migrenskih glavobolov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Hypersensitivity reactions were reported with fremanezumab in less than 1% of patients in clinical trials.
O preobčutljivostnih reakcijah pri uporabi fremanezumaba so poročali pri manj kot 1 % bolnikov v kliničnih preskušanjih.
(95% CI)
(95-odstotni IZ)
AJOVY has no or negligible influence on the ability to drive and use machines.
Zdravilo AJOVY nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
The formed small peptides and amino acids may be re-used in the body for de novo synthesis of proteins or are excreted by the kidney.
Majhne peptide in aminokisline, ki nastanejo, lahko telo ponovno uporabi za sintezo beljakovin de novo ali pa se izločijo skozi ledvice.
The most frequently observed local reactions at the injection site were pain, induration and erythema.
Lokalne reakcije na mestu injiciranja, ki so jih najpogosteje opazili, so bile bolečina, induracija in eritem.
Fremanezumab has an estimated half-life of 30 days.
Ocenjeni razpolovni čas fremanezumaba je 30 dni.
When switching dosing regimens, the first dose of the new regimen should be administered on the next scheduled dosing date of the prior regimen.
Če zamenjamo režim odmerjanja, je treba prvi odmerek po novem režimu dati na datum načrtovanega naslednjega odmerka po prejšnjem režimu.
CGRP levels have been shown to increase significantly during migraine and return to normal with headache relief.
Dokazano je, da se ravni CGRP med migreno pomembno povišajo, ko glavobol popusti, pa se vrnejo na normalno raven.
All local injection site reactions were transient and predominantly mild to moderate in severity.
Vse lokalne reakcije na mestu injiciranja so bile prehodne in v glavnem blage do zmerne.
If your dose is 675 mg, inject the three injections one after another, each in a different place.
Če je vaš odmerek 675 mg, si injicirajte tri injekcije eno za drugo, vsako v različno mesto.
Furthermore, concomitant use of acute migraine treatments (specifically analgesics, ergots, and triptans) and migraine preventive medicinal products during the clinical studies did not affect the pharmacokinetics of fremanezumab.
Poleg tega sočasna uporaba zdravil za zdravljenje akutne migrene (natančneje analgetikov, alkaloidov ergot in triptanov) in zdravil za preprečevanje migrene v kliničnih študijah ni vplivala na farmakokinetiko fremanezumaba.
While the precise mechanism of action by which fremanezumab prevents migraine attacks is unknown, it is believed that prevention of migraine is obtained by its effect modulating the trigeminal system.
Točen mehanizem delovanja, preko katerega fremanezumab preprečuje migrenske napade, ni znan, vendar domnevamo, da migreno prepreči z učinkom, ki ga ima na uravnavanje trigeminalnega sistema.
You hear a second “click” (about 15 seconds after the first “click”; the plunger will be moving to the bottom of the viewing window as the medicine is being injected).
Zaslišite drugi »klik« (približno 15 sekund po prvem »kliku«; bat se bo med injiciranjem zdravila pomikal proti dnu pregledovalnega okenca).
If you have used more AJOVY than you should, tell your doctor.
Če ste uporabili večji odmerek zdravila AJOVY, kot bi smeli, to povejte zdravniku.
− As the pre-filled pen is lifted from the skin, the needle shield returns to the original position and locks into place, covering the needle.
− Ob dviganju peresnika s kože se ščitnik igle vrne v prvotni položaj in zaskoči na mestu, kjer pokriva iglo.
For multiple injections, injection sites should be alternated.
Če damo več injekcij, je mesta injiciranja treba menjavati.
If a hypersensitivity reaction occurs, discontinuation of fremanezumab administration should be considered and appropriate therapy should be initiated.
Če se pojavi preobčutljivostna reakcija, je treba razmisliti o prekinitvi uporabe fremanezumaba in uvesti ustrezno zdravljenje.
This medicine may be removed from the refrigerator and stored at a temperature below 25°C for a maximum period of up to 24 hours.
Zdravilo lahko vzamete iz hladilnika in ga shranjujete pri temperaturi do 25 °C za obdobje do največ 24 ur.
Demographics and baseline disease characteristics were balanced and comparable between the study arms.
Demografske značilnosti in značilnosti bolezni ob izhodišču so bile v vseh treh proučevanih skupinah uravnotežene in primerljive.
Solution for injection (injection)
raztopina za injiciranje (injekcija)
Very common (may affect more than 1 in 10 people) Pain, hardening or redness at the injection site
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) bolečina, otrdelost ali rdečina na mestu injiciranja
Episodic migraine study (Study 1)
Študija pri epizodni migreni (študija 1)
Fremanezumab attaches to CGRP and prevents it from working.
Fremanezumab se veže na CGRP in prepreči, da bi deloval.
− Press down on the pre-filled pen and keep pressed down against the skin for about 30 seconds.
− Pritisnite na napolnjeni injekcijski peresnik in ga držite pritisnjenega ob kožo približno 30 sekund.
The patients enrolled had at least a 12-month history of migraine (with and without aura) according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria.
Pri bolnikih, vključenih v študiji, se je že vsaj 12 mesecev pojavljala migrena (z avro ali brez nje) po diagnostičnih merilih mednarodne klasifikacije glavobolov (ICHD-III
AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and attaches to a specific target in the body.
AJOVY je zdravilo, ki vsebuje učinkovino fremanezumab, monoklonsko protitelo, ki je vrsta beljakovine, ki prepozna specifično tarčno mesto v telesu in se nanj priključi.
Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Zaradi reakcij na mestu injiciranja ponavadi ni bilo treba prekiniti zdravljenja.
Clear to opalescent, colourless to slightly yellow solution with a pH of 5.5 and an osmolality of 300-450 mOsm/kg.
Bistra do opalescentna, brezbarvna do rahlo rumena raztopina z vrednostjo pH 5,5 in osmolalnostjo 300-450 mOsm/kg.
Contents of the pack and other information What AJOVY contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo AJOVY
c) Wait for 30 minutes to let AJOVY reach room temperature (<30°C) to reduce discomfort during injection.
c) Počakajte 30 minut, da se zdravilo AJOVY segreje na sobno temperaturo (< 30 °C), kar bo zmanjšalo neprijeten občutek med injiciranjem.
Population pharmacokinetic analysis of integrated data from the AJOVY clinical studies did not reveal a difference in the pharmacokinetics of fremanezumab in patients with mild to moderate renal impairment or hepatic impairment relative to those with normal renal or hepatic function (see section 4.2).
Populacijska farmakokinetična analiza združenih podatkov iz kliničnih študij zdravila AJOVY ni pokazala razlik v farmakokinetiki fremanezumaba pri bolnikih z blago do zmerno ledvično okvaro ali jetrno okvaro v primerjavi s farmakokinetiko pri tistih z normalno ledvično ali jetrno funkcijo (glejte poglavje 4.2).
Dose proportionality, based on population pharmacokinetics, was observed between 225 mg to 675 mg.
Na podlagi populacijske farmakokinetike so opazili sorazmernost med odmerki od 225 mg do 675 mg.
There is a limited amount of data from the use of AJOVY in pregnant women.
Podatki o uporabi zdravila AJOVY pri nosečnicah so omejeni.
Since monoclonal antibodies are not known to be eliminated via renal pathways or metabolised in the liver, renal and hepatic impairment are not expected to impact the pharmacokinetics of fremanezumab.
Glede na to, da ni znano, da bi se monoklonska protitelesa izločala po ledvičnih poteh ali presnavljala v jetrih, ni pričakovati, da bi ledvična in jetrna okvara vplivali na farmakokinetiko fremanezumaba.
Patients were allowed to use acute headache treatments during the study.
Bolniki so med študijo lahko uporabljali zdravila za zdravljenje akutnega glavobola.
Overall, 30% of the patients had previously used topiramate and 15% onabotulinumtoxin A. A total of 1,034 patients completed the 12-week double-blind treatment period.
Skupno 30 % bolnikov je predhodno uporabljalo topiramat, 15 % pa onabotulinski toksin tipa A. 12-tedensko dvojno slepo obdobje zdravljenja je dokončalo skupno 1.034 bolnikov.
Patients had a median age of 42 years (range: 18 to 70 years), 85% were female, and 80% were white.
Mediana starost bolnikov je bila 42 let (razpon: od 18 do 70 let), 85 % je bilo žensk in 80 % je bilo belcev.
A sub-set of patients (21%) was also allowed to use one commonly used concomitant, preventive medicinal product (beta-blockers, calcium channel blocker/benzocycloheptene, antidepressants, anticonvulsants).
Podskupini bolnikov (21 %) so dovolili tudi uporabo enega pogosto uporabljanega sočasnega zdravila za preprečevanje migrene (antagonisti adrenergičnih receptorjev beta, zaviralci kalcijevih kanalčkov/benzociklohepten, antidepresivi, antikonvulzivi).
What you need to know before you use AJOVY Do not use AJOVY
Kaj morate vedeti, preden boste uporabili zdravilo AJOVY Ne uporabljajte zdravila AJOVY
Within each system organ class, ADRs are ranked by frequency, most frequent reactions first.
Znotraj vsakega organskega sistema so neželeni učinki razvrščeni po pogostnosti, pri čemer so najprej navedeni najpogostejši neželeni učinki.
Based on the results of population pharmacokinetic analysis, no dose adjustment is required (see section 5.2).
Glede na rezultate populacijske farmakokinetične analize prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
Baseline (SD)
izhodišče (SD)
The effect also occurred from as early as the first month and sustained over the treatment period (see Figure 1).
Poleg tega se je učinek pojavil že v prvem mesecu in se ohranil skozi celotno obdobje zdravljenja (glejte sliko 1).
Similar to other monoclonal antibodies, fremanezumab is expected to be degraded by enzymatic proteolysis into small peptides and amino acids.
Podobno kot pri drugih monoklonskih protitelesih je tudi pri fremanezumabu pričakovati encimsko proteolitično razgradnjo na majhne peptide in aminokisline.
Patients may self-inject if instructed in subcutaneous self-injection technique by a healthcare professional.
Bolniki si lahko zdravilo injicirajo sami, če jih je zdravstveni delavec poučil o tehniki subkutanega samoinjiciranja.
c) Check that the blue plunger has filled the viewing window and remove the pre-filled pen from your skin.
e) Prepričajte se, da je modri bat zapolnil pregledovalno okence, in injekcijski peresnik odstranite s kože.
Push the plunger all the way down as far as it will go to inject all of the medicine.
Bat potisnite do konca, da injicirate vse zdravilo.
In placebo-controlled studies, 0.4 % of patients (6 out of 1,701) treated with fremanezumab developed anti-drug antibodies (ADA).
V s placebom nadzorovanih študijah so se pri 0,4 % bolnikov (6 od 1.701), zdravljenih s fremanezumabom, razvila protitelesa proti zdravilu.
The efficacy and safety of fremanezumab was demonstrated regardless of age, gender, race, use of concomitant preventive medicinal products (beta-blockers, calcium channel blocker/benzocycloheptene, antidepressants, anticonvulsants), use of topiramate or onabotulinumtoxin A for migraine in the past, and acute headache medication overuse.
Učinkovitost in varnost fremanezumaba so dokazali ne glede na starost, spol, raso, uporabo sočasnih zdravil za preprečevanje migrene (antagonisti adrenergičnih receptorjev beta, zaviralci kalcijevih kanalčkov/benzociklohepten, antidepresivi, antikonvulzivi), uporabo topiramata ali onabotulinskega toksina tipa A zaradi migrene v preteklosti in prekomerno uporabo zdravil za zdravljenje akutnega glavobola.
Tell your doctor if you have or have had cardiovascular disease (problems affecting the heart and blood vessels) before using this medicine, because AJOVY has not been studied in patients with certain cardiovascular diseases.
Pred uporabo tega zdravila obvestite zdravnika, če imate ali ste kdaj imeli srčno-žilno bolezen (težave, ki vplivajo na srce in ožilje), saj zdravila AJOVY niso proučevali pri bolnikih z nekaterimi srčno-žilnimi boleznimi.
The effect also occurred from as early as the first month and sustained over the treatment period (see Figure 2).
Poleg tega se je učinek pojavil že v prvem mesecu in se ohranil skozi celotno obdobje zdravljenja (glejte sliko 2).
b) Inject by following the 4 steps below.
b) Injicirajte si zdravilo v naslednjih 4 korakih:
Doses up to 2,000 mg have been administered intravenously in clinical trials without dose-limiting toxicity.
V kliničnih preskušanjih so intravensko injicirali odmerke do 2.000 mg brez toksičnega učinka, ki bi omejeval odmerek.
Do not use this medicine if you are allergic to fremanezumab or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte tega zdravila, če ste alergični na fremanezumab ali katero koli sestavino tega zdravila
- The active substance is fremanezumab.
- Učinkovina je fremanezumab.
With 12 months of treatment, ADA were detected in 2.3% of the patients (43 out of 1,888) with 0.95% of the patients developing neutralising antibodies.
Pri 12-mesečnem zdravljenju so protitelesa proti zdravilu odkrili pri 2,3 % bolnikov (43 od 1.888), pri čemer so se pri 0,95 % teh bolnikov razvila nevtralizirajoča protitelesa.
As fremanezumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted.
Ker je fremanezumab monoklonsko protitelo, niso izvedli študij genotoksičnosti ali kancerogenega potenciala.
− After you have injected all of the medicine, i.e. the blue plunger has filled the viewing window and you are able to see the grey stopper, remove the pre-filled pen from the skin by lifting the pre-filled pen straight up and dispose straightaway into a sharp disposal container (see step 3).
− Ko ste injicirali vse zdravilo, tj. modri bat je zapolnil pregledovalno okence in vidite lahko sivi zamašek, odstranite napolnjeni injekcijski peresnik s kože, tako da ga dvignete v ravni smeri, in ga nemudoma zavrzite v posodo za odstranjevanje ostrih pripomočkov.
The mean headache frequency at baseline was approximately 21 headache days per month (of which 13 headache days were of at least moderate severity).
Povprečna pogostnost glavobolov ob izhodišču je bila približno 21 dni glavobola na mesec (od tega je bil 13 dni glavobol vsaj zmerno hud).
Pooled across the two dosing regimens, a reduction of 6.6 monthly migraine days was observed after 15 months relative to Study 1 and Study 2 baseline.
Skupno so pri obeh režimih odmerjanja po 15 mesecih opazili zmanjšanje mesečnega števila migrenskih dni za 6,6 dneva v primerjavi z izhodiščem v študiji 1 in študiji 2. 61 %
The mean migraine frequency at baseline was approximately 9 migraine days per month.
Povprečna pogostnost migrene ob izhodišču je bila približno 9 migrenskih dni na mesec.
No dose adjustments are required for fremanezumab.
Prilagajanje odmerkov fremanezumaba ni potrebno.
c) Wait for 30 minutes to let AJOVY reach room temperature to reduce discomfort during injection.
c) Počakajte 30 minut, da se zdravilo AJOVY segreje na sobno temperaturo, kar bo zmanjšalo neprijeten občutek med injiciranjem.
If you use more AJOVY than you should
Če ste uporabili večji odmerek zdravila AJOVY, kot bi smeli
Talk to your doctor, pharmacist or nurse if you get any symptoms of an allergic reaction, e.g. trouble breathing, swelling of the lips and tongue, or severe rash, after injecting AJOVY.
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, če po injiciranju zdravila AJOVY dobite katere koli simptome alergijske reakcije, npr. težave z dihanjem, oteklost ustnic in jezika ali hud izpuščaj.
AJOVY is a clear, colourless to slightly yellow solution.
Zdravilo AJOVY je bistra, brezbarvna do rahlo rumena raztopina.
If a fremanezumab injection is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen.
Če bolnik izpusti injiciranje fremanezumaba na predvideni datum, mora zdravljenje nadaljevati takoj, ko je to mogoče, z indiciranim odmerkom in režimom.
There is limited data available on the use of fremanezumab in patients ≥65 years of age (2% of the patients).
Podatki o uporabi fremanezumaba pri bolnikih, starih ≥ 65 let (2 % bolnikov), so omejeni.
What are the benefits of using AJOVY
Kakšne so koristi uporabe zdravila AJOVY
Median accumulation ratio, based on once monthly and once quarterly dosing regimens, is approximately 2.4 and 1.2, respectively.
Mediani faktor akumulacije je pri režimu odmerjanja enkrat na mesec znašal približno 2,4, pri režimu odmerjanja enkrat na četrt leta pa približno 1,2.
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov proizvajalca (proizvajalcev) biološke učinkovine (učinkovin)
− 1 alcohol swab per injection
− 1 alkoholno blazinico za vsako injiciranje,
After single subcutaneous administrations of 225 mg and 675 mg fremanezumab, median time to maximum concentrations (tmax) in healthy subjects was 5 to 7 days.
Po enkratnem subkutanem injiciranju 225 mg in 675 mg fremanezumaba je bil mediani čas do najvišjih koncentracij (tmax) pri zdravih preskušancih 5 do 7 dni.
Fremanezumab selectively binds the calcitonin gene-related peptide (CGRP) ligand and blocks both CGRP isoforms (α-and β-CGRP) from binding to the CGRP receptor.
Fremanezumab se selektivno veže na peptidni ligand, povezan z genom za kalcitonin (CGRP - calcitonin gene-related peptide), in prepreči vezavo obeh izooblik CGRP (α- in β-CGRP) na receptor za CGRP.
Step 1: Getting ready for an injection a) Gather the following supplies for your injection:
1. korak: Priprava na injiciranje a) Pripravite naslednje pripomočke, ki jih boste potrebovali pri injiciranju:
Fremanezumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Fremanezumab je humanizirano monoklonsko protitelo, pridobljeno iz ovarijskih celic kitajskega hrčka (CHO - Chinese Hamster Ovary) s tehnologijo rekombinantne DNA.
You hear the first “click” (this signals the start of the injection and the blue plunger starts to move).
(to označuje začetek injiciranja in modri bat se začne premikati).
• The blue plunger moves down the viewing window during the injection.
• Modri bat se ob injiciranju pomika navzdol ob pregledovalnem okencu.
Insert the needle into the pinched skin at a 45° to 90° angle.
V stisnjeno kožo vstavite iglo pod kotom od 45° do
The absolute bioavailability of fremanezumab after subcutaneous administration of 225 mg and 900 mg in healthy subjects was 55% (±SD of 23%) to 66% (±SD of 26%).
Absolutna biološka uporabnost fremanezumaba po subkutanem injiciranju 225 mg in 900 mg pri zdravih preskušancih je 55 % (± SD 23 %) do 66 % (± SD 26 %).
As a precautionary measure, it is preferable to avoid the use of AJOVY during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila AJOVY bolje izogibati.
79% of patients completed the 12-month treatment period of Study 3.
12-mesečno obdobje zdravljenje v študiji 3 je dokončalo 79 % bolnikov.
g) Clean your injection area.
g) Očistite predel injiciranja.
Percentage [%] P-value (vs. placebo)
odstotek [%] p-vrednost (v primerjavi s placebom)
HIT-6 total
Skupen rezultat na lestvici HIT-6
− Choose an injection area from the following areas: Your stomach area (abdomen), avoid about 5 cm around the belly button The front of your thighs, about 5 cm above the knee and 5 cm below the groin The back of your upper arms, in the fleshy areas of the upper back portion
− Izberite predel injiciranja, ki je lahko: predel trebuha, razen približno 5 cm okrog popka, prednja stran stegen, in sicer približno 5 cm nad kolenom in 5 cm pod dimljami, zadnja stran nadlakti, in sicer debeli predeli na zgornjem zadnjem delu.
− Use a clean, dry cotton ball, or gauze to gently press on the injection site for a few seconds.
− S čistim, suhim kosom vate ali gazo nežno pritisnite na mesto injiciranja za nekaj sekund.
AJOVY may be stored unrefrigerated for up to 24 hours at a temperature up to 25°C.
Zdravilo AJOVY lahko shranjujete zunaj hladilnika do 24 ur pri temperaturi do 25 °C.
Commonly reported adverse drug reactions (ADRs) were local reactions at the injection site (pain [24%], induration [17%], erythema [16%] and pruritus [2%]).
[24%], induracija [17 %], eritem [16 %] in pruritus [2 %]).
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially “sodium-free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
There is limited data available on the use of fremanezumab in patients ≥65 years of age.
Razpoložljivi podatki o uporabi fremanezumaba pri bolnikih, starih ≥ 65 let, so omejeni.
AJOVY can be injected into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated.
Zdravilo AJOVY se lahko injicira v predele trebuha, stegen ali nadlakti, ki niso občutljivi, poškodovani, pordeli ali otrdeli.
AJOVY is used to prevent migraine in adults who have at least 4 migraine days per month.
Zdravilo AJOVY uporabljamo za preprečevanje migrene pri odraslih, ki imajo migreno vsaj 4 dni na mesec.
What AJOVY is and what it is used for What AJOVY is
Kaj je zdravilo AJOVY in za kaj ga uporabljamo Kaj je zdravilo AJOVY
Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Merckle GmbH Graf-Arco-Str. 3 89079 Ulm
f) Choose your injection area.
f) Izberite predel injiciranja.
AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
Zdravilo AJOVY je indicirano za profilakso migrene pri odraslih, ki imajo migreno vsaj 4 dni na mesec.
• Put the carton back in the refrigerator immediately, if you have any unused pre-filled pens in the carton.
• Škatlo dajte takoj nazaj v hladilnik, če je v njej še kakšna neuporabljena napolnjena injekcijska brizga.
You should not inject yourself until you have been trained by your doctor or nurse.
Sami si ga ne smete injicirati, dokler vas za to ne usposobi zdravnik ali medicinska sestra.
If your dose is 675 mg, repeat steps 1 e) to 3 a) with the second and third pre-filled syringe to inject the full dose.
Če je vaš odmerek 675 mg, ponovite korake 1 e) do 3 a) z drugo in tretjo napolnjeno injekcijsko brizgo, da si injicirate polni odmerek.
TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany
TEVA GmbH Graf-Arco-Str. 3 89079 Ulm