natgillin/translations-raw huggingface dataset:
Therapy should be reinitiated at approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/dl (7.45 mmol/l) or below.
Terapiju treba ponovo uvesti, primjenjujući dozu koja je oko 25% niža od prethodne doze i to nakon što se razine hemoglobina spuste na 12 g/dl (7,45 mmol/l) ili niže.
- Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.
- Liječenje simptomatske anemije povezane s kroničnim zatajenjem bubrega u odraslih bolesnika.
The haemoglobin values in your blood should not exceed a value of 12 g/dl (7.45 mmol/l).
Vrijednosti hemoglobina u krvi ne smiju biti više od 12 g/dl (7,45 mmol/l).
Packs of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 6 pre-filled syringes with safety device.
Pakiranja od 1, 4 i 6 napunjenih štrcaljki; 1, 4 i 6 napunjenih štrcaljki sa sigurnosnom iglom ili 1, 4 i 6 napunjenih štrcaljki sa sigurnosnom napravom.
If the frequency of administration is changed, dose adjustments may be necessary.
Ako se mijenja učestalost primjene, može biti potrebno prilagoditi dozu.
If typical causes of non-response are excluded, and the patient has a sudden drop in haemoglobin associated with reticulocytopenia, an examination of anti-erythropoietin antibodies and the bone marrow for diagnosis of pure red cell aplasia should be considered.
Ako su isključeni tipični uzroci izostanka odgovora i ako je zabilježen nagli pad hemoglobina kod bolesnika povezan s retikulocitopenijom, potrebno je provjeriti antieritropoetinska antitijela i pregledati koštanu srž radi dijagnoze izolirane aplazije crvene krvne loze.
The pharmacokinetics of epoetin theta are independent of age or gender.
Farmakokinetika epoetina theta ne ovisi o dobi ili spolu.
In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and
U bolesnika sa slabim hemoglobinskim odgovorom na epoetine potrebno je razmotriti druga moguća objašnjenja slabog odgovora (vidjeti dijelove 4.2 i 5.1).
In the event of polycythaemia, epoetin theta should be temporarily withheld.
U slučaju policitemije treba privremeno prekinuti primjenu epoetina theta.
Open the needle bag at the flaps (see picture 1).
Otvorite vrećicu s iglom na tim slobodnim krajevima (vidjeti sliku 1).
Attach the needle to the syringe (see picture 3).
Pričvrstite iglu na štrcaljku (vidjeti sliku 3).
Caution should be exercised with escalation of epoetin theta doses in patients with chronic renal failure.
Potreban je oprez kod povećavanja doza epoetina theta u bolesnika s kroničnim zatajenjem bubrega.
Pure red cell aplasia (PRCA)*
Izolirana aplazija crvene krvne loze*
Open the blister and take the pre-filled syringe and the needle bag out of the blister.
Otvorite blister i izvadite napunjenu štrcaljku i vrećicu s iglom iz blistera.
- The other ingredients are sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment) and water for injections.
- Drugi sastojci su natrijev dihidrogenfosfat dihidrat, natrijev klorid, polisorbat 20, trometamol, kloridna kiselina (6 M) (za podešavanje pH) i voda za injekcije.
If you are being treated with Biopoin, the dose of the anticoagulant medicine may have to be increased.
Ako se liječite lijekom Biopoin, može biti potrebno povećati dozu lijeka koji sprečava zgrušavanje krvi (antikoagulansa).
In controlled clinical studies, use of epoetins has shown: - shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin level in excess of 14 g/dl (8.69 mmol/l), - shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin value of 12-14 g/dl (7.45-8.69 mmol/l), - increased risk of death when administered to target a haemoglobin value of 12 g/dl (7.45 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
kontroliranim kliničkim ispitivanjima, uporaba epoetina pokazala je: - skraćeno vrijeme do progresije tumora u bolesnika s uznapredovalim karcinomom glave i vrata koji primaju radioterapiju, a u kojih su se primjenom epoetina trebala postići razina hemoglobina veća od 14 g/dl (8,69 mmol/l), - skraćeno ukupno preživljavanje i povećanu smrtnost povezanu s progresijom bolesti u razdoblju od 4 mjeseca kod bolesnica s metastatskim karcinomom dojke koje primaju kemoterapiju, a u kojih su se primjenom epoetina trebala postići vrijednost hemoglobina od
There is a cap at the end of the needle container.
Na kraju spremnika s iglom nalazi se zatvarač.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dl, is unclear because few patients with these characteristics were included in the data reviewed.
da bi se postigle koncentracije hemoglobina niže od 13 g/dl, jer je samo nekoliko bolesnika s tim karakteristikama bilo uključeno u reviziju podataka.
Biopoin 1,000 IU/0.5 ml, Biopoin 2,000 IU/0.5 ml, Biopoin 3,000 IU/0.5 ml, Biopoin 4,000 IU/0.5 ml and Biopoin 5,000 IU/0.5 ml: Each pre-filled syringe contains 0.5 ml of solution.
Biopoin 1000 IU/0,5 ml, Biopoin 2000 IU/0,5 ml, Biopoin 3000 IU/0,5 ml, Biopoin 4000 IU/0,5 ml i Biopoin 5000 IU/0,5 ml: svaka napunjena štrcaljka sadrži 0,5 ml otopine.
In two long-term studies, the efficacy of epoetin theta was evaluated in 124 haemodialysis patients and 289 patients not yet undergoing dialysis.
U dva dugoročna ispitivanja djelotvornost epoetina theta ispitana je u 124 bolesnika na hemodijalizi i
PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including with epoetin theta.
Izolirana aplazija crvene krvne loze uzrokovana neutralizirajućim antieritropoetinskim antitijelima zabilježena je u vezi s terapijom eritropoetinom, uključujući epoetin theta.
The solution should be visually inspected prior to use.
Prije primjene, otopinu treba vizualno pregledati.
Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications.
4.2 Doziranje i način primjene Liječenje epoetinom theta trebaju započeti liječnici s iskustvom u navedenim indikacijama.
Non-response to therapy with epoetin theta should prompt a search for causative factors.
Ako bolesnik ne odgovori na terapiju epoetinom theta, odmah treba istražiti uzročne faktore.
TEVA GmbH Graf-Arco-Straße 3 89079 Ulm Germany
TEVA GmbH Graf-Arco-Straße 3 89079 Ulm
In clinical trials, patients over 75 years of age had a higher incidence of serious and severe adverse events irrespective of a causal relationship to treatment with epoetin theta.
U kliničkim ispitivanjima, veća incidencija ozbiljnih i teških nuspojava, neovisno o uzročnoposljedičnoj vezi s liječenjem epoetinom theta, zabilježena je u bolesnika starijih od 75 godina.
Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO-K1) by recombinant DNA technology.
Epoetin theta (rekombinantni humani eritropoetin) proizveden je tehnologijom rekombinantne DNK
Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.
Pomoćne tvari: natrijev dihidrogenfosfat dihidrat, natrijev klorid, polisorbat 20, trometamol, kloridna kiselina (6 M) (za podešavanje pH), voda za injekcije.
Remove the tip cap from the pre-filled syringe (see picture 2).
Uklonite zatvarač vrha s napunjene štrcaljke (vidjeti sliku 2).
In the case of injections under the skin, the weekly dose can be given either as 1 injection per week or as 3 divided injections per week.
U slučaju injekcije potkožno, tjedna doza može se primijeniti bilo kao 1 injekcija tjedno ili u 3
Erythropoietin is a growth factor that primarily stimulates red cell production.
Eritropoetin je čimbenik rasta koji primarno stimulira stvaranje crvenih krvnih stanica.
- Dispose of the full puncture-proof container as instructed by your doctor, pharmacist or nurse.
- Puni neprobojni spremnik odložite u skladu s uputama liječnika, ljekarnika ili medicinske sestre.
Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy 409 cancer patients receiving chemotherapy were included in two prospective, randomised double-blind, placebo-controlled studies.
409 bolesnika koji primaju kemoterapiju uključeno je u dva prospektivna, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja.
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/l or with transferrin saturation below 20%.
Nadomjesna terapija željezom preporučuje se za sve bolesnike s vrijednostima feritina u serumu ispod
Open the blister and take the pre-filled syringe and the needle container out of the blister.
Otvorite blister i izvadite napunjenu štrcaljku i spremnik s iglom iz blistera.
Press down the needle with a firm, quick motion until a distinct audible click is heard (see picture 14).
Pritisnite iglu prema dolje čvrstim, brzim pokretom sve dok se ne začuje jasan, glasni škljocaj
Anaemia caused by chronic renal failure
Anemija uzrokovana kroničnim zatajenjem bubrega
If the rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) in 4 weeks or the haemoglobin level exceeds 12 g/dl (7.45 mmol/l), the dose should be reduced by 25 to 50%.
Ako je porast hemoglobina veći od 2 g/dl (1,24 mmol/l) u 4 tjedna ili ako su razine hemoglobina veće od 12 g/dl (7,45 mmol/l), dozu treba smanjiti za 25 do 50%.
The dose should be adjusted as necessary to maintain the individual target haemoglobin level between 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l), whereby a haemoglobin level of 12 g/dl (7.45 mmol/l) should not be exceeded.
Dozu treba prilagoditi po potrebi da se individualna ciljna vrijednost hemoglobina održi između 10 g/dl (6,21 mmol/l) i 12 g/dl (7,45 mmol/l), pri čemu se ne smije prekoračiti vrijednost hemoglobina od 12 g/dl (7,45 mmol/l).
Name and address of the manufacturer responsible for batch release
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Teva Biotech GmbH
- Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
- Liječenje simptomatske anemije u odraslih bolesnika s nemijeloičnim malignim bolestima koji primaju kemoterapiju.
The initial dose for injections into veins is 40 IU per kg of bodyweight, given 3 times per week.
Početna doza injekcije u venu je 40 IU po kg tjelesne težine, primijenjena 3 puta tjedno.
For both routes of administration, the maximum dose should not exceed 700 IU/kg body weight per week.
Za oba puta primjene najviša doza ne smije biti veća od 700 IU/kg tjelesne težine tjedno.
Misuse
Zlouporaba
The maximum dose should not exceed 700 IU/kg body weight per week.
Najviša doza ne smije prelaziti 700 IU/kg tjelesne težine tjedno.
There are flaps at the end of the needle bag.
Pri kraju vrećice s iglom nalaze se slobodni krajevi.
A sustained haemoglobin level of greater than 12 g/dl (7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment if haemoglobin values exceeding 12 g/dl (7.45 mmol/l) are observed are described below.
Treba izbjeći kontinuiranu vrijednost hemoglobina veću od 12 g/dl (7,45 mmol/l); smjernice za ispravno prilagođavanje doze ako su vrijednosti hemoglobina veće od 12 g/dl (7,45 mmol/l) obrađene su i opisane u daljnjem tekstu.
Do not use any Biopoin that is left in the syringe.
Biopoin preostao u štrcaljki se ne smije ponovno koristiti.
Break the labelled seal and remove the cap (see picture 1).
Prelomite zaštitni spoj i odstranite zatvarač (vidjeti sliku 1).
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe
Biopoin 1000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Biopoin 2000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Biopoin 3000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Biopoin 4000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Biopoin 5000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Biopoin 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Biopoin 20 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Biopoin 30 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l).
Varijabilnost hemoglobina treba riješiti prilagođavanjem doze, pri čemu treba uzeti u obzir ciljni raspon hemoglobina od 10 g/dl (6,21 mmol/l) do 12 g/dl (7,45 mmol/l).
Information for injecting yourself
Informacije za samoprimjenu injekcije
Skin reactions such as rash, pruritus or injection site reactions may occur.
Mogu se dogoditi i kožne reakcije poput osipa, svrbeža li reakcija na mjestu primjene injekcije.
What Biopoin is used for
Za što se Biopoin koristi
Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy Epoetin theta should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl [6.21 mmol/l]).
Epoetin theta treba primjenjivati supkutanim putem kod bolesnika s anemijom (npr. kod koncentracije hemoglobina ≤ 10 g/dl [6,21 mmol/l]).
Put everything you need within easy reach (the Biopoin pre-filled syringe, an alcohol wipe and a piece of gauze bandage or a sterile gauze swab).
Stavite sve što Vam treba nadohvat ruke (napunjenu štrcaljku lijeka Biopoin, maramicu s alkoholom, komadić gaze ili sterilni štapić s gazom).
Do not remove the needle cover at this time.
Još ne smijete skinuti zaštitni poklopac s igle.
Packs of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Pakiranja od 6 napunjenih štrcaljki; 6 napunjenih štrcaljki sa sigurnosnom iglom ili 6 napunjenih štrcaljki sa sigurnosnom napravom.
Please speak with your doctor if you belong to one of these patient groups: - patients with liver problems, - patients with pathological changes in their red blood cells (homozygous sickle cell anaemia).
Molimo razgovarajte sa svojim liječnikom ako se ubrajate u neku od sljedećih skupina: - bolesnici s jetrenim poteškoćama,
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
1,12; 53 ispitivanja i 13 933 bolesnika), a omjer rizika u ukupnom preživljavanju bolesnika koji su primali kemoterapiju bio je 1,04 (interval pouzdanosti 95%: 0,97, 1,11; 38 ispitivanja i
Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy
Simptomatska anemija u bolesnika s nemijeloičnim malignim bolestima koji primaju kemoterapiju
A patient-level data analysis has also been performed on more than 13,900 cancer patients (chemo-, radio-, chemoradio- or no therapy) participating in 53 controlled clinical trials involving several epoetins.
radioterapija, kemoradioterapija ili bez terapije) koji su sudjelovali u 53 kontrolirana klinička ispitivanja nekoliko epoetina.
6 pre-filled syringes containing 0.5 ml.
6 napunjenih štrcaljki koje sadrže 0,5 ml.
Dispose of syringes with a safety device as instructed by your doctor, pharmacist or nurse.
Štrcaljke sa sigurnosnom napravom za iglu odložite prema uputama liječnika, ljekarnika ili medicinske sestre
Put everything you need within easy reach (the Biopoin pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the puncture-proof container).
Stavite sve što Vam treba nadohvat ruke (napunjenu štrcaljku lijeka Biopoin, maramicu s alkoholom, komadić gaze ili sterilni štapić s gazom te neprobojni spremnik).
Common in cancer patients (may affect up to 1 in 10 people) - Joint pain.
Često u bolesnika sa zloćudnom bolešću (mogu se javiti u do 1 na 10 osoba)
Intravenous administration: The initial posology is 40 IU/kg body weight 3 times per week.
Intravenska primjena: Početna doza je 40 IU/kg tjelesne težine, 3 puta tjedno.
The maximum dose should not exceed 700 IU per kg of bodyweight per week.
Najviša doza ne smije prelaziti 700 IU po kg tjelesne mase tjedno.
How to use Biopoin
Kako primjenjivati Biopoin
If a dose adjustment is required to maintain the desired haemoglobin level, it is recommended that the dose be adjusted by approximately 25%.
preporučuje se prilagoditi dozu za oko 25%.
The initial dose for injections under the skin is 20 IU per kg of bodyweight, given 3 times per week.
Početna doza injekcije potkožno je 20 IU po kg tjelesne težine, primijenjena 3 puta tjedno.
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at a temperature not above 25 °C for a single period of up to 7 days without exceeding the expiry date.
U svrhu kućne primjene, bolesnik može izvaditi lijek iz hladnjaka i čuvati ga na temperaturi do 25 °C
Symptomatic anaemia associated with chronic renal failure
Simptomatska anemija povezana s kroničnim zatajenjem bubrega
If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current dose should be continued.
tjedna terapije vrijednosti hemoglobina porastu za najmanje 1 g/dl (0,62 mmol/l), treba nastaviti primjenjivati istu dozu.
What Biopoin is and what it is used for 2.
Što je Biopoin i za što se koristi
Put the shielded needle without hesitation and in one continuous motion fully into the skin as shown by your doctor or nurse.
Ubodite zaštićenu iglu u kožu odlučnim i koninuiranim pokretom, kao što Vam je pokazao Vaš liječnik ili medicinska sestra.
Injections are given under the skin.
Injekcije se daju potkožno.
One pre-filled syringe contains 30,000 international units (IU) (250 micrograms) epoetin theta in 1 ml solution for injection corresponding to 30,000 IU (250 micrograms) epoetin theta per ml.
Jedna napunjena štrcaljka sadrži 30 000 internacionalnih jedinica (IU) (250 mikrograma) epoetina theta u 1 ml otopine za injekciju, što odgovara 30 000 IU (250 mikrograma) epoetina theta po ml.
If, after 12 weeks of therapy, the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), response is unlikely and treatment should be discontinued.
Ako nakon 12 tjedana terapije vrijednosti hemoglobina nisu porasle za najmanje 1 g/dl (0,62 mmol/l),
One pre-filled syringe contains 20,000 international units (IU) (166.7 micrograms) epoetin theta in 1 ml solution for injection corresponding to 20,000 IU (166.7 micrograms) epoetin theta per ml.
Jedna napunjena štrcaljka sadrži 20 000 internacionalnih jedinica (IU) (166,7 mikrograma) epoetina theta u 1 ml otopine za injekciju, što odgovara 20 000 IU (166,7 mikrograma) epoetina theta po ml.
Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Takvi su slučajevi zabilježeni kod bolesnika tijekom istovremene primjene epoetina s interferonom i ribavirinom u bolesnika s hepatitisom C. Epoetini nisu odobreni u liječenju anemije povezane s hepatitisom C. Hipertenzija
How Biopoin is used
Kako se Biopoin primjenjuje
To give yourself an injection into the tissue under the skin you will need: - a pre-filled syringe of Biopoin, - an alcohol wipe, - a piece of gauze bandage or a sterile gauze swab, - a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely.
- komadić gaze ili sterilni štapić s gazom, - neprobojni spremnik (plastični spremnik kojeg daje bolnica ili ljekarna) u koji na siguran način možete odložiti štrcaljke.
Before you give yourself an Biopoin injection, you must do the following: Hold the syringe and gently remove the cover from the needle without twisting.
Prije nego primijenite Biopoin injekciju, morate učiniti sljedeće:
Biopoin 20,000 IU/1 ml: One pre-filled syringe contains 20,000 international units (IU) (166.7 micrograms) epoetin theta in 1 ml solution for injection corresponding to 20,000 international units (IU) (166.7 micrograms) per ml.
Biopoin 20 000 IU/1 ml: Jedna napunjena štrcaljka sadrži 20 000 internacionalnih jedinica (IU) (166,7 mikrograma) epoetina theta u 1 ml otopine za injekciju što odgovara 20 000 internacionalnih jedinica (IU) (166,7 mikrograma) po ml.
Biopoin 30,000 IU/1 ml: One pre-filled syringe contains 30,000 international units (IU) (250 micrograms) epoetin theta in 1 ml solution for injection corresponding to 30,000 international units (IU) (250 micrograms) per ml.
Biopoin 30 000 IU/1 ml: Jedna napunjena štrcaljka sadrži 30 000 internacionalnih jedinica (IU) (250 mikorgrama) epoetina theta u 1 ml otopine za injekciju što odgovara 30 000 internacionalnih jedinica (IU) (250 mikrograma) po ml.
6 pre-filled syringes containing 1 ml.
6 napunjenih štrcaljki koje sadrže 1 ml.
Blood pressure should be controlled adequately before initiation and during therapy to avoid acute complications, such as hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke), which may also occur in individual patients with otherwise normal or low blood pressure.
Krvni tlak treba biti adekvatno kontroliran prije terapije i tijekom nje kako bi se izbjegle akutne komplikacije poput hipertenzivne krize sa simptomima nalik encefalopatiji (npr. glavobolje,
EU/1/09/565/017 1 pre-filled syringe EU/1/09/565/018 1 pre-filled syringe with safety device EU/1/09/565/019 4 pre-filled syringes EU/1/09/565/020 4 pre-filled syringes with safety device EU/1/09/565/021 6 pre-filled syringes EU/1/09/565/022 6 pre-filled syringes with safety device EU/1/09/565/037 1 pre-filled syringe with safety needle EU/1/09/565/038 4 pre-filled syringes with safety needle EU/1/09/565/039 6 pre-filled syringes with safety needle
EU/1/09/565/017 1 napunjena štrcaljka EU/1/09/565/018 1 napunjena štrcaljka sa sigurnosnom napravom EU/1/09/565/019 4 napunjenih štrcaljki EU/1/09/565/020 4 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/021 6 napunjenih štrcaljki EU/1/09/565/022 6 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/037 1 napunjena štrcaljka sa sigurnosnom iglom EU/1/09/565/038 4 napunjene štrcaljke sa sigurnosnom iglom EU/1/09/565/039 6 napunjenih štrcaljki sa sigurnosnom iglom
EU/1/09/565/011 1 pre-filled syringe EU/1/09/565/012 1 pre-filled syringe with safety device EU/1/09/565/013 4 pre-filled syringes EU/1/09/565/014 4 pre-filled syringes with safety device EU/1/09/565/015 6 pre-filled syringes EU/1/09/565/016 6 pre-filled syringes with safety device EU/1/09/565/034 1 pre-filled syringe with safety needle EU/1/09/565/035 4 pre-filled syringes with safety needle EU/1/09/565/036 6 pre-filled syringes with safety needle
EU/1/09/565/011 1 napunjena štrcaljka EU/1/09/565/012 1 napunjena štrcaljka sa sigurnosnom napravom EU/1/09/565/013 4 napunjenih štrcaljki bez zaštite za iglu EU/1/09/565/014 4 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/015 6 napunjenih štrcaljki EU/1/09/565/016 6 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/034 1 napunjena štrcaljka sa sigurnosnom iglom EU/1/09/565/035 4 napunjene štrcaljke sa sigurnosnom iglom EU/1/09/565/036 6 napunjenih štrcaljki sa sigurnosnom iglom
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe 30 months
Biopoin 5000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 30 mjeseci