FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Hemlibra are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Hemlibra, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The dose of Hemlibra depends on the patient's bodyweight.
Slovenian: Odmerek zdravila Hemlibra je odvisen od bolnikove telesne mase.
English: What is Hemlibra and what is it used for?
Slovenian: Kaj je zdravilo Hemlibra in za kaj se uporablja?
English: Because emicizumab has a different structure to factor VIII, it is not affected by factor VIII inhibitors.
Slovenian: Ker ima emicizumab drugačno zgradbo od faktorja VIII, zaviralci faktorja VIII nanj ne vplivajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hemlibra have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Hemlibra upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Patients or their carers may be able to inject Hemlibra at home once they have been trained appropriately.
Slovenian: Bolniki ali njihovi skrbniki lahko po ustreznem usposabljanju zdravilo Hemlibra injicirajo sami doma.
English: The company that markets Hemlibra will issue educational materials for healthcare professionals, patients, carers and laboratory professionals about abnormal clotting side effects, the risk of taking Hemlibra at the same time as bypassing agents and how laboratory tests should be carried out for these patients.
Slovenian: Družba, ki trži zdravilo Hemlibra, bo izdala izobraževalno gradivo za zdravstvene delavce, bolnike, skrbnike in laboratorijske delavce o neželenih učinkih nenormalnega strjevanja, tveganju jemanja zdravila Hemlibra sočasno z obvodnimi zdravili in načinu izvajanja laboratorijskih preiskav pri teh bolnikih.
English: Patients receiving Hemlibra also had better quality of life scores than those who were not given Hemlibra.
Slovenian: Bolniki, ki so prejemali zdravilo Hemlibra, so tudi bolje ocenili kakovost življenja kot tisti, ki tega zdravila niso prejemali.
English: For more information about using Hemlibra, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Hemlibra glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The most serious side effect is thrombotic microangiopathy (clots in small blood vessels, which may affect up to 1 in 100 people).
Slovenian: Najresnejši neželeni učinki so trombotična mikroangiopatija (strdki v majhnih krvnih žilah, ki se lahko pojavijo pri največ 1 bolniku od 100).
English: The active substance in Hemlibra, emicizumab, is a monoclonal antibody which has been designed to do the work that factor VIII normally does - bringing together 2 clotting factors (IXa and X) as part of a chain of reactions needed for blood to clot.
Slovenian: Učinkovina v zdravilu Hemlibra, emicizumab, je monoklonsko protitelo, ki je bilo zasnovano za opravljanje dela, ki ga običajno opravlja faktor VIII - povezovanje dveh faktorjev strjevanja krvi (IXa in X) kot del verige reakcij, potrebnih za strjevanje krvi.
English: The side effects with Hemlibra are tolerable and information on how to manage the risks of serious side effects is in the prescribing information and educational materials.
Slovenian: Neželeni učinki zdravila Hemlibra so sprejemljivi, informacije o obvladovanju tveganja za resne neželene učinke pa so v informacijah o predpisovanju zdravila in izobraževalnem gradivu.
English: This overview was last updated in 03-2019.
Slovenian: Nadaljnje informacije o zdravilu Hemlibra so na voljo na spletni strani agencije: Pregled je bil nazadnje posodobljen 03-2019.
English: The most common side effects with Hemlibra (which may affect 1 in 10 people or more) are redness, itching or pain at the place where it is injected, headache and joint pain.
Slovenian: Najpogostejši neželeni učinki zdravila Hemlibra (ki se lahko pojavijo pri 1 ali več od 10 bolnikov) so pordelost, srbenje ali bolečina na mestu injiciranja, glavobol in bolečina v sklepih.
English: The arm injection should only be given by a caregiver or healthcare professional.
Slovenian: Injekcijo v nadlaket smejo dajati samo skrbniki ali zdravstveni delavci.
English: Hemlibra is available as a solution for injection under the skin in the belly, thigh or upper arm.
Slovenian: Zdravilo Hemlibra je na voljo v obliki raztopine za injiciranje pod kožo v trebuh, stegno ali nadlaket.
English: Abnormal clotting, affecting between 1 and 10 in 1,000 people, may also occur and includes cavernous sinus thrombosis (clotting at the base of the brain) and superficial vein thrombosis (clotting in veins under the skin, usually in the arms or legs) with skin damage.
Slovenian: Pri 1 do 10 od 1 000 bolnikov se lahko pojavi tudi nenormalno strjevanje, ki vključuje trombozo kavernoznega sinusa (strjevanje na možganski bazi) in trombozo povrhnjih ven (strjevanje v venah pod kožo, običajno v rokah ali nogah) s poškodbo kože.
English: The day before starting Hemlibra treatment, patients should stop treatment with bypassing agents (medicines used to prevent bleeding in patients with factor VIII inhibitors, such as activated prothrombin complex concentrate or recombinant factor VIIa).
Slovenian: Na dan pred začetkom zdravljenja z zdravilom Hemlibra morajo bolniki prenehati zdravljenje z obvodnimi zdravili (zdravili, ki se uporabljajo za preprečevanje krvavitev pri bolnikih z zaviralci faktorja VIII, kot so aktivirani koncentrat protrombinskega kompleksa ali rekombinantni faktor VIIa).
English: Hemlibra can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia or bleeding disorders.
Slovenian: Predpisovanje in izdaja zdravila Hemlibra je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem hemofilije ali motenj strjevanja krvi.
English: For the full list of side effects and restrictions with Hemlibra, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Hemlibra glejte navodilo za uporabo.
English: Hemlibra is a medicine used to prevent or reduce bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Slovenian: Hemlibra je zdravilo, ki se uporablja za preprečevanje ali zmanjševanje krvavitev pri bolnikih s hemofilijo A (dedno motnjo strjevanja krvi zaradi pomanjkanja faktorja VIII).
English: The medicine is used in patients who have developed factor VIII inhibitors, which are antibodies in the blood that act against factor VIII medicines and prevent them from working properly.
Slovenian: Uporablja se pri bolnikih, pri katerih so se pojavili zaviralci faktorja VIII, to so protitelesa v krvi, ki delujejo proti zdravilom, ki vsebujejo faktor VIII, in preprečujejo njihovo ustrezno delovanje.
English: When these patients were switched to Hemlibra, the number of treated bleeds per patient fell from the equivalent of around 16 bleeds per year before the switch to the equivalent of around 3 bleeds per year afterwards.
Slovenian: Po prehodu teh bolnikov na jemanje zdravila Hemlibra se je število zdravljenih krvavitev na bolnika zmanjšalo s povprečno 16 krvavitev na leto pred prehodom na povprečno tri krvavitve na leto po prehodu.
English: Patients with haemophilia A lack factor VIII, a substance in the body that helps the blood to clot.
Slovenian: Bolnikom s hemofilijo A primanjkuje faktorja VIII, tj. snovi v telesu, ki pomaga pri strjevanju krvi.
English: A study in 152 patients showed that Hemlibra is also effective at preventing bleeding in patients with severe haemophilia A without factor VIII inhibitors: patients given Hemlibra for prevention had around 1 bleed per year that needed to be treated, compared with 38 bleeds per year in patients who received no preventive treatment.
Slovenian: V študiji, ki je vključevala 152 bolnikov, je bilo dokazano, da je zdravilo Hemlibra učinkovito tudi pri preprečevanju krvavitev pri bolnikih s hudo obliko hemofilije A brez zaviralcev VIII: bolniki, ki so prejemali zdravilo Hemlibra za preprečevanje krvavitev, so imeli približno eno krvavitev na leto, ki jo je bilo treba zdraviti, v primerjavi z 38 krvavitvami na leto pri bolnikih, ki niso prejemali preventivnega zdravljenja.
English: How is Hemlibra used?
Slovenian: Kako se zdravilo Hemlibra uporablja?
English: How does Hemlibra work?
Slovenian: Kako zdravilo Hemlibra deluje?
English: A study in 109 patients showed that Hemlibra is effective at preventing bleeding in patients with haemophilia A of any severity who have factor VIII inhibitors: patients given Hemlibra for prevention had fewer bleeds that needed to be treated (equivalent to 3 per year) than patients who received no preventive treatment (equivalent to 23 per year).
Slovenian: V študiji, ki je vključevala 109 bolnikov, je bilo dokazano, da je zdravilo Hemlibra učinkovito pri preprečevanju krvavitev pri bolnikih s hemofilijo A katere koli težavnosti, ki imajo zaviralce VIII: bolniki, ki so prejemali zdravilo Hemlibra za preprečevanje krvavitev, so imeli manj krvavitev, ki jih je bilo treba zdraviti (kar je znašalo 3 na leto) kot bolniki, pri katerih ni bilo preventivnega zdravljenja (kar je znašalo 23 na leto).
English: Hemlibra also reduces bleeding in patients with severe haemophilia A without factor VIII inhibitors.
Slovenian: Zdravilo prav tako zmanjšuje krvavitve pri bolnikih s hudo obliko hemofilije A brez zaviralcev faktorja VIII.
English: It is also used in patients without factor VIII inhibitors if their haemophilia A is severe.
Slovenian: Prav tako se uporablja pri bolnikih brez zaviralcev faktorja VIII, če imajo hudo obliko hemofilije A. Zdravilo Hemlibra vsebuje učinkovino emicizumab.
English: Only a few medicines, called bypassing agents, are suitable for patients with haemophilia A who have developed factor VIII inhibitors.
Slovenian: Za zdravljenje bolnikov s hemofilijo A, pri katerih so se pojavili zaviralci faktorja VIII, je primernih le nekaj zdravil, imenovanih obvodna zdravila.
English: [other monocomponent]
Slovenian: [druga monokomponenta]
English: [relevant text]
Slovenian: [zadevno besedilo]
English: Warnings and precautions
Slovenian: o Opozorila in previdnostni ukrepi
English: - The text: “(to be divided into 2-3 daily doses)” should be omitted.]
Slovenian: - Besedilo: “(je treba razdeliti v 2-3 odmerke na dan)” se izpusti.]
English: If no adequate strength of [product name] is available, individual monocomponents should be used instead of the fixed dose combination.
Slovenian: Če ni na voljo ustrezna jakost zdravila [ime zdravila], je treba namesto fiksne kombinacije uporabiti posamične monokomponente.
English: [The dosing table above should be adapted for extended-release products containing metformin as single agent as follows: - The total maximum daily dose for patients with GFR 60-89 mL/min should be the same as the currently approved dose in adults with normal renal function.
Slovenian: [Zgornja preglednica za odmerjanje se prilagodi za zdravilo s podaljšanim sproščanjem, ki vsebuje metformin kot edino učinkovino, kot sledi: - Skupni največji dnevni odmerek za bolnike z GFR 60-89 ml/min mora biti enak kot trenutno odobreni odmerek za odrasle z normalnim delovanjem ledvic.
English: Section 4: Possible side effects [Include among the most serious side effects at the top of section 4:]
Slovenian: • Poglavje 4: Možni neželeni učinki [Vključiti med najresnejše neželene učinke na začetku poglavja 4:]
English: <If you have reduced kidney function, your doctor may prescribe a lower dose.> [Text to be included for products where dose reduction is recommended, only if the PL provides specific information about the dose]
Slovenian: <Če imate zmanjšano delovanje ledvic, vam bo morda zdravnik predpisal manjši odmerek.> [Besedilo se vključi za zdravila, pri katerih se priporoča zmanjšanje odmerka, vendar le če navodilo za uporabo vsebuje specifične informacije o odmerkih.]
English: Other medicines and <Product name>
Slovenian: o Druga zdravila in zdravilo <Product name>
English: Adults with normal renal function (GFR≥ 90 mL/min)
Slovenian: Odrasli z normalnim delovanjem ledvic (GFR ≥ 90 ml/min)
English: <Product name> with alcohol
Slovenian: Zdravilo <ime zdravila> skupaj z alkoholom
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Slovenian: Obstoječe informacije o zdravilu se dopolni (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) tako, da ustrezajo spodnjemu dogovorjenemu besedilu.
English: During treatment with <Product name>, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Slovenian: Med zdravljenjem z zdravilom <Ime zdravila> bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
English: Annex III Amendments to relevant sections of the Product Information
Slovenian: Priloga III Spremembe, ki se vključijo v ustrezna poglavja informacij o zdravilu
English: B. Package leaflet [The following texts should be added to or replace existing texts, as appropriate:]
Slovenian: B. Navodilo za uporabo [Treba je dodati naslednje besedilo ali nadomestiti obstoječe besedilo, kot je ustrezno:]
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (>5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.
Slovenian: Diagnostični laboratorijski izvidi so zmanjšan pH krvi (< 7,35), zvišane ravni laktata v plazmi (> 5 mmol/l) in povečana anionska vrzel ter razmerje laktat/piruvat.
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of <Product name>.
Slovenian: Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic, zdravnik pa bo morda moral prilagoditi odmerek zdravila <Ime zdravila>.
English: • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) • Severe renal failure (GFR <30 mL/min)
Slovenian: • Vse vrste akutne metabolične acidoze (kot sta laktacidoza, diabetična ketoacidoza) • Huda ledvična odpoved (GFR < 30 ml/min)
English: If you have severely reduced kidney function.
Slovenian: Če imate hudo oslabljeno delovanje ledvic.
English: 4.5 Interaction with other medicinal products and other forms of interaction [The wording should be revised as follows:]
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij [Besedilo se popravi kot sledi:]
English: Amendments to relevant sections of the Product Information
Slovenian: Spremembe, ki se vključijo v ustrezna poglavja informacij o zdravilu
English: Stop taking <Product name> for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Slovenian: Za kratek čas prenehajte jemati zdravilo <Ime zdravila>, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, zvišana telesna temperatura, izpostavljenost vročini ali če pijete manj tekočine, kot običajno.
English: Section 2: What you need to know before you <take> <use> <Product name>
Slovenian: • Poglavje 2: Kaj morate vedeti, preden <boste vzeli> <boste uporabili> zdravilo X o Ne <jemljite> <uporabljajte> zdravila X
English: Section 3: How to <take> <use> <Product name>
Slovenian: • Poglavje 3: Kako <jemati> <uporabljati> zdravilo <Ime zdravila>
English: For fixed dose combination products containing metformin:
Slovenian: Za zdravila s fiksno kombinacijo, ki vsebujejo metformin:
English: Metformin is contraindicated in patients with GFR<30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
Slovenian: Metformin je kontraindiciran pri bolnikih z GFR< 30 ml/min in ga je treba začasno ukiniti, če se pojavijo stanja, ki spremenijo delovanje ledvic, glejte poglavje 4.3.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking <Product name> before or at the time of the injection.
Slovenian: Če vam bodo v krvni obtok injicirali kontrastno sredstvo, ki vsebuje jod, na primer zaradi rentgenskega ali drugega slikanja, morate pred časom injiciranja ali v tem času prenehati z jemanjem zdravila <Ime zdravila>.
English: medicines which increase urine production (diuretics) medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
Slovenian: zdravila, ki povečajo nastajanje urina (diuretiki) zdravila za zdravljenje bolečine in vnetja (nesteroidna protivnetna zdravila in ali zaviralci COX-2, kot sta ibuprofen in celekoksib) nekatera zdravila za zdravljenje visokega krvnega tlaka (zaviralci ACE in antagonisti receptorjev angiotenzina II)
English: If this happens you must stop taking <Product name> and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Slovenian: V tem primeru morate prenehati jemati zdravilo <Ime zdravila> in se takoj obrniti na zdravnika ali najbližjo bolnišnico, saj lahko laktacidoza vodi v komo.
English: If you need to have major surgery you must stop taking <Product name> during and for some time after the procedure.
Slovenian: Če morate na večji kirurški poseg, morate v času posega in še nekaj časa po tem prenehati z jemanjem zdravila <Ime zdravila>.
English: <Product name> may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Slovenian: Zdravilo <Ime zdravila> lahko povzroči zelo redek (pojavi se lahko pri do 1 od 10.000 bolnikov), a zelo resen neželeni učinek, imenovan laktacidoza (glejte poglavje "Opozorila in previdnostni ukrepi").
English: Stop taking <Product name> and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Slovenian: Takoj prenehajte jemati zdravilo <Ime zdravila> in se obrnite na zdravnika ali najbližjo bolnišnico, če se pojavijo nekateri od simptomov laktacidoze, saj lahko to stanje vodi v komo.
English: Risk of lactic acidosis <Product name> may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Slovenian: Zdravilo <Ime zdravila> lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
English: Avoid excessive alcohol intake while taking <Product name> since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Slovenian: Med jemanjem zdravila <Ime zdravila> ne uživajte čezmernih količin alkohola, saj lahko to poveča tveganje za laktacidozo (glejte poglavje "Opozorila in previdnostni ukrepi").
English: Your doctor will decide when you must stop and when to restart your treatment with <Product name>.
Slovenian: Zdravnik se bo odločil, kdaj morate z jemanjem zdravila <Ime zdravila> prenehati in kdaj lahko nadaljujete.
English: 4.4 Special warnings and precautions for use [Warnings should be revised as follows:]
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi [Opozorila se popravijo kot sledi:]
English: For products containing metformin as single agent:
Slovenian: Za zdravila, ki vsebujejo metformin kot edino učinkovino:
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Slovenian: Popravki zadevnih poglavij povzetka glavnih značilnosti zdravila in navodilo za uporabo so rezultat postopka napotitve.
English: 4.3 Contraindications [This section should be revised as follows:]
Slovenian: 4.3 Kontraindikacije [To poglavje se popravi kot sledi:]
English: vomiting stomach ache (abdominal pain) muscle cramps a general feeling of not being well with severe tiredness difficulty in breathing reduced body temperature and heartbeat
Slovenian: Simptomi laktacidoze vključujejo: bruhanje bolečina v trebuhu (abdominalna bolečina) mišične krče splošno slabo počutje s hudo utrujenostjo težave z dihanjem znižano telesno temperaturo in počasen srčni utrip
English: If you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Slovenian: če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
English: Additional considerations
Slovenian: Dodatni podatki, ki jih je treba upoštevati
English: For both products containing metformin as single agent and for fixed dose combination products containing metformin:
Slovenian: Za zdravila, ki vsebujejo metformin kot edino učinkovino in zdravila s fiksno kombinacijo, ki vsebujejo metformin kot:
English: Lactic acidosis
Slovenian: Tveganje za laktacidozo
English: 4.2 Posology and method of administration [This section should be revised as follows:]
Slovenian: 4.2 Odmerjanje in način uporabe [To poglavje se popravi kot sledi:]
English: Metformin must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.
Slovenian: Metformin je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.4.
English: 3000 mg
Slovenian: 60 do 89 3.000 mg
English: Total maximum daily dose (to be divided into 2-3 daily doses)
Slovenian: GFR ml/min Skupni največji dnevni odmerek (razdeli se v 2 do 3 dnevne odmerke)
English: 1000 mg
Slovenian: 30 do 44 1.000 mg
English: 2000 mg
Slovenian: 45 do 59 2.000 mg
English: Surgery
Slovenian: Laktacidoza
English: Posology
Slovenian: Odmerjanje
English: Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin.
Slovenian: Pred načrtovanjem uvedbe metformina je treba oceniti dejavnike, ki lahko povečajo tveganje za laktacidozo (glejte poglavje 4.4).
English: • If you have any questions or concerns, speak to your dentist.
Slovenian: • Če imate kakršna koli vprašanja ali pomisleke, se posvetujte z zobozdravnikom.
English: The products were authorised in Estonia, France, Italy, Latvia and Lithuania.
Slovenian: Zdravila so bila odobrena v Estoniji, Franciji, Latviji in Litvi.
English: The majority of cases occurred within 7 days of using the pastes.
Slovenian: Večina primerov se je zgodila v 7 dneh po uporabi past.
English: 11 July 2014 EMA/431170/2014
Slovenian: 11. julij 2014 EMA/431170/2014
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision on 11 July 2014.
Slovenian: Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki ga je potrdila in dne 11. julija 2014 izdala končno pravno zavezujoč sklep.
English: The review was initiated at the request of the French medicines agency (ANSM) after new data became available that raised concerns about the safety of these products.
Slovenian: Pregled se je začel na zahtevo francoske agencije za zdravila (ANSM), potem ko so postali na voljo novi podatki, ki so vzbudili pomisleke glede varnosti teh zdravil.