natgillin/translations-raw huggingface dataset:
In patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance), strontium clearance decreases as creatinine clearance decreases (approximately 30% decrease over the creatinine clearance range 30 to 70 ml/min) and thereby induces an increase in strontium plasma levels.
klirens stroncija smanjuje se s klirensom kreatinina (oko 30 % smanjenja pri klirensu kreatinina u rasponu od 30 do 70 ml/min), zbog čega raste razina stroncija u plazmi.
As a divalent cation, strontium is not metabolised.
Stroncij se, kao dvovalentni kation, ne metabolizira.
New vertebral fracture over the 1st year
Novi prijelom kralješnice tijekom 1. godine
- If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after OSSEOR.
- Uzimate li antacide (lijekovi protiv žgaravice), smijete ih uzeti tek nakon što prođu najmanje dva sata od uzimanja OSSEOR-a.
TROPOS involved 5,091 postmenopausal women with osteoporosis (low femoral neck BMD and prevalent fracture in more than half of them) and a mean age of 77 years.
U ispitivanju TROPOS sudjelovala je 5091 žena u poslijemenopauzi s osteoporozom (niska BMD vrata bedrene kosti i prisutnost prijeloma u više od polovine ispitanica), srednje dobi od 77 godina.
Before starting treatment, patients should be evaluated with respect to cardiovascular risk.
Potrebno je procjeniti rizik za razvoj kardiovaskularnih bolesti kod bolesnika prije početka liječenja.
In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in OSSEOR treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]).
Iz zbirnih podataka iz randomiziranih placebom kontroliranih ispitivanja bolesnica s osteoporozom u postmenopauzi primjećen je značajan porast infarkta miokarda kod bolesnica liječenih OSSEOR-om u usporedbi s placebom (1,7% u usporedbi s 1,1 %), s relativnim rizikom od 1,6 (95% CI = [1,07 ;
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).
Prijavljeni su moguće po život opasni osipi (Stevens-Johnson-ov sindrom, toksična epidermalna nekroliza) (vidjeti dio 2).
New clinical vertebral fracture over 3 years
Novi klinički prijelom kralješnice tijekom 3 godine
In particular, in intact rats, strontium ranelate increases trabecular bone mass, trabeculae number and thickness; this results in an improvement of bone strength.
Stroncijev ranelat osobito je u štakora povećao masu trabekularne kosti te broj trabekula i njihovu debljinu; što rezultira povećanom čvrstoćom kosti.
If the patient has developed SJS, TEN or DRESS with the use of OSSEOR, OSSEOR must not be restarted in this patient at any time.
Ukoliko je bolesnik razvio SJS, TEN ili DRESS za vrijeme primjene OSSEOR-a, kod takvog bolesnika se nikad ne smije ponovno započeti liječenje s OSSEOR-om.
It is therefore preferable to take antacids at least two hours after OSSEOR.
Stoga antacide treba, po mogućnosti, uzimati najmanje dva sata nakon OSSEOR-a.
The data on skeletal strontium ranelate accumulation in longer term exposure is limited.
Ograničeni su podaci o nakupljanju stroncijevog ranelata u kosturu pri dugotrajnoj izloženosti.
In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, OSSEOR is not recommended in patients with a creatinine clearance below 30 ml/min (see section 5.2).
Budući da nema podataka o sigurnosti terapije stroncijevim ranelatom s obzirom na utjecaj na koštano tkivo u osoba s teško oštećenom funkcijom bubrega, OSSEOR se ne preporučuje u bolesnika s klirensom kreatinina manjim od 30 ml/min (vidjeti dio 5.2).
A higher incidence, although still rare, of hypersensitivity reactions including skin rash, SJS or TEN in patients of Asian origin has been reported.
Zabilježena je veća incidencija, iako još uvijek rijetka, reakcije preosjetljivosti uključujući kožni osip,
OSSEOR reduced the relative risk of new vertebral fracture by 41% over 3 years in the SOTI study (table 1).
OSSEOR je u ispitivanju SOTI tijekom 3 godine smanjio relativni rizik od novog prijeloma kralješnice za 41 % (Tablica 1).
SOTI involved 1,649 postmenopausal women with established osteoporosis (low lumbar BMD and prevalent vertebral fracture) and a mean age of 70 years.
Ispitivanje SOTI obuhvatilo je 1649 žena u poslijemenopauzi, s potvrđenom osteoporozom (smanjena BMD donjih slabinskih kralješaka i prisutnost prijeloma kralješnice), srednje dobi od 70 godina.
Efficacy of OSSEOR to reduce the risk of new vertebral fracture was confirmed in the TROPOS study, including for osteoporotic patients without fragility fracture at baseline.
Ispitivanjem TROPOS potvrđena je djelotvornost OSSEOR-a u smanjenju rizika od novih prijeloma kralješnice, uključujući i za bolesnice s osteoporozom bez prijeloma zbog krhkosti kosti na početku ispitivanja.
A number of risk factors are associated with postmenopausal osteoporosis including low bone mass, low bone mineral density, early menopause, a history of smoking and a family history of osteoporosis.
Brojni su čimbenici rizika povezani s pojavom osteoporoze u poslijemenopauzi, uključivši malu koštanu masu, slabu mineralnu gustoću kosti, ranu menopauzu,
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/09/2004
Datum prvog odobrenja: 21.09.2004.
Blood clots.
Krvni ugrušci.
In postmenopausal women, strontium ranelate reduces the risk of fracture at the spine and at the hip.
Kod žena u poslijemenopauzi, stroncijev ranelat smanjuje rizik nastanka prijeloma kralježnice i kuka.
How to store OSSEOR
Kako čuvati OSSEOR
Driving and using machines: Osseor is unlikely to affect your ability to drive or use machines.
Nije vjerojatno da će OSSEOR utjecati na Vašu sposobnost upravljanja motornim vozilima i strojevima.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sachet
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that OSSEOR reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs. 26.5% with placebo).
Združena analiza podataka iz ispitivanja SOTI i TROPOS u bolesnica starijih od 80 godina pri uključivanju u ispitivanje, pokazala je da je OSSEOR tijekom 3 godine smanjio relativni rizik od novih prijeloma kralješnice za 32 % (pojavnost prijeloma 19,1 % u skupini koja je uzimala stroncijev ranelat naspram 26,5 % u skupini koja je uzimala placebo).
In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase in myocardial infarction has been observed in OSSEOR treated patients compared to placebo (see section 4.8).
Kardijalni ishemijski događaji Iz zbirnih podataka iz randomiziranih placebom kontroliranih ispitivanja bolesnika s osteoporozom u postmenopauzi primijećen je značajan porast infarkta miokarda kod bolesnika liječenih OSSEOR-om u usporedbi s placebom (vidjeti dio 4.8).
OSSEOR 2 g granules for oral suspension Strontium ranelate
OSSEOR 2 g granule za oralnu suspenziju stroncijev ranelat
7 sachets
7 vrećica
A. MANUFACTURER(S)RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U
Each sachet contains 2 g of strontium ranelate.
Jedna vrećica sadržava 2 g stroncijeva ranelata.
The environmental risk assessment of strontium ranelate has been conducted in accordance to European guidelines on ERA.
Procjena rizika koji stroncijev ranelat može imati na okoliš provedena je u skladu s Europskim smjernicama o procjeni rizika koji lijek može imati na okoliš.
-You should stop taking OSSEOR if you have to take oral tetracyclines or quinolones (two types of antibiotics).
Ako morate uzimati kroz usta tetracikline ili kinolone (dvije vrste antibiotika), morate prestati uzimati OSSEOR.
With respect to clinical vertebral fractures (defined as fractures associated with back pain and/or a body height loss of at least 1 cm), the relative risk was reduced by 38%.
S obzirom na kliničke prijelome kralješnice (definirane kao prijelome povezane s boli u leđima i/ili smanjenjem visine tijela za barem
Good tolerance was shown in a clinical study investigating the repeated administration of 4 g strontium ranelate per day over 25 days in healthy postmenopausal women.
Kliničko istraživanje višekratnih doza od 4 g stroncijeva ranelata dnevno tijekom 25 dana pokazalo je da su zdrave žene u poslijemenopauzi dobro podnosile lijek.
What OSSEOR looks like and contents of the pack OSSEOR is available in sachets containing yellow granules for oral suspension.OSSEOR is supplied in boxes of 7, 14, 28, 56, 84 or 100 sachets.
OSSEOR je pakiran u kutijama sa 7, 14, 28, 56, 84 ili 100 vrećica.
Physico-chemical data suggest excretion of Strontium ranelate in human milk OSSEOR should not be used during breast-feeding
Fizikalno-kemijski podaci ukazuju da se stroncijev ranelat izlučuje u majčino mlijeko.
The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of postmenopausal women with osteoporosis.
Starije osobe Djelotvornost i sigurnost stroncijeva ranelata provjerena je u žena širokog dobnog raspona (do 100
Treatment should only be initiated by a physician with experience in the treatment of osteoporosis.
4.2 Doziranje i način primjene Liječenje treba započeti samo liječnik s iskustvom u liječenju osteoporoze.
This results in a rebalance of bone turnover in favour of bone formation.
Time se ravnoteža pri pregradnji kosti pomiče na stranu stvaranja kosti.
In Asian countries reported as rare d In pooled placebo-controlled studies of post-menopausal osteoporotic patients, strontium ranelate treated patients (N=3803, 11270 patient years of treatment) compared to placebo (N=3769, 11250 patient years of treatment)
Zbirni podaci iz placebom kontroliranih kliničkih ispitivanja na bolesnicama s postmenopauzalnom osteoporozom, bolesnice liječene stroncijevim ranelatom (N=3803, 11 270 bolesnik-godina liječenja)
Talk to your doctor or pharmacist before taking OSSEOR: - if you are at risk of heart disease, this includes high blood pressure, high cholesterol, diabetes,
- ako imate rizik za srčanu bolest, što uključuje visoki krvni tlak, visoku razinu kolesterola, šećernu bolest, pušenje.
OSSEOR is for oral use.
OSSEOR se uzima kroz usta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OSSEOR 2 g granules for oral suspension.
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA OSSEOR 2 g granule za oralnu suspenziju stroncijev ranelat.
In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), OSSEOR reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
lumbalne kralješnice i/ili vrata bedrene kosti na početku ispitivanja bila u rasponu osteopenije, bez prisutnosti prijeloma, no s najmanje jednim dodatnim čimbenikom rizika za prijelom (N = 176), pokazala je da je OSSEOR tijekom 3 godine smanjio rizik od prvog prijeloma kralješnice za 72 % (incidencija prijeloma kralješnice 3,6 % u skupini koja je uzimala stroncijev ranelat naspram 12,0 % u skupini koja je uzimala placebo).
No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see section 5.2).
U osoba s blago do umjereno oštećenom funkcijom bubrega (klirens kreatinina 30-70 ml/min) dozu ne treba prilagođavati (vidjeti dio 5.2).
Tabulated list of adverse reactions
Tabularni prikaz nuspojava
smoking.
Vrećica
Uncommon: Seizures.
Učestalost nepoznata:a Povraćanje
METHOD AND ROUTE(S) OF ADMINISTRATION For oral use
NAČIN I PUT(EVI) PRIMJENE LIJEKA
o If symptoms or signs of Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) (e.g. rash, fever, eosinophilia and systemic involvement, e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, OSSEOR treatment should be discontinued immediately.
o Ukoliko su prisutni simptomi ili znakovi Stevens-Johnsonova sindroma (SJS), toksične epidermalne nekrolize (TEN) ili osipa uzrokovanog lijekom uz eozinofiliju i sustavne simptome (DRESS) (npr. osip, vrućica, eozinofilija i sustavni simptomi npr.
During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking OSSEOR and seek medical advice.
Ukoliko Vam se tijekom liječenja dogodi alergijska reakcija (npr. oticanje lica, jezika ili grla,
An a-posteriori analysis was performed on a subgroup of patients from the TROPOS study of particular medical interest and at high-risk of fracture [defined by a femoral neck BMD T-score ≤3 SD (manufacturer's range corresponding to -2.4 SD using NHANES III) and an age ≥ 74 years (n=1,977, i.e. 40% of the TROPOS study population)].
BMD vrata bedrene kosti ≤ -3 SD (raspon proizvođača lijeka, jednak je rasponu od -2,4 SD prema ljestvici NHANES III) i dobi ≥ 74 godine (n=1977, tj. oko 40 % populacije uključene u istraživanje
Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, dry mouth, pins and needles, dizziness, vertigo, difficulty in sleeping, inflammation of the liver (hepatitis), oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/or joint pain, muscle cramps, hair loss, reduction in production of blood cells in the bone marrow, itching, hives, blistering, angioedema
Povraćanje, bol u trbuhu, povrat kiseline, probavne tegobe, zatvor, vjetrovi, suha usta, trnci i bockanje, omaglica, vrtoglavica, poteškoće sa spavanjem, upala jetre (hepatitis), iritacija usne šupljine
Treatment should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled (see section 4.3).
cerebrovaskularnu bolest ili ako ima nekontroliranu hipertenziju (vidjeti dio 4.3).
At high doses, animal studies have shown reversible bone effects in the offspring of rats and rabbits treated during pregnancy (see section 5.3).
Istraživanja u životinja pokazala su reverzibilne učinke na kost u mladunčadi ženki štakora i kunića,
Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of OSSEOR.
Pri primjeni OSSEOR-a zabilježeni su slučajevi po život opasnih kožnih reakcija (Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) i osip uzrokovan lijekom uz eozinofiliju i sustavne simptome (DRESS).
- if you have severe kidney disease
- ako imate rizik za nastanak krvnih ugrušaka - ako imate tešku bolest bubrega.
OSSEOR is a non-hormonal medicine used to treat severe osteoporosis: - in postmenopausal women, - in men, at high risk of fracture, for whom other alternative treatments are not possible.
- u žena u poslijemenopauzi - u muškaraca s visokim rizikom za nastanak prijeloma, kod kojih drugo liječenje nije moguće.
(such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling unwell, feeling confused, bronchial hyperreactivity (symptoms include wheezing,shortness of breath and cough).
gubitak kose, smanjena proizvodnja krvnih stanica u koštanoj srži, svrbež, koprivnjača, pojava mjehurića, angioedem (oticanje lica, jezika ili grla, poteškoće u gutanju ili disanju), otekline na rukama ili nogama, malaksalost, osjećaj smetenosti, bronhijalna hiperreaktivnost (simptomi uključuju piskanje, nedostatak zraka i kašalj).
In vitro, strontium ranelate: - increases bone formation in bone tissue culture as well as osteoblast precursor replication and collagen synthesis in bone cell culture; - reduces bone resorption by decreasing osteoclast differentiation and resorbing activity.
- pospješuje stvaranje kosti u kulturama koštanoga tkiva, kao i umnažanje preteča osteoblasta i sintezu kolagena u kulturi koštanih stanica;
Tel: +39 (055) 623271
Stroder S.r.l. Tel: +39 (055) 623271
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of OSSEOR.
Tijekom uzimanja OSSEOR-a prijavljena je pojava moguće po život opasnih osipa na koži (StevensJohnson-ov sindrom, toksična epidermalna nekroliza i teške reakcije preosjetljivosti (DRESS)).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g of strontium ranelate.
TVARI Jedna vrećica sadrži 2 g stroncijeva ranelata.
In iliac crest bone biopsies obtained after up to 60 months of treatment with strontium ranelate 2 g/day in phase III trials, no deleterious effects on bone quality or mineralisation were observed.
U materijalu dobivenom biopsijom kriste ilijake nakon terapije stroncijevim ranelatom u dozi od 2 g na dan tijekom razdoblja do 60 mjeseci u sklopu ispitivanja III.
System Organ Class (SOC) Frequency category
Klasifikacija organskih sustava
Similar benefits were demonstrated in women with multiple fractures at baseline.
Slična je korist uočena i u žena s više prijeloma na početku ispitivanja.
Strontium ranelate.
- Djelatna tvar je stroncijev ranelat.
OTHER Read the package leaflet before use
Prije uporabe pročitati Uputu o lijeku
MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/287/002
However, it is recommended to drink the suspension immediately after preparation (see section 4.2) 6.4 Special precautions for storage
Međutim, preporučuje se suspenziju popiti odmah nakon njene pripreme (vidjeti dio 3.) Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
Treatment of postmenopausal osteoporosis:
Liječenje osteoporoze u poslijemenopauzi:
Hepatic impairment
Parestezija Omaglica Vrtoglavica
MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/287/001
NAME OF THE MEDICINAL PRODUCT OSSEOR 2 g granules for oral suspension Strontium ranelate
NAZIV LIJEKA OSSEOR 2 g granule za oralnu suspenziju
No dosage adjustment is therefore required in patients with mild-to-moderate renal impairment.
Stoga u bolesnika s blago do umjereno oštećenom funkcijom bubrega dozu ne treba prilagođavati.
What you need to know before you take osseor Do not take OSSEOR: - if you are allergic to strontium ranelate or any of the other ingredients of OSSEOR (listed in section 6).
- ako ste preosjetljivi (alergični) na stroncijev ranelat ili na bilo koji drugi sastojak OSSEOR-a
EXP
Ekcem
MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/003
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/287/003
Servier Polska Sp. z o.o.
Servier Nederland Farma B.V.
Pregnancy
Napadaji
New vertebral fracture over 3 years
Novi prijelom kralješnice tijekom 3 godine
Mannitol (E421)
6.1 Popis pomoćnih tvari aspartam (E951) maltodekstrin manitol (E421) 6.2 Inkompatibilnosti
Statistically significant increases in femoral neck BMD and total hip BMD (p<0,001) were observed after 12 months.
Nakon 12 mjeseci uočeno je statistički značajno povećanje BMD-a vrata bedrene kosti i ukupnog
Stroder S.r.l.
Servier Laboratories (Ireland) Ltd.
Patients with hepatic impairment
Infarkt miokarda
Tel: +48 (0) 22 594 90 00
Servier Polska Sp. z o.o. Tel: +48 (0) 22 594 90 00
Batch
Dispepsija
OSSEOR is contra-indicated in patients with a past history of venous thromboembolic events (see section 4.3) and should be used with caution in patients at risk of VTE.
VTE u anamnezi (vidjeti dio 4.3), a mora se primjenjivati s oprezom u osoba s povećanim rizikom od
EXPIRY DATE
Periferni edemi
• The treatment should be either discontinued or stopped in the following situations: o If the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled, the treatment should be stopped.
Liječenje se mora prekinuti ako bolesnik razvije ishemijsku bolest srca, perifernu arterijsku bolest,
Symptoms
Hepatitis
Breast-feeding
Flatulencija
o Temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest. o Hypersensitivity to the active substance (strontium ranelate) or any of the excipients.
o Preosjetljivosti na djelatnu tvar (stroncijev ranelat) ili neku od pomoćnih tvari.
Moreover, the intended uses do not require medical supervision.
Štoviše, predviđena uporaba ne zahtijeva liječnički nadzor.
This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in these ways for at least 30 years (including at least 15 years within the EU).
To znači da iako nema dovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna te postoji dokaz o njihovoj sigurnoj uporabi na ovaj način tijekom najmanje 30 godina (uključujući najmanje 15 godina na području EU).
Although a possible improvement in symptoms was observed, shortcomings in the design of the study prevented any firm conclusions being drawn.
Iako je uočeno moguće poboljšanje simptoma, nedostaci u dizajnu studije spriječili su donošenje čvrstih zaključaka.
Melissa leaf should only be used in adults and children over the age of 12 years.
Matičnjakov list smije se koristiti samo u odraslih i djece starije od 12 godina.
It can also be used to treat the symptoms of mild digestive disorders including bloating and flatulence (wind).
Može se također koristiti za liječenje simptoma blagih probavnih poremećaja uključujući nadimanje i flatulenciju (vjetrovi).
At the time of the HMPC assessment, no side effects had been reported with these medicines.
U vrijeme ocjene HMPC-a, nije bilo prijavljenih nuspojava s ovim lijekovima.
This may be used to prepare extracts or tinctures (an alcoholic extract of the plant material).
Takav se pripravak može koristiti za pripremu ekstrakta ili tinktura (alkoholnog ekstrakta biljnog materijala).
The HMPC also considered published clinical studies, including a small study that examined the effects of melissa leaf preparations on symptoms of mild to moderate anxiety and sleep disturbance.
HMPC je također razmotrio objavljene kliničke studije, uključujući malu studiju koja je ispitala učinke pripravaka matičnjakovog lista na simptome blage do umjerene anksioznosti i poremećaja spavanja.
Further information on the risks associated with melissa leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Više informacija o rizicima povezanim s lijekovima koji sadrže matičnjakov list , uključujući odgovarajuće mjere opreza za njihovu sigurnu uporabu, možete pronaći u monografiji u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
Further information on the HMPC assessment of melissa leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže matičnjakov list, uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
Any applications for the licensing of medicines containing melissa leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Svi zahtjevi za odobrenje lijekova koji sadrže matičnjakov list moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.