natgillin/translations-raw huggingface dataset:
The best results in managing SJS, TEN or DRESS come from early diagnosis and immediate discontinuation of any suspect drug.
Najboljši izidi zdravljenja Stevens-Johnsonovega sindroma, toksične epidermalne nekrolize ali sindroma DRESS so posledica zgodnje diagnoze in takojšnje prekinitve zdravljenja s katerim koli zdravilom, za katerega obstaja sum.
A higher incidence, although still rare, of hypersensitivity reactions including skin rash, SJS or TEN in patients of Asian origin has been reported.
Pri bolnikih azijskega porekla so poročali o večji pojavnosti preobčutljivostnih reakcij, vključno s kožnim izpuščajem, SJS ali TEN, čeprav so bile te še vedno redke.
OSSEOR should be discontinued as soon as possible in the event of an illness or a condition leading to immobilisation (see section 4.3) and adequate preventive measures taken.
V primeru bolezni ali stanja, ki privede do nepokretnosti bolnika (glejte poglavje 4.3), je treba zdravljenje z zdravilom OSSEOR nemudoma prekiniti in izvajati ustrezne preventivne ukrepe.
OTHER Read the package leaflet before use
DRUGI PODATKI Pred uporabo preberite priloženo navodilo.
smoking.
VREČKA
In phase III studies, the annual incidence of venous thromboembolism (VTE) observed over 5 years was approximately 0.7%, with a relative risk of 1.4 (95% CI = [1.0 ; 2.0]) in strontium ranelate treated patients as compared to placebo (see section 4.4).
V študijah III. faze je ob stroncijevem ranelatu v primerjavi s placebom letna pojavnost venske trombembolije, zabeležena v petletnem obdobju, znašala približno 0,7 %, z relativnim tveganjem 1,4 (95-% interval zaupanja = [1,0; 2,0]) (glejte poglavje 4.4).
Treatment of severe osteoporosis:
Zdravljenje bolnic s pomenopavzno osteoporozo:
- if you are immobilised permanently or for some time such as being wheel-chair bound, or confined to bed or if you are to undergo an operation or recovering from an operation.
- če imate ali ste imeli krvni strdek (npr. v žilah v nogah ali v pljučih); - če ste trajno ali nekaj časa nepokretni, npr. ste vezani na invalidski voziček ali na posteljo, če čakate na operacijo ali po njej okrevate.
As a divalent cation, strontium is not metabolised.
Kot dvovalentni kation se stroncij ne presnavlja.
Overall incidence rates for adverse reactions with strontium ranelate did not differ from placebo and adverse reactions were usually mild and transient.
Skupne stopnje pojavnosti neželenih učinkov ob stroncijevem ranelatu se niso razlikovale od placeba.
No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see section 5.2).
Za bolnike z blago do zmerno ledvično okvaro (očistek kreatinina 30 do 70 ml/min) odmerka ni treba prilagajati (glejte poglavje 5.2).
7 sachets
7 vrečk
OSSEOR 2 g granules for oral suspension Strontium ranelate
OSSEOR 2 g zrnca za peroralno suspenzijo stroncijev ranelat
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OSSEOR 2 g granules for oral suspension.
IME ZDRAVILA IN POT(I) UPORABE OSSEOR 2 g zrnca za peroralno suspenzijo stroncijev ranelat za peroralno uporabo
SOTI
SERIJ
In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section
Pri ženskah po menopavzi stroncijev ranelat zmanjša tveganje za zlome vretenc in kolka (glejte poglavje 5.1).
The outcome of DRESS is favorable in most cases upon discontinuation of OSSEOR and after initiation of corticosteroid therapy when necessary.
V večini primerov je izid sindroma DRESS ugoden po prekinitvi jemanja zdravila
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.
Če se je zaradi zdravljenja z zdravilom OSSEOR pri bolniku pojavil SJS, TEN ali DRESS, mu zdravljenja z zdravilom OSSEOR nikoli ne smemo ponovno uvesti.
Continuation of treatment with OSSEOR in patients developing severe renal impairment should be considered on an individual basis.
Če se razvije huda ledvična okvara, se o nadaljevanju zdravljenja z zdravilom OSSEOR odloča pri vsakem bolniku posebej.
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,
- če imate tveganje za bolezen srca, ki vključuje zvišan krvni tlak, zvišan holesterol, sladkorno bolezen in kajenje
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.
V 25-dnevni študiji so proučevali večkratno jemanje stroncijevega ranelata po 4 g na dan pri zdravih ženskah v obdobju po menopavzi in ugotovili dobro prenašanje.
Hip fracture over 3 years
zlomi kolka v 3 letih
38% (17-53), p<0.001
38 % (17 do 53), P < 0,001
Physico-chemical data suggest excretion of Strontium ranelate in human milk OSSEOR should not be used during breast-feeding
Fizikalnokemijski podatki nakazujejo izločanje stroncijevega ranelata v materino mleko.
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.
Johnsonovem sindromu (SJS), toksični epidermalni nekrolizi (TEN) in z zdravilom povzročenem kožnem izpuščaju z eozinofilijo in sistemskimi simptomi (DRESS - drug rash with eosinophilia and systemic symptoms)).
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of OSSEOR, you must not be re-started on OSSEOR at any time If you develop a rash or these skin symptoms, stop taking OSSEOR, seek urgent advice from a doctor and tell him that you are taking this medicine.
Če na koži opazite izpuščaj ali opisane simptome, prenehajte z jemanjem zdravila OSSEOR in nemudoma poiščite zdravniško pomoč ter zdravniku povejte, da jemljete to zdravilo.
Psychiatric disorders Frequency unknown:a Confusional state Insomnia Nervous system disorders Common: Headache Disturbances in consciousness Memory loss Uncommon: Seizures Frequency unknown:a Paraesthesia Dizziness Vertigo Cardiac disorders Commond: Myocardial infarction Vascular disorders Common: Venous thromboembolism (VTE) Respiratory, thoracic and mediastinal disorders Frequency unknown:a Bronchial hyperreactivity Gastrointestinal disorders Common: Nausea Diarrhoea Loose stools
Pogostid: miokardni infarkt Žilne bolezni Pogosti: venske trombembolije (VTE) Bolezni dihal, prsnega koša in mediastinalnega prostora Neznana pogostnost:a hiperaktivnost bronhijev Bolezni prebavil Pogosti: slabost diareja mehko blato Neznana pogostnost:a bruhanje bolečine v trebuhu razdraženje ustne sluznice (stomatitis in/ali razjede v ustih) gastroezofagealni refluks dispepsija zaprtje flatulenca suha usta
No dose adjustment is required in relation to age.
Prilagajanje odmerka pri starejših bolnikih ni potrebno.
There is no pharmacokinetic data in patients with severe renal impairment (creatinine clearance below 30 ml/min).
Za bolnike s hudo ledvično okvaro (očistek kreatinina pod 30 ml/min) ni farmakokinetičnih podatkov.
Statistically significant increases in femoral neck BMD and total hip BMD (p<0,001) were observed after 12 months.
Po 12 mesecih so opazili statistično značilno povečanje mineralne kostne gostote v vratu stegnenice in celotne mineralne kostne gostote v kolku (p < 0,001).
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).
- če ste alergični na stroncijev ranelat ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
- in adult men, at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
Zdravljenje hude osteoporoze - pri ženskah po menopavzi, - pri odraslih moških, z velikim tveganjem za zlome, pri katerih zdravljenje z drugimi zdravili, ki so odobrena za zdravljenje osteoporoze, zaradi kontraindikacij ali neprenašanja ni mogoče.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/004 56 sachets
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/287/004 56 vrečk
It is recommended that you take OSSEOR at bedtime, preferably at least 2 hours after dinner.
Priporočeni odmerek je ena vrečka po 2 g na dan. Priporočljivo je, da OSSEOR jemljete pred spanjem, najbolje vsaj 2 uri po večerji.
If you are unsure about this ask your doctor or pharmacist.
Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom.
How to store OSSEOR
Shranjevanje zdravila OSSEOR
See a doctor straight away if you experience any of these symptoms.
V primeru pojava kateregakoli od opisanih simptomov morate nemudoma obiskati zdravnika.
Blood clots.
Krvni strdki.
49% (26-64), p<0.001
49 % (26 do 64), P < 0,001
New vertebral fracture over the 1st year
novi zlomi vretenc v 1 letu
Symptoms
Zdravila
No dosage adjustment is therefore required in patients with mild-to-moderate renal impairment.
Pri bolnikih z blago do zmerno ledvično okvaro torej odmerka ni potrebno prilagajati.
Uncommon: Seizures.
Občasni: Epileptični napadi.
41% (27-52), p<0.001
41 % (27 do 52), P < 0,001
o Patients at risk of VTE.
o bolnikih s tveganjem za vensko trombembolijo.
Maximum plasma concentrations are reached 3-5 hours after a single dose of 2 g. Steady state is reached after 2 weeks of treatment.
odmerku po 2 g. Stanje dinamičnega ravnovesja doseže po 2 tednih zdravljenja.
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.
Škatle zdravila OSSEOR vsebujejo 7, 14, 28, 56, 84 ali 100 vrečk.
39% (27-49), p<0.001
39 % (27 do 49), P < 0,001
EU/1/04/287/005/ 84 sachets (3 packs of 28) EU/1/04/287/006 100 sachets
EU/1/04/287/005 84 vrečk (3 pakiranja po 28 vrečk)
- if you have severe kidney disease
- če imate tveganje za pojav krvnih strdkov, - če imate hudo bolezen ledvic.
When a VTE occurs, OSSEOR should be stopped.
Če se pojavi venska trombembolija, moramo zdravljenje z zdravilom OSSEOR ukiniti.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of OSSEOR.
Pri zdravljenju z zdravilom OSSEOR so poročali o morebitno življenje ogrožajočih kožnih izpuščajih (Stevens-Johnsonovem sindromu, toksični epidermalni nekrolizi in hudih preobčutljivostnih reakcijah
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).
pokazala, da je OSSEOR v 3-letnem zdravljenju zmanjšal relativno tveganje za pojav novih zlomov vretenc za 32 % (ob stroncijevem ranelatu je bila pojavnost 19,1 % v primerjavi s 26,5 % ob placebu).
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.
Kaj je zdravilo OSSEOR in za kaj ga uporabljamo OSSEOR je nehormonsko zdravilo za zdravljenje hude osteoporoze: - pri ženskah po menopavzi, - pri moških,
Hepatic impairment
Srčni ishemični dogodki
NAME OF THE MEDICINAL PRODUCT OSSEOR 2 g granules for oral suspension Strontium ranelate
IME ZDRAVILA OSSEOR 2 g zrnca za peroralno suspenzijo
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).
toda z vsaj enim dodatnim dejavnikom tveganja zanje (n = 176), je skupna analiza a posteriori pokazala, da je OSSEOR zmanjšal tveganje prvega zloma vretenc za 72 % v 3 letih (pojavnost zlomov vretenc 3,6 % ob stroncijevem ranelatu v primerjavi z 12,0 % ob placebu).
Tabulated list of adverse reactions
limfadenopatija (v povezavi s preobčutljivostnimi kožnimi reakcijami) Preiskave
Maltodextrin
dermatitis ekcem
Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2).
zdravilo OSSEOR ni priporočeno pri bolnikih z očistkom kreatinina pod 30 ml/min (glejte poglavje
In addition to their treatment (2 g/day strontium ranelate or placebo), the patients received adapted calcium and vitamin D supplements throughout both studies.
Poleg zdravljenja s stroncijevim ranelatom po 2 g na dan ali placebom so bolnice ves čas obeh študij jemale prilagojene pripravke kalcija in vitamina D. V 3-letnem zdravljenju v študiji SOTI je OSSEOR zmanjšal relativno tveganje novih zlomov vretenc za 41 % (preglednica 1).
Method of administration
študija TROPOS
MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/002
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/287/002
New vertebral fracture over 3 years
novi zlomi vretenc v 3 letih
MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/287/001
Servier Laboratories c/o Icepharma hf Sími: +354 540 8000
Servier Laboratories c/o Icepharma hf
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).
Poročali so o morebitno življenje ogrožajočih kožnih izpuščajih (Stevens-Johnsonovem sindromu,
MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/003
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/287/003
TROPOS
Način uporabe
• 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.
o če se pri bolniku pojavi ishemična bolezen srca, periferna arterijska bolezen, možgansko žilna bolezen ali nenadzorovana arterijska hipertenzija, je potrebno z zdravljenjem prenehati, o v primeru bolezni ali stanja, ki privede do nepokretnosti bolnika, je potrebno zdravljenje z zdravilom OSSEOR prekiniti,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
Strontium ranelate.
- Zdravilna učinkovina je stroncijev ranelat.
Treatment of postmenopausal osteoporosis:
Mehanizem delovanja In vitro stroncijev ranelat:
This should be taken into account when interpreting BMD changes during treatment with OSSEOR.
Med razlaganjem sprememb mineralne kostne gostote ob zdravilu
Strontium excretion occurs via the kidneys and the gastrointestinal tract.
Izločanje stroncija poteka skozi ledvice in prebavila.
PHARMACEUTICAL FORM AND CONTENTS
Izgled zdravila OSSEOR in vsebina pakiranja
o Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
o s prisotno ali predhodno vensko trombembolijo (VTE), vključno z globoko vensko trombozo in pljučnim embolizmom, o ki so začasno ali stalno nepokretni zaradi npr. pooperativnega okrevanja ali podaljšanega mirovanja v postelji,
Table 2: Incidence of patients with hip fracture and relative risk reduction in patients with BMD ≤ -2.4 SD (NHANES III) and age ≥ 74 years
Preglednica 2: Pojavnost zlomov kolka in zmanjšanje relativnega tveganja pri bolnicah z mineralno kostno gostoto ≤
Moreover, the intended uses do not require medical supervision.
Prav tako predvidena uporaba ne zahteva zdravniškega nadzora.
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 pomeni, da je kljub nezadostnim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi o njihovi varni uporabi na navedene načine za vsaj 30 let (najmanj 15 let tudi v EU).
Melissa leaf should only be used in adults and children over the age of 12 years.
List melise se lahko uporablja samo pri odraslih in otrocih, starejših od 12 let.
Although a possible improvement in symptoms was observed, shortcomings in the design of the study prevented any firm conclusions being drawn.
Čeprav so zabeležili možno izboljšanje simptomov, zaradi pomanjkljivosti v zasnovi študije ni bilo mogoče izpeljati nobenih trdnih zaključkov.
Melissa leaf EMA/HMPC/310761/2013
List melise EMA/HMPC/310761/2013
This may be used to prepare extracts or tinctures (an alcoholic extract of the plant material).
Uporabljajo se lahko za pripravo izvlečkov ali tinktur (alkoholnega izvlečka rastlinskega materiala).
A doctor should be consulted if the symptoms persist following 2 weeks of treatment.
Če so simptomi po 2 tednih zdravljenja še vedno prisotni, se je treba posvetovati z zdravnikom.
This summary is not intended to provide practical advice on how to use medicines containing melissa leaf.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo list melise.
Melissa leaf is the common name for the leaf of the plant Melissa officinalis L. The plant is cultivated or gathered to obtain the leaf for medicinal use.
List melise je splošno ime za list rastline Melissa officinalis L. Rastlino se goji ali nabira, da se pridobijo listi za medicinsko uporabo.
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.
Odbor HMPC je prav tako preučil objavljene klinične študije, vključno z manjšo študijo, v kateri so preučevali učinke pripravkov lista melise pri simptomih blage do zmerne tesnobe in motnjah spanca.
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.
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo list melise, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of melissa leaf.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo lista melise.
Melissa leaf preparations are obtained by drying and powdering or comminuting (reducing into tiny pieces) the leaf.
Pripravki lista melise se pridobijo s sušenjem in z upraševanjem ali drobljenjem (zmanjšanjem na zelo majhne dele).
In its assessment, the HMPC took into account the well documented use of Melissa leaf for these indications.
Odbor HMPC je pri oceni upošteval dobro dokumentirano uporabo lista melise pri teh indikacijah.
The HMPC conclusions on the use of melissa leaf medicines for mild symptoms of stress, sleep aid and mild digestive disorders are based on their ‘traditional use' in these conditions.
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo list melise, za lajšanje blagih simptomov stresa, kot pomoč za uspavanje in lajšanje blagih prebavnih motenj temeljijo na njihovi „tradicionalni uporabi“ pri teh stanjih.
What is melissa leaf?
Kaj je list melise?
Melissa leaf can also be found in combination with other herbal substances in some herbal medicines.
List melise je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing melissa leaf.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo list melise.
The HMPC concluded that, on the basis of its long-standing use, melissa leaf can be used for the relief of mild symptoms of stress and to aid sleep.
Odbor HMPC je na osnovi dolgoletne uporabe lista melise zaključil, da se ga lahko uporablja za lajšanje blagih simptomov stresa in kot pomoč za uspavanje.
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 oceni zdravil, ki vsebujejo list melise, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
EMA/HMPC/310761/2013
EMA/HMPC/310761/2013 Odbor za zdravila rastlinskega izvora (HMPC)
Detailed instructions on how to take melissa leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o jemanju zdravil, ki vsebujejo list melise, in o tem, kdo jih lahko jemlje, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
Information on the use and licensing of melissa leaf medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo list melise, v državah članicah EU se obrnite na pristojni nacionalni organ.
How are melissa leaf medicines approved in the EU?
Kako so zdravila, ki vsebujejo list melise, odobrena v EU?
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.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo list melise, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
It can also be used to treat the symptoms of mild digestive disorders including bloating and flatulence (wind).
Uporablja se lahko tudi za zdravljenje simptomov blagih prebavnih motenj, vključno z napenjanjem in flatulenco (nabiranje plinov v želodcu in črevesju, plini).
Melissa leaf
List melise
Herbal medicines containing melissa leaf are usually available as a herbal tea to be drunk, and in solid and liquid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo list melise, so navadno na voljo kot zdravilni čaj za pitje ter v trdnih ali tekočih oblikah, ki se jemljejo peroralno (zaužijejo skozi usta).
Other information about melissa leaf medicines
Druge informacije o zdravilih, ki vsebujejo list melise
For more information about treatment with melissa leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo list melise, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
Therefore, the HMPC conclusions on the use of melissa leaf medicines are based on their long-standing use.
Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo list melise, zato temeljijo na njihovi dolgotrajni uporabi.
What evidence supports the use of melissa leaf medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo list melise?
What are the risks associated with melissa leaf medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo list melise?
For practical information about using melissa leaf medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.