natgillin/translations-raw huggingface dataset:
Ovulation occurred in two subjects (5.71% of the women) during the second 28-day period, one whom also ovulated in the third period, resulting in an overall ovarian activity rate of 2.86 (95% CI: 0.78 -7.22) over a period of 91 days. 
Pri dveh preizkušankah (5,71 % žensk) je v drugem 28─dnevnem obdobju prišlo do ovulacije, ena od njiju pa je imela ovulacijo tudi med tretjim obdobjem, kar je pomenilo skupno dejavnost jajčnikov 2,86 (95 % IZ: 0,78─7,22) v obdobju 91 dni.
Therefore the CHMP considered that the bleeding pattern with Seasonique neither constitutes a safety issue for women nor impairs the contraceptive efficacy and adequate information in this respect is already included in the proposed product information. 
Odbor CHMP je zato menil, da vzorec krvavitev pri uporabi zdravila Seasonique ne predstavlja varnostnega tveganja za ženske niti ne zmanjšuje kontracepcijske učinkovitosti in da so v predlagane informacije o zdravilu že vključene ustrezne informacije v zvezi s tem.
One-year pregnancy rates were statistically significantly lower with the 84/7 regimen compared with the 21/7 (4.4% vs. 7.3%; p<0.0001) and with the 24/4 (4.4% vs. 6.9%, p<0.0001) regimens. 
Stopnje zanositve v obdobju enega leta so bile statistično značilno nižje pri režimu 84/7 kot pri režimih 21/7 (4,4 % v primerjavi s 7,3 %; p < 0,0001) in 24/4 (4,4 % v primerjavi s 6,9 %, p < 0,0001).
In addition, the OMS considered that the bleeding pattern is not favourable and could not rule out a potential impact on treatment compliance and contraceptive efficacy. 
Poleg tega je država članica, ki je izrazila pomisleke, menila, da vzorec krvavitev ni ugoden in da ni mogoče izključiti, da bi lahko vplival na upoštevanje navodil za zdravljenje in kontracepcijsko učinkovitost.
• The Committee is of the opinion that the available data is supportive of the efficacy of Seasonique and associated names as an extended regimen of an existing combined oral contraceptive. 
• odbor meni, da razpoložljivi podatki podpirajo učinkovitost zdravila Seasonique in povezanih imen kot obstoječih kombiniranih peroralnih kontraceptivov s podaljšanim režimom;
A referral was thus triggered at the CMDh. 
Skupina CMDh je zato sprožila napotitveni postopek.
Additionally several published pharmacodynamic studies demonstrated that the degree of ovulation inhibition is increased with a shorter HFI. 
Poleg tega so objavljene farmakodinamične študije pokazale, da je stopnja zaviranja ovulacije pri krajšem presledku brez hormonov povečana.
Statistically significantly higher rates of pregnancy with 21/7 and 24/4 regimens compared to the 84/7 regimen (p<0.0001) were also seen in the 2- and 3-year cohorts (Howard, 2014). 
Statistično značilno višje stopnje zanositve pri režimih 21/7 in 24/4 v primerjavi z režimom 84/7 (p < 0,0001) so opazili tudi v 2─ in 3─letni kohortni študiji (Howard 2014).
Indeed, as in the pivotal study PSE-301 the classic Poisson method failed to reach adequate precision for the 95% CI of the overall Pearl Index (PI) point estimate for Seasonique in women aged 18-35 years (point estimate 0.76, 95% CI of 0.16 - 2.22), the Applicant presented additional analyses using a bootstrap method for calculation of the 95% CI. 
Dejansko je predlagatelj zaradi dejstva, da v ključni študiji PSE─301 klasična Poissonova metoda ni zagotovila zadostne natančnosti pri 95─odstotnem intervalu zaupanja (IZ) ocenjene vrednosti skupnega Pearlovega indeksa za zdravilo Seasonique pri ženskah, starih od 18 do 35 let (ocenjena vrednost 0,76, 95─odstotni IZ 0,16─2,22), predložil dodatne analize, pri katerih je za izračun 95─odstotnega intervala zaupanja uporabil metodo zankanja („bootstrap“).
Further analyses including both arms (DP384/30 (higher dose of EE than Seasonique in the last 7 days of the cycle) and DP3-84/10 (Seasonique)) of the pivotal study PSE-301 and the supportive study PSE-302 did not provide a more reliable estimation of contraceptive efficacy of Seasonique despite the increase in sample size and resulted in a higher PI of 1.67 (95% CI 0.91 - 2.80). 
Dodatne analize, ki so zajele obe skupini (DP3─84/30 (večji odmerek EE kot zdravila Seasonique v zadnjih 7 dneh cikla) in DP3─84/10 (zdravilo Seasonique)) iz ključne študije PSE─301 ter podporne študije PSE─302, kljub večji velikosti vzorca niso zagotovile zanesljivejše ocene kontracepcijske učinkovitosti zdravila Seasonique in so pokazale višji Pearlov indeks, ki je znašal 1,67 (95─odstotni IZ 0,91─2,80).
On the contrary, the total number of unscheduled bleeding/spotting days was twice higher for Seasonique than for the comparator (mean 53 vs. 24). 
Nasprotno pa je bilo skupno število nepredvidenih krvavitev/krvavkastega izcedka dvakrat večje pri zdravilu Seasonique kot pri primerjalnem zdravilu (povprečno 53 v primerjavi s 24).
It has also been shown in the literature that the elimination of the HFI is associated with a better inhibition of the ovarian activity. 
V literaturi so pokazali, da je odsotnost presledka brez hormonov povezana z boljšim zaviranjem delovanja jajčnikov.
The increased number of unscheduled bleeding/spotting days with Seasonique appeared not to have an effect on compliance compared to other 21/7-day OC. 
Kot kaže, pa višje število dni nepričakovane krvavitve/krvavkastega izcedka pri uporabi zdravila Seasonique ni vplivalo na upoštevanje navodil za zdravljenje v primerjavi z drugimi 21/7─dnevnimi peroralnimi kontraceptivi.
The bleeding pattern of Seasonique was compared to the standard 21/7-day cycle regimen (Nordette, LGN 150 µg/ EE 30 µg and 7-day HFI) in the study PSE 302. 
Vzorec krvavitev pri zdravilu Seasonique so v študiji PSE-302 primerjali s standardnim 21/7─dnevnim režimom (Nordette, LGN 150 µg/EE 30 µg in 7─dnevni presledek brez hormonov).
As expected, due to the extended regimen, the total number of scheduled bleeding/spotting within the planned study duration was 3 times lower for Seasonique than for the comparator (mean 11 vs. 33). 
Skupno število rednih krvavitev/krvavkastega izcedka v načrtovanem obdobju trajanja študije je bilo zaradi podaljšanega režima po pričakovanju 3─krat nižje pri zdravilu Seasonique kot pri primerjalnem zdravilu (povprečno 11 v primerjavi s 33).
Of note, combined analyses including both arms (DP3-84/30 (higher dose of EE than Seasonique in the last 7 days of the cycle) and DP3-84/10 (Seasonique regimen)) of the pivotal study PSE-301 and the supportive study PSE-302 resulted in a higher PI of 1.67 (95% CI 0.91 - 2.80). 
Treba je omeniti, da so v analizah, ki so vključevale obe skupini DP3─84/30 (večji odmerek EE kot v zdravilu Seasonique v zadnjih 7 dneh cikla) in DP3─84/10 (režim zdravila Seasonique) ključne študije PSE─301 in podporne študije PSE─302, dobili večji Pearlov indeks 1,67 (95 % IZ 0,91─2,80).
Another published pharmacodynamic study reported a continuous COC regimen with Levonorgestrel/EE and norgestimate/EE to result in a more effective follicular suppression than the same COC dosing regimen with a monthly 7-day HFI (Birtch, 2006). 
V drugi objavljeni farmakodinamični študiji so poročali, da je neprekinjen režim s KPK, levonogesrelom/EE in norgestimatom/EE povzročil učinkovitejše folikularno zaviranje kot enak režim odmerjanja KPK s
The absence of a comparator arm was considered justified given that the mechanism of action of this hormonal combination in this dose is well known, that the only differences between Seasonique and existing LNG/EE combination products are the treatment duration (84 days versus 21 days, respectively) and the administration of 10µg EE during the last 7 days of the cycle instead of an hormone free interval (HFI), respectively. 
Edini razliki med zdravilom Seasonique in obstoječimi kombiniranimi zdravili LNG/EE sta trajanje zdravljenja (84 dni v primerjavi z 21 dnevi) in uporaba 10 µg EE v zadnjih 7 dneh cikla namesto presledka brez hormonov.
Comparable withdrawal rates, including discontinuation due to adverse events, were also observed in an open label, randomised phase II study comparing Seasonique (34.5%) to two 28-day OC (35.2% and 39.1%) in 265 women for 8 months. 
faze, v kateri so primerjali zdravilo Seasonique (34,5 %) z dvema 28─dnevnima peroralnima kontraceptivoma (35,2 % in 39,1 %) pri 265 ženskah v obdobju 8 mesecev.
In the pivotal study PSE-301, 3 pregnancies were observed for Seasonique in 1,578 91-day cycles in 621 women aged 18-35 years, resulting in an overall PI of 0.76 with a 95% CI of 0.16 - 2.22 using the Poisson model. 
91─dnevnih ciklov pri 621 ženskah, starih od 18 do 35 let, tako da so s Poissonovim modelom dobili skupni Pearlov indeks 0,76 s 95─odstotnim IZ 0,16─2,22.
For these reasons the CHMP did not consider this higher PI as relevant in the assessment of the efficacy of Seasonique. 
Zato je odbor CHMP menil, da pri oceni učinkovitosti zdravila Seasonique ta večji Pearlov indeks ni enako pomemben.
It must not be used in women who are more than three months pregnant. 
Ne smejo ga uporabljati ženske, ki so noseče več kot tri mesece.
Its use during the first three months of pregnancy is not recommended. 
Uporaba zdravila v prvih treh mesecih nosečnosti ni priporočljiva.
‘Essential' means that the hypertension has no obvious cause. 
Esencialna pomeni, da za hipertenzijo ni jasnega vzroka.
The European Commission granted a marketing authorisation valid throughout the EU for Dafiro on 16 January 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Dafiro, veljavno po vsej Evropski uniji, izdala 16. januarja 2007.
The full EPAR for Dafiro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Dafiro je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s. 
Obe učinkovini sta zdravili proti zvišanemu krvnemu tlaku, ki sta bili v Evropski uniji (EU) od sredine 90. let prejšnjega stoletja na voljo kot ločeni zdravili.
It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. 
Povzroča zaporo posebnih kanalčkov na površini celic, imenovanih kalcijevi kanalčki, skozi katere v celico običajno vstopajo kalcijevi ioni.
The medicine can only be obtained with a prescription 
Izdaja zdravila je le na recept.
Dafiro amlodipine / valsartan 
Dafiro amlodipin/valsartan
This is a summary of the European public assessment report (EPAR) for Dafiro. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dafiro.
In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats). 
V vseh študijah je bilo glavno merilo učinkovitosti znižanje diastoličnega krvnega tlaka (krvnega tlaka, izmerjenega med dvema srčnima utripoma).
Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances. 
Ker se zdravili amlodipin in valsartan uporabljata že vrsto let, je družba predložila podatke, ki so o obeh učinkovinah na razpolago že iz prejšnjih študij in znanstvene literature, kot tudi iz novih študij, v katerih so raziskovali kombinacijo obeh zdravilnih učinkovin.
Other information about Dafiro 
Druge informacije o zdravilu Dafiro
The CHMP decided that Dafiro's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Dafiro večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
For more information about treatment with Dafiro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Dafiro preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan). 
Na voljo je v obliki tablet (5 mg amlodipina in 80 mg valsartana; 5 mg amlodipina in 160 mg valsartana; 10 mg amlodipina in 160 mg valsartana).
What benefit has Dafiro shown during the studies? 
Kakšne koristi je zdravilo Dafiro izkazalo med študijami?
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Dafiro and people taking the separate medicines. 
Družba je prav tako predložila dokaze o tem, da sta bili ravni amlodipina in valsartana v krvi enaki pri ljudeh, ki so jemali zdravilo Dafiro, in ljudeh, ki so obe zdravilni učinkovini jemali ločeno.
Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. 
Valsartan je antagonist receptorja za angiotenzin II, kar pomeni, da zavira delovanje telesnega hormona, imenovanega angiotenzin II.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dafiro. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo , na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced. 
znižanjem krvnega tlaka se zmanjša možnost tveganj, povezanih z visokim krvnim tlakom, kot je na primer kap.
The most common side effects with Dafiro (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes. 
Najpogostejši neželeni učinki zdravila Dafiro (opaženi pri 1 do 10 bolnikih od 100) so glavobol, nazofaringitis (vnetje nosne votline in grla), influenca (gripa), hipokaliemija (nizke ravni kalija v krvi), različne vrste edemov (oteklin), utrujenost, pordelost, astenija (oslabelost) in navali vročine.
Five main studies involving nearly 5,200 patients, mostly with mild to moderate hypertension, were carried out. 
Opravili so pet glavnih študij, v katere je bilo vključenih skoraj 5 200 bolnikov z blago do zmerno hipertenzijo.
The patient may need to take separate tablets or capsules before switching to the combination tablet. 
Bolnik bo morda moral pred prehodom na tablete s kombinacijo obeh učinkovin nekaj časa jemati učinkovini v ločenih tabletah ali kapsulah.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). 
Angiotenzin II je močan vazokonstriktor (snov, ki zožuje krvne žile).
Dafiro is taken by mouth as one tablet once a day with some water. 
Zdravilo Dafiro se jemlje peroralno, in sicer se zaužije ena tableta na dan z malo vode.
What is the risk associated with Dafiro? 
Kakšna tveganja so povezana z zdravilom Dafiro?
In the studies comparing the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively. 
V študijah, v katerih so kombinacijo primerjali pri bolnikih, ki so že jemali amlodipin ali valsartan, je krvni tlak bolnikov, ki so prejemali samo valsartan, po osmih tednih padel za 6,6 mmHg v primerjavi z 9,6 in 11,4 mmHg pri bolnikih, ki so prejemali še dodatnih 5 mg oziroma 10 mg amlodipina.
When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. 
Kadar kalcijevi ioni vstopajo v celice mišic v žilnih stenah, se te začnejo krčiti.
The combination of amlodipine and valsartan was more effective at reducing blood pressure than placebo or either valsartan or amlodipine taken alone. 
Kombinacija amlodipina in valsartana je bila pri nižanju krvnega tlaka učinkovitejša od placeba oziroma zdravljenja samo z valsartanom ali samo z amlodipinom.
For the full list of all side effects reported with Dafiro, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Dafiro, glejte navodilo za uporabo.
The dose of Dafiro to be used depends on the doses of amlodipine or valsartan that the patient was taking before. 
Odmerek zdravila Dafiro, ki ga je treba vzeti, je odvisen od odmerkov amlodipina ali valsartana, ki ju je bolnik jemal prej.
Dafiro must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure). 
Zdravila Dafiro prav tako ne smejo jemati bolniki, ki imajo hude težave z jetri ali izločanjem žolča, bolniki z nekaterimi obolenji srca ter bolniki s hudo hipotenzijo (nizkim krvnim tlakom).
By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen. 
Ker valsartan ustavi njegovo delovanje z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, hormonu prepreči učinkovanje, zaradi česar se krvne žile lahko razširijo.
Two studies (involving almost 3,200 patients) compared amlodipine, valsartan or a combination of both substances with placebo (a dummy treatment). 
V dveh študijah (s skoraj 3 200 bolniki) so amlodipin, valsartana ali kombinacijo obeh učinkovin primerjali s placebom (zdravilom brez zdravilne učinkovine).
Dafiro is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. 
Zdravilo Dafiro se uporablja pri bolnikih, ki imajo esencialno hipertenzijo (visok krvni tlak), ki je ni mogoče ustrezno uravnati samo z amlodipinom ali valsartanom.
Why has Dafiro been approved? 
Zakaj je bilo zdravilo Dafiro odobreno?
Dafiro must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients. 
Zdravila Dafiro ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) amlodipin ali druga zdravila iz razreda derivatov dihidropiridina, valsartan ali katero koli drugo sestavino zdravila.
Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan. 
Tlak bolnikov, ki so jemali le amlodipin, je padel za 10,0 mmHg v primerjavi z 11,8 mmHg pri bolnikih, ki so prejemali še dodatnih 160 mg valsartana.
Dafiro must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment. 
Zdravilo Dafiro se prav tako ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), pri bolnikih s sladkorno boleznijo tipa 2 ali zmerno do hudo ledvično okvaro.
Two studies (involving 1,891 patients) compared the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan. 
V dveh študijah (s 1 891 bolniki) so kombinacijo primerjali pri bolnikih, pri katerih 10-miligramski odmerek amlodipina ali 160-miligramski odmerek valsartana nista učinkovito uravnala hipertenzije.
Dafiro is a medicine that contains two active substances, amlodipine and valsartan. 
Dafiro je zdravilo, ki vsebuje dve zdravilni učinkovini, amlodipin in valsartan.
By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax. 
Amlodipin z zmanjšanjem pretoka kalcija v celice prepreči njihovo krčenje in pomaga pri sproščanju sten žil ter tako znižuje krvni tlak.
The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension. 
V peti, manjši študiji s 130 bolniki s hudo hipertenzijo so kombinacijo primerjali s lizinoprilom in hidroklorotiazidom (drugo kombinacijo zdravil za zdravljenje zvišanega krvnega tlaka).
What is Dafiro used for? 
Za kaj se zdravilo Dafiro uporablja?
They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. 
Obe podobno način sproščata napetost žil, zaradi česar se zniža krvni tlak.
What is Dafiro? 
Kaj je zdravilo Dafiro?
How does Dafiro work? 
Kako zdravilo Dafiro deluje?
How has Dafiro been studied? 
Kako je bilo zdravilo Dafiro raziskano?
Dafiro contains two active substances, amlodipine and valsartan. 
Zdravilo Dafiro vsebuje dve zdravilni učinkovini, amlodipin in valsartan.
How is Dafiro used? 
Kako se zdravilo Dafiro uporablja?
Approximately 25 µg 
približno 25 µg
and tetanus toxoid (T), adsorbed (PRP-T) 
vezan na tetanusni toksoid (T), adsorbiran (PRP-T)
50 (5 X 10) vials + 50 (5 X 10) pre-filled syringes without needles (multipack) 
50 (5 X 10) vial + 50 (5 X 10) napolnjenih injekcijskih brizg brez igel (pakiranje, ki vsebuje več posameznih pakiranj)
MA (EU) number (Invented)n ame 
Številka (EU) dovoljenja za promet
10 vials + 10 pre-filled syringes + 20 needles 
10 vial + 10 napolnjenih injekcijskih brizg + 20 igel
_ _1 After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid, adsorbed 
_ _1 Po rekonstituciji en odmerek cepiva (0,5 ml) vsebuje: davični toksoid, adsorbiran tetanusni toksoid, adsorbiran toksoid bordetele pertusis, adsorbiran filamentozni hemaglutinin, adsorbiran pertaktin, adsorbiran površinski antigen virusa hepatitisa B, rekombinantni (S protein), adsorbiran polisaharid hemofilusa tipa b (PRP)
1 vial + 1 prefilled syringe + 2 needles 
1 viala + 1 napolnjena injekcijska brizga + 2 igli
10 vials + 10 prefilled syringes without needles 
10 vial + 10 napolnjenih injekcijskih brizg brez igel
1 vial + 1 prefilled syringe without needle 
1 viala + 1 napolnjena injekcijska brizga brez igle
Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have full baths with lavender oil. 
Bolniki z odprtimi ranami, težavami s kožo, zelo povišano telesno temperaturo, resnimi okužbami in resnimi težavami s srcem in krvnim obtokom ne smejo uporabljati kopeli z eteričnim oljem prave sivke za celo telo.
The plant is cultivated or gathered to obtain the oil for medicinal use. 
Rastlina se goji ali nabira za pridobivanje eteričnega olja za uporabo v medicinske namene.
The HMPC concluded that, on the basis of its long-standing use, lavender oil can be used for the relief of mild symptoms of mental stress and exhaustion, and to aid sleep. 
Odbor HMPC je zaključil, da se na podlagi njegove dolgotrajne uporabe eterično olje prave sivke lahko uporablja za lajšanje blagih simptomov stresa in izčrpanosti ter za pomoč pri spanju.
Lavender oil medicines should only be used in adults and children over the age of 12 years. 
Zdravila, ki vsebujejo eterično olje prave sivke, se lahko uporabljajo samo pri odraslih in otrocih, starejših od 12 let.
For detailed information on the data assessed by the HMPC, see the HMPC assessment report. 
Za podrobnejše informacije o podatkih, ki jih je ocenil odbor HMPC, glejte njegovo poročilo o oceni zdravila.
At the time of the HMPC assessment, there were no major concerns over the safety of lavender oil. 
V času postopka ocenjevanja odbora HMPC ni bilo večjih zadržkov glede varnosti eteričnega olja prave sivke.
Lavender oil is the common name for the essential oil of the plant Lavandula angustifolia Mill. 
Eterično olje prave sivke je splošno ime za eterično olje rastline Lavandula angustifolia Mill.
This summary is not intended to provide practical advice on how to use medicines containing lavender oil. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo eterično olje prave sivke.