natgillin/translations-raw huggingface dataset:
Alofisel will be used after adequate preparation of the fistula, see section 3.
Zdravilo Alofisel se uporablja po ustrezni pripravi fistule, glejte poglavje 3.
BATCH NUMBER, DONATION AND PRODUCT CODES
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV
Treatment with Alofisel is not recommended during pregnancy or while breast-feeding.
Zdravljenje z zdravilom Alofisel med nosečnostjo ali dojenjem ni priporočljivo.
What Alofisel is and what it is used for
Kaj je zdravilo Alofisel in za kaj ga uporabljamo
What you need to know before you are given Alofisel
Kaj morate vedeti, preden vam bodo dali zdravilo Alofisel
Alofisel may contain traces of benzylpenicillin or streptomycin (antibiotics).
Zdravilo Alofisel lahko vsebuje sledi benzilpenicilina in streptomicina (antibiotikov).
The MAH shall ensure that in each Member State where Alofisel is marketed, all healthcare professionals who are expected to handle and administer Alofisel have access to the educational package for health professionals.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da v vsaki državi članici, v kateri bo tržil zdravilo Alofisel, vsi zdravstveni delavci, ki bodo predvidoma uporabljali in dajali zdravilo Alofisel, prejmejo naslednji izobraževalni paket oziroma imajo dostop do njega:
Therefore, no dose adjustment is required in hepatically or renally impaired patients.
Zato prilagoditev odmerka pri bolnikih z jetrno ali ledvično okvaro ni potrebna.
Anal abscess
Analni absces
Preparation a) The expiry time: date of Alofisel should be re-confirmed; vials should then be removed from the outer packaging.
Pri tem sledite naslednjima korakoma: Priprava a) Ponovno preverite datum in uro izteka roka uporabe zdravila Alofisel; viale nato odstranite iz zunanje ovojnine.
Alofisel may contain trace amounts of benzylpenicillin and streptomycin.
Zdravilo Alofisel lahko vsebuje sledi benzilpenicilina in streptomicina.
b) Injection along the walls of the fistula tracts: insert the needle through the external openings and, from within the fistulas lumen: - If there is a single external opening, inject separately the content of each of the remaining two vials superficially into the tissue walls along the length of the fistula tracts, making small deposits of the cell suspension.
b) Injiciranje vzdolž sten traktov fistule: vstavite iglo skozi zunanje odprtine in skozi notranjost svetline fistul: - Če obstaja ena zunanja odprtina, injicirajte posebej vsebino vsake izmed preostalih dveh vial v stene tkiva vzdolž dolžine traktov fistule, tako da ustvarite majhne depozite celične suspenzije.
Vigorous curettage of all fistula tracts is recommended, with special emphasis in the internal openings area, using a metallic curette.
Priporoča se močna kiretaža vseh traktov fistule s kovinsko kireto, s posebnim poudarkom na območju notranjih odprtin.
Alofisel must not be filtered, or administered using a needle thinner than 22G (see section 4.4).
Zdravila Alofisel ne smete filtrirati ali dajati z iglo, tanjšo od 22G (glejte poglavje 4.4).
As a precautionary measure, darvadstrocel is not recommended for administration during breast-feeding.
Kot previdnostni ukrep se uporaba darvadstrocela med dojenjem ne priporoča.
Data on the use of darvadstrocel in the elderly population are limited, however, given the cell-based nature of darvadstrocel and its local administration route it is not expected that the benefit-risk profile of darvadstrocel in elderly patients will differ from that observed in non-elderly patients.
Podatki o uporabi darvadstrocela pri starejši populaciji so omejeni, vendar glede na celično naravo darvadstrocela in lokalno pot uporabe ni pričakovati, da bi se profil koristi in tveganja darvadstrocela pri starejših bolnikih razlikoval od tistega, ki so ga opazili pri ostalih bolnikih.
eASC were not present in any of the tissues analysed after 3 months or 6 months.
Po 3 mesecih oz. 6 mesecih celice eASC niso bile prisotne v nobenem izmed analiziranih tkiv.
Then inject the content of the second vial in small deposits into the tissue around the second internal opening.
Nato injicirajte vsebino druge viale v majhnih depozitih še v tkivo okoli druge notranje odprtine.
c) Perform a vigorous curettage of all fistula tracts, with special emphasis in the internal openings areas, using a metallic curette.
c) Izvedite močno kiretažo vseh traktov fistule s kovinsko kireto, s posebnim poudarkom na območjih notranjih odprtin.
After the cells have been resuspended (by gentle manual tapping), Alofisel is a white to yellowish homogenous suspension.
Ko so celice znova suspendirane (z nežnim trkanjem z roko), je zdravilo Alofisel bela do rumenkasta homogena suspenzija.
When injected close to the perianal fistulas, Alofisel reduces their inflammation, increasing the likelihood of the fistulas healing.
Kadar se zdravilo Alofisel injicira v bližino perianalnih fistul, zmanjša vnetje in poveča verjetnost njihovega celjenja.
Anal fistulas typically present as fissures penetrating the intestinal lumen and perianal skin surface, and are characterised by local inflammation that is exacerbated by bacterial infections and faecal contamination.
Analne fistule se običajno kažejo v obliki fisur, ki prodirajo v svetlino črevesa in površino kože ob anusu, zanje pa je značilno lokalno vnetje, ki ga poslabšajo baterijske okužbe in kontaminacija z blatom.
Alofisel must not be administered using a needle thinner than 22G.
Zdravilo Alofisel se ne sme dajati z iglo, tanjšo od 22G.
Each vial contains 30 million cells in 6 mL of suspension.
Ena viala vsebuje 30 milijonov celic v 6 ml suspenzije.
After inserting the needle tip into each intended injection site, perform a slight aspiration to avoid intravascular administration.
Za tem, ko vbodete konico igle v želeno mesto injiciranja, izvedite rahlo aspiracijo, da preprečite neželeno intravaskularno vbrizgavanje.
During shipment, the cells may have settled in the bottom of the vials forming a sediment and will need to be resuspended.
Med dostavo se celice lahko usedejo na dno vial in ustvarijo usedlino, ki jo je treba znova suspendirati.
Alofisel must not be irradiated or otherwise sterilised.
Zdravila Alofisel ne smete obsevati ali drugače sterilizirati.
Alofisel is injected by a surgeon in the fistula tract tissue.
Zdravilo Alofisel kirurg injicira v tkivo traktov fistule.
Data on the use of darvadstrocel in patients with hepatic or renal impairment are not available, however, given the cell-based nature of darvadstrocel and its local administration route it is not expected that the benefit-risk profile of darvadstrocel in hepatically or renally impaired patients will differ from that observed in non-hepatically or non-renally impaired patients.
Podatki o uporabi darvadstrocela pri bolnikih z jetrno ali ledvično okvaro niso na voljo, vendar glede na celično naravo darvadstrocela in lokalno pot uporabe ni pričakovati, da bi se profil koristi in tveganj darvadstrocela pri bolnikih z jetrno ali ledvično okvaro razlikoval od tistega, ki so ga opazili pri ostalih bolnikih.
a) Injection around the internal openings of the fistulas tracts: insert the needle through the anus and proceed as follows: - If there is a single internal opening, inject the content of each of the two vials (one after the other) in small deposits into the tissue surrounding the single internal opening.
a) Injiciranje okrog notranjih odprtin traktov fistul: vstavite iglo skozi anus in nadaljujte, kot je opisano: - Če obstaja samo ena notranja odprtina, injicirajte vsebino obeh vial (eno za drugo) v tkivo okoli notranje odprtine v večih posameznih majhnih odmerkih.
Once activated, eASC impair proliferation of activated lymphocytes and reduce the release of pro-inflammatory cytokines.
Ko so celice eASC aktivirane, zavirajo proliferacijo aktiviranih limfocitov in zmanjšajo sproščanje provnetnih citokinov.
Alofisel is supplied on an individual patient basis.
Zdravilo Alofisel se dostavlja za vsakega bolnika posebej.
- If there are two internal openings, inject the content of the first of two vials in small deposits into the tissue around one internal opening.
- Če obstajata dve notranji odprtini, injicirajte vsebino ene viale v večih posameznih majhnih odmerkih v tkivo okoli prve notranje odprtine.
An individual dose of Alofisel comprises 4 glass vials each containing 6 millilitres of Alofisel contained within a cardboard box.
Posamezni odmerek zdravila Alofisel je sestavljen iz 4 steklenih vial, ki vsebujejo po 6 mililitrov zdravila Alofisel v kartonski škatli.
After gentle re-suspension, the product is a white to yellowish homogeneous suspension.
Po nežnem vnovičnem suspendiranju je zdravilo bela do rumenkasta homogena suspenzija.
In vitro interaction studies have shown that the cell viability and immunomodulatory function of Alofisel is not affected by the presence of clinically-relevant concentrations of conventional therapies for Crohn's disease (infliximab, methotrexate and azathioprine).
Študije medsebojnega delovanja in vitro so pokazale, da prisotnost klinično pomembnih koncentracij konvencionalnih zdravil za Crohnovo bolezen (infliksimaba, metotreksata in azatioprina) ne vpliva na viabilnost celic in imunomodulacijsko delovanje zdravila Alofisel.
Immediately before use, Alofisel must be re-suspended by gently tapping the bottom of the vial until a homogeneous suspension is obtained, avoiding bubble formation.
Neposredno pred uporabo morate zdravilo Alofisel znova suspendirati z nežnim trkanjem po dnu viale, dokler ne dobite homogene suspenzije.
The injection of any other substance through the fistula tracts, such as hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions is not allowed, as these agents compromise the viability of the cells to be injected (see section 4.4 and section 4.5).
Injiciranje katere koli druge snovi skozi trakte fistule, npr. vodikovega peroksida, metilenskega modrila, raztopin joda ali hipertoničnih raztopin glukoze ni dovoljeno, saj lahko te učinkovine ogrozijo viabilnost celic, ki bodo injicirane (glejte poglavje 4.4 ter poglavje 4.5).
If you have any further questions on the use of this medicine, ask your doctor or surgeon.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali kirurgom.
If you have any further questions, ask your doctor or surgeon.
Če imate dodatna vprašanja, se posvetujte z zdravnikom ali kirurgom.
Injuring, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih pogosti bolečina pri postopku*
The full content of the 4 vials must be administered for the treatment of up to two internal openings and up to three external openings.
Za zdravljenje največ dveh notranjih odprtin in največ treh zunanjih odprtin je treba uporabiti celotno vsebino 4 vial.
The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) (see section 4.2 and section 4.4) through the fistula tracts and use of local anaesthesia is not recommended due to the unknown effect on the injected cells (see section 4.4).
Injiciranje katere koli druge snovi, razen 0,9-odstotne raztopine natrijevega klorida (9 mg/ml), (npr. vodikovega peroksida, metilenskega modrila, raztopin joda ali hipertoničnih raztopin glukoze) (glejte poglavje 4.2 ter poglavje 4.4) v traktih fistule in uporaba lokalne anestezije nista priporočljiva, ker učinek na injicirane celice ni znan (glejte poglavje 4.4).
The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) (see section 4.2 and section 4.5) through the fistula tracts is not allowed before, during, or after the injection of Alofisel as these may compromise the viability of the cells and, therefore, may affect the effectiveness of the treatment.
Injiciranje katere koli druge snovi, razen 0,9-odstotne raztopine natrijevega klorida (9 mg/ml), (npr. vodikovega peroksida, metilenskega modrila, raztopin joda ali hipertoničnih raztopin glukoze) (glejte poglavje 4.2 ter poglavje 4.5) v traktih fistule ni dovoljeno pred, med ali po injiciranju zdravila Alofisel, saj lahko to ogrozi viabilnost celic in posledično vpliva na učinkovitost zdravljenja.
2.2 Qualitative and quantitative composition Each vial contains a suspension of 30 million cells (eASC) in 6 mL solution, corresponding to a concentration of 5 million cells/mL.
Ena viala vsebuje suspenzijo 30 milijonov celic (eASC) v 6 ml raztopine, kar ustreza koncentraciji 5 milijonov celic/ml.
Darvadstrocel is an expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells - eASC).
Darvadstrocel so razmnožene človeške alogenske mezenhimske odrasle matične celice, pridobljene iz maščobnega tkiva (expanded adipose stem cells - eASC).
In the ADMIRE-CD study, 63/103 of the eASC-treated patient population were analysed for the presence of donor-specific antibodies (DSA) at baseline and Week 12.
V študiji ADMIRE-CD so v začetku in v 12. tednu analizirali 63/103 populacije bolnikov, ki je prejela eASC glede pojava protiteles proti darovalcu.
• stitch up the inner openings of the fistulas.
• zašil notranje odprtine fistul.
No association between DSA results and safety or efficacy up to Week 52 was seen in the subset tested.
Po preučitvi podskupine spremljanje do 52. tedna ni bila ugotovljena nobena povezava med pojavnostjo DSA ter varnostjo in učinkovitostjo.
Adverse reactions System Organ Class
Neželeni učinki Organski sistem
d) Replace the needle with a longer needle, also no thinner than 22G, in order to reach the intended sites of injection.
d) Da boste dosegli želena mesta injiciranja, zamenjajte iglo z daljšo, ki prav tako ne sme biti tanjša od 22G.
In Alofisel group, the number of patients who had combined remission at Week 24 and subsequently developed anal abscess/anal fistula by Week 52 was 2.9% (3/103), whereas the number of patients without combined remission at Week 24 who subsequently developed anal abscess/anal fistula by Week 52 was 9.7% (10/103).
V skupini, ki je prejemala zdravilo Alofisel, je bilo število bolnikov, pri katerih je v 24. tednu prišlo do kombinirane remisije ter pri katerih so se naknadno do 52. tedna pojavili analni abscesi/analne fistule, 2,9% (3/103), število bolnikov brez kombinirane remisije v 24. tednu, pri katerih so se naknadno do 52. tedna pojavili analni abscesi/analne fistule, pa je bilo 9,7% (10/103).
Each vial contains 6 mL of a suspension of 30 million of darvadstrocel.
Ena viala vsebuje 6 ml suspenzije s 30 milijoni celic darvadstrocela.
Description of selected treatment-emergent adverse events (adverse events)
Opis izbranih neželenih učinkov, ki se pojavijo med zdravljenjem
Do not store above 25 °C or below 15 °C.
Shranjujte pri temperaturi od 15 °C do 25 °C.
Alofisel should be used only after conditioning of the fistulas (see section 4.2).
Pred uporabo zdravila Alofisel je treba obvezno pripraviti fistule (glejte poglavje 4.2).
b) Re-suspend the cells by gently tapping the bottom of the vials until a homogeneous suspension is obtained, avoiding bubble formation.
b) Z nežnim trkanjem po dnu vial znova suspendirajte celice, dokler ne dobite homogene suspenzije.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
Results of the key secondary endpoints show that the proportion of patients with clinical remission at Week 24 was 55% in the Alofisel group and 42% in the control group (p = 0.052) and the corresponding figures for response were 69% and 55% (p = 0.039).
Rezultati ključnih sekundarnih opazovanih dogodkov kažejo, da je bil v 24. tednu delež bolnikov s klinično remisijo v skupini, ki je prejemala zdravilo Alofisel, 55%, v kontrolni skupini pa 42% (p = 0,052).
Preserve the container away from heat and direct light sources and do not refrigerate or freeze.
Vsebnik pri shranjevanju zaščitite pred toploto in neposrednimi viri svetlobe.
Lack of de novo DSA generation was observed between Week 12 and Week 52.
Med 12. in 52. tednom so opazili odsotnost nastanka protiteles DSA de novo.
The proportion of patients with clinical remission at Week 52 was 59% in the Alofisel group and 41% in the control group (p = 0.012) and corresponding figures for response were 66% and 55% (p = 0.114).
V 52. tednu je bil delež bolnikov s klinično remisijo v skupini, ki je prejemala zdravilo Alofisel, 59%, v kontrolni skupini pa 41% (p = 0,012).
Of patients with DSA at Week 12, 7/23 (30%) had cleared DSA by Week 52.
Med bolniki, ki so v 12. tednu imeli protitelesa, specifična za darovalca (donor-specific antibodies - DSA), so pri 7/23 (30%) protitelesa DSA izginila do 52. tedna.
In control group, the number of patients who had combined remission at Week 24 who developed anal abscess/anal fistula by Week 52 was 4.9% (5/102), whereas the number of patients without combined remission at Week 24 who developed anal abscess/anal fistula by Week 52 was 2.9% (3/102).
V kontrolni skupini je bilo število bolnikov, pri katerih je v 24. tednu prišlo do kombinirane remisije ter pri katerih so se do 52. tedna pojavili analni abscesi/analne fistule, 4,9% (5/102), število bolnikov brez kombinirane remisije po 24 tednih, pri katerih so se do 52. tedna pojavili analni abscesi/analne fistule, pa je bilo 2,9% (3/102).
Alofisel 5 million cells/mL suspension for injection
Alofisel 5 milijonov celic/ml suspenzija za injiciranje
Half of the dose will be injected into the tissue around the inner openings of the fistulas, and half of the dose in the tissue walls along the fistulas.
Polovico odmerka bo injiciral v tkivo okrog notranjih odprtin fistul,
What Alofisel contains
Kaj vsebuje zdravilo Alofisel
In line with standards for the management of complex perianal fistulas, characterisation of the patient's fistulas is needed prior to treatment.
Pred zdravljenjem je treba določiti značilnosti bolnikovih fistul skladno s standardi za obravnavanje zapletenih perianalnih fistul.
There were no patients in Alofisel group with events of proctalgia of severe intensity and 3.9% patients with 4 events in the control group.
V skupini, ki je prejemala zdravilo Alofisel ni bilo dogodkov hude proktalgije, v kontrolni skupini pa so bili 4 taki dogodki (pri 3,9% bolnikov).
The active ingredient of Alofisel is darvadstrocel which consists of stem cells which are taken from the fat tissue of a healthy adult donor (so-called allogenic stem cells) and then grown in a laboratory.
Učinkovina v zdravilu Alofisel je darvadstrocel, ki je sestavljen iz matičnih celic, ki so pridobljene iz maščobnegatkivazdravihodraslihdarovalcev(t.i.alogenskihzarodnihcelic)innatogojenev laboratoriju.
d) Suture closed the internal openings.
d) Notranje odprtine zaprite s šivi.
The active ingredient of Alofisel is darvadstrocel which consists of human stem cells obtained from the fat tissue of a healthy adult donor that are subsequently grown (expanded) in the laboratory and provided at a concentration of 5 million cells per millilitre in vials which each contain 6 millilitres, i.e. 30 million cells per vial.
Te celice se nato gojijo (razmnožujejo) v laboratoriju, na voljo pa so v koncentraciji 5 milijonov celic na mililiter v vialah, ki vsebujejo po 6 mililitrov, t.j.
What Alofisel looks like and contents of the pack Alofisel is a suspension for injection.
Zdravilo Alofisel je suspenzija za injiciranje.
How to store Alofisel
Shranjevanje zdravila Alofisel
How Alofisel is given
Kako se daje zdravilo Alofisel
If you get any side effects, talk to your surgeon or doctor.
Če opazite kateri koli neželeni učinek, se posvetujte s kirurgom ali zdravnikom.
Keep the product within the outer carton.
Zdravilo shranjujte v zunanji škatli.
Up to Week 104, 5 (4.9%) and one (< 1.0%) patients developed 5 and 1 anal fistula serious adverse events in the Alofisel and control groups, respectively.
Do 104. tedna se je v skupini, ki je prejemala zdravilo Alofisel, pojavilo 5 resnih neželenih dogodkov analne fistule pri 5 (4,9%) bolnikih, v kontrolni skupini pa eden pri enem (< 1,0%) bolniku.
Alofisel 5 million cells/mL suspension for injection Darvadstrocel
ALOFISEL 5 milijonov celic/ml suspenzija za injiciranje darvadstrocel injekcija
Proctalgia
Proktalgija
ALOFISEL 5 million cells/mL suspension for injection Darvadstrocel
Alofisel 5 milijonov celic/ml suspenzija za injiciranje darvadstrocel
Up to Week 52, 20 (19.4%) and 14 (13.7%) patients developed 21 and 19 anal abscess adverse events in the Alofisel and control groups, respectively, of which 4 and 5 adverse events in respective groups (3.9% patients in both groups) were of severe intensity.
Do 52. tedna se je v skupini, ki je prejemala zdravilo Alofisel, pojavilo 21 neželenih dogodkov analnega abscesa pri 20 (19,4%) bolnikih, v kontrolni skupini pa 19 pri 14 (13,7%) bolnikih.
Up to Week 52, 11 (10.7%) and 8 (7.8%) patients developed 12 and 8 anal fistula adverse events in the Alofisel and control groups, respectively, none of these being of severe intensity.
Do 52. tedna se je v skupini, ki je prejemala zdravilo Alofisel, pojavilo 12 neželenih dogodkov analne fistule pri 11 (10,7%) bolnikih, v kontrolni skupini pa 8 pri 8 (7,8%) bolnikih.
Up to Week 104, 15 (14.6%) and 8 (7.8%) patients developed 15 and 9 serious adverse events of anal abscess in the Alofisel and control groups, respectively.
Do 104. tedna se je v skupini, ki je prejemala zdravilo Alofisel, pojavilo 15 resnih neželenih dogodkov analnega abscesa pri 15 (14,6%) bolnikih, v kontrolni skupini pa 9 pri 8 (7,8%) bolnikih.
e) Repeat steps (b), (c) and (d) for each of the vials in turn after the cells from one vial have been injected.
Za to boste potrebovali iglo, ki se uporablja na primer za spinalno anestezijo, dolgo približno 90 mm. e) Ko injicirate celice iz ene viale, ponovite korake (b), (c) in (d) za vse ostale viale.
Up to Week 52, 15 (14.6%) and 12 (11.8%) patients developed 20 and 17 proctalgia adverse events in the Alofisel and control groups, respectively, none of these events being serious in any group up to Week 104.
Do 52. tedna se je v skupini, ki je prejemala zdravilo Alofisel, pojavilo 20 neželenih dogodkov proktalgije pri 15 (14,6%) bolnikih, v kontrolni skupini pa 17 pri 12 (11,8%) bolnikih.
Each vial contains 6 mL of eASC suspension and is closed with a rubber stopper and a flip-off seal.
Zdravilo Alofisel je na voljo v obliki enega odmerka za zdravljenje, shranjenega v 4 vialah iz stekla vrste I. Ena viala vsebuje 6 ml suspenzije celic eASC, zaprta pa je z gumijastim zamaškom in dvižno zaporko.
Warnings and precautions Talk to your doctor or surgeon before youare given Alofisel.
Opozorilainprevidnostniukrepi PredenvamdajozdraviloAlofisel,seposvetujtezzdravnikomalikirurgom.
• The other ingredients are:
• Druge sestavine so:
The safety and effectiveness in these patients were not evaluated.
Varnosti in učinkovitosti pri teh bolnikih niso ovrednotili.
Do not over-exercise and drink plenty of water.
Ne pretiravajte s fizično aktivnostjo in pijte veliko vode.
It is especially important to mention the following medicines to your doctor:
Še posebej pomembno je, da zdravniku omenite naslednja zdravila:
Close medical supervision and monitoring should continue until the patient recovers.
Zdravniški nadzor in spremljanje je treba nadaljevati, dokler bolnik ne okreva.
Suicidal thoughts and behaviours are more likely at the beginning of the treatment.
Samomorilne misli in vedenja so bolj verjetna na začetku zdravljenja.
• medicines having an effect on the central nervous system.
• zdravila, ki vplivajo na osrednji živčni sistem.
• dementia (loss of memory and other mental abilities) especially if you are elderly.
• demenco (izguba spomina in drugih miselnih sposobnosti), zlasti če ste starejši.
Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.
Ne vozite in ne uporabljajte nobenega orodja ali strojev, dokler ne veste, da to zdravilo na vas ne vpliva negativno.