natgillin/translations-raw huggingface dataset:
Thrombocytopenia has been reported in patients receiving filgrastim.
Trombocitopenija Pri bolnikih, ki so prejemali filgrastim, so poročali o trombocitopeniji.
• It is important to tell your doctor if you:are pregnant or breast-feeding
morate zdravniku povedati, da imate (ali ima vaš otrok) dedno intoleranco za fruktozo.
Myelodysplastic syndrome or Chronic myeloid leukemia
mielodisplastičnega sindroma ali levkemične preobrazbe.
Tevagrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Pri bolnikih, pri katerih se pojavi resna alergijska reakcija, je treba zdravljenje s filgrastimom trajno prekiniti.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.3 Kontraindikacije Preobčutljivost na zdravilno učinkovino (zdravilne učinkovine) ali katero koli pomožno snov,
Fatiguea Mucosal inflammatio na
Bolezni živčevja glavobola omotica hipestezija parestezija
- to increase the number of white blood cells after a bone marrow transplant to help prevent infections.
- za povečevanje števila belih krvničk po zdravljenju s kemoterapijo, kot pomoč pri preprečevanju okužb; - za povečanje števila belih krvničk po presaditvi kostnega mozga, kot pomoč pri preprečevanju okužb; - pred visokimi odmerki kemoterapije, da kostni mozeg proizvede več matičnih celic, ki jih je mogoče odvzeti in vrniti po zdravljenju.
EU/1/08/445/012 1 pre-filled syringe with a needle safety guard EU/1/08/445/013 5 pre-filled syringe with a needle safety guard EU/1/08/445/014 10 pre-filled syringe with a needle safety guard
EU/1/08/445/013 5 napolnjenih injekcijskih brizg z varnostno zaščito za iglo EU/1/08/445/014 10 napolnjenih injekcijskih brizg z varnostno zaščito za iglo
Agents such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation, may reduce progenitor yield.
Dolgotrajna uporaba zdravil, kot so melfalan, karmustin (BCNU) in karboplatin pred poskusom izplavljanja krvotvornih matičnih celic, lahko zmanjša pričakovani donos teh celic, vendar pa je bilo ugotovljeno, da je uporaba melfalana, karboplatina ali BCNU skupaj s filgrastimom učinkovita pri izplavljanju krvnih matičnih celic.
Manufacturer
Nemčija Izdelovalec
• bumpy skin rash (rash macuo-papular)
• izbočen kožni izpuščaj (makulopapulozni izpuščaj)
Congenital neutropenia
Zaustavitev napredovanja nevtropenije
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TEVA GmbH
Tevagrastim can be used - to increase the number of white blood cells after treatment with chemotherapy to help prevent infections.
Matične celice se vrnejo v kostni mozeg in tvorijo krvničke; - za povečevanje števila belih krvničk, če imate hudo kronično nevtropenijo, kot pomoč pri preprečevanju okužb; - pri bolnikih z napredovalo okužbo z virusom HIV, kar bo pripomoglo k zmanjšanju tveganja za okužbe.
Injection site reaction
Napolnjena injekcijska brizga
Acute respiratory distress syndromea Respiratory failurea Pulmonary oedemaa Pulmonary haemorrhag e
Bolezni krvi in limfatičnega sistema trombocitopenija anemijae splenomegalijaa zmanjšanje vrednosti hemoglobinae levkocitozaa ruptura vranicea srpastocelična anemija s krizoa
Infestations
ZDRAVILA
• increased)
• tekočine)
The recommended starting dose of filgrastim is 1.0 MIU (10 μg)/kg/day The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
Bolnik lahko prvi odmerek filgrastima prejme po najmanj 24 urah po citotoksični kemoterapiji oziroma po najmanj 24 urah v primeru presaditve kostnega mozga.
Please tell your doctor before starting treatment, if you have
Preden boste dobili zdravilo,
Gastrointestinal disorders
Navodila za samoinjiciranje
Key pharmaceutical parameters of the drug product, manufacturing process and control are established .
Vzpostavitev ključnih farmacevtskih parametrov zdravila, proizvodnega postopka in nadzora.
Conditions for the lifting of the marketing authorisation suspension
Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Pred preklicem začasnega umika dovoljenj za promet z zdravilom bodo nacionalni pristojni organi, ki jih usklajuje referenčna država članica, zagotovili, da imetnik dovoljenja za promet z zdravilom izpolni naslednja pogoja:
• the rapporteur's and co-rapporteur's assessment reports;
• poročil poročevalca in soporočevalca o oceni zdravila,
Therefore, the Committee adopted an opinion recommending the refusal of the marketing authorisation in the concerned member states and the suspension of the marketing authorisation in the reference member state, subject to the conditions outlined in annex III of the Opinion.
Odbor je zato sprejel mnenje, v katerem priporoča zavrnitev dovoljenja za promet z zdravilom v zadevnih državah članicah in začasni umik dovoljenja za promet z zdravilom v referenčni državi članici v skladu s pogoji, opredeljenimi v Dodatku III tega mnenja.
Therapeutic equivalence to the reference product, through an appropriate clinical study or other validated model is demonstrated.
Prikaz terapevtske enakovrednosti z referenčnim zdravilom z ustrezno klinično študijo ali drugim validiranim modelom.
• the description of the pharmaceutical development was considered to be unsatisfactory and the deficiencies resulting from this, including the absence of skin permeation or similar in vitro studies, were considered to be critical;
• opis farmacevtskega razvoja ni bil zadosten in pomanjkljivosti, ki izhajajo iz tega, vključno z odsotnostjo študije kožne prepustnosti ali podobne študije in vitro, so se štele kot kritične;
the CHMP was of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
• znanstvene razprave v odboru je CHMP menil, da podatki, predloženi v podporo vlogi, ne izpolnjujejo zahtev iz člena 10 Direktive 2001/83/ES, kakor je bila spremenjena.
The CHMP considered that the data submitted in support of this application failed to show therapeutic equivalence between the test and the reference product:
CHMP je menil, da podatki, predloženi v podporo vlogi, niso ustrezno dokazali terapevtske enakovrednosti testnega in referenčnega zdravila:
• the data provided by the company was considered to be neither robust nor extensive enough to warrant waiving a clinical study, or other validated model, to show therapeutic equivalence.
• podatki, ki jih je predložila družba, niso bili trdni niti dovolj obsežni, da bi utemeljili opustitev klinične študije ali drugega validiranega modela, ki bi dokazal terapevtsko enakovrednost.
• the results from the studies provided by the MAH;
• rezultatov študij, ki jih je predložil imetnik dovoljenja za promet z zdravilom;
The study lasted four months.
Študija je trajala štiri mesece.
The name of the medicine was changed to Alli on 12 September 2008.
Ime zdravila je bilo 12. septembra 2008 spremenjeno v Alli.
Previously known as Orlistat GSK.
Prej znano kot Orlistat GSK
This authorisation was based on the authorisation already granted in 1998 to Xenical capsules.
Dovoljenje je temeljilo na dovoljenju, ki je leta 1998 že bilo odobreno za kapsule Xenical.
Alli should not be taken for more than six months.
Zdravilo Alli se ne sme uporabljati več kot šest mesecev.
Other information about Alli
Druge informacije o zdravilu Alli
The European Commission granted a marketing authorisation valid throughout the EU for Orlistat GSK on 23 July 2007.
Evropska komisija je dovoljenje za promet z zdravilom Orlistat GSK, veljavno po vsej Evropski uniji, odobrila dne 23. julija 2007.
What benefit has Alli shown during the studies?
Kakšne koristi je zdravilo Alli izkazalo med študijami?
Neither the patients nor the doctors knew which treatment each patient was taking until the end of the study.
Niti zdravniki niti bolniki do konca študije niso vedeli katero zdravilo bolnik prejema.
What is the risk associated with Alli?
Kakšna tveganja so povezana z zdravilom Alli?
The patient should be on a diet in which about 30% of the calories come from fat.
Bolnik mora biti na dieti, ki vsebuje približno 30 % kalorij iz maščob.
The full EPAR for Alli can be searched for 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 Alli je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
In all of the studies, the main measure of effectiveness was the change in weight.
V vseh študijah je bilo glavno merilo učinkovitosti sprememba telesne mase.
Alli capsules have been studied in three main studies.
Zdravilo Alli v obliki kapsul so proučevali v treh glavnih študijah.
It is available as capsules (60 mg) and as chewable tablets (27 mg).
Na voljo je v obliki kapsul (60 mg) in žvečljivih tablet (27 mg).
In general, they are mild, and occur at the beginning of treatment, going away after some time.
Večinoma so blagi, pojavijo se na začetku zdravljenja in sčasoma izginejo.
This is a summary of the European public assessment report (EPAR) for Alli.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Alli.
The CHMP decided that the benefits of Alli are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Alli večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
For more information about treatment with Alli, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Alli preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Patients taking Alli should start a diet and exercise regime before beginning treatment.
Bolniki, ki jemljejo zdravilo Alli, morajo z dieto in telesno vadbo začeti pred začetkom zdravljenja.
One Alli capsule or chewable tablet is taken just before, during, or up to one hour after each main meal, three times a day.
Ena kapsula ali žvečljiva tableta zdravila Alli se vzame trikrat na dan tik pred vsakim glavnim obrokom, med njimi ali do eno uro po njem.
The most common side effects with Alli (seen in more than 1 patient in 10) are oily spotting, flatus (gas) with discharge, faecal urgency (urgent need to open the bowels), fatty oily stool, oily evacuation (bowel movements of just oil, without stool), flatulence (gas) and soft stools.
Najpogostejši neželeni učinki zdravila Alli (opaženi pri več kot 1 od 10 bolnikov) so oljni madeži, flatus (vetrovi) z uhajanjem, nujnost odvajanja (nujna potreba po izpraznitvi črevesa), mastno ali oljnato blato, oljnato odvajanje (odvajanje samo olja, brez blata), flatulenca (vetrovi) in mehko blato.
Alli is a medicine that contains the active substance orlistat.
Alli je zdravilo, ki vsebuje zdravilno učinkovino orlistat.
Because Alli is based on another medicine containing the same active substance already authorised in the EU (Xenical 120 mg capsules), some of the studies involved patients who took Xenical.
Ker je osnova za zdravilo Alli drugo zdravilo, ki vsebuje enako zdravilno učinkovino in je že odobreno v EU (zdravilo Xenical, 120 mg, kapsule), so bili v nekatere študije vključeni bolniki, ki so jemali zdravilo Xenical.
It must not be used in people who are being treated with ciclosporin (used to prevent organ rejection in transplant patients) or with medicines used to prevent blood clots such as warfarin.
Ne smejo ga uporabljati osebe, ki se zdravijo s ciklosporinom (ki se uporablja proti zavrnitvi organov pri bolnikih, pri katerih je bila opravljena presaditev) ali z zdravili za preprečevanje nastanka krvnih strdkov, kot je na primer varfarin.
The company also carried out studies to show that Alli 27 mg chewable tablets have the same effect on fat absorption as Alli 60 mg capsules.
Družba je študije izvedla tudi zato, da pokaže, da imajo 27-miligramske žvečljive tablete enak učinek na absorpcijo maščobe kot 60-miligramske kapsule zdravila Alli.
When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to be passed out in the stools undigested.
Če so ti encimi blokirani, ne morejo prebaviti dela maščob, zaradi česar se približno četrtina maščob, zaužitih z hrano, neprebavljenih izloči z blatom.
Why has Alli been approved?
Zakaj je bilo zdravilo Alli odobreno?
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 Alli.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Alli, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Orlistat blocks gastrointestinal lipases (enzymes that digest fat).
Orlistat zavira lipaze v prebavilih (encime, ki prebavljajo maščobo).
It is used in adults who are overweight with a body mass index (BMI) greater than or equal to 28 kg per square metre, in combination with a low calorie diet with reduced fat levels.
Uporablja se pri odraslih s čezmerno telesno maso, katerih indeks telesne mase (ITM) je večji ali enak 28 kg na kvadratni meter, ob hkratni nizkokalorični dieti z zmanjšanim vnosom maščob.
Alli must not be used in people who are hypersensitive (allergic) to orlistat or any of the other ingredients.
Zdravila Alli ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) orlistat ali katero koli drugo sestavino zdravila.
The active substance in Alli, orlistat, is an anti-obesity medicine, which does not affect appetite.
Zdravilna učinkovina zdravila Alli, orlistat, je zdravilo proti debelosti, ki ne vpliva na tek.
If a meal is missed or contains no fat, Alli should not be taken.
Če bolnik obrok izpusti ali če ta ne vsebuje maščob, naj bolnik zdravila Alli ne vzame.
If patients taking Alli have been unable to lose weight after 12 weeks, they should speak to their doctor or pharmacist.
Če bolniki, ki jemljejo zdravilo Alli, po 12 tednih zdravljenja niso uspeli zmanjšati telesne mase, naj se pogovorijo z zdravnikom ali farmacevtom, saj bo morda treba zdravljenje prekiniti.
Most of the side effects with Alli affect the digestive system and are less likely to occur with a low fat diet.
Večina neželenih učinkov zdravila Alli je povezanih s prebavnim sistemom, njihov pojav pa je manj verjeten pri dietah z malo maščobami.
It must also not be used in people with chronic malabsorption syndrome (a long-term disease where nutrients from food are not easily absorbed during digestion) or cholestasis (a liver disorder), or in women who are pregnant or breast-feeding.
Prav tako ga ne smejo uporabljati osebe s kroničnim malabsorpcijskim sindromom (dolgotrajno boleznijo, pri kateri se hranilne snovi iz hrane med prebavljanjem ne absorbirajo zlahka), osebe s holestazo (motnjo delovanja jeter) ali doječe matere.
In the two studies of patients with a BMI of 28 kg/m2 or more, patients taking Alli 60 mg capsules had lost an average of 4.8 kg after a year, compared with 2.3 kg in those taking placebo.
Študiji bolnikov, pri katerih je ITM znašal 28 kg/m2 ali več, sta pokazali, da so bolniki, ki so jemali zdravilo Alli v obliki 60-miligramskih kapsul, po enem letu v povprečju izgubili 4,8 kg v primerjavi z 2,3 kg pri tistih, ki so jemali placebo.
For the full list of all side effects reported with Alli, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Alli, glejte navodilo za uporabo.
The third study compared Alli with placebo in 391 overweight patients with a BMI between 25 and 28 kg/m2.
V tretji študiji so zdravilo Alli primerjali s placebom pri 391 bolnikih s čezmerno telesno maso, pri katerih je ITM znašal med 25 in 28 kg/m2.
What is Alli used for?
Za kaj se zdravilo Alli uporablja?
The study of Alli in patients with a BMI between 25 and 28 kg/m2 failed to show a degree of weight loss that would be relevant for patients.
V študiji zdravila Alli pri bolnikih z ITM med 25 in 28 kg/m2 ni bilo doseženo takšno zmanjšanje telesne mase, ki bi bilo pomembno za bolnike.
The studies comparing the chewable tablets with the capsules showed that the amount of undigested fat passed out in patients' stools was the same after taking either formulation.
V študijah, v katerih so primerjali žvečljive tablete s kapsulami, so bolniki po jemanju ene in druge formulacije v blatu izločili enako količino neprebavljene maščobe.
How has Alli been studied?
Kako je bilo zdravilo Alli raziskano?
Alli is used to help patients lose weight.
Zdravilo Alli bolnikom pomaga pri zmanjševanju telesne mase.
How is Alli used?
Kako se zdravilo Alli uporablja?
Alli was more effective than placebo in reducing weight in patients with a BMI of 28 kg/m2 or more.
Zdravilo Alli je bilo pri zmanjševanju telesne mase pri bolnikih z ITM 28 kg/m2 ali več učinkovitejše od placeba.
What is Alli?
Kaj je zdravilo Alli?
How does Alli work?
Kako zdravilo Alli deluje?
Two of the studies involving a total of 1,353 overweight or obese patients with a BMI of 28 kg/m2 or more and lasted from one to two years, comparing Alli given at different doses with placebo (a dummy treatment), in combination with dieting.
V dveh študijah, ki sta trajali od enega do dveh let, je sodelovalo skupaj 1 353 bolnikov s prekomerno telesno maso ali debelih bolnikov, pri katerih je ITM znašal 28 kg/m2 ali več.
• under 18 years old;
• osebe, mlajše od 18 let;
Generally, one vial is sufficient, but a further vial can be used if necessary.
Običajno zadošča ena viala, vendar pa je po potrebi mogoče uporabiti še eno.
Osigraft must also not be used by the following groups of patients:
Zdravila Osigraft ne smejo uporabljati naslednje skupine bolnikov:
The main measure of effectiveness, which was assessed after nine months, was whether the broken bone had healed.
Glavno merilo učinkovitosti, ki so jo ocenjevali po devetih mesecih, je bilo, ali se je zlomljena kost zacelila.
The European Commission granted a marketing authorisation valid throughout the European Union for Osigraft to Howmedica International S. de R. L. on 17 May 2001.
Evropska komisija je dovoljenje za promet z zdravilom Osigraft, veljavno po vsej Evropski uniji, odobrila družbi Howmedica International S. de R. L. dne 17. maja 2001.
Other information about Osigraft
Druge informacije o zdravilu Osigraft
• with an active infection at the surgery site or another serious infection;
• osebe z aktivno okužbo na območju kirurškega posega ali drugo resno okužbo;
The full EPAR for Osigraft 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 Osigraft je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
• with an autoimmune disease (where the immune system attacks parts of the body);
• osebe z avtoimunsko boleznijo (pri katerih imunski sistem napada dele telesa);
It is used in skeletally mature patients (who have stopped growing).
Uporablja se pri bolnikih z zrelim okostjem (ki so prenehali rasti).
The replacement eptotermin alfa acts in same way as naturally produced BMP-7.
Nadomestni eptotermin alfa deluje na enak način kot naravno proizvedeni BMP-7.
It is a copy of a protein called osteogenic protein 1, also known as bone morphogenetic protein 7 (BMP-7), that is produced naturally by the body and which helps the formation of new bone tissue.
Je kopija proteina, imenovanega osteogeni protein 1, znanega tudi kot morfogenetski protein 7 (BMP-7), ki naravno nastaja v telesu in spodbuja tvorbo novega kostnega tkiva.
What benefit has Osigraft shown during the studies?
Kakšne koristi je zdravilo Osigraft izkazalo med študijami?
After nine months, 81% of the patients receiving Osigraft had responded to treatment (less pain and more weight bearing), compared with 77% of the patients treated with an autograft.
Po devetih mesecih se je na zdravljenje odzvalo 81 % bolnikov, ki so prejeli zdravilo Osigraft (zmanjšanje bolečin in povečana zmožnost obremenitve golenice), v primerjavi s 77 % bolnikov, ki so bili zdravljeni z avtolognim presadkom.
For more information about treatment with Osigraft, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Osigraft preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Osigraft.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Osigraft.
The main study of Osigraft was carried out in 122 patients with unhealed tibial fractures who were treated either with the medicine or with an autograft.
Glavna študija zdravila Osigraft je bila izvedena pri 122 bolnikih z nezaceljenim zlomom golenice, ki so bili zdravljeni bodisi z zdravilom Osigraft ali z avtolognim presadkom.
• receiving chemotherapy, radiation treatment or immunosuppression.
• osebe, ki prejemajo kemo-, radio- ali imunosupresivno terapijo.
Immediately before use, Osigraft is mixed with 2 to 3 ml of sodium chloride solution to make up a suspension that has the consistency of wet sand.
Neposredno pred uporabo se zdravilo Osigraft zmeša z 2 do 3 ml raztopine natrijevega klorida, s čemer dobimo suspenzijo s konsistenco mokrega peska.
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 Osigraft.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Osigraft, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The most common side effects with Osigraft (seen in between 1 and 10 patients in 100) are erythema (redness), tenderness, swelling over the implant site, heterotopic ossification (development of bone in abnormal areas) or myositis ossificans (abnormal bone growth in the muscle), and the formation of antibodies against eptotermin alfa.
Najpogostejši neželeni učinki (opaženi pri 1 do 10 bolnikih izmed 100) so eritem (pordelost), občutljivost, zatekanje na mestu vsadka, heterotopična okostenitev (tvorba kostnine zunaj mesta zloma) ali osificirajoči miozitis (nenormalna rast kosti v mišico) ter tvorba protiteles proti eptoterminu alfa.
The CHMP decided that Osigraft's benefits are greater than its risks and recommended that Osigraft be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Osigraft večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
• with a tumour near the fracture;
• osebe s tumorjem v bližini mesta zloma;
• where the fracture is disease-related (such as metabolic bone disease or cancer);
• osebe, pri katerih je zlom povezan z boleznijo (npr. presnovnimi boleznimi ali rakom);
This was detected by looking at signs of repair of the fracture on an X-ray, whether the patient had any pain and was able to bear weight on the tibia, and whether there was any need for further treatment of the fractured tibia.
To so ugotavljali s preverjanjem znakov zacelitve zloma na rentgenski sliki ter ugotavljanjem, ali ima bolnik bolečine in ali lahko obremeni golenico, kakor tudi s preverjanjem, ali obstaja potreba po nadaljnjem zdravljenju zloma.
What is the risk associated with Osigraft?
Kakšna tveganja so povezana z zdravilom Osigraft?
The surrounding soft tissues, such as muscle and skin, are then closed around the implant.
Zatem se okrog vsadka zaprejo obkostna mehka tkiva, kot so mišice in koža.