PROSPECT: Informatii pentru utilizator
PROBIOS - Burete (pansament) din colagen nativ
Dispozitiv medical steril, de unica folosinta

Substanta activa: 100 mg burete contine min. 95% colagen derivat din tesut de origine animala ( tesut bovin / cabalin ).

Cititi cu atentie si in intregime acest prospect inainte de a incepe sa utilizati acest dispozitiv medical deoarece contine informatii importante pentru dumneavoastra.

• Pastrati acest prospect. S-ar putea sa fie necesar sa-l recititi.
• Daca aveti orice intrebari suplimentare, adresati-va medicului sau farmacistului.
• Acest dispozitiv medical a fost prescris numai pentru dumneavoastra. Nu trebuie sa-l dati altor persoane. Le poate face rau, chiar daca au aceleasi semne de boala ca dumneavoastra.
• Daca manifestati orice reactii adverse, adresati-va medicului sau farmacistului. Acestea includ orice posibile reactii adverse nementionate in acest prospect.
• Daca dupa 5 zile nu va simtiti mai bine sau va simtiti mai rau, trebuie sa va adresati unui medic.

Utilizati intotdeauna acest dispozitiv medical conform indicatiilor din acest prospect sau indicatiilor medicului sau farmacistului.

• Pastrati acest prospect. S-ar putea sa fie necesar sa-l recititi.
• Intrebati farmacistul daca aveti nevoie de mai multe informatii sau recomandari.
• Daca manifestati orice reactii adverse, adresati-va medicului sau farmacistului. Acestea includ orice posibile reactii adverse nementionate in acest prospect.

Ce gasiti in acest prospect:

• Ce este PROBIOS si pentru ce se utilizeaza
• Ce trebuie sa stiti inainte sa utilizati PROBIOS
• Cum sa utilizatI PROBIOS
• Reactii adverse posibile
• Cum se pastreaza PROBIOS

Continutul ambalajului si alte informatii

1. Ce este PROBIOS si pentru ce se utilizeaza

PROBIOS este un dispozitiv medical alcatuit 95% burete poros realizat prin liofilizarea unei solutii de colagen derivat din surse animale (vaca sau cal). Colagenul, proteina care ofera pielii fermitate, joaca un rol important in toate etapele de vindecare a ranilor. Acesta atrage celulele necesare vindecarii ranii, cum ar fi fibroblastele si keratinocitele, care incurajeaza debridarea, angiogeneza si reepitalizarea. In plus, colagenul reprezinta un substrat pentru creșterea de tesut nou. Astfel, stimuleaza creșterea de noi tesuturi și incurajeaza depozitarea si organizarea unor noi fibre de colagen, determinand o perioada de recuperare mult mai rapida in comparatie cu pansamentele clasice. In plus, gelul care se formeaza prin interactia pansamentului cu exudatul de pe rana este biodegradabil si nu necesita a fi indepartat la fiecare reinnoire a pansamentelor, decat in cazul in care este necesara curatarea ranii din diferite motive (prezenta unor infectii). Stratul de hidrocoloid, format din particule cu capacitate mare de a absorbi fluidele, creeaza astfel un mediu umed ideal si se stimuleaza granulatia si epitelizarea.

INDICATII:

Tratamentul ranilor superficiale si supurante, cum ar fi cele traumatice, ulceratii, escare, arsuri si rani post-transplant.

FORME DE PREZENTARE:

PROBIOS (burete de colagen nativ de vaca sau cal) este disponibil in mai multe forme de ambalare:

• Cutie pliant cu 1 pansament dimensiunea 2 cm x 3 cm
• Cutie pliant cu 1 pansament dimensiunea 5 cm x 5 cm
• Cutie pliant cu 1 pansament dimensiunea 5 cm x 10 cm
• Cutie pliant cu 1 pansament dimensiunea 10 cm x 10 cm
• Cutie pliant cu 1 pansament dimensiunea 10 cm x 20 cm

2. Ce trebuie sa stiti inainte sa utilizati PROBIOS

Nu utilizati PROBIOS daca sunteti alergic la proteinele de origine animala.

3. Cum sa utilizati PROBIOS

Utilizati intotdeauna acest dispozitiv medical exact asa cum este descris in acest prospect sau asa cum v-a spus medicul dumneavoastra sau farmacistul. Discutati cu medicul sau cu farmacistul daca nu sunteti sigur.

In cazul aplicatiilor topice cu buretele de colagen ca agent hemostatic pe traumatisme superficiale si rani, acesta se plaseaza pe rana pentru cateva minute (5-30 min.), pana cand curgerea sangelui este oprita. In acest timp are loc o dezintegrare a structurii spongioase. In situatia ranilor cu secretii, produsul se aplica pe rana sub bandaj, care este schimbat o data la cateva zile (1-3 zile). In acest timp buretele se dizolva in secretiile proteolitice care emulsioneaza cu buretele dizolvat pentru a forma un gel; aminoacizii astfel eliberati din structura favorizeaza procesele de proliferare celulara, granulare si epitelizare.

UTILIZAREA LA COPII SI ADOLESCENTI

PROBIOS poate fi utilizat de copii si de adolescenti.
Daca aveti orice intrebari suplimentare cu privire la acest dispozitiv medical adresati-va medicului dumneavoastra sau farmacistului.

4. Reactii adverse posibile

• Acest dispozitiv medical poate provoca reactii adverse, cu toate ca nu apar la toate persoanele.
• Nu au fost identificate reactii adverse pana in prezent.
• Nu au fost raportate reactii adverse asupra copiilor sau adolescentilor.
• Nu au fost raportate reactii adverse asupra sportivilor.
• Nu se cunosc efecte adverse relationate cu utilizarea PROBIOS impreuna cu alte medicamente.
• Spuneti medicului dumneavoastra sau farmacistului daca utilizati, ati utilizat recent sau s-ar putea sa utilizati orice alte medicamente.
• Daca manifestati orice reactii adverse, adresati-va medicului dumneavoastra sau farmacistului. Acestea includ orice reactii adverse nementionate in acest prospect.

CONTRAINDICATII

• A nu se utiliza pe plagi infectate sau inflamate.
• A nu se utiliza in caz de hipersensibilitate (alergie) la colagen. A nu se utiliza de catre pacientii aflati sub tratament de desensibilizare la produsele din carne.
• A nu se utiliza in interiorul plagilor dearece poate interactiona cu marginile plagii. Buretele de colagen PROBIOS se aplica mecanic deasupra plagii, ca un pansament uscat.
• A nu se utiliza in caz de hemoragii masive deoarece poate masca cauza sangerarii si determina aparitia de hematoame.
• PROBIOS nu trebuie folosit ca tampon hemostatic in interiorul plagilor hemoragice, intravascular sau in chirurgia craniana, cardiaca sau intraabdominala, deoarece sangele se poate strange in spatele buretelui, cauzand hematoame.
• A nu se utiliza pentru tratarea problemelor sistemice de coagulare sau la pacientii cu haemofilie.
• A nu se utiliza intraocular, intravascular sau injecta.
• In cazul aparitiei unei reactii anormale la nivelul pielii intrerupeti imediat utilizarea produsului.
• Nu sunt cunoscute cazuri de supradozaj.
• Nu sunt cunoscute interactiuni cu medicamente si substante medicamentoase.

ATENTIONARI SI PRECAUTII

Inainte sa utilizati PROBIOS, adresati-va medicului dumneavoastra sau farmacistului.

• Nu folositi acest produs in alte scopuri decat cele mentionate in prospect.
• Inainte de aplicare spalati-va bine mainile.
• A se utiliza produsul imediat dupa deschidere.
• A nu se utiliza daca ambalajul este deschis sau deteriorat.
• A nu se utiliza dupa data de expirare inscrisa pe ambalaj. Data de expirare se refera la ultima zi a lunii respective.
• A se pastra la temperatura de pana la 25 ℃, ferit de surse de caldura.
• A nu se congela.
• A nu se lasa la indemana copiilor.
• Recomandat strict pentru administrare locala - a nu se inghiti.
• Produsul este destinat pentru o singura utilizare, fiind resorbabil dupa aplicare.
• Produs steril, sterilizat prin iradiere cu radiatii gamma.
• Daca observati aparitia unor reactii anormale la nivelul pielii opriti imediat utilizarea si adresati-va medicului sau farmacistului.

SARCINA SI ALAPTAREA

Daca sunteti gravida sau alaptati, credeti ca ati putea fi gravida sau intentionati sa ramaneti gravida, adresati-va medicului sau farmacistului pentru recomandari inainte de a lua acest dispozitiv medical.

CONDUCEREA VEHICULELOR SI FOLOSIREA UTILAJELOR

PROBIOS contine colagen nativ liofilizat de vaca sau cal.

5. Cum se pastreaza PROBIOS

• Nu lasati acest dispozitiv medical la vederea si indemana copiilor.
• A se feri de umezeala si caldura.
• Nu aruncati nici un dispozitiv medical pe calea apei sau a reziduurilor menajere. Intrebati farmacistul cum sa aruncati dispozitivele medicale pe care nu le mai folositi. Aceste masuri vor ajuta la protejarea mediului.

Detinatorul autorizatiei de punere pe piata si fabricantul este SC SANIMED INTERNATIONAL IMPEX S.A.
Adresa: Sos. Bucuresti-Magurele, Nr. 70F, Sector 5, Bucuresti, Romania,
website: www.sanimed.ro,
E-mail: office@sanimed.ro, Tel/Fax: 021 420 54 93 / 021 420 54 94
Pentru orice informatii referitoare la acest dispozitiv medical, va rugam sa contactati detinatorul autorizatiei de punere pe piata.

Revizuirea textului: mai 2016

Patient Information Leaflet
PROBIOS - Sponge (dressing) of native collagen
Disposable sterile medical device

Active substance: 100 mg sponge containing min. 95% collagen derived from animal tissue ( bovine / equine tissue).

Carefully read all the information in this leaflet before you start using this medical device because it contains important information for you.

• Keep this leaflet. You might need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medical device has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, ask your doctor or pharmacist. This includes any side effects not listed in this leaflet.
• If after 5 days of using this product you don't feel better or you feel worse, you should contact a physician.

Always use this medical device as described in this leaflet or according to the indications you received from the doctor or pharmacist.

What you may find in this leaflet:

1. What is Probios and what it is used for
2. What you should know before using Probios
3. How to use Probios
4. Possible side effects
5. How to store Probios

Contents of the pack and other information

1. What is Probios and what it is used for

Probios is a medical device made up of 95% porous sponge resulted after freeze-drying a solution of collagen derived from animal sources (cow or horse). Collagen, the protein that gives skin firmness, plays an important role in all phases of wound healing. It attracts the cells that heal the wound, such as fibroblasts and keratinocytes, which stimulate debridement, angiogenesis and re-epithelization. In addition, collagen is a substrate for the growth of new tissue. Thus, it stimulates the growth of new tissue and encourages the storage and organization of new collagen fibers, resulting in a much faster recovery period compared with conventional dressings. In addition, the gel formed through the interaction with the exudate from the wound dressing is biodegradable and does not need to be removed at each dressing renewal, except for the situation when cleaning the wound is necessary for various reasons (presence of infection). Hydrocolloid layer consisting of particles with high capacity to absorb fluids, creates an ideal moist environment stimulating granulation and epithelization.

Indications:

Treatment of superficial wounds and festering, such as traumatic ulcers, bedsores, burns and post-transplant wounds.

Presentations

Probios (native collagen sponge from cow or horse) is available in several forms of packaging:

• Box with 1 dressing, size 2 cm x 3 cm
• Box with 1 dressing, size 5 cm x 5 cm
• Box with 1 dressing, size 5 cm x 10 cm
• Box with 1 dressing, size 10 cm x 10 cm
• Box with 1 dressing, size 10 cm x 20 cm

2. What you should know before using Probios

Do not use PROBIOS if you are allergic to proteins of animal origin.

3. How to use PROBIOS

Always use this medical device exactly as described in this leaflet or as your doctor or pharmacist told you. Ask your doctor or pharmacist if you are not sure about how to use it.

In topical applications with the collagen sponge as haemostatic agent on superficial injuries and wounds, it should be placed on the wound for a few minutes (5-30 min.), until blood flow is stopped. During this time there is a disintegration of the foam structure. In case of wounds with secretions, the product is applied to the wound under the bandage, which is changed once every few days (1-3 days). During this time the sponge is dissolved in the proteolytic secretions which emulsify with the dissolved sponge in order to form a gel; the amino-acids released from the structure promote cellular proliferation, granulation and epithelization.

Use in children and teenagers

PROBIOS may be used by children and teenagers.

If you have any question regarding this medical device, ask your medical doctor or pharmacist.

4. Possible adverse reactions and side effects

• Like all the medical devices, this one may cause adverse reactions, even if those do not occur to everyone using it.
• No adverse reactions have been identified so far.
• There were no reported adverse effects in children and teenagers.
• There were no reported adverse effects on athletes.
• There are no known side effects related to use of Probios together with other medicinal products.
• Tell your doctor or pharmacist if you have used, you currently use or you might use in the near future any other medicinal products.
• If any adverse reaction occurs after using this medical device, please inform immediatly your medical doctor or pharmacist. These include any adverse reaction not mentioned in this leaflet.

Contraindications

• Do not use on infected or inflamed wounds.
• Do not use in case of hypersensitivity (allergy) to collagen.
• Not for use by patients undergoing desensitization treatment for meat products.
• Do not use inside the wounds since it can interact with the edges of the wound. Probios collagen sponge is mechanically applied over the wound, like a dry dressing.
• Do not use in case of massive bleeding because it can mask the bleed source and cause hematomas.
• Probios has not be used as a haemostatic pad inside the bleeding wounds, intravascular or in brain, heart or abdominal surgery because blood can gather behind the sponge, causing bruising.
• Do not use for treatment of systemic coagulation problems or in patients with hemophilia.
• Do not use intraocular, intravascular or as injection.
• If an abnormal skin reaction occurs, immediately discontinue the use of the product.
• There are no known cases of overdose.
• There are no known interactions with medicines and medicinal substances.

Warnings and cautions

Before using PROBIOS, inform your medical doctor or pharmacist.

• Do not use this product for other purposes than those specified in the leaflet.
• Before application wash your hands thoroughly.
• Use the product immediately after opening.
• Do not use if the package is opened or damaged.
• Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the mentioned month.
• Keep the product at a temperature below 25 ℃, away from heat sources.
• Do not freeze.
• Keep out of reach of children.
• Recommended strictly for local administration - do not swallow the product.
• The product is intended for a single use, being resorbable after application.
• Sterile product, sterilized by gamma irradiation.
• If you notice abnormal skin reactions immediately stop using the product and contact your medical doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before using this medical device.

Driving and using machines

No known effect of the product on drivers or users of machineries.

5. Storage conditions PROBIOS

• Keep this medical device out of reach of children.
• Keep away from moisture and heat.
• Do not throw any medical device away via wastewater or household waste.
• Ask the pharmacist about the way of throwing away the unused medical devices. This may keep the environment clean and safe.

The manufacturer and marketing authorization holder of this product is SC SANIMED INTERNATIONAL IMPEX S.A.
Address: Sos. Bucuresti-Magurele, Nr. 70F, Sector 5, Bucharest, Romania,
website: www.sanimed.ro,
E-mail: office@sanimed.ro, Tel/Fax: 004021 420 54 93 / 004021 420 54 94
For any information regarding this medical device, please contact the marketing authorization holder
Date of the last text revision: may 2016