Calciparine 5'000 U.I.

Informazioni principali

  • Nome commerciale:
  • Calciparine 5'000 U.I. soluzione per iniezione s. c.
  • Forma farmaceutica:
  • soluzione per iniezione s. c.
  • Composizione:
  • heparinum calcicum 5000 U. I., aqua ad iniectabilia q s. annuncio solutionem pro 0,2 ml.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Calciparine 5'000 U.I. soluzione per iniezione s. c.
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Biotechnologika
  • Area terapeutica:
  • Anticoagulante

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 38212
  • Data dell'autorizzazione:
  • 05-09-1973
  • Ultimo aggiornamento:
  • 17-10-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Patienteninformation

Calciparine®

SANOFI-AVENTIS

Che cos'è Calciparine e quando si usa?

Calciparine è un medicamento ottenuto a partire da mucosa intestinale di maiale. Si tratta di

un’eparina, cioè di una sostanza che fluidifica il sangue diminuendone la capacità di coagulazione.

Calciparine si usa su prescrizione del medico per prevenire e curare le tromboemboli, cioè la

formazione di coaguli di sangue che possono obliterare vasi sanguigni bloccando la circolazione.

Quando non si può usare Calciparine?

Non si può usare Calciparine nei seguenti casi:

antecedenti di modificazione del sangue quali diminuzione del numero di piastrine per effetto

dell’eparina,

emorragie o rischio di emorragie (disturbi della coagulazione, malattie dei vasi sanguigni, malattie

gastrointestinali con emorragie),

disturbi della funzionalità dei reni e del fegato,

pressione arteriosa troppo alta,

allergia all’eparina,

dopo un intervento chirurgico al cervello, al midollo spinale e agli occhi,

incidente vascolare cerebrale.

Se ha dubbi è indispensabile consultare il suo medico.

Quando è richiesta prudenza nella somministrazione di Calciparine?

La prudenza si impone in presenza di una malattia dei reni o del fegato, una pressione arteriosa alta,

di antecedenti d’ulcera dell’apparato digerente o di qualsiasi altra lesione organica che può

determinare un’emorragia.

Calciparine diminuisce la capacità di coagulazione del sangue. Deve dunque essere molto prudente

in caso di traumi - a causa del rischio d’emorragia - e prendere immediatamente contatto col suo

medico se constata il manifestarsi di un’emorragia.

Per un uso appropriato di Calciparine il suo medico dovrà effettuare frequenti controlli che

richiedono prelievi di sangue, in modo da poter verificare gli effetti del medicamento.

In caso di somministrazione concomitante di altri farmaci gli effetti degli stessi e/o di Calciparine

possono essere modificati.

Se assume medicamenti contro il dolore o i reumatismi (antinfiammatori), per fluidificare il sangue

(anticoagulanti) oppure a base di cortisone (corticosteroidi) deve comunicarlo al suo medico prima di

iniziare la terapia con Calciparine.

Informi il suo medico o il suo farmacista se soffre di altre malattie, soffre di allergie o assume o

applica esternamente altri medicamenti (anche acquistati di sua iniziativa!).

Si può somministrare Calciparine durante la gravidanza o l'allattamento?

Spetta al suo medico decidere se può usare Calciparine durante la gravidanza o l’allattamento.

Come usare Calciparine?

La dose giornaliera di Calciparine varia secondo il tipo di malattia, il peso e l’età del paziente. Il suo

medico determinerà la posologia adatta al suo caso mediante gli esami di sangue.

Non modifichi di propria iniziativa la posologia prescritta. Se ritiene che l’azione del medicamento

sia troppo debole o troppo forte ne parli al suo medico o al suo farmacista.

Calciparine s’inietta per via sottocutanea (sotto la pelle), a livello della parete addominale inferiore

(parte bassa del ventre), ora a destra ora a sinistra.

Per iniettare Calciparine usi la siringa contenuta nella confezione.

Calciparine 0,2 ml siringhe pronte all’uso

Le siringhe di Calciparine sono già riempite e pronte all’uso.

Prima dell’iniezione tolga il cappuccio dell’ago. Per evitare eventuali lesioni, lo rimetta sull’ago

dopo l’iniezione.

Calciparine 0,5 ml fiale

La soluzione iniettabile Calciparine è contenuta nella fiala. La apra spezzandola all’altezza del segno

bianco sul collo. Prenda la siringa acclusa alla confezione e tolga il cappuccio dell’ago. Per evitare

eventuali lesioni, lo rimetta sull’ago dopo l’iniezione.

Prelevi la quantità necessaria di soluzione tirando lo stantuffo. Se necessario può eliminare un

eccesso di soluzione premendo lo stantuffo fino alla graduazione voluta.

Eventuale bolle d’aria vanno eliminate prima dell’iniezione. A tal fine tenga la siringa verticalmente

con l’ago in alto e dia colpetti con le unghie sulla parte alta (ma non sull’ago).

Le siringhe si possono usare una volta sola.

Prepari la zona di pelle per l’iniezione disinfettandola con ovatta e alcol. Formi una piega della pelle

sollevandola col pollice e l’indice della mano sinistra (se non è mancino) e prenda la siringa nella

destra. Introduca l’ago perpendicolarmente nello spessore della piega della pelle e mantenga la piega

per tutta la durata dell’iniezione. Prema lentamente col pollice sullo stantuffo fino a fine corsa. Finita

l’iniezione estragga perpendicolarmente l’ago dalla piega della pelle. Se l’introduzione dell’ago

provoca un dolore acuto interrompa l’iniezione (probabilmente è stato toccato un vaso sanguigno). In

tal caso estragga l’ago e faccia l’iniezione sul lato opposto (dopo aver disinfettato la zona in

questione).

Quali effetti collaterali può avere Calciparine?

Con l’applicazione di Calciparine possono manifestarsi i seguenti effetti collaterali:

Emorragie leggere o più gravi possono sopravvenire. In tal caso, oppure se costata la comparsa di

macchie violacee nella zona dell’iniezione e/o un’allergia locale o generale, prenda immediatamente

contatto col suo medico.

È possibile una diminuzione del numero di piastrine (trombocitopenia). Per evitare questo incidente

il suo medico effettuerà controlli del sangue.

Possono pure manifestarsi piccoli ematomi e noduli nelle zone di iniezione. Essi scompaiono dopo

qualche giorno senza che sia necessario interrompere la terapia.

Se osserva tali sintomi o effetti collaterali qui non descritti, dovrebbe informare il suo medico o il

suo farmacista.

Di che altro occorre tener conto?

Conservare Calciparine fuori dalla portata dei bambini e a temperatura ambiante (15-25 °C).

Il medicamento non dev’essere utilizzato oltre la data indicata con «EXP» sulla confezione. Se ha

delle confezioni la cui data di scadenza è trascorsa, le riporti al suo farmacista.

Il medico o il farmacista, che sono in possesso di un’informazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene Calciparine?

Il principio attivo di Calciparine è l’eparina calcica.

1 siringa pronta all’uso di Calciparine 0,2 ml contiene 5’000 U.I. di eparina calcica in soluzione

acquosa.

1 fiala di Calciparine 0,5 ml contiene 12’500 U.I. di eparina calcica in soluzione acquosa.

Numero dell'omologazione

38212 (Swissmedic).

Dov'è ottenibile Calciparine? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Sono disponibili le confezioni seguenti:

Siringhe pronte all’uso da 0,2 ml: scatola da 10.

Fiale da 0,5 ml con siringhe graduate mono-uso: scatola da 2 e da 10.

Titolare dell’omologazione

sanofi-aventis (svizzera) sa, 1214 Vernier/GE.

Questo foglietto illustrativo è stato controllato l’ultima volta nel dicembre 2010 dall’autorità

competente in materia di medicamenti (Swissmedic).

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Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

2-10-2018

Zavesca (Janssen-Cilag International NV)

Zavesca (Janssen-Cilag International NV)

Zavesca (Active substance: Miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5472 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000435/T/0063

Europe -DG Health and Food Safety

2-10-2018

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Active substance: Parecoxib ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6471 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000381/T/0073

Europe -DG Health and Food Safety

2-10-2018

Vfend (Pfizer Europe MA EEIG)

Vfend (Pfizer Europe MA EEIG)

Vfend (Active substance: voriconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6490 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000387/T/0130

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

27-8-2018

Somavert (Pfizer Europe MA EEIG)

Somavert (Pfizer Europe MA EEIG)

Somavert (Active substance: Pegvisomant ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5684 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000409/T/0087

Europe -DG Health and Food Safety

22-8-2018

Luveris (Merck Europe B.V.)

Luveris (Merck Europe B.V.)

Luveris (Active substance: Lutropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5631 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000292/T/0077

Europe -DG Health and Food Safety

22-8-2018

Xelevia (Merck Sharp and Dohme B.V.)

Xelevia (Merck Sharp and Dohme B.V.)

Xelevia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000762/T/0069

Europe -DG Health and Food Safety

22-8-2018

Pergoveris (Merck Europe B.V.)

Pergoveris (Merck Europe B.V.)

Pergoveris (Active substance: follitropin alfa / lutropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5629 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000714/T/0059

Europe -DG Health and Food Safety