RINGER Maco Pharma

Information principale

  • Nom commercial:
  • RINGER Maco Pharma, solution pour perfusion
  • Dosage:
  • 0,40 g
  • forme pharmaceutique:
  • solution
  • Composition:
  • composition pour 1000 ml > potassium (chlorure de) : 0,40 g > calcium (chlorure de) dihydraté : 0,27 g > sodium (chlorure de) : 6 g
  • Mode d'administration:
  • intraveineuse
  • Unités en paquet:
  • 1 poche(s) (MACOFLEX) PVC souple plastifié avec du DEHP suremballée(s)/surpochée(s) de 250 ml
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • RINGER Maco Pharma, solution pour perfusion
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • SOLUTIONS MODIFIANT LE BILAN ELECTROLYTIQUE
  • Descriptif du produit:
  • 362 016-3 ou 4009 362 016 3 7 - 1 poche(s) (MACOFLEX) PVC souple plastifié avec du DEHP suremballée(s)/surpochée(s) de 250 ml - Déclaration d'arrêt de commercialisation:17/11/2008;362 018-6 ou 4009 362 018 6 6 - 1 poche(s) (MACOFLEX) PVC souple plastifié avec du DEHP suremballée(s)/surpochée(s) de 500 ml - Déclaration d'arrêt de commercialisation:17/11/2008;362 019-2 ou 4009 362 019 2 7 - 1 poche(s) (MACOFLEX) PVC souple plastifié avec du DEHP suremballée(s)/surpochée(s) de 1000 ml - Déclaration d'arrêt de commercialisation:17/11/2008;

Autres informations

Statut

  • Source:
  • ANSM - Agence Nationale de Sécurité du Médicament et des Produits de Santé
  • Statut de autorisation:
  • Abrogée
  • Numéro d'autorisation:
  • 63108605
  • Date de l'autorisation:
  • 05-04-1989
  • Dernière mise à jour:
  • 25-06-2018

Notice: composition, indications thérapeutiques, interactions, posologie, effets indésirable, grossesse, allaitement

NOTICE

ANSM - Mis à jour le : 21/06/2005

Dénomination du médicament

RINGER MACO PHARMA, solution pour perfusion

Encadré

Veuillez lire attentivement cette notice avant de prendre ce médicament. Elle contient des informations importantes

pour votre traitement.

Si vous avez d'autres questions, si vous avez un doute, demandez plus d'informations à votre médecin ou à votre

pharmacien.

Gardez cette notice, vous pourriez avoir besoin de la relire.

Si vous avez besoin de plus d'informations et de conseils, adressez-vous à votre pharmacien.

Si les symptômes s'aggravent ou persistent, consulter un médecin.

Si vous remarquez des effets indésirables non mentionnés dans cette notice, ou si vous ressentez un des effets

mentionnées comme étant grave, veuillez en informez votre médecin ou votre pharmacien.

Sommaire notice

Dans cette notice :

1. QU'EST-CE QUE RINGER MACO PHARMA, solution pour perfusion ET DANS QUELS CAS EST-IL UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT D'UTILISER RINGER MACO PHARMA, solution pour

perfusion ?

3. COMMENT UTILISER RINGER MACO PHARMA, solution pour perfusion ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER RINGER MACO PHARMA, solution pour perfusion ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE RINGER MACO PHARMA, solution pour perfusion ET DANS QUELS CAS EST-IL UTILISE ?

Classe pharmacothérapeutique

SOLUTIONS MODIFIANT LE BILAN ELECTROLYTIQUE.

Indications thérapeutiques

Ce médicament est une solution pour perfusion de cristalloïdes, destinée au traitement des états de déshydratation dans les

situations où l'administration d'une solution hypotonique est nécessaire.

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT D'UTILISER RINGER MACO PHARMA, solution pour

perfusion ?

Liste des informations nécessaires avant la prise du médicament

Sans objet.

Contre-indications

N'utilisez jamais RINGER MACO PHARMA, solution pour perfusion dans les cas suivants:

situations où l'administration d'une solution hypotonique peut être délétère pour le patient,

hyperhydratation à prédominance extra-cellulaire (augmentation anormale du volume du sang circulant),

insuffisance cardiaque congestive décompensée,

hyperkaliémie (taux anormalement élevé de potassium dans le sang),

hypercalcémie (taux anormalement élevé de calcium dans le sang),

Ainsi qu'en association avec les médicaments digitaliques (voir Prise ou utilisation d'autres médicaments).

EN CAS DE DOUTE, IL EST INDISPENSABLE DE DEMANDER L'AVIS DE VOTRE MEDECIN OU DE VOTRE

PHARMACIEN

Précautions d'emploi ; mises en garde spéciales

Faites attention avec RINGER MACO PHARMA, solution pour perfusion :

Mises en gardes spéciales et précautions d'emploi

En raison de la composition en électrolytes (sels de l'organisme) de la solution, la perfusion doit être faite avec précautions

en cas d'insuffisance cardiaque, de choc septique, d'insuffisance rénale sévère.

Surveillance de l'état clinique et biologique, notamment de l'équilibre hydroélectrolytique (balance des sels et de l'eau de

l'organisme).

Cette solution contenant du calcium ne doit pas être administrée en même temps que du sang, ni avec le même nécessaire

à perfusion, en raison du risque de coagulation.

Précautions d'emploi de la poche

Utiliser immédiatement après ouverture du suremballage.

Vérifier que la solution est limpide.

Vérifier l'ouverture de l'anneau de suspension.

Vérifier que la poche ne présente pas de fuite, éliminer toute poche endommagée ou partiellement utilisée, ou dont

l'anneau de suspension ne serait pas ouvert.

Ne pas utiliser de prise d'air, ne pas connecter en série.

EN CAS DE DOUTE, IL EST INDISPENSABLE DE DEMANDER L'AVIS DE VOTRE MEDECIN OU DE VOTRE

PHARMACIEN.

Interactions avec d'autres médicaments

Prise ou utilisation d'autres médicaments

L'association aux médicaments dérivés de la digitale est contre-indiquée (en raison de la présence de calcium), car elle peut

entraîner des troubles du rythme cardiaque graves.

L'association aux diurétiques hyperkaliémiants (qui augmentent le taux de potassium dans le sang): amiloride,

spironolactone, triamtérène, qu'ils soient seuls ou associés, est déconseillée, excepté en cas d'hypokaliémie (taux

anormalement bas de potassium dans le sang).

L'association au tacrolimus, aux médicaments inhibiteurs de l'enzyme de conversion (IEC) et par extrapolation aux

antagonistes des récepteurs de l'angiotensine II, est déconseillée.

Avant toute addition de médicaments, vérifier sa compatibilité avec la solution de Ringer et le contenant.

Lorsqu'un médicament est ajouté à la solution de Ringer, le mélange doit être administré immédiatement.

Si vous prenez ou avez pris récemment un autre médicament, y compris un médicament obtenu sans ordonnance, parlez-en

à votre médecin ou à votre pharmacien.

Interactions avec les aliments et les boissons

Sans objet.

Interactions avec les produits de phytothérapie ou thérapies alternatives

Sans objet.

Utilisation pendant la grossesse et l'allaitement

Grossesse - Allaitement

Cette solution peut être utilisée pendant la grossesse ou l'allaitement si besoin.

Demandez conseil à votre médecin ou à votre pharmacien avant de prendre tout médicament.

Sportifs

Sans objet.

Effets sur l'aptitude à conduire des véhicules ou à utiliser des machines

Sans objet.

Liste des excipients à effet notoire

Sans objet.

3. COMMENT UTILISER RINGER MACO PHARMA, solution pour perfusion ?

Instructions pour un bon usage

Sans objet.

Posologie, Mode et/ou voie(s) d'administration, Fréquence d'administration et Durée du traitement

L'administration doit se faire sous surveillance médicale.

Posologie

La posologie est à adapter à chaque cas particulier.

SE CONFORMER A L'AVIS MEDICAL.

Mode et voie d'administration

Perfusion intraveineuse.

SE CONFORMER A L'AVIS MEDICAL.

Mode d'emploi de la poche:

retirer la poche du suremballage. Utiliser immédiatement après ouverture;

enlever le protecteur du site de perfusion;

connecter le perfuseur à la poche;

l'addition de médicaments est réalisée par le site d'injection.

Fréquence d'administration

SE CONFORMER A L'AVIS MEDICAL.

Durée du traitement

SE CONFORMER A L'AVIS MEDICAL.

Symptômes et instructions en cas de surdosage

Si vous avez pris plus de RINGER MACO PHARMA, solution pour perfusion que vous n'auriez dû:

Un surdosage, peut entraîner des effets indésirables qui seront traités en milieu spécialisé: SE CONFORMER A L'AVIS

MEDICAL.

Instructions en cas d'omission d'une ou de plusieurs doses

Sans objet.

Risque de syndrome de sevrage

Sans objet.

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

Description des effets indésirables

Comme tous les médicaments, RINGER MACO PHARMA, solution pour perfusion est susceptible d'avoir des effets

indésirables, bien que tout le monde n'y soit pas sujet.

Aucun effet indésirable n'est attendu dans les conditions normales d'utilisation.

Si vous remarquez des effets indésirables non mentionnés dans cette notice, ou si certains effets indésirables deviennent

graves, veuillez en informer votre médecin ou votre pharmacien.

5. COMMENT CONSERVER RINGER MACO PHARMA, solution pour perfusion ?

Tenir hors de la portée et de la vue des enfants.

Date de péremption

Ne pas utiliser RINGER MACO PHARMA, solution pour perfusion après la date de péremption mentionnée sur la poche.

Conditions de conservation

Pas de précautions particulières de conservation.

Si nécessaire, mises en garde contre certains signes visibles de détérioration

Les médicaments ne doivent pas être jetés au tout à l'égout ou avec les ordures ménagères. Demandez à votre pharmacien

ce qu'il faut faire des médicaments inutilisés. Ces mesures permettront de protéger l'environnement.

6. INFORMATIONS SUPPLEMENTAIRES

Liste complète des substances actives et des excipients

Que contient RINGER MACO PHARMA, solution pour perfusion ?

Les substances actives sont:

Chlorure de sodium ............................................................................................................................ 6,00 g

Chlorure de potassium ........................................................................................................................ 0,40 g

Chlorure de calcium dihydraté ............................................................................................................. 0,27 g

Pour 1 000 ml de solution.

L'autre composant est : eau pour préparations injectables.

Composition ionique par litre:

: 102,6 mmol

: 5,36 mmol

: 1,83 mmol

: 111,62 mmol

Osmolarité: 221,4 mOsm/L

Forme pharmaceutique et contenu

Qu'est-ce que RINGER MACO PHARMA, solution pour perfusion et contenu de l'emballage extérieur ?

Ce médicament se présente sous forme de solution pour perfusion en poche de 250, 500 ou 1000 ml.

Nom et adresse du titulaire de l'autorisation de mise sur le marché et du titulaire de l'autorisation de fabrication responsable

de la libération des lots, si différent

Titulaire

Laboratoires pharmaceutiques MACO PHARMA

rue Lorthiois

59420 Mouvaux

Exploitant

MACO PHARMA

200, chaussée Fernand Forest

59200 TOURCOING

Fabricant

MACO PRODUCTION SAS

rue Lorthiois

59420 MOUVAUX

Noms du médicament dans les Etats membres de l'Espace Economique Européen

Sans objet.

Date d’approbation de la notice

La dernière date à laquelle cette notice a été approuvée est le {date}.

AMM sous circonstances exceptionnelles

Sans objet.

Informations Internet

Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’Afssaps (France).

Informations réservées aux professionnels de santé

Sans objet.

Autres

Sans objet.

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PRAC recommends strengthening the restrictions on the use of valproate in women and girls

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the antiepileptic valproate due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

Danish Medicines Agency

14-10-2014

Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - October 2014

Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - October 2014

The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 6-9 October 2014.

Danish Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (Active substance: Docosahexaenoic acid ethyl ester) - Orphan designation - Commission Decision (2018)1880 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/235/17

Europe -DG Health and Food Safety