SOLU MODERIN

Informació principal

  • Denominació comercial:
  • SOLU MODERIN 125 mg 50 viales
  • Vía de administración:
  • Forma: Viales
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • SOLU MODERIN 125 mg 50 viales
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 608539
  • última actualització:
  • 06-06-2018

Prospecte: composició, indicacions, interacció, posologia, embaràs, lactància, reaccions adverses

SOLU MODERIN 125 mg 50 viales

metilprednisolona

Indicacions

Medicament que serveix per al tractament d'al

rgies, asma, artritis, inflamacions. Tamb

s'utilitza

per prevenir el rebuig en el trasplantament d'

rgans (CORTICOIDE).

Consideracions

NO s'administri aquest medicament si

s al

rgic a CORTICOIDES.

Aquest medicament ha de ser administrat per via intravenosa, via intramuscular, via intrapleural o via

intratecal.

Aquest medicament ha de ser administrat per un metge o un altre professional sanitari amb experi

ncia.

Aquest medicament

s d'un sol

s; rebutgi qualsevol resta de medicament que pugui quedar a l'env

s una vegada utilitzat.

Avisi el seu metge si pateix hipertensi

, diabetis o epil

psia.

Avisi el seu metge si pateix o ha patit problemes de cor, problemes de fetge, problemes de tiroides,

lcera d'est

mac o de duod

o problemes de rony

Aquest medicament modifica l'acci

d'altres f

rmacs, NO prengui altres medicaments sense consultar

abans al seu metge o farmac

utic.

Aquest medicament pot modificar l'acci

d'algunes vacunes, si li han administrat una vacuna

recentment o li han d'administrar alguna pr

ximament, digui-li-ho al seu metge.

Aquest medicament pot donar un resultat positiu en els controls de dopatge.

Informi immediatament el seu metge si est

embarassada o creu que pot estar-ho, aix

com si qued

s embarassada durant el tractament.

Avisi al seu metge si t

algun fill a qui estigui alletant.

Efectes adversos

En tractaments curts no solen apar

ixer efectes adversos.

Avisi el seu metge si durant el tractament apareix mal de gola, febre, augment de pes, debilitat muscular,

una coloraci

negrosa de les femtes o canvis en el cicle menstrual.

Si not

s qualsevol altre s

mptoma que creu que pot ser causat per aquest medicament, digui-li-ho al

seu metge.

Posologia

Administrar 1 injectable cada mat

VIA INTRAMUSCULAR.

23-3-2019

Baxter recalls two lots of Extraneal peritoneal dialysis solution because of high levels of sodium hypochlorite, which may pose serious health risks

Baxter recalls two lots of Extraneal peritoneal dialysis solution because of high levels of sodium hypochlorite, which may pose serious health risks

Affected products Product DIN Product Code Lot Expiry Extraneal 2L/2L Twinbag 02240806 JB9912 W9B28T0 02/29/2020 Extraneal 7.5% 2.5L SYSII 02240806 JB9923LP W9C05T1 03/31/2020

Health Canada

13-3-2019

Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative

Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative

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FDA - U.S. Food and Drug Administration

21-12-2018

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

Teva Canada is voluntarily recalling one lot (Lot 150261) of two products because of a labelling error. While the outer carton of Equate brand Lens Care System is correctly labelled, the bottle within the carton is mislabelled as Equate brand Multi-Purpose Solution. Because of the labelling error, the company is recalling both products labelled with Lot 150261. Bottles labelled as Equate Multi-Purpose Solution should contain a 0.0001% w/v polyhexanide based disinfecting solution for rinsing. The mislabel...

Health Canada

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

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28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

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Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

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FDA - U.S. Food and Drug Administration

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

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Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

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Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: ProSolution contains hidden drug ingredient

Public Notification: ProSolution contains hidden drug ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Pro Solution, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

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Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

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Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

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Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

12-7-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages

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FDA - U.S. Food and Drug Administration

3-7-2018

DKMA Update June 2018

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In this issue of DKMA Update you can read about new rules on private individuals' import of medicines, Danish Medicines Agency being key driver in European solution for complex clinical trials and much more.

Danish Medicines Agency

25-6-2018

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

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FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.

FDA - U.S. Food and Drug Administration

26-5-2018

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

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Shadow Holdings is voluntarily recalling all lots, within expiry, of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit to the retail level. The products may be contaminated with bacteria.

FDA - U.S. Food and Drug Administration

25-5-2018

Link Product Solutions Limited recalls Summer Time TM Puffer Balls

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These toys do not meet the Canadian safety requirements for toys. Some of the soft, stretchy parts of the toys can stretch to extreme lengths, posing a strangulation hazard to children.

Health Canada

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

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FDA - U.S. Food and Drug Administration

9-11-2011

Danish Pharmacovigilance Update, 20 October 2011

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In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.

Danish Medicines Agency

19-3-2019


Fentanyl (transdermal patches, solution for injection - nationally authorised product only): List of nationally authorised medicinal products - PSUSA/00001370/201804

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Europe - EMA - European Medicines Agency

19-3-2019


Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804

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Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804

Europe - EMA - European Medicines Agency

6-3-2019

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

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This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

20-2-2019


Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

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Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

21-1-2019

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

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Europe -DG Health and Food Safety

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, decision type: , therapeutic area: , PIP number: P/0328/2018

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Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

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Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

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Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Active substance: Autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand) - Orphan designation - Commission Decision (2018)7794 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/18

Europe -DG Health and Food Safety

21-8-2018

Always use contact lens solution, not water, to clean and store your lenses!  #OnePairTakeCare  https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89  pic.twitter.com/Jm50z0UFVu

FDA - U.S. Food and Drug Administration

27-7-2018

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)5047 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/03

Europe -DG Health and Food Safety

19-7-2018

HES (hydroxyethyl starch)

HES (hydroxyethyl starch)

HES (hydroxyethyl starch) (Active substance: hydroxyethyl starch (HES), solutions for infusion) - Community Referrals - Art 107i - Commission Decision (2018)4832 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-107i/1457

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

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This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

29-5-2018

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)3397 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/02

Europe -DG Health and Food Safety

2-5-2018

Agenda:  Agenda - Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges

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Big data workshop: regulatory solutions for big data challenges

Europe - EMA - European Medicines Agency