Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Methylprednisolone hydrogen succinate ph. eur.
Pfizer Healthcare Ireland
H02AB; H02AB04
Methylprednisolone hydrogen succinate ph. eur.
500 milligram/vial
Powder and solvent for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Glucocorticoids; methylprednisolone
Marketed
1978-04-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SOLU-MEDRONE ® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION 40 MG/VIAL, 125 MG/VIAL, 500 MG/VIAL, 1000 MG/VIAL methylprednisolone (as sodium succinate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. SOLU-MEDRONE IS A STEROID MEDICINE, prescribed for many different conditions, including serious illnesses. YOU NEED TO TAKE IT REGULARLY to get the maximum benefit. DON’T STOP TAKING THIS MEDICINE without talking to your doctor – you may need to reduce the dose gradually. SOLU-MEDRONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4. Possible side effects). Some problems such as mood changes (feeling depressed, or “high”), or stomach problems can happen straight away. If you feel unwell in any way, keep taking Solu-Medrone, but SEE YOUR DOCTOR STRAIGHT AWAY. SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS. These include weakness of arms and legs, or developing a round face (read section 4. Possible side effects for more information). IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE “STEROID CARD”: always keep it with you and show it to any doctor or nurse treating you. KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN-POX OR SHINGLES, if you have never had them. They could affect you severely. If you do come into contact with chicken-pox or shingles, SEE YOUR DOCTOR STRAIGHT AWAY. NOW READ THE REST OF THIS LEAFLET. It includes other important information on the safe and effective use of this medicine that might be especially important for you. Keep this leaflet. You may need to read it again If you have any further questions please ask your doctor, pharmacist or nurse. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT SOLU-MEDRONE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEE Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 14 November 2023 CRN00DX02 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 500 mg/vial 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains methylprednisolone sodium succinate equivalent to 500 mg of methylprednisolone (62.5 mg/ml following reconstitution as directed). Excipients with known effect Solu-Medrone 500 mg contains 58.3 mg of sodium in each vial. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection or concentrate for solution for infusion. A white to off-white lyophilised powder, supplied with sterile water for reconstitution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Solu‑Medrone is indicated for any condition in which rapid and intense corticosteroid effect is required such as: 1. Allergic states, for example: bronchial asthma, angioneurotic oedema, anaphylaxis. 2. Dermatological conditions severe erythema multiforme (for example: Stevens‑Johnson syndrome). 3. Acute adrenal insufficiency with supplemental salt and/or desoxycorticosterone. Solu-Medrone is not first line treatment for acute adrenal insufficiency because it does not possess sufficient mineralocorticoid properties. 4. Acute systemic lupus erythematosus. 5. Acute rheumatic carditis. 6. Suppression of graft rejection reactions following transplantation. 7. Cerebral oedema secondary to cerebral tumour. 8. The prevention of nausea and vomiting associated with cancer chemotherapy. 9. Ulcerative colitis. 10. Crohn's disease. 11. Aspiration of gastric contents. 12. Acute spinal cord injury. Treatment should begin within eight hours of injury. Health Products Regulatory Authority 14 November 2023 CRN00DX02 Page 2 of 17 13. The treatment of acute exacerbations of multiple sclerosis superimposed on either a relapsing-remitting or chronic progressive background. 4.2 POSOLOGY AND METHOD OF ADMINIST Διαβάστε το πλήρες έγγραφο