国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
HYDROCORTISONE PH. EUR.
Pfizer Healthcare Ireland
H02AB; H02AB09
HYDROCORTISONE PH. EUR.
100 milligram(s)
Powder and solvent for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Glucocorticoids; hydrocortisone
Marketed
1978-04-01
Page 1 of 11 2022-0082235 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SOLU-CORTEF ® POWDER FOR SOLUTION FOR INJECTION OR INFUSION 100 MG hydrocortisone (as sodium succinate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • SOLU-CORTEF 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-CORTEF 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-Cortef, 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 CHICKENPOX OR SHINGLES, if you have never had them. They could affect you severely. If you do come into contact with chickenpox 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, ask your doctor or pharmacist. • 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-Cortef is and what it is used for 2. What you need to know before you are given Solu-Cortef 3. How Solu-Cortef is given to you 4 阅读完整的文件
Health Products Regulatory Authority 25 September 2023 CRN00DGYF Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solu-Cortef Powder for Solution for Injection or Infusion 100mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains hydrocortisone sodium succinate 133.7mg equivalent to hydrocortisone 100.0mg. (50mg/ml when reconstituted as recommended) Excipient with known effect Each vial contains 10.1 mg of sodium. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion Or Powder and solvent for solution for injection or infusion Vial containing white to off-white powder and vial containing sterile water for injections. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Solu-Cortef is indicated for any condition in which rapid and intense corticosteroid effect is required such as: 1. Endocrine disorders Primary or secondary adrenocortical insufficiency. 2. Collagen diseases Systemic lupus erythematosus. 3. Dermatological diseases Severe erythema multiforme (Stevens-Johnson syndrome). 4. Allergic states Bronchial asthma, anaphylactic reactions. 5. Gastro-intestinal diseases Ulcerative colitis, Crohn’s disease. 6. Respiratory diseases Aspiration of gastric contents. 7. Medical emergencies Solu-Cortef is indicated in the treatment of shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenocortical insufficiency may be present. Health Products Regulatory Authority 25 September 2023 CRN00DGYF Page 2 of 13 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Solu-Cortef may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation. Dosage usually ranges from 100 mg to 500 mg depending on the severity of the condition, admini 阅读完整的文件