Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Dexamethasone sodium phosphate
Noridem Enterprises Limited
H02AB02
Dexamethasone sodium phosphate
4 milligram(s)/millilitre
Solution for injection
dexamethasone
Marketed
2021-05-28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DEXAMETHASONE PHOSPHATE NORIDEM 4 MG/ML SOLUTION FOR INJECTION dexamethasone phosphate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dexamethasone phosphate Noridem is and what it is used for 2. What you need to know before you are given Dexamethasone phosphate Noridem 3. How Dexamethasone phosphate Noridem is given 4. Possible side effects 5. How to store Dexamethasone phosphate Noridem 6. Contents of the pack and other information 1. WHAT DEXAMETHASONE PHOSPHATE NORIDEM IS AND WHAT IT IS USED FOR Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone). Dexamethasone belongs to a group of medicines called steroids. This medicine is given by injection to patients unable to take a tablet form of the medicine. Dexamethasone reduces inflammation and suppresses the immune system and is used normally for patients with: • severe allergic reactions causing swelling of the face and throat, low blood pressure and collapse (angioneurotic oedema and anaphylaxis) • shock caused by infection or severe tuberculosis (also with anti-infective treatments e.g. antibiotics) • raised pressure in the skull caused by tumours or infantile spasms (seizure disorder in babies) • Sometimes, the injection is given into the painful area itself for example inflammation of the joints (rheumatoid arthritis and osteoarthritis) Dexamethasone phosphate Noridem is used as a treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) with difficulty breathing and need of oxygen therapy. Dexamethasone can sometimes also be g Izlasiet visu dokumentu
Health Products Regulatory Authority 28 April 2022 CRN00CV8D Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone phosphate Noridem 4 mg/mL Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 millilitre (mL) of solution for injection contains 3.32 mg of dexamethasone (as dexamethasone sodium phosphate) which is equivalent to 4.00 mg of dexamethasone phosphate or 4.37 mg dexamethasone sodium phosphate. Each 2 mL of solution for injection contains 6.64 mg of dexamethasone (as dexamethasone sodium phosphate) which is equivalent to 8.00 mg of dexamethasone phosphate or 8.74 mg dexamethasone sodium phosphate. Each 5 mL of solution for injection contains 16.6 mg of dexamethasone (as dexamethasone sodium phosphate) which is equivalent to 20.00 mg of dexamethasone phosphate or 21.85 mg dexamethasone sodium phosphate. _ _ Excipients with known effect Sodium: Each ampoule of 1 mL solution for injection contains 0.575 mg sodium. Each ampoule of 2 mL solution for injection contains 1.150 mg sodium. Each ampoule of 5 mL solution for injection contains 2.875 mg sodium. Propylene glycol: This medicinal product contains 20 mg propylene glycol (E 1520) in each mL of solution for injection. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. Clear and colourless solution. pH: 7.00 – 8.50 Osmalility: approximately 300 mOsm/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Corticosteroid For use in certain endocrine and non-endocrine disorders responsive to corticosteroid therapy. INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION Dexamethasone phosphate Noridem is recommended for systemic administration by intravenous or intramuscular injection when oral therapy is not feasible or desirable in the following conditions. _Endocrine disorders_ _Primary or secondary adrenocortical insufficiency_ (Hydrocortisone or cortisone is the first choice, but synthetic analogues may be used with mineralocorticoids where applicable and, in infan Izlasiet visu dokumentu