Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Fondaparinux sodium
Aspen Pharma Trading Limited
B01AX05
Fondaparinux sodium
Solution for injection
fondaparinux
Not marketed
2022-07-29
1 June 2022 PACKAGE LEAFLET 2 June 2022 PACKAGE LEAFLET: INFORMATION FOR THE USER FONDAPARINUX SODIUM ASPEN 5 MG/0.4 ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE FONDAPARINUX SODIUM ASPEN 7.5 MG/0.6 ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE FONDAPARINUX SODIUM ASPEN 10 MG/0.8 ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE _fondaparinux sodium _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 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 Fondaparinux Sodium Aspen is and what it is used for 2. What you need to know before you use Fondaparinux Sodium Aspen 3. How to use Fondaparinux Sodium Aspen 4. Possible side effects 5. How to store Fondaparinux Sodium Aspen 6. Contents of the pack and other information 1. WHAT FONDAPARINUX SODIUM ASPEN IS AND WHAT IT IS USED FOR FONDAPARINUX SODIUM ASPEN IS A MEDICINE THAT TREATS OR HELPS TO PREVENT BLOOD CLOTS FROM FORMING IN THE BLOOD VESSELS ( _an antithrombotic agent_ ). Fondaparinux Sodium Aspen contains a synthetic substance called fondaparinux sodium. This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents unwanted blood clots ( _thromboses_ ) from forming in the blood vessels. FONDAPARINUX SODIUM ASPEN IS USED TO TREAT ADULTS WITH A BLOOD CLOT IN THE BLOOD VESSELS OF THEIR LEGS ( _deep vein thrombosis_ ) AND/OR LUNGS ( _pulmonary embolism_ ). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FONDAPARINUX SODIUM ASPEN DO NOT USE FONDAPARINUX SODIUM ASPEN: IF YOU ARE ALLERGIC to fondaparinux sodium or to any of the other ingredients of this medicine (listed in s Aqra d-dokument sħiħ
Health Products Regulatory Authority 29 July 2022 CRN00CKLN Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fondaparinux sodium Aspen 5 mg/0.4 ml solution for injection, pre-filled syringe. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection. Excipient(s) with known effect: Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. The solution is a clear and colourless to slightly yellow liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adults with acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of fondaparinux is 7.5 mg (patients with body weight ³ 50, £ 100kg) once daily administered by subcutaneous injection. For patients with body weight < 50 kg, the recommended dose is 5 mg. For patients with body weight > 100 kg, the recommended dose is 10 mg. Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3). Concomitant oral anticoagulation treatment should be initiated as soon as possible and usually within 72 hours. The average duration of administration in clinical trials was 7 days and the clinical experience from treatment beyond 10 days is limited. _ _ _Special populations_ _Elderly patients_ - No dosing adjustment is necessary. In patients ³ 75 years, fondaparinux should be used with care, as renal function decreases with age (see section 4.4). _Renal impairment - _Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4). There is no experience in the subgroup of patients with _both_ high body weigh Aqra d-dokument sħiħ