Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Nadroparin calcium
Aspen Pharma Trading Limited
B01AB; B01AB06
Nadroparin calcium
15,200 I.U.anti-Xa/0.8 millilitre(s)
Solution for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Heparin group; nadroparin
Not marketed
2018-05-04
PACKAGE LEAFLET: INFORMATION FOR THE USER NADROPARIN CALCIUM ASPEN FORTE 19,000 I.U. ANTI-XA/ML SOLUTION FOR INJECTION in a pre-filled syringeNADROPARIN CALCIUM ASPEN FORTE 15,200 I.U. ANTI-XA/0.8ML SOLUTION FOR INJECTION in a pre- filled syringe NADROPARIN CALCIUM ASPEN FORTE 11,400 I.U. ANTI-XA/0.6ML SOLUTION FOR INJECTION in a pre-filled syringe Nadroparin calcium 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 Nadroparin Calcium Aspen Forte is and what it is used for 2. What you need to know before you use Nadroparin Calcium Aspen Forte 3. How to use Nadroparin Calcium Aspen Forte 4. Possible side effects 5. How to store Nadroparin Calcium Aspen Forte 6. Contents of the pack and other information 1. WHAT NADROPARIN CALCIUM ASPEN FORTE IS AND WHAT IT IS USED FOR Nadroparin Calcium Aspen Forte is an antithrombotic medicine belonging to the class of low- molecular weight heparins. NADROPARIN CALCIUM ASPEN FORTE IS USED FOR: Treatment of deep venous thrombosis. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NADROPARIN CALCIUM ASPEN FORTE DO NOT USE NADROPARIN CALCIUM ASPEN FORTE: - if you are allergic to nadroparin calcium, to heparin or any of the other ingredients of this medicine (listed in section 6) - with existing or a history of known heparin-induced decrease in the number of blood platelets (thrombocytopenia Type II) or a history of decrease in the number of platelets due to nadroparin calcium. - with organ lesions that may have a tendency to bleed, such as: o acute gastro-intestinal ulcers o ce Read the complete document
Health Products Regulatory Authority 09 November 2018 CRN008QHX Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nadroparin calcium Aspen Forte 15,200 I.U. anti-Xa/0.8ml solution for injection in a pre-filled syringe. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 Pre-filled syringe with 0.8 ml solution for injection contains 15,200 I.U. anti-Xa nadroparin calcium derived from porcine intestinal mucosa. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injectionin pre-filled syringe. The solution is sterile and clear, pH 4.5 to 7.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of deep venous thrombosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Treatment of deep venous thrombosis._ Nadroparin calcium Aspen Forte 15,200 I.U. should be injected subcutaneously once daily for the duration of 10 days in a dosage appropriately adjusted for the patient’s body weight (see Table below). The administration of oral anticoagulants should be started on the first day. The duration of treatment with Nadroparin calcium Aspen Forte 15,200 I.U. is at least 5 days and should be continued until sufficient oral anticoagulation has been achieved. In patients with thrombophilia or complicated deep venous thrombosis, or in patients with increased risk of bleeding complications, a twice-daily administration of nadroparin calcium should be considered (see Fraxiparine). The prefilled syringes are graduated in 0.1 ml increments. For patients needing dosages of 0.4 ml, 0.5 ml, 0.7 ml or 0.9 ml, in accordance with their individual body Health Products Regulatory Authority 09 November 2018 CRN008QHX Page 2 of 18 weight, the correct dosage can be obtained by using the respective higher-dose prefilled syringe and discarding the excess amount of 0.1 or 0.2 ml before use. _Treatment of deep venous thrombosis_ Weight in kg Treatment of deep venous thrombosis ml subcutaneous injection once daily < 50 50 to 59 60 to 69 70 to 79 80 to 89 ≥ 90 0.4 ml 0.5 ml 0. Read the complete document