Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tacrolimus monohydrate
Astellas Pharma Ltd
L04AD02
Tacrolimus monohydrate
200microgram
Granules
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020200; GTIN: 5013346088439
Modigraf because the active substance in Modigraf may stick to PVC. Carefully open the prescribed number of sachets, e.g. with a pair of scissors at the point indicated with an arrow. Hold the opened sachet between thumb and index finger above the cup with the open side of the sachet facing downwards. Gently tap on the closed end of the sachet and pour the contents of each sachet into the glass or cup containing the water. Do not use any utensils or liquids to empty the sachet. If you follow these instructions, you will get the right amount of granules from the sachet. It is normal that some granules stay behind; the sachet was designed that way. Stir, or swirl gently until the granules have been suspended completely. The suspension can be drawn up with a syringe or swallowed directly by the patient. The liquid has a sweet taste. Rinse the glass or cup once with the same amount of water and drink this, too. The liquid should be drunk immediately after preparation. IF YOU TAKE MORE MODIGRAF THAN YOU SHOULD If you have accidentally taken too much Modigraf, contact your doctor or nearest hospital emergency department immediately. IF YOU FORGET TO TAKE MODIGRAF Do not take a double dose to make up for forgotten individual doses. If you have forgotten to take your Modigraf, wait until it is time for the next dose, and then continue as before. IF YOU STOP TAKING MODIGRAF Stopping your treatment with Modigraf may increase the risk of rejection of your transplanted organ. Do not stop your treatment unless your doctor tells you to do so. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. Modigraf reduces your body’s defence mechanism (immune system), which will not be as good at fighting infections. Therefore, you may be more prone to infections while you are taking Modigraf. Severe effects may occur, including allergic and anaphylactic reactions (a very serious Đọc toàn bộ tài liệu
OBJECT 1 MODIGRAF 0.2MG GRANULES FOR ORAL SUSPENSION Summary of Product Characteristics Updated 07-Aug-2015 | Astellas Pharma Ltd 1. Name of the medicinal product Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension 2. Qualitative and quantitative composition MODIGRAF 0.2 MG GRANULES FOR ORAL SUSPENSION Each sachet contains 0.2 mg tacrolimus (as monohydrate). Excipient with known effect: Each sachet contains 94.7 mg lactose (as monohydrate). MODIGRAF 1 MG GRANULES FOR ORAL SUSPENSION Each sachet contains 1 mg tacrolimus (as monohydrate). Excipient with known effect: Each sachet contains 473 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Granules for oral suspension. White granules. 4. Clinical particulars 4.1 Therapeutic indications Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients. 4.2 Posology and method of administration This medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. Modigraf is a granular formulation of tacrolimus, for twice-a-day administration. Modigraf therapy requires careful monitoring by adequately qualified and equipped personnel. Posology The recommended initial doses presented below are intended to act solely as a guideline. Modigraf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period. The dose may vary depending upon the immunosuppressive regimen chosen. Modigraf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below under Therapeutic drug monitoring). If clinical signs of rejection are apparent, alterati Đọc toàn bộ tài liệu