국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
lacosamide, Quantity: 150 mg
Pharmacor Pty Ltd
Tablet, film coated
Excipient Ingredients: hyprolose; magnesium stearate; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black
Oral
56 tablets, 168 tablets, 14 tablets
(S4) Prescription Only Medicine
Lacosamide film-coated tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.
Visual Identification: Peach, oval shaped, film coated tablets debossed with "LAC" on one side and "150" on other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-02-08
LACOVIM 1 LACOVIM _lacosamide _ _ _ _ _ _ _ The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist . LACOVIM film-coated tablets contains the active ingredient lacosamide. LACOVIM work by controlling brain chemicals which send signals to nerves so that seizures do not happen. For more information, see Section 1. Why am I using LACOVIM? In the full CMI. Do not use if you have ever had an allergic reaction to LACOVIM or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING . For more information, see Section 2. What should I know before I use LACOVIM? In the full CMI . Some medicines may interfere with LACOVIM and affect how it works. A list of these medicines is in section 3. What if I am taking other medicines? In the full CMI. Your doctor will tell you how much LACOVIM you will need to take each day. This may depend on your condition, your body weight, and whether or not you are taking any other medicines. More instructions can be found in Section 4. How do I use LACOVIM? In the full CMI. THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using LACOVIM. • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking LACOSAMIDE. • Stop taking LACOVIM and contact your doctor immediately if you become pregnant while you are taking LACOVIM. THINGS YOU SHOULD NOT DO • Do not give this medicine to anyone else, even if their condition seems similar to yours. • Do not use it to treat any other complaints unless your doctor tells you to. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how LACOVIM affects you. • LACOVIM cause problems with your ability to drive a car or operate machinery. DRINKING ALCOHOL • Tell your doctor if you drink alcohol. LOOKING AF 전체 문서 읽기
AUSTRALIAN PRODUCT INFORMATION LACOVIM (LACOSAMIDE) TABLETS 1. NAME OF THE MEDICINE Lacosamide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION LACOVIM film-coated tablets are available in strengths of 50 mg, 100 mg, 150 mg and 200 mg lacosamide. For the full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Film-coated tablets LACOVIM film coated tablets 50 mg Pink, oval shaped, film coated tablets debossed with "LAC" on one side and "50" on other side. LACOVIM film coated tablets 100 mg Dark yellow, oval shaped, film coated tablets debossed with "LAC" on one side and "100" on other side. LACOVIM film coated tablets 150 mg Peach, oval shaped, film coated tablets debossed with "LAC" on one side and "150" on other side. LACOVIM film coated tablets 200 mg Blue, oval shaped, film coated tablets debossed with "LAC" on one side and "200" on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LACOVIM film-coated tablets are indicated as: monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older. 4.2 DOSE AND METHOD OF ADMINISTRATION _Lacosamide oral solution and injection are unavailable in this brand however are available _ _in other brands. Where correct dosing requires lacosamide oral solution and injection _ _formulations refer to the specific product information for these formulations for their _ _complete dosage and administration instructions. _ LACOVIM therapy can be initiated with either oral or IV administration. The film-coated tablets may be taken with or without food. The film-coated tablets must not be divided. Conversion to or from oral and IV administration can be done directl 전체 문서 읽기