40 mg \/ 0.8 ml injection solution
adalimumab<\/p>\n\n\n\n
Emerald contains the active substance adalimumab, a medicine that affects the body’s immune system.<\/p>\n\n\n\n
Emerald is indicated for the treatment of:<\/p>\n\n\n\n
The active substance in Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.<\/p>\n\n\n\n
The target of adalimumab is a protein called tumor necrosis factor (TNF\u03b1), which is found in elevated levels in the inflammatory diseases listed above. By attaching to TNF\u03b1, Imraldi reduces the inflammatory process in these diseases.<\/p>\n\n\n\n
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis<\/strong><\/p>\n\n\n\n Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually occur for the first time in childhood.<\/p>\n\n\n\n Emerald is used to treating polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.<\/p>\n\n\n\n Patients may first receive other disease-modifying drugs, such as methotrexate. If these drugs do not work well enough, patients will receive Imraldi to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.<\/p>\n\n\n\n Children and adolescents with plaque psoriasis<\/strong><\/p>\n\n\n\n Plaque psoriasis is an inflammatory skin disease that causes red, flaky, and dry plaques on the skin covered by silvery scales. Plaque psoriasis can also involve the nails, which can then crumble, become thicker and lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a disorder in the body’s immune system that leads to increased production of skin cells.<\/p>\n\n\n\n Emerald is used to treating severe plaque psoriasis in children and adolescents 4\u201117 years of age where topical treatment and light therapy have not worked or are not appropriate.<\/p>\n\n\n\n Adolescents with hidradenitis suppurativa<\/strong><\/p>\n\n\n\n Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease. The symptoms can be sore nodules ( lumps ) and abscesses (boils) that can leak anywhere. The disease usually affects specific areas of the skin, e.g. under the breasts, armpits, inside of the thighs, groin, and buttocks. Scarring can also occur in the affected areas.<\/p>\n\n\n\n Emerald is used to treating hidradenitis suppurativa in adolescents from 12 years of age. Emerald can reduce the number of lumps and boils you have as well as the pain that is often associated with the disease. You may be given other medicines first. If these medicines do not work well enough, you will receive Imraldi.<\/p>\n\n\n\n Children and adolescents with Crohn’s disease<\/strong><\/p>\n\n\n\n Crohn’s disease is an inflammatory disease of the digestive system.<\/p>\n\n\n\n Emerald is used to treating Crohn’s disease in children aged 6-17 years. Patients can first receive other medicines. If these drugs do not work well enough, patients will receive Imraldi to reduce the signs and symptoms of the disease.<\/p>\n\n\n\n Children and adolescents with ulcerative colitis<\/strong><\/p>\n\n\n\n Ulcerative colitis is an inflammatory disease of the colon. Emerald is used to treating moderate to severe ulcerative colitis in children aged 6-17 years. Your child may be given other medicines first. If these medicines do not work well enough, your child will be given Imralid to reduce the signs and symptoms of the disease.<\/p>\n\n\n\n Children and adolescents with uveitis<\/strong><\/p>\n\n\n\n Uveitis without infection is an inflammatory disease that affects certain parts of the eye.<\/p>\n\n\n\n Emerald is used to treating children from 2 years of age with chronic uveitis without infection where inflammation affects the front of the eye. Inflammation can lead to impaired vision and\/or the presence of floaters in the eye (black dots or striped lines moving across the field of view ). Emerald works by reducing this inflammation.<\/p>\n\n\n\n Talk to your child’s doctor or pharmacist before using Imraldi.<\/p>\n\n\n\n Allergic reaction<\/strong><\/p>\n\n\n\n Infection<\/strong><\/p>\n\n\n\n Tuberculosis<\/strong><\/p>\n\n\n\n Travel \/ recurrent infection<\/strong><\/p>\n\n\n\n Hepatitis B virus<\/strong><\/p>\n\n\n\n Surgery or dental surgery<\/strong><\/p>\n\n\n\n Demyelinating disease<\/strong><\/p>\n\n\n\n Vaccine<\/strong><\/p>\n\n\n\n Heart failure<\/strong><\/p>\n\n\n\n Fever, bruising, bleeding, or pallor<\/strong><\/p>\n\n\n\n Cancer<\/strong><\/p>\n\n\n\n Lupus-like syndrome<\/strong><\/p>\n\n\n\n Tell your child’s doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.<\/p>\n\n\n\n Emerald can be taken with methotrexate or certain disease-modifying anti-rheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and gold preparations for injection ), corticosteroids, or painkillers, including non-steroidal anti-inflammatory drugs ( NSAIDs ).<\/p>\n\n\n\n Your child should not use Imraldi with medicines containing the active substances anakinra or abatacept due to the increased risk of serious infections. If you have any further questions, ask your doctor.<\/p>\n\n\n\n Emerald may have a slight effect on your ability to drive, cycle or use machines. A feeling that the room is spinning (dizziness) and visual disturbances can occur when Imraldi is used.<\/p>\n\n\n\n This medicine contains 20 mg of sorbitol per vial. If your child does not tolerate certain sugars, you should consult your doctor before taking this medicine.<\/p>\n\n\n\n This medicine contains less than 1 mmol sodium (23 mg) per 0.8 ml dose, ie essentially ‘sodium-free.<\/p>\n\n\n\n Always use this medicine exactly as your child’s doctor or pharmacist has told you. Consult your child’s doctor or pharmacist if you are unsure about the instructions or if you have any questions. Your doctor may prescribe another strength of Imraldi if your child needs a different dose.<\/p>\n\n\n\n Children and adolescents with polyarticular juvenile idiopathic arthritis<\/strong><\/p>\n\n\n\n Children and adolescents from 2 years of age weighing from 10 kg up to 30 kg<\/em><\/p>\n\n\n\n The recommended dose of Imraldi is 20 mg every two weeks. <\/p>\n\n\n\n Children, adolescents, and adults from 2 years of age weighing 30 kg or more<\/em><\/p>\n\n\n\n The recommended dose of Imraldi is 40 mg every two weeks. <\/p>\n\n\n\n Children, adolescents, and adults with arthritis-related arthritis<\/strong><\/p>\n\n\n\n Children and adolescents from 6 years of age weighing from 15 kg up to 30 kg<\/em><\/p>\n\n\n\n The recommended dose of Imraldi is 20 mg every two weeks.<\/p>\n\n\n\n Children, adolescents, and adults from 6 years of age weighing 30 kg or more<\/em><\/p>\n\n\n\n The recommended dose of Imraldi is 40 mg every two weeks.<\/p>\n\n\n\n Children and adolescents with plaque psoriasis<\/strong><\/p>\n\n\n\n Children and adolescents 4 <\/em>– <\/em>17 years who weigh from 15 kg up to 30 kg<\/em><\/p>\n\n\n\n The recommended dosage of Imraldi is a starting dose of 20 mg, followed by 20 mg a week later. Thereafter, the usual dose is 20 mg every two weeks.<\/p>\n\n\n\n Children and adolescents 4\u201317 years old weighing 30 kg or more<\/em><\/p>\n\n\n\n The recommended dosage of Imraldi is a starting dose of 40 mg, followed by 40 mg a week later. Thereafter, the usual dose is 40 mg every two weeks.<\/p>\n\n\n\n Adolescents with hidradenitis suppurativa 12\u201317 years who weigh 30 kg or more<\/strong><\/p>\n\n\n\n The recommended dose of Imraldi is a starting dose of 80 mg (as two 40 mg injections on the same day) followed by 40 mg every other week starting one week later. If this dose does not work well enough, your doctor may increase the dose to 40 mg every week or 80 mg every two weeks.<\/p>\n\n\n\n It is recommended that you use a bactericidal solution on the affected areas daily.<\/p>\n\n\n\n Children and adolescents with Crohn’s disease<\/strong><\/p>\n\n\n\n Children and adolescents aged 6\u201317 weighing less than 40 kg<\/em><\/p>\n\n\n\n The usual dose is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your child’s doctor may prescribe a starting dose of 80 mg (as two 40 mg injections on the same day) followed by 40 mg two weeks later.<\/p>\n\n\n\n Thereafter, the usual dose is 20 mg every two weeks. If this dose does not work well enough, your child’s doctor may increase the dose to one to 20 mg each week.<\/p>\n\n\n\n Children and adolescents aged 6\u201317 weighing 40 kg or more<\/em><\/p>\n\n\n\n The usual dose is 80 mg (as two 40 mg injections on the same day) initially followed by 40 mg two weeks later. If a faster response is required, your child’s doctor may prescribe a starting dose of 160 mg (as four 40 mg injections on the same day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injection on the same day) two weeks later.<\/p>\n\n\n\n Thereafter, the usual dose is 40 mg every two weeks. If this dose does not work well enough, your doctor may increase the dose to 40 mg every week or 80 mg every two weeks.<\/p>\n\n\n\n Children and adolescents with ulcerative colitis<\/strong><\/p>\n\n\n\n Children and adolescents from 6 years of age weighing less than 40 kg<\/em><\/p>\n\n\n\n The usual dose of Imraldi is 80 mg (as two 40 mg injections on the same day) initially, followed by 40 mg (as one 40 mg injection ) two weeks later. Thereafter, the usual dose is 40 mg every two weeks.<\/p>\n\n\n\n Patients who turn 18 while on 40 mg every two weeks should continue with their prescribed dose.<\/p>\n\n\n\n Children and adolescents from 6 years of age weighing 40 kg or more<\/em><\/p>\n\n\n\n The usual dose of Imraldi is 160 mg (as four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days) initially, followed by 80 mg (as two 40 mg injections on the same day) for two weeks later. Thereafter, the usual dose is 80 mg every two weeks.<\/p>\n\n\n\n Patients who turn 18 while on 80 mg every two weeks should continue with their prescribed dose.<\/p>\n\n\n\n Children and adolescents from 2 years of age with chronic uveitis without infection<\/strong><\/p>\n\n\n\n Children and adolescents from 2 years of age weighing less than 30 kg<\/em><\/p>\n\n\n\n The usual dose of Imraldi is 20 mg every two weeks with methotrexate.<\/p>\n\n\n\n Your child’s doctor may also prescribe a starting dose of 40 mg given one week before starting the usual dose.<\/p>\n\n\n\n Children and adolescents from 2 years of age weighing 30 kg or more<\/em><\/p>\n\n\n\n The usual dose of Imraldi is 40 mg every two weeks with methotrexate.<\/p>\n\n\n\n Your child’s doctor may also prescribe a starting dose of 80 mg given one week before starting the usual dose.<\/p>\n\n\n\n Imraldi is given by injection under the skin (by subcutaneous injection ). Instructions for use can be found in section 7.<\/p>\n\n\n\n If you happen to inject a larger amount of Imraldi solution, or if you happen to inject Imraldi more often than you should, contact your child’s doctor or pharmacist and explain that your child has taken too much. Always carry the outer carton or vial with you, even if it is empty.<\/p>\n\n\n\n If you use less Imraldi than you should<\/strong><\/p>\n\n\n\n If you have accidentally injected a small amount of Imraldi solution or if you inject Imraldi less often than you should, contact your child’s doctor or pharmacist and explain that your child has received a smaller dose than intended. Always carry the outer carton or vial with you, even if it is empty.<\/p>\n\n\n\n If you forget to give your child an injection, take a dose of Imraldi as soon as you remember. Then give your child the next dose on a specific day that you would have done if you had not forgotten a dose.<\/p>\n\n\n\n The decision to stop using Imraldi should be discussed with your child’s doctor. Your child’s symptoms may return when treatment is stopped.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects can occur up to 4 months or later after the last Imraldi injection.<\/p>\n\n\n\n Seek medical attention immediately<\/strong> if you notice any of the following:<\/p>\n\n\n\n Tell your doctor as soon as possible<\/strong> if you notice any of the following:<\/p>\n\n\n\n The symptoms described above may be signs of side effects described below that have been observed with the use of adalimumab.<\/p>\n\n\n\n Very common<\/strong> (may affect more than 1 user in 10):<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 people):<\/p>\n\n\n\n Uncommon<\/strong> (may affect up to 1 in 100 people):<\/p>\n\n\n\n Rare<\/strong> (may affect up to 1 in 1,000 people):<\/p>\n\n\n\n Has been reported<\/strong> (occurs in an unknown number of users):<\/p>\n\n\n\n Some side effects observed with adalimumab may not show symptoms and can only be detected by blood tests.<\/p>\n\n\n\n These include:<\/p>\n\n\n\n Very common<\/strong> (may affect more than 1 user in 10):<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 people):<\/p>\n\n\n\n Uncommon<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\n Rare<\/strong> (may affect up to 1 in 1,000 people):<\/p>\n\n\n\n Reporting of side effects<\/em><\/p>\n\n\n\n If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C \u2011 8 \u00b0 C). Do not freeze.<\/p>\n\n\n\n Keep the vial in the outer carton. Sensitive to light.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n Imraldi 40 mg solution for injection in a vial comes in a 0.8 ml clear and colorless solution.<\/p>\n\n\n\n An Emerald vial is a glass vial containing a solution of adalimumab. One pack contains 2 cartons, each containing 1 vial, 1 empty sterile syringe , 1 needle, 1 bottle adapter and 2 alcohol swabs.<\/p>\n\n\n\n Emerald may be available as a vial , pre-filled syringe and \/ or as a pre-filled pen .<\/p>\n\n\n\n Samsung Bioepis NL BV<\/p>\n\n\n\n Olof Palmestraat 10<\/p>\n\n\n\n 2616 LR Delft<\/p>\n\n\n\n Netherlands<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n FUJIFILM Diosynth Biotechnologies Denmark ApS<\/p>\n\n\n\n Biotek All\u00e9 1<\/p>\n\n\n\n 3400 Hiller\u00f8d<\/p>\n\n\n\n Denmark<\/p>\n\n\n\n Biogen Netherlands BV<\/p>\n\n\n\n Prins Mauritslaan 13<\/p>\n\n\n\n 1171 LP Badhoevedorp<\/p>\n\n\n\n Netherlands<\/p>\n\n\n\n Samsung Bioepis NL BV<\/p>\n\n\n\n Olof Palmestraat 10<\/p>\n\n\n\n 2616 LR Delft<\/p>\n\n\n\n Netherlands<\/p>\n\n\n\n Contact your local marketing authorization holder for more information on this medicine:<\/p>\n\n\n\n2. What you need to know before your child uses Imraldi<\/h2>\n\n\n\n
Do not use Imraldi <\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Other drugs and Imraldi <\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Imraldi contains sodium and sorbitol<\/h2>\n\n\n\n
3. How to use Imraldi <\/h2>\n\n\n\n
Method of administration and route of administration<\/h2>\n\n\n\n
If you use more Imraldi than you should<\/h2>\n\n\n\n
If you forget to use Imraldi <\/h2>\n\n\n\n
If you stop using Imraldi <\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
5. How to store Imraldi<\/h2>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n
Belgium \/ Belgique \/ Belgien<\/strong>Biogen Belgium NV \/ SATel: + 32 (0) 2 808 5947<\/td> Lithuania<\/strong>Ewopharma AG Atstovyb\u0117Tel: +370 52 07 91 38<\/td><\/tr> Bulgaria<\/strong> Ewopharma AG Representative OfficeTel .: + 359 249 176 81<\/td> Luxembourg \/ Luxemburg<\/strong>Biogen Belgium NV \/ SATel: +35 227 772 038<\/td><\/tr> Czech Republic<\/strong>Biogen (Czech Republic) sroTel: + 420 228 884 152<\/td> Hungary<\/strong>Biogen Hungary Kft.Tel .: + 36 1 848 04 64<\/td><\/tr> Denmark<\/strong>Biogen (Denmark) A \/ STel: + 45 78 79 37 53<\/td> Malta<\/strong>Pharma.MT LtdTel: + 356 27 78 15 79<\/td><\/tr> Germany<\/strong>Biogen GmbHTel: + 49 (0) 30 223 864 72<\/td> The Netherlands<\/strong>Biogen Netherlands BVTel: + 31 (0) 20 808 02 70<\/td><\/tr> Eesti<\/strong>Ewopharma AG Eesti subsidiaryTel: + 372 6 68 30 56<\/td> Norway<\/strong>Biogen Norway ASTel: + 47 21 93 95 87<\/td><\/tr> Greece<\/strong>Genesis Pharma SA:\u0397\u03bb: + 30 211 176 8555<\/td> Austria<\/strong>Biogen Austria GmbHTel: + 43 (0) 1 267 51 42<\/td><\/tr> Spain<\/strong>Biogen Spain, SLTel: + 34 931 790 519<\/td> Poland<\/strong>Biogen Poland Sp. z ooTel .: + 48 22 116 86 94<\/td><\/tr> France<\/strong>Biogen France SASTel: + 33 (0) 1 776 968 14<\/td> Portugal<\/strong>Biogen Portugal Pharmaceutical Society,Unipessoal, LdaTel: + 351 308 800 792<\/td><\/tr> Croatia<\/strong>Ewopharma dooTel: + 385 (0) 1 777 64 37<\/td> Romania<\/strong>Ewopharma AG Representative OfficeTel: + 40 377 881 045<\/td><\/tr> Ireland<\/strong>Biogen Idec (Ireland) Ltd.Tel: +353 (0) 1 513 33 33<\/td> Slovenia<\/strong>Biogen Pharma dooTel: + 386 (0) 1 888 81 07<\/td><\/tr> Iceland<\/strong>Icepharma hf.Phone: + 354 800 9836<\/td> Slovak Republic<\/strong>Biogen Slovakia sroTel: + 421 (0) 2 333 257 10<\/td><\/tr> Italy<\/strong>Biogen Italia srlTel: + 39 (0) 6 899 701 50<\/td> Finland \/ Finland<\/strong>Biogen Finland OyPuh \/ Tel: + 358 (0) 9 427 041 08<\/td><\/tr> \u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>Genesis Pharma (Cyprus) Ltd:\u0397\u03bb: + 357 22 00 04 93<\/td>