40 mg \/ 0.8 ml injection solution
adalimumab<\/p>\n\n\n\n
Hulio contains the active substance adalimumab. Adalimumab is a drug that acts on the body’s immune system (defense).<\/p>\n\n\n\n
Hulio is intended for the treatment of the following inflammatory diseases:<\/p>\n\n\n\n
The active substance in Hulio, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target in the body.<\/p>\n\n\n\n
The target of adalimumab is another protein called tumor necrosis factor (TNF\u03b1), which is found in elevated levels in the inflammatory diseases listed above. By binding to TNF\u03b1, Hulio can reduce the inflammatory process in these diseases.<\/p>\n\n\n\n
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis<\/p>\n\n\n\n
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that often first occur in childhood.<\/p>\n\n\n\n
Hulio is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2\u201317 years and encephalitis-related arthritis in children and adolescents aged 6\u201317 years. Your child may first be given other medicines for their illness, such as methotrexate. If these medicines do not help enough, your child will get Hulio to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.<\/p>\n\n\n\n
Children with Crohn’s disease<\/p>\n\n\n\n
Crohn’s disease is an inflammatory disease of the intestines.<\/p>\n\n\n\n
Hulio is used to treat Crohn’s disease in children aged 6-17 years. Your child will first be given other medicines. If these drugs do not help enough, your child will get Hulio to reduce the signs and symptoms of Crohn’s disease.<\/p>\n\n\n\n
Children with plaque psoriasis<\/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
Hulio is used to treat severe plaque psoriasis in children and adolescents 4\u201317 years of age where drugs applied to the skin and light therapy have not worked well enough or are not appropriate<\/p>\n\n\n\n
Adolescents with hidradenitis suppurativa<\/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
Hulio is used to treat hidradenitis suppurativa in adolescents from 12 years of age. Hulio can reduce the number of lumps and boils that the disease causes as well as the pain that is often associated with the disease. Patients may first receive other medicines. If these drugs do not help enough, patients will get Hulio<\/p>\n\n\n\n
Chronic non-infectious uveitis affecting the front of the eye<\/p>\n\n\n\n
Non- infectious uveitis is an inflammatory disease that affects certain parts of the eye. Inflammation leads to impaired vision and\/or the presence of floaters in the eye (black dots or striped lines moving across the field of vision ). Hulio works by reducing this inflammation.<\/p>\n\n\n\n
Hulio is used to treat children aged 2\u201317 years with chronic non-infectious uveitis where inflammation affects the front of the eye.<\/p>\n\n\n\n
Talk to your child’s doctor or pharmacist before using Hulio.<\/p>\n\n\n\n
Allergic reaction<\/p>\n\n\n\n
If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or rash, stop injecting Hulio and contact a doctor immediately as these reactions can be life-threatening in rare cases.<\/p>\n\n\n\n
Infection is<\/p>\n\n\n\n
Tuberculosis (TB)<\/p>\n\n\n\n
Travel \/ recurrent infection s<\/p>\n\n\n\n
Hepatitis B virus<\/p>\n\n\n\n
Surgery or dental surgery<\/p>\n\n\n\n
Demyelinating disease<\/p>\n\n\n\n
Vaccine<\/p>\n\n\n\n
Heart failure<\/p>\n\n\n\n
Fever, bruising, bleeding, or pallor<\/p>\n\n\n\n
Cancer<\/p>\n\n\n\n
Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.<\/p>\n\n\n\n
Hulio 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 Hulio with medicines containing the active substances anakinra or abatacept. Concomitant use of Hulio and anakinra or abatacept is not recommended due to the possible increased risk of infections, including serious infections, and other possible drug interactions. If you have any further questions, ask your doctor.<\/p>\n\n\n\n
\u2022 Your child should consider using adequate contraception to prevent becoming pregnant and continue to use it for at least 5 months after the last treatment with Hulio.<\/p>\n\n\n\n
\u2022 If your child is pregnant thinks she may be pregnant or is planning to have a baby, consult her doctor before using this medicine.<\/p>\n\n\n\n
Hulio should only be used during pregnancy if necessary.<\/p>\n\n\n\n
\u2022 According to a pregnancy study, there was no increased risk of birth defects when the mother had received Hulio during pregnancy compared to mothers with the same disease who had not used Hulio.<\/p>\n\n\n\n
\u2022 Hulio can be used during breastfeeding.<\/p>\n\n\n\n
If your baby gets Hulio during her pregnancy, her newborn baby may be at increased risk of getting an infection.<\/p>\n\n\n\n
\u2022 It is important that you tell your pediatrician and other healthcare professionals that she used Hulio during her pregnancy before vaccinating your newborn baby. For more information on vaccines, see the section “Warnings and precautions”.<\/p>\n\n\n\n
Hulio may have a slight effect on your ability to drive, cycle or use machines. A feeling that the room is spinning ( vertigo ) and visual disturbances can occur when Hulio is used.<\/p>\n\n\n\n
Each vial of Hulio contains 38.2 mg of sorbitol. Sorbitol is a source of fructose. If your child has hereditary fructose intolerance, a rare, inherited disease, your child should not use this medicine. Patients with hereditary fructose intolerance cannot break down fructose, which can cause serious side effects. Contact a doctor before your child uses this medicine.<\/p>\n\n\n\n
This medicine contains less than 1 mmol sodium (23 mg) per vial, ie essentially ‘sodium-free.<\/p>\n\n\n\n
Always use this medicine exactly as your doctor or pharmacist has told you. If you have any further questions on the use of this product, ask your doctor or pharmacist. Your doctor may prescribe a different strength of Hulio if your child needs a different dosage.<\/p>\n\n\n\n
Children and adolescents with polyarticular juvenile idiopathic arthritis<\/p>\n\n\n\n
Children and adolescents 2\u201317 years of age weighing from 10 kg to less than 30 kg:<\/em><\/p>\n\n\n\n The recommended dosage of Hulio is 20 mg every two weeks.<\/p>\n\n\n\n Children and adolescents 2\u201317 years of age weighing 30 kg or more<\/em> :<\/p>\n\n\n\n The recommended dosage of Hulio is 40 mg every two weeks.<\/p>\n\n\n\n Children and adolescents with arthritis-related arthritis<\/p>\n\n\n\n Children and adolescents aged 6-17 weighing from 15 kg to less than 30 kg:<\/em><\/p>\n\n\n\n The recommended dosage of Hulio is 20 mg every two weeks.<\/p>\n\n\n\n Children and adolescents 6\u201317 years weighing 30 kg or more:<\/em><\/p>\n\n\n\n The recommended dosage of Hulio is 40 mg every two weeks.<\/p>\n\n\n\n Children and adolescents with Crohn’s disease<\/p>\n\n\n\n Children and adolescents 6\u201317 years 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 an initial 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 is not sufficient, your child’s doctor may increase the dose to one to 20 mg each week.<\/p>\n\n\n\n Children and adolescents 6\u201317 years weighing 40 kg or more:<\/em><\/p>\n\n\n\n The usual dose is 80 mg initially (as two 40 mg injections on the same day) 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 is not sufficient, your child’s 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 plaque psoriasis<\/p>\n\n\n\n Children and adolescents 4\u201317 years weighing from 15 kg to less than 30 kg:<\/em><\/p>\n\n\n\n The recommended dose of Hulio 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 weighing 30 kg or more:<\/em><\/p>\n\n\n\n The recommended dosage one of Hulio 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 old weighing at least 30 kg)<\/p>\n\n\n\n The recommended dosage one of Hulio 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 is not sufficient, your child’s 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 a bactericidal solution be used daily on the affected areas.<\/p>\n\n\n\n Children and adolescents with chronic non- infectious uveitis<\/p>\n\n\n\n Children and adolescents 2\u201317 years weighing less than 30 kg:<\/em><\/p>\n\n\n\n The usual dose of Hulio 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 B <\/em>arn and adolescents 2-17 years of age who weigh 30 kg or more:<\/em><\/p>\n\n\n\n The usual dose of Hulio 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 the start of the usual dose.<\/p>\n\n\n\n For patients who have been prescribed a full 40 mg dose, Hulio is also available as a 40 mg pre-filled pen and 40 mg pre-filled syringe at the pharmacy.<\/p>\n\n\n\n How Hulio is given<\/strong><\/p>\n\n\n\n Hulio is given by injection under the skin ( subcutaneous use).<\/p>\n\n\n\n Detailed instructions on how to inject Hulio can be found in section 7 – Instructions for use.<\/p>\n\n\n\n If you accidentally inject Hulio more often than your doctor advised, contact your doctor or pharmacist and tell them that your child has received too much. Always take the outer carton or medicine with you, even if it is empty.<\/p>\n\n\n\n If you forget to give your child an injection, give a Huliodos 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 Hulio 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.<\/p>\n\n\n\n Most side effects are mild to moderate. However, some may be serious and require urgent treatment.<\/p>\n\n\n\n Side effects can occur up to 4 months or longer after the last Hulio injection.<\/p>\n\n\n\n Seek medical attention immediately<\/strong> if your child develops any of the following signs of allergic reaction or heart failure:<\/p>\n\n\n\n Tell<\/strong> your doctor as soon as possible if<\/strong> you notice any of the following:<\/p>\n\n\n\n The following side effects have been seen with 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\nIf you use more Hulio than you should<\/h2>\n\n\n\n
If you forget to use Hulio<\/h2>\n\n\n\n
If your child stops using Hulio<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n