Imraldi – Adalimumab uses, dose and side effects

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Contents hide
1 1. What Imraldi is and what it is used for
2 2. What you need to know before your child uses Imraldi
3 Do not use Imraldi
4 Warnings and cautions
5 Other drugs and Imraldi
6 Pregnancy and breastfeeding
7 Driving and using machines
8 Imraldi contains sodium and sorbitol
9 3. How to use Imraldi
10 Method of administration and route of administration
11 If you use more Imraldi than you should
12 If you forget to use Imraldi
13 If you stop using Imraldi
14 4. Possible side effects
15 5. How to store Imraldi
16 6. Contents of the packaging and other information
17 Content declaration
18 What the medicine looks like and contents of the pack
19 Marketing Authorisation Holder

40 mg / 0.8 ml injection solution
adalimumab

1. What Imraldi is and what it is used for

Emerald contains the active substance adalimumab, a medicine that affects the body’s immune system.

Emerald is indicated for the treatment of:

  • polyarticular juvenile idiopathic arthritis ,
  • enthesitis-related arthritis ,
  • children and adolescents with plaque psoriasis,
  • adolescents with hidradenitis suppurativa,
  • children and adolescents with Crohn’s disease ,
  • children and adolescents with ulcerative colitis ,
  • children and adolescents with uveitis .

The active substance in Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.

The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is found in elevated levels in the inflammatory diseases listed above. By attaching to TNFα, Imraldi reduces the inflammatory process in these diseases.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually occur for the first time in childhood.

Emerald is used to treating polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.

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.

Children and adolescents with plaque psoriasis

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.

Emerald is used to treating severe plaque psoriasis in children and adolescents 4‑17 years of age where topical treatment and light therapy have not worked or are not appropriate.

Adolescents with hidradenitis suppurativa

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.

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.

Children and adolescents with Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive system.

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.

Children and adolescents with ulcerative colitis

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.

Children and adolescents with uveitis

Uveitis without infection is an inflammatory disease that affects certain parts of the eye.

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.

2. What you need to know before your child uses Imraldi

Do not use Imraldi 

  • If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
  • If your child has a serious infection , including tuberculosis (see “Warnings and Precautions”). It is important that you tell your doctor if your child has symptoms of infection , e.g. fever, sores, tiredness, dental problems.
  • If your child has moderate or severe heart failure . It is important to tell your doctor if your child has or has had a serious heart condition (see “Warnings and Precautions”).

Warnings and cautions

Talk to your child’s doctor or pharmacist before using Imraldi.

Allergic reaction

  • If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, stop injecting Imraldi and contact your doctor immediately as these reactions, in rare cases, can be life-threatening.

Infection

  • If your child has any infection , including chronic infections or local infections (such as leg ulcers), you must consult your doctor before starting Imraldi. If you are not sure, talk to your doctor.
  • Your child can more easily get you infection while you are being treated with Imraldi. This risk may increase if he / she has impaired lung function. These infections can be serious and include tuberculosis , infections caused by viruses , fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning). In rare cases, these can be infectedis becoming life threatening. It is important to tell your doctor if your child develops symptoms such as fever, sores, tiredness or dental problems. Your doctor may advise you to temporarily stop using Imraldi.

Tuberculosis

  • Because cases of tuberculosis have been reported in patients treated with Imraldi, your doctor will examine your child for signs and symptoms of tuberculosis before starting treatment with Imraldi. This includes a thorough medical evaluation including your child’s medical history and screening tests (eg lung x-ray and a tuberculin test). The performance and results of these tests must be stated on your child’s Patient Card. It is very important that you tell your doctor if your child has ever had tuberculosis , or if he / she has been in close contact with someone who has had tuberculosis . Tuberculosismay develop during treatment even if your child has received preventive treatment for tuberculosis . If symptoms of tuberculosis (persistent cough, weight loss, lethargy , mild fever), or if any other infection occurs during or after treatment, you must tell your doctor immediately.

Travel / recurrent infection

  • Tell your doctor if your child lives or travels in regions where fungal infections such as histoplasmosis , coccidioidomycosis or blastomycosis are constantly present (endemic).
  • Tell your doctor if your child has previously had problems with recurrent infections or other conditions that increase the risk of infection .

Hepatitis B virus

  • Tell your doctor if your child is a carrier of the hepatitis B virus (HBV) , if he / she has an active HBV infection or if you think he / she is at risk of getting HBV. Your child’s doctor should test your child for Hepatitis B. Imraldi, may reactivate HBV‑ infection in people who carry this virus . In some rare cases, especially if your child is taking other medicines that inhibit the immune system, reactivation of HBV‑ infection can be life-threatening.

Surgery or dental surgery

  • If your child is about to have surgery or a dental procedure, tell your doctor that he / she is taking Imraldi. Your doctor may advise you to temporarily stop treatment.

Demyelinating disease

  • If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves) such as multiple sclerosis (MS), your doctor will make an assessment of whether he / she can or should continue treatment with Imraldi. Tell your doctor immediately if your child develops symptoms such as changes in vision, weakness in the arms or legs, or numbness or tingling anywhere on the body.

Vaccine

  • Some vaccines contain attenuated but live forms of pathogenic bacteria or viruses and these vaccines should not be given during treatment with Imraldi. Check with your doctor before vaccinating your child. It is recommended that children, if possible, receive all planned vaccinations for their age before starting treatment with Imraldi. If you get Imraldi during your pregnancy, your newborn baby may have an increased risk of getting an infection for up to about five months after the last dose you received during pregnancy. It is important that you tell your child’s doctor and other healthcare professionals that you used Imraldi during your pregnancy so that they can decide when your newborn baby should be vaccinated.

Heart failure

  • If your child has mild heart failure and is being treated with Imraldi, his / her heart problems must be closely monitored by your doctor. It is important to tell your doctor if your child has or has had a serious heart condition. If he / she develops new symptoms or if the symptoms of heart failure worsen (eg shortness of breath or swollen feet), you must contact your doctor immediately. Your doctor will decide if your child should receive Imraldi.

Fever, bruising, bleeding, or pallor

  • In some patients, the body is unable to produce enough blood cells to fight infection or stop bleeding. If your child develops a fever that does not go down, gets bruises or if he / she bleeds easily or looks very pale , you should call your doctor immediately. Your doctor may then decide to stop treatment.

Cancer

  • Very rare cases of certain cancers have occurred in children and adults treated with Imraldi or other TNFα blockers. Patients with more severe rheumatoid arthritis who have had the disease for a long time may have an increased risk of developing lymphoma (a cancer that affects the lymphatic system ) and leukemia (cancer that affects the blood and bone marrow ). If your child is being treated with Imraldi, the risk of developing lymphoma , leukemia or another type of cancer may increase. On rare occasions have a specific and severe type of lymphomaobserved in patients using Imraldi. Some of these patients were also treated with the drug azathioprine or mercaptopurine. Tell your doctor if your child is taking azathioprine or mercaptopurine with Imraldi.
  • Cases of non- melanoma skin cancer have also been reported in patients treated with Imraldi. If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
  • There have been cancers other than lymphoma , in those patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) and who are being treated with other TNFα blockers. If your child has COPD, or is a heavy smoker, discuss with your doctor whether it is appropriate to treat your child with a TNFα blocker.

Lupus-like syndrome

  • In rare cases, treatment with Imraldi may cause a lupus-like syndrome. Contact your doctor if symptoms such as persistent, unexplained rash, fever, joint pain or fatigue occur.

Other drugs and Imraldi 

Tell your child’s doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

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 ).

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.

Pregnancy and breastfeeding

  • You should consider using an adequate contraceptive method to prevent pregnancy while using Imraldi and continue to use it for at least 5 months after the last treatment with Imraldi.
  • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
  • Imraldi should only be used during pregnancy if needed.
  • According to a pregnancy study, there was no increased risk of birth defects when the mother had received adalimumab during pregnancy compared to mothers with the same disease who had not used adalimumab.
  • Imraldi can be used during breast-feeding.
  • If you get Imraldi during your pregnancy, your newborn baby may be at increased risk of getting an infection .
  • It is important that you tell your pediatrician and other healthcare professionals that you used Imraldi during your pregnancy before vaccinating your newborn baby. (For more information on vaccines, see the section “Warnings and Precautions”).

Driving and using machines

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.

Imraldi contains sodium and sorbitol

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.

This medicine contains less than 1 mmol sodium (23 mg) per 0.8 ml dose, ie essentially ‘sodium-free.

3. How to use Imraldi 

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.

Children and adolescents with polyarticular juvenile idiopathic arthritis

Children and adolescents from 2 years of age weighing from 10 kg up to 30 kg

The recommended dose of Imraldi is 20 mg every two weeks. 

Children, adolescents, and adults from 2 years of age weighing 30 kg or more

The recommended dose of Imraldi is 40 mg every two weeks. 

Children, adolescents, and adults with arthritis-related arthritis

Children and adolescents from 6 years of age weighing from 15 kg up to 30 kg

The recommended dose of Imraldi is 20 mg every two weeks.

Children, adolescents, and adults from 6 years of age weighing 30 kg or more

The recommended dose of Imraldi is 40 mg every two weeks.

Children and adolescents with plaque psoriasis

Children and adolescents 4 – 17 years who weigh from 15 kg up to 30 kg

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.

Children and adolescents 4–17 years old weighing 30 kg or more

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.

Adolescents with hidradenitis suppurativa 12–17 years who weigh 30 kg or more

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.

It is recommended that you use a bactericidal solution on the affected areas daily.

Children and adolescents with Crohn’s disease

Children and adolescents aged 6–17 weighing less than 40 kg

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.

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.

Children and adolescents aged 6–17 weighing 40 kg or more

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.

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.

Children and adolescents with ulcerative colitis

Children and adolescents from 6 years of age weighing less than 40 kg

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.

Patients who turn 18 while on 40 mg every two weeks should continue with their prescribed dose.

Children and adolescents from 6 years of age weighing 40 kg or more

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.

Patients who turn 18 while on 80 mg every two weeks should continue with their prescribed dose.

Children and adolescents from 2 years of age with chronic uveitis without infection

Children and adolescents from 2 years of age weighing less than 30 kg

The usual dose of Imraldi is 20 mg every two weeks with methotrexate.

Your child’s doctor may also prescribe a starting dose of 40 mg given one week before starting the usual dose.

Children and adolescents from 2 years of age weighing 30 kg or more

The usual dose of Imraldi is 40 mg every two weeks with methotrexate.

Your child’s doctor may also prescribe a starting dose of 80 mg given one week before starting the usual dose.

Method of administration and route of administration

Imraldi is given by injection under the skin (by subcutaneous injection ). Instructions for use can be found in section 7.

If you use more Imraldi than you should

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.

If you use less Imraldi than you should

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.

If you forget to use Imraldi 

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.

If you stop using Imraldi 

The decision to stop using Imraldi should be discussed with your child’s doctor. Your child’s symptoms may return when treatment is stopped.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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.

Seek medical attention immediately if you notice any of the following:

  • Severe rash, hives or other signs of allergic reaction;
  • swollen face, swollen hands, feet;
  • labored breathing, difficulty swallowing;
  • shortness of breath during exertion or when lying down or if the feet swell.

Tell your doctor as soon as possible if you notice any of the following:

  • signs of infection such as fever, nausea, sores, dental problems, burning sensation when urinating;
  • feeling weak or tired;
  • cough;
  • knitting;
  • loss of sensation;
  • double vision;
  • arm or leg weakness;
  • a bump or open wound that does not heal;
  • signs and symptoms of blood diseases such as prolonged fever, bruising, bleeding, pallor.

The symptoms described above may be signs of side effects described below that have been observed with the use of adalimumab.

Very common (may affect more than 1 user in 10):

  • injection site reactions (including pain, swelling, redness or itching );
  • respiratory tract infections (including colds, runny nose, sinusitis, pneumonia );
  • headache;
  • abdominal pain;
  • nausea and vomiting;
  • rash;
  • pain in the muscles.

Common (may affect up to 1 in 10 people):

  • serious infection (including sepsis and influenza );
  • infection is in the intestines (including gastroenteritis );
  • skin infections (including cellulite and shingles );
  • ear infections;
  • oral infections (including dental infections and cold sores);
  • infection is in the reproductive organs;
  • urinary tract infections;
  • fungal infections;
  • joint infections;
  • benign tumors;
  • skin cancer;
  • allergic reactions (including seasonal allergy);
  • dehydration;
  • mood swings (including depression);
  • concern;
  • problems sleeping;
  • sensory disturbances such as tingling, ant crawling or numbness;
  • migraine;
  • symptoms of nerve root compression (including low back pain and leg pain);
  • visual disturbances;
  • eye inflammation;
  • inflammation of the eyelid and swelling of the eyes;
  • dizziness (feeling that the room is spinning);
  • feeling of heart beating fast;
  • Hypertension;
  • redness;
  • bleeding (bruising);
  • cough;
  • asthma;
  • shortness of breath;
  • bleeding in the gastrointestinal tract;
  • dyspepsia (indigestion, bloating, heartburn);
  • gastric acid reflux;
  • sicca syndrome (including dry eyes and dry mouth);
  • itching;
  • itchy rash;
  • bruises;
  • dermatitis (such as eczema );
  • fragile fingernails and toenails;
  • increased sweating;
  • hair loss;
  • new onset or worsening of psoriasis;
  • muscle spasms;
  • blood in the urine;
  • kidney problems;
  • chest pain;
  • edema (fluid accumulation in the body that causes the affected tissue to swell);
  • fever;
  • decreased platelet count ( platelets ) which increases the risk of bleeding or bruising;
  • impaired healing.

Uncommon (may affect up to 1 in 100 people):

  • opportunistic infections (which include tuberculosis and other infections that may occur when resistance to the disease is reduced);
  • neurological infections (including meningitis caused by viruses );
  • eye infections;
  • bacterial infections;
  • diverticulitis ( inflammation and infection of the colon);
  • cancers, including lymphoma (cancer of the lymphatic system ) and melanoma (a type of skin cancer);
  • immune disorders that can affect the lungs, skin and lymph nodes (most often as the disease sarcoidosis );
  • vasculitis ( inflammation of the blood vessels);
  • shaking;
  • neuropathy (nerve damage);
  • stroke;
  • hearing loss, ringing;
  • feeling of the heart beating irregularly like a missed heartbeat;
  • heart problems that can cause shortness of breath or swollen feet;
  • myocardial infarction;
  • a hernia in the great artery wall, inflammation and clot in a vein, blockage of a blood vessel;
  • lung disease causing shortness of breath (including inflammation );
  • pulmonary embolism (blockage in a pulmonary artery);
  • pleural effusion (abnormal fluid accumulation between the lungs and chest);
  • inflammation of the pancreas that causes severe pain in the abdomen and back;
  • difficulty swallowing;
  • facial edema (accumulation of fluid in the face);
  • gallbladder inflammation, gallstones;
  • fatty liver (accumulation of fat in liver cells);
  • night sweats;
  • scar;
  • abnormal muscle breakdown;
  • systemic lupus erythomatosus (including inflammation of the skin, heart, lungs, joints and other organ systems);
  • sleep interruption;
  • impotence;
  • inflammation is.

Rare (may affect up to 1 in 1,000 people):

  • leukemia (cancer that affects the blood and bone marrow );
  • severe allergic reaction with shock;
  • multiple sclerosis;
  • nerve disorders (such as inflammation of the optic nerve of the eye and Guillain ‑ Barré syndrome, a disease that can cause muscle weakness, sensory disturbances, tingling in the arms and upper body);
  • the heart stops pumping;
  • pulmonary fibrosis (scarring of the lung);
  • holes in the intestine;
  • hepatitis;
  • reactivation of hepatitis B;
  • autoimmune hepatitis (inflammation of the liver caused by the body’s own immune system);
  • cutaneous vasculitis ( inflammation of the blood vessels in the skin);
  • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);
  • facial edema associated with allergic reactions;
  • erythema multiforme (inflammatory skin rash);
  • lupus-like syndrome;
  • angioedema (local swelling of the skin);
  • lichenoid skin reactions (itchy red-purple skin rash):

Has been reported (occurs in an unknown number of users):

  • hepatosplenic T cell lymphoma (a rare blood cancer that is often fatal);
  • Merkel cell carcinoma (a type of skin cancer);
  • Kaposi’s sarcoma , a rare cancer associated with infection with human herpesvirus 8 Kaposi sarcoma occurs most often as purple spots on the skin;
  • liver failure;
  • aggravation of a condition called dermatomyositis (looks like a rash and is accompanied by muscle weakness);
  • Weight gain (for most patients the weight gain was small).

Some side effects observed with adalimumab may not show symptoms and can only be detected by blood tests.

These include:

Very common (may affect more than 1 user in 10):

  • low blood cell counts;
  • low blood cell counts;
  • elevated lipids in the blood;
  • elevated liver enzymes.

Common (may affect up to 1 in 10 people):

  • high blood cell counts;
  • low blood platelet counts;
  • elevated uric acid in the blood;
  • aberrant blood sodium levels;
  • low blood levels of calcium;
  • low blood levels of phosphate;
  • high blood sugar;
  • high blood levels of lactate dehydrogenase;
  • autoantibodies present in the blood;
  • low blood levels of potassium .

Uncommon (may affect up to 1 in 100 people)

  • elevated levels of bilirubin (blood test of the liver).

Rare (may affect up to 1 in 1,000 people):

  • low blood counts for white blood cells, red blood cells and platelets .

Reporting of side effects

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.

5. How to store Imraldi

Keep this medicine out of the sight and reach of children.

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.

Store in a refrigerator (2 ° C ‑ 8 ° C). Do not freeze.

Keep the vial in the outer carton. Sensitive to light.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is adalimumab.
  • The other ingredients are sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate and water for injections.

What the medicine looks like and contents of the pack

Imraldi 40 mg solution for injection in a vial comes in a 0.8 ml clear and colorless solution.

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.

Emerald may be available as a vial , pre-filled syringe and / or as a pre-filled pen .

Marketing Authorisation Holder

Samsung Bioepis NL BV

Olof Palmestraat 10

2616 LR Delft

Netherlands

Manufacturer

FUJIFILM Diosynth Biotechnologies Denmark ApS

Biotek Allé 1

3400 Hillerød

Denmark

Biogen Netherlands BV

Prins Mauritslaan 13

1171 LP Badhoevedorp

Netherlands

Samsung Bioepis NL BV

Olof Palmestraat 10

2616 LR Delft

Netherlands

Contact your local marketing authorization holder for more information on this medicine:

Belgium / Belgique / BelgienBiogen Belgium NV / SATel: + 32 (0) 2 808 5947LithuaniaEwopharma AG AtstovybėTel: +370 52 07 91 38
Bulgaria Ewopharma AG Representative OfficeTel .: + 359 249 176 81Luxembourg / LuxemburgBiogen Belgium NV / SATel: +35 227 772 038
Czech RepublicBiogen (Czech Republic) sroTel: + 420 228 884 152HungaryBiogen Hungary Kft.Tel .: + 36 1 848 04 64
DenmarkBiogen (Denmark) A / STel: + 45 78 79 37 53MaltaPharma.MT LtdTel: + 356 27 78 15 79
GermanyBiogen GmbHTel: + 49 (0) 30 223 864 72The NetherlandsBiogen Netherlands BVTel: + 31 (0) 20 808 02 70
EestiEwopharma AG Eesti subsidiaryTel: + 372 6 68 30 56NorwayBiogen Norway ASTel: + 47 21 93 95 87
GreeceGenesis Pharma SA:Ηλ: + 30 211 176 8555AustriaBiogen Austria GmbHTel: + 43 (0) 1 267 51 42
SpainBiogen Spain, SLTel: + 34 931 790 519PolandBiogen Poland Sp. z ooTel .: + 48 22 116 86 94
FranceBiogen France SASTel: + 33 (0) 1 776 968 14PortugalBiogen Portugal Pharmaceutical Society,Unipessoal, LdaTel: + 351 308 800 792
CroatiaEwopharma dooTel: + 385 (0) 1 777 64 37RomaniaEwopharma AG Representative OfficeTel: + 40 377 881 045
IrelandBiogen Idec (Ireland) Ltd.Tel: +353 (0) 1 513 33 33SloveniaBiogen Pharma dooTel: + 386 (0) 1 888 81 07
IcelandIcepharma hf.Phone: + 354 800 9836Slovak RepublicBiogen Slovakia sroTel: + 421 (0) 2 333 257 10
ItalyBiogen Italia srlTel: + 39 (0) 6 899 701 50Finland / FinlandBiogen Finland OyPuh / Tel: + 358 (0) 9 427 041 08
ΚύπροςGenesis Pharma (Cyprus) Ltd:Ηλ: + 357 22 00 04 93SwedenBiogen Sweden ABTel: +46 (0) 8 525 038 36
LatviaEwopharma AG pārstāvniecībaTel: + 371 66 16 40 32United Kingdom (Northern Ireland)Biogen Idec (Ireland) Ltd.Tel: +44 (0) 20 360 886 22
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