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HUMIRA 40 mg. / 0.8 ml. 2 injections

Brand: BOIRON
Product Code: HUMIRA 40 mg. / 0.8 ml. 2 injections
Availability: In Stock
Product viewed: 964

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What Humira is and what it is used
Humira contains the active substance adalimumab - selective immunosuppressive agent. Humira is intended for treatment of polyarticular juvenile idiopathic arthritis in children aged 2-17 years, arthritis associated with enthesitis in children aged 6-17 years, and Crohn's disease in children aged 6-17 years. This is a drug that reduces inflammation in such diseases. The active ingredient, adalimumab, is a human monoclonal antibody produced by cell cultures. Monoclonal antibodies are proteins that recognize and bind to other specific proteins. Adalimumab binds to a specific protein (tumor necrosis factor or TNFα), which is present in elevated levels in inflammatory diseases such as polyarticular juvenile idiopathic arthritis, arthritis associated with enthesitis and Crohn's disease.

Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis
Humira is administered for treatment of polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis. Polyarticular JIA and arthritis associated with enthesitis are inflammatory diseases. Initially your child may be given other disease modifying drugs such as methotrexate. If your child does not respond well enough to these medicines, he will be given Humira to treat your polyarticular juvenile idiopathic arthritis or arthritis associated with enthesitis.

Crohn's disease in pediatric patients
Crohn's disease is an inflammatory disease of the gastrointestinal tract. Humira is indicated for the treatment of Crohn's disease in children aged 6 to 17 years. Initially your child will be given other medicines. If your child does not respond well enough to these medicines, he / she will be given Humira to reduce the signs and symptoms of Crohn's disease.

2. What you need to know before your child to use Humira
Do not use Humira:
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 severe infection, including active tuberculosis (see "Warnings and Precautions"). It is important to tell your doctor if your child has symptoms of infection such as fever, wounds, feeling tired, dental problems;
if your child has moderate to severe heart failure. It is important to tell your doctor if it had or has a serious heart condition (see "Warnings and Precautions").
Warnings and Precautions
Talk to your child's doctor or pharmacist before using Humira.
If your child has an allergic reaction with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and immediately contact your doctor.
If your child has an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before taking Humira. If you are unsure, please contact your doctor.
During treatment with Humira, your child may get sick more easily from infections. This risk may increase if the functions of his lungs is impaired. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening. It is important to tell your doctor if your child shows symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may recommend suspending the use of Humira.
Since there are reports of tuberculosis in patients treated with Humira, your doctor will examine your child for signs and symptoms of tuberculosis before starting treatment with Humira. This includes a thorough medical evaluation, including history and appropriate tests for screening (eg, x-ray of the chest and a tuberculin test. The conduct and results of these studies should be scored Alert Card to your child. It is important to tell your doctor if your child is suffering from tuberculosis or has been in close contact with someone who has TB. during treatment may develop TB even if you have received treatment for the prevention of tuberculosis. If during treatment or after symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection, your doctor immediately.
Ask your doctor if your child lived or traveled in areas of endemic fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis.
Ask your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.
Ask your doctor if your child is a carrier of hepatitis B (HBV) or has active HBV infection or think is at risk of contracting HBV. Your child's doctor should examine your child for hepatitis B (HBV). Humira can cause reactivation of HBV in people who carry this virus. In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
It is important to tell your doctor if your child has symptoms of infection such as fever, wounds, feeling tired, dental problems.
If your child is having surgery or dental procedures please inform your doctor that it applies Humira. Your doctor may recommend suspending the use of Humira.
If your child has a demyelinating disease such as multiple sclerosis, your doctor will decide whether it is necessary to apply Humira.
Certain vaccines may cause infections and should not be given during treatment with Humira. Please consult your doctor before applying any vaccines your child. It is recommended that children be completed, if possible, with all immunizations according to current immunization guidelines prior to initiating treatment with Humira. If you received Humira, while you were pregnant, your baby may be at higher risk of such an infection, five months after the last dose you received during pregnancy. It is important to tell your doctor and other health care professionals to your baby that you are being treated with Humira during your pregnancy so they can decide when your baby should be done any vaccination.
If your child has a mild heart failure and is being treated with Humira, his state of heart failure should be closely monitored by your doctor. It is important to tell your doctor if your child has had or has a serious heart condition. If they develop new or worsening symptoms of heart failure (eg shortness of breath or swelling of your feet), you should immediately contact your doctor. Your doctor will decide whether it is necessary to apply Humira.
In some patients the body may fail to produce enough blood cells to help the body of your child fight infections or help stop bleeding. If your child develops a fever that does not go away, bruise or bleed very easily or look very pale, immediately contact your doctor. Your doctor may decide to stop treatment.
There are very rare cases of certain kinds of cancer in children and adults applying Humira or other TNF-blockers. People with more serious rheumatoid arthritis who have a longer duration of the disease may have a higher risk than the average for the development of lymphoma (a type of cancer that affects the lymph system), and leukemia (a type of cancer that affects the blood and bone marrow). If your child is given Humira, the risk of occurrence of lymphoma, leukemia or other cancers may increase. In rare cases it has been observed a specific and severe type of lymphoma in patients treated with Humira. Some of these patients were also treated with azathioprine or 6-mercaptopurine. Inform your child's doctor if your child is taking azathioprine or 6-mercaptopurine with Humira. Moreover Very rare cases of non-melanoma skin cancer in patients applying Humira. If during or after therapy, a new lesion on the skin or if existing lesions change appearance, tell your doctor.
In patients with a specific type of lung disease known as chronic obstructive pulmonary disease, treated with another blocking agent to TNF, have been observed in other cancers, other than lymphoma. If your child suffers from COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for your child.
Children and adolescents
Vaccinations: if possible, your child should be placed on a schedule all vaccines before applying Humira.
Do not use Humira in children with polyarticular juvenile arthritis under the age of 2 years.
Other medicines and Humira
Inform your child's doctor or pharmacist if your child is taking, has recently taken or might take other medicines.
Humira can be administered together with methotrexate or down, changing the course of the disease modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Your child should not be given Humira with medicines containing the active substance anakinra or abatacept. If you have questions, please ask your doctor.

Humira with food and drink
Since Humira is injected under the skin (subcutaneous), food and drink should not affect the operation of Humira.

Pregnancy and lactation
The effects of Humira in pregnant women are unknown. Therefore, it is recommended the use of Humira in pregnant women. Your child should be advised to avoid becoming pregnant and to use adequate contraception while applying Humira and for at least five months after the last treatment with Humira. If your child becomes pregnant, talk to your doctor.
It is not known whether adalimumab passes into breast milk.
If your child is a breast-feeding mother, she should stop breast-feeding during Humira treatment and for at least five months after the last treatment with Humira. If you received Humira during your pregnancy, your baby may have a higher risk of infection. It is important to inform physicians and other medical professionals to your baby, use of Humira during your pregnancy before the baby to make any vaccination (for more information see section on vaccination).
If you think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.

Driving and using machines
Humira has negligible influence on the ability to drive, ride a bicycle or use machines. After taking Humira may appear dizziness and visual impairment.

3. How to use Humira
Always use this medicine exactly as told your child's doctor or pharmacist. If you are unsure about any of the instructions or if you have any questions, ask your child's doctor or pharmacist.

Children with polyarticular juvenile idiopathic arthritis
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 2 to 12 years depends on the height and weight of your child.
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 13 to 17 years is 40 mg every other week.

Children with arthritis associated with enthesitis
The recommended dose of Humira in patients with arthritis associated with enthesitis, aged 6 to 17 years depends on the height and weight of the child.

Children and adolescents with Crohn's disease
Children or adolescents who weigh less than 40 kg:
The usual regimen is 40 mg initially followed by 20 mg two weeks later. If you require a more rapid response, your child's doctor may prescribe a starting dose of 80 mg (as two injections in one day), followed by 40 mg, two weeks later.
Then, the usual dose is 20 mg every other week. Depending on the response of your child, your child's doctor may increase the dosing frequency to 20 mg every week.

Children and adolescents weighing 40 kg or more:
The usual regimen is 80 mg initially followed by 40 mg two weeks later. If required a more rapid response, your child's doctor may prescribe a starting dose of 160 mg initially (4 injections at 1 day or 2 injections per day for two consecutive days), followed by 80 mg, two weeks later.
Then, the usual dose is 40 mg every two weeks. Depending on the response of your child, your child's doctor may increase the dosing frequency to 40 mg every week.
For patients who have been prescribed a full dose of 40 mg Humira, are available, and 40 mg pen and 40 mg pre-filled syringe.
Route of administration and route of administration
Humira is administered by injection under the skin (subcutaneous injection).

Instructions for preparing and giving an injection of Humira:
The following instructions explain how to inject Humira. Please read the instructions carefully and follow them step by step. You will be instructed by your child's doctor or his assistant on the technique of self-injection and the amount that you apply to your child. Do not attempt to inject your child before you are sure that you understand how to prepare and give the injection. After proper training, the injection can be done independently or by another person, as a family member or friend.
Error executing the next steps as described may cause infection, which can lead to infection of your child.
The solution for injection should not be mixed in the same syringe or vial with another medicinal product.

1) Preparation of
Make sure you know the proper amount (volume) needed for implementation. If you do not know the amount, stop here and contact your doctor for further instructions.
You'll need a special container, like a sharps container or as recommended by your nurse, doctor or pharmacist. Put the container in the place where you work.
Wash your hands thoroughly.
Remove from packaging one carton containing one syringe, one vial adapter, one vial, two alcohol pads and one needle. If the package has a second box for another injection, immediately return it to the refrigerator.
Check the expiration date on the box. Do not use anything from the pack after the date indicated on the box.
Place the following items on a clean surface, DO NOT REMOVE still their individual packages:
A syringe of 1 ml;
Reduction A vial adapter;
One vial of Humira for injection for pediatric use;
Two alcohol pads;
One needle.
Humira is a clear, colorless liquid. DO NOT use liquid if it is cloudy or discolored or has flakes or particles.
2) Preparation of Humira dose for injection
Basic rule: DO NOT put anything until you have finished your injection.
Prepare the needle by partially opening the package from the proximal end to the yellow tip of the syringe. Open the package so as to show the yellow tip of the syringe. Leave the box with transparent side up.
Open the white plastic cap of the vial, so you can see the top of the vial stopper.
Use one of the two alcohol pads to wipe the vial stopper. DO NOT touch the vial stopper after you clean it with a swab.
Open the vial adapter, but still not remove the vial adapter.
Hold the vial stopper up.
Attach the adapter as still in transparent packaging to the stopper by pressing down until the adapter snaps into place.
When you are sure that the adapter is attached to the vial, pull the pack from the adapter.
Carefully place the vial adapter on the cleaned area to work. Be careful not to fall. DO NOT touch the adapter.
Prepare the syringe by partially opening the package from the nearest white piston end.
Remove the transparent packaging so that you unpack only the piston, but do not remove the syringe from the pack.
Keep the container of the syringe and slowly pull the plunger to 0,1 ml the prescribed dose (for example, if the prescribed dose is 0,5 ml, pull the plunger to 0,6 ml). Never be routed position of 0,9 ml, regardless of the prescribed dose.
You will set the volume to the prescribed dose in a later step.
DO NOT remove the plunger completely out of the syringe.
NOTE:
If the piston is pulled completely out of the syringe, discard the syringe and contact that you received Humira to return. DO NOT attempt to insert the plunger back.
DO NOT use the white plunger to remove the syringe from the pack. Hold the syringe graduated Region remove it from the package. At no point did leave the syringe.
While holding the vial adapter firmly, insert the syringe tip adapter and twist the syringe clockwise with one hand while seated firmly. Do not overtighten!
While holding the vial, push the white piston down. This step is important to download the correct dose. Hold the plunger and turn the vial and syringe upside down.
Slowly pull the white plunger to 0,1 ml the prescribed dose. It is important to download the correct dose. You will determine the exact volume of the prescribed dose in step 4. Preparation of the dose. If the prescribed dose is 0,5 ml, pull the plunger to 0,6 ml. You will see the liquid medication to flow from the vial into the syringe.
Click the white plunger back to return the liquid medicine
Choosing and preparing an injection site
Choose a place in the abdomen or thigh. DO NOT use the last injection.
Each injection should be given at least 3 cm from the last injection site.
Do not inject into areas where the skin is reddened, bruised, or hard. This may mean there is an infection and you should contact your doctor.
To reduce the risk of infection, clean the injection site with the other alcohol pad. DO NOT touch the area again before injecting.
4) Dose Preparation
Take the syringe with the needle upwards.
Use the other hand to pull the pink needle cover down toward the syringe.
Take the transparent cap by pulling up with the other hand.
The needle is clean.
DO NOT touch the needle.
DO NOT leave the syringe after removing the transparent needle cap.
DO NOT attempt to put the cap back on the needle.
Hold the syringe at eye level with the needle pointing up to see clearly the amount. Be careful not to spray into his eyes.
Recheck the prescribed amount of medicine.
Click the white piston carefully into the syringe until the contents become as prescribed. Excess fluid may exit the needle while pressing the piston. Do not wipe the needle tip.
Injecting Humira
Gently grasp a free hand cleaned of skin and hold firmly.
With the other hand the syringe at an angle of 45 ° to the skin.
With a quick jerk and drop a needle to its base in the skin.
Drop skin that you caught.
Pushing the plunger to inject the drug solution until the syringe is empty.
When the syringe is empty, remove the needle from the skin, being careful to remove it at the same angle.
Gently pull the pink needle cap over the needle, click on the place and put the syringe with the needle in the workplace.
DO NOT put the transparent cap back on the needle.
Using a piece of gauze over the injection site for 10 seconds. It may appear slight bleeding. DO NOT rub the injection site. Optionally you can put tape.
Disposal of material
You'll need a special container, like a sharps container or as recommended by your nurse, doctor or pharmacist.
Put the syringe with needle and vial adapter into a special sharps container. DO NOT put these items in household waste.
The syringe, needle, and vial adapter MUST NOT be used again.
Throughout store special container out of the reach of children.
Throw away all other used items in your household waste.
If you use more than the required dose of Humira
If you accidentally inject a larger amount of Humira or if you inject Humira more frequently than prescribed, you should contact your doctor and tell him that your child has received more medicine. Always take the outer carton or vial of the drug, even if it is empty.

If you use more than the required dose of Humira
If you accidentally inject a smaller amount of Humira or if you inject Humira less frequently than prescribed by your child's doctor or pharmacist should contact your child's doctor or pharmacist to tell her / him that your child has received less medicine. Always take the outer carton or vial of the drug, even if it is empty.

If you forget to use Humira
If you miss an injection of your child, you should inject the next dose as soon as you remember. Inject the next dose of your child's scheduled day as you would in case you've missed the first injection.

If your child has stopped the use of Humira
The decision to stop using Humira should be discussed with your child's doctor. If stopping treatment, the symptoms your child can resume.

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

4. Possible side effects
As with all drugs, this drug may cause side effects, although not everyone gets them. Most adverse events were mild to moderate. However, some side effects can be serious and require treatment. Side effects may occur until at least four months after the last injection of Humira.

Tell your doctor immediately if you notice the following:
severe rash, hives or other signs of allergic reaction;
swelling of the face, hands, feet;
difficulty breathing and swallowing;
shortness of breath with exertion or upon lying down or swelling of the feet;
Tell your doctor as soon as possible if any of the following:
signs of infection such as fever, nausea, wounds, dental problems, burning in urine
The above-described symptoms may be signs of the below listed side effects that have been observed with Humira:
Very common (may affect more than 1 in 10 people):
site reactions (including pain, swelling, redness or itching);
respiratory tract infections (including colds, runny nose, sinus infection, pneumonia);
headache;
stomach ache;
nausea and vomiting;
rash;
musculoskeletal pain.
Common (may affect up to 1 in 10 people):
serious infections (including blood poisoning and influenza (flu));
skin infections (including cellulitis and shingles);
ear infections;
oral infections (including infections of the teeth, and herpes);
infections of the reproductive system;
urinary tract infection;
fungal infections;
joint infections;
benign tumors;
skin cancer;
allergic reactions (including seasonal allergy);
dehydration;
mood changes (including depression);
anxiety;
difficulty sleeping;
sensory disturbances such as tingling, "pins and needles" or numbness;
migraine;
pinched nerve endings (including pain in the lower back and pain in the legs);
visual impairment;
eye irritation;
inflammation of the eyelids and eye swelling;
vertigo / dizziness;
sensation of rapid heart beat (palpitations);
high blood pressure;
hot flashes;
hematoma (hematoma);
cough;
asthma;
shortness of breath;
bleeding from the gastrointestinal tract;
dyspepsia (indigestion, bloating, burning);
acid reflux disease (return acid from the stomach);
"Dry" syndrome (including dry eye and mouth);
itching;
itchy rash;
bruising;
inflammation of the skin (such as eczema);
splitting nails and toes;
increased sweating;
hair loss;
new onset or worsening of psoriasis;
muscle spasms;
blood in the urine;
kidney problems;
chest pain;
swelling;
fever;
reducing the number of platelets in the blood with an increased risk of bleeding or bruising;
impaired healing.
Uncommon (may affect up to 1 in 100 people):
opportunistic infections (including tuberculosis and other infections occurring in reducing the body's resistance to disease);
neurological infections (including viral meningitis);
infections of the joints;
eye infections;
bacterial infections;
diverticulitis (inflammation and infection of the large intestine);
cancer;
cancer affects the lymph system;
melanoma;
immune system disorders that may affect the lungs, skin and lymph nodes (often sarcoidosis);
vasculitis (inflammation of blood vessels);
tremor;
stroke;
neuropathy;
inflammation of the eyelids and eye swelling;
double vision;
hearing loss, tinnitus;
feelings of irregular beat, palpitations;
heart problems that can cause shortness of breath or swelling of the ankles;
heart attack;
saccular dilatation of the wall of a large artery, inflammation and clot in a vein, obstruction of a blood vessel;
lung diseases causing shortness of breath (including inflammation);
pulmonary embolism (blockage of an artery in the lungs);
pleural effusion (abnormal retention of fluid in the pleural cavity);
inflammation of the pancreas which causes severe pain in the abdomen and back;
difficulty swallowing;
swelling of the face;
inflammation of the gall bladder, gall bladder stones;
fatty degeneration of liver cells;
night sweats;
signs;
allocation (burst) of the abdominal muscles;
systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organ systems);
interrupted sleep (frequent awakenings);
impotence;
inflammations.
Rare (may affect up to 1 in 1000 people):
leukemia (cancer affecting the blood and bone marrow);
severe allergic reactions;
multiple sclerosis;
Nervous (inflammation of the optic nerve and Guillain-Barre syndrome, which can result in muscle weakness, altered sensation, numbness in the arms and upper body);
stop pumping blood from the heart;
pulmonary fibrosis (scarring of the lung);
intestinal perforation;
hepatitis;
reactivation of hepatitis B;
Autoimmune hepatitis (liver inflammation caused by the body's immune system);
cutaneous vasculitis (inflammation of blood vessels in the skin);
Stevens-Johnson (early symptoms include malaise, fever, headache, rash);
facial swelling associated with allergic reactions;
erythema multiforme (inflammatory skin rash);
lupus-like syndrome.
Not known (from the available data can not be estimated):
Hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Merkel cell carcinoma (a type of skin cancer);
Hepatic failure;
Deterioration of the condition, called dermatomyositis (affecting skin rashes accompanied by muscle weakness).
Some adverse events observed with Hyumira may not be related to the development of symptoms and can only be established by means of blood tests:
They include:
Very common (may affect more than 1 in 10 people):
low levels of white blood cells;
low levels of red blood cells;
elevated blood lipids;
elevated liver enzymes.
Common (may affect up to 1 in 10 people):
high levels of white blood cells;
low levels of blood platelets;
increase in uric acid in the blood;
violation in the values ​​of sodium in the blood;
low levels of calcium in the blood;
low levels of phosphate in the blood;
high blood sugar;
high levels of blood lactate dehydrogenase;
autoantibodies present in the blood.
Rare (may affect up to 1 in 1000 people):
low levels of white blood cells, red blood cells and platelets in the blood.
Not known (from the available data can not be estimated):
liver failure.
Adverse event reporting
If your child get any side effects, tell your child's doctor or pharmacist. This includes any possible effects not listed in this leaflet.
You can also report side effects directly via the national reporting system. By reporting side effects, you can do your bit for obtaining more information on the safety of this medicine.

5. How to store Humira
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the label / blister / carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze.
Keep the container in the outer carton to protect from light.
Do not dispose of medications in wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
Any unused product or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information
What Humira contains
The active substance is adalimumab.
The other ingredients are mannitol, citric acid, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
This product contains less than 1 mmol sodium (23 mg) per dose of 0,8 ml, ie virtually sodium-free and contains no preservatives.

How Humira vial looks like and contents of the pack
Humira 40 mg solution for injection in vials supplied in the form of a sterile solution containing 40 mg adalimumab dissolved in 0,8 ml of solution.
Humira vial is a glass vial containing a solution of adalimumab. Each pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle, 1 vial adapter and two alcohol pads.
Humira is also available as a prefilled syringe or prefilled pen.

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