Namaxir injection 10 mg. / 0.4 ml.

What is Namaxir and what it is used for
Namaxir contains methotrexate as active substance.

Methotrexate is a substance with the following properties:

inhibits the growth of certain cells in the body that are rapidly multiplying;
reduces the activity of the immune system (the body's own protective mechanism);
has anti-inflammatory action.
Namaxir is indicated for the treatment of:

active rheumatoid arthritis in adult patients;
polyarthritic forms of severe, active juvenile idiopathic arthritis that are not affected by non-steroidal anti-inflammatory drugs (NSAIDs);
severe, resistant psoriasis that is unaffected by other forms of therapy such as phototherapy, PUVA (type of phototherapy) and retinoids and severe psoriatic arthritis in adult patients;
mild to moderate Crohn's disease in adult patients when adequate treatment with other drugs is not possible.
Rheumatoid arthritis (RA) is chronic collagenosis, characterized by inflammation of the synovial membranes (joint membranes). These membranes form a fluid that acts as a lubricant for many joints. Inflammation causes thickening of the membrane and swelling of the joint.
Juvenile arthritis affects children and adolescents under 16 years of age. Polyarthritic forms are shown when affecting 5 or more joints during the first 6 months of the disease.
Psoriatic arthritis is a type of arthritis with psoriatic lesions on the skin and nails, especially the joints of the fingers and toes.
Psoriasis is a common chronic skin disease characterized by red plaques covered with thick, dry, silvery, clinging flakes.
Namaxir modifies and slows the progression of the disease.
Crohn's disease is a type of inflammatory bowel disease that can affect any part of the gastrointestinal tract and cause symptoms such as abdominal pain, diarrhea, vomiting, or weight loss.

2. What you need to know before using Namaxir
Do not use Namaxir if:

are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6);
suffer from severe liver or kidney disease or blood disorders;
regularly drink large amounts of alcohol;
you suffer from a severe infection, such as tuberculosis, HIV or other immune deficiency syndromes;
suffer from ulcers in the mouth, stomach or intestinal ulcer;
are pregnant or breast-feeding;
at the same time you are vaccinated with a live vaccine.
Warnings and precautions
Talk to your doctor or pharmacist before using Namakir if:

you are elderly or if you feel general malaise and weakness;
your liver function is impaired;
you suffer from dehydration (dehydration).
Recommended follow up reviews and safety precautions
Even when NAMAXIR is given in low doses, serious side effects may occur. In order to be found in time, you should have reviews and laboratory tests done by your doctor.

Before treatment
Before starting treatment, you will be given blood samples to check if you have enough blood cells to test your liver function, serum albumin (blood protein) and kidney function. Your doctor will also check if you are suffering from tuberculosis (an infectious disease in combination with small nodules in the affected tissue) and an x-ray of the chest.

During treatment
You will be given the following studies at least once a month during the first six months of the following:

Review of the mouth and throat for mucosal changes;
Blood tests;
Hepatic function check;
Verification of renal function;
Check the respiratory system and, if necessary, study the pulmonary function.
Methotrexate may affect your immune system and the vaccination results. It may also affect the outcome of immunological studies. Inactive, chronic infections (eg herpes zoster, tuberculosis, hepatitis B or C) can be activated. You should not be vaccinated with live vaccines during treatment with Namakir.
During treatment with methotrexate, repeated reactions of radiation-induced dermatitis and sunburn may occur. Psoriatic lesions may be exacerbated by UV irradiation and concomitant administration of methotrexate.
Larger lymph nodes (lymphoma) may occur and treatment should be stopped.
Diarrhea may be a toxic effect of NAMIXX and require discontinuation of treatment. If you suffer from diarrhea, please contact your doctor.
Cancer patients treated with methotrexate have been reported to be encephalopathy (brain disease) / leukoencephalopathy (especially white brain damage) and can not be excluded in the treatment of other methotrexate diseases.

Children
Namaxir is not recommended in children under the age of 3 due to lack of experience in this age group.

Other medicines and Namaxir
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
medicinal products that may have adverse effects on the bone marrow, for example trimethoprim-sulfamethoxazole (antibacterial) and pyrimethamine;
sulfasalazine (an antirheumatic drug);
azathioprine (an immunosuppressive agent that is sometimes used in severe forms of rheumatoid arthritis);
mercaptopurine (cytostatic agent);
retinoids (medicines against psoriasis and other skin diseases);
theophylline (a medicine against bronchial asthma and other lung diseases);
proton pump inhibitors (drugs for stomach problems);
hypoglycaemic agents (medicines used to lower blood sugar).
Vitamins containing folic acid may reduce the effect of treatment and should only be taken when recommended by your doctor.
Vaccination with a live vaccine should be avoided.

Namaxir with food, beverages and alcohol
During treatment with Namaksir, alcohol should be avoided as well as large amounts of coffee, non-alcoholic beverages containing caffeine and black tea.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine.
You should not use Namaxir during pregnancy. There is a risk of fetal harm and spontaneous abortion. Men and women should use an effective method of preventing pregnancy during treatment and another six months after discontinuation of Namakir treatment.
In women of childbearing age, sure pregnancy is to be ruled out, taking the necessary precautions, such as pregnancy test before treatment.
Since methotrexate may be genotoxic, it is recommended that all women who want to become pregnant should have genetic counseling if possible before treatment, and men should seek information about the possibility of semen storage prior to initiation of treatment.
Breastfeeding should be discontinued prior to and during treatment with Namakir.

Driving and using machines
Treatment with Namaxir may cause side effects that affect the central nervous system, such as tiredness and dizziness. In this way, the ability to drive and / or operate machinery in certain cases can be compromised.
If you feel tired or sleepy you should not drive or operate machinery.

Namaxir contains sodium
This medicinal product contains sodium less than 1 mmol (23 mg) per dose, ie practically does not contain sodium.

3. How to use Namaxir
Your doctor will determine the dose that is adjusted individually. It usually takes 4-8 weeks before any treatment effect is achieved.
Namaxir is given by or under the supervision of a doctor or medical staff in the form of an injection only once a week. Together with your doctor, you will determine the appropriate day of the week in which you will receive the injection every week. NAMIXIR should be injected subcutaneously (under the skin).
The doctor decides what is the appropriate dose in children and adolescents with polyarteritic forms of juvenile idiopathic arthritis.

Use in children
Namaxir is not recommended for use in children below 3 years of age due to lack of experience in this age group.

Method and duration of application
Namaxir is injected once a week!
The duration of treatment is determined by the attending physician. The treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis vulgaris, psoriatic arthritis and Crohn's disease with Namaksir is prolonged.
At the beginning of your treatment, Namaxir may be injected by medical personnel. In some cases, your doctor may decide to give you instructions on how to inject Nanaxir subcutaneously. You will then receive the appropriate training.
Under no circumstances should you try to inject Namaxir before you have received such training.
Please refer to the instructions for use at the end of the leaflet.
The manner of handling and disposal must be in accordance with local standard requirements as with other cytotoxic medicinal products. Pregnant women of medical staff should not work and / or administer Namakir.
Methotrexate should not come into contact with the surface of the skin or mucous membranes. In case of contamination, the affected area should be flushed thoroughly with water.

If you use more Nemaxir than you should
Follow your doctor's recommendations regarding the dosage. Do not change the dose yourself.
If you suspect that you have used too much Namaxir, contact your doctor immediately. He will decide on adequate treatment depending on the severity of the intoxication.

If you forget to use Namaxir
Do not take a double dose to make up for the missed dose. Ask your doctor for advice. Take the dose prescribed by your doctor as soon as possible and then every week.

If you stop using Namaxir
You should not interrupt or discontinue treatment
Here are other side effects that may occur:
Very common: may affect more than 1 in 10 people:

inflammation of the mouth, indigestion, nausea (feeling sick), loss of appetite;
increase in liver enzymes.
Common: may affect up to 1 in 10 people:

mouth ulcers, diarrhea;
rash, flushing, itching;
headache, fatigue, drowsiness;
decreased blood cell production with decreased white and / or red blood cells and / or platelets (leucopenia, anemia, thrombocytopenia).
Uncommon: may affect up to 1 in 100 people:

inflammation of the throat, inflammation of the intestine, vomiting;
increased sensitivity to light, hair loss, increased number of rheumatic nodes, herpes zoster, inflammation of the blood vessels, herpes-like skin rash, urticaria;
the occurrence of diabetes mellitus;
dizziness, confusion, depression;
decrease in serum albumin;
decreasing the number of blood cells and platelets;
inflammation and ulceration of the bladder or vagina, decreased kidney function, impaired urination;
joint pain, muscle pain, osteoporosis (reduction of bone mass).
Rare: may affect up to 1 in 1,000 people:

increased pigmentation of the skin, acne, blue spots due to bleeding from the vessels;
allergic inflammation of the blood vessels, fever, redness of the eyes, infection, wound healing, reduced blood counts;
visual disturbances;
inflammation of the sac around the heart, collecting fluid in the bag around the heart;
low blood pressure;
pulmonary fibrosis, dyspnoea and bronchial asthma, fluid collection in the envelope around the lung;
electrolyte disturbances.
Very rare: may affect up to 1 in 10,000 people:

heavy bleeding, toxic megacolon (acute toxic bowel enlargement);
increased nail pigmentation, keloid inflammation, furunculosis (deep hair follicle infection), visible enlargement of the small blood vessels;
local damage (formation of sterile abscess, changes in adipose tissue) at the site of injection after intramuscular or subcutaneous administration;
poor vision, pain, fatigue or tingling sensation or tingling in the hands and feet, changes in taste (metallic taste), convulsions, paralysis, severe headache with fever;
retinopathy (non-inflammatory eye disease);
loss of sexual desire, impotence, breast enlargement in men (gynecomastia), formation of defective spermatozoa, menstrual disorders, vaginal discharge;
enlarged lymph nodes (lymphoma).
Not known: frequency can not be estimated from the available data:

leukoencephalopathy (white brain disease).
Subcutaneous administration of methotrexate has good local tolerance. Only slight local skin reactions were observed which weakened during therapy.
How to store Namaxir
Keep out of the reach and sight of children.
Store below 25 ° C.
Store the pre-filled syringes in the carton to protect from light.
Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiry date refers to the last day of that month.
For single use only. Any unused solution should be discarded.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Namaxir contains:
The active substance is methotrexate.
Namaxir 2.5 mg: Each 0.33 ml pre-filled syringe contains 2.5 mg methotrexate. Namaxir 7.5 mg: Each pre-filled syringe of 0.30 ml contains 7.5 mg of methotrexate.
Namaxir 10 mg: Each pre-filled syringe of 0.40 ml contains 10 mg methotrexate.
 Namaxir 15 mg: Each pre-filled syringe of 0.38 ml contains 15 mg methotrexate.

The other ingredients are: sodium chloride, sodium hydroxide, water for injections.

What Namaxir looks like and contents of the pack
The pre-filled Nasamx syringes contain a clear, yellow-orange solution without visible particles.

Types of packaging
Pre-filled syringes Namaxir with a needle for subcutaneous injection are available in 1 and 4 syringe packs.
Not all pack sizes may be marketed.
Injection
Insert the needle completely into the crease of the skin. Inject the liquid under your skin by pushing the plunger slowly toward the bottom of the syringe. Keep the skin firm while the injection is complete.
Gently pull the needle straight up.
To avoid any injury, using one of your hands carefully put the needle back into the protective cap and gently push the cap back into place.

5. Injection
The pre-filled Nasraxer syringe is equipped with a protective needle protection system after use.
The following instructions are specific to this safety system and may differ from those for other injection systems.
Insert the needle completely into the crease of the skin. Inject the liquid under your skin by pushing the plunger slowly toward the bottom of the syringe. Keep the skin firm while the injection is complete.
Gently pull the needle straight up by holding your finger on the plunger.
Orient the needle away from yourself and other people, activate the protective system by pushing the plunger firmly. The protective cover will automatically cover the needle and a "click" will be heard, which will confirm the activation of the protection.

6. Immediately discard the syringe in the sharps container.
Methotrexate should not come into contact with the surface of the skin or mucous membrane. In case of contamination, the affected area should be flushed thoroughly with water.
If you or someone around you is injured by the needle, consult your doctor immediately and do not use this pre-filled syringe.

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