Namaxir

Package leaflet: Information for the user

Namaxir, 7.5 mg, solution for injection in pre-filled syringe
Namaxir, 10 mg, solution for injection in pre-filled syringe
Namaxir, 15 mg, solution for injection in pre-filled syringe
Namaxir, 20 mg, solution for injection in pre-filled syringe
Namaxir, 25 mg, solution for injection in pre-filled syringe
Methotrexatum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Namaxir is and what it is used for
2. What you need to know before you use Namaxir
3. How to use Namaxir
4. Possible side effects
5. How to store Namaxir
6. Contents of the pack and other information

1. What Namaxir is and what it is used for

Namaxir contains the active substance methotrexate.
Methotrexate has the following properties:

• interferes with the growth of certain rapidly dividing cells in the body
• reduces the activity of the immune system (the body's defence mechanism)
• has anti-inflammatory effects.

Indications for Namaxir:

• active rheumatoid arthritis in adult patients
• polyarticular forms of severe, active juvenile idiopathic arthritis when response to non-steroidal anti-inflammatory drugs (NSAIDs) is inadequate
• severe, treatment-resistant, disabling psoriasis that has not responded adequately to phototherapy, PUVA therapy, and retinoids, and severe psoriatic arthritis in adult patients
• mild to moderate Crohn's disease in adult patients when adequate treatment with other medications is not possible.

Rheumatoid arthritis (RA) is a chronic disease classified as a collagenosis, characterized by inflammation of the synovial membranes lining the joints. These membranes produce fluid that acts as a lubricant for many joints. The inflammatory process causes thickening of the membranes and joint swelling.
Juvenile arthritis occurs in children and adolescents under the age of 16. The polyarticular form is diagnosed when the disease affects five or more joints within the first six months.
Psoriatic arthritis is joint inflammation, particularly in the fingers and toes, associated with psoriatic skin and nail changes.
Psoriasis is a common chronic skin disease characterized by red patches covered with thick, dry, silvery, tightly adherent scales.
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, causing symptoms such as abdominal pain, diarrhoea, vomiting, or weight loss.

2. Important information before using Namaxir

When not to use Namaxir:

• if the patient is allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6)
• if the patient has liver disease, severe kidney disease or blood disorders
• if the patient regularly consumes significant amounts of alcohol
• if the patient has severe infections, such as tuberculosis, HIV infection or other immunodeficiency syndromes
• if the patient has peptic ulcers or intestinal ulcers
• if the patient is pregnant or breastfeeding (see section "Pregnancy, breastfeeding and fertility")
• if the patient is simultaneously receiving a vaccine containing live microorganisms.

Warnings and precautions
Before starting treatment with Namaxir, discuss with your doctor or pharmacist:

• if the patient is elderly, weakened or in poor general health
• if the patient has impaired liver function
• if the patient has dehydration (lack of water in the body)
• if the patient has diabetes and is being treated with insulin.

Special precautions for using Namaxir
Methotrexate temporarily impairs the production of sperm and egg cells, although this effect usually resolves in most cases. Methotrexate may cause miscarriage and severe congenital malformations. Women must avoid becoming pregnant during treatment with methotrexate and for at least 6 months after treatment ends. Men undergoing methotrexate therapy should avoid impregnating their partner during treatment and for at least 3 months after treatment ends. See also section "Pregnancy, breastfeeding and fertility".

Recommended monitoring and safety measures
Severe adverse effects may occur even after administration of low doses of methotrexate. To detect them early, the doctor must perform laboratory tests and examinations.

Before treatment
Prior to initiating therapy, blood samples will be taken to confirm adequate blood cell counts. Blood will also be tested to assess liver function and to rule out hepatitis. Additionally, serum albumin levels (a blood protein), signs of liver inflammation (liver infection), and kidney function will be evaluated. The doctor may also decide to perform additional liver function tests, some of which may involve imaging studies, while others may require a small liver tissue sample (biopsy) for more detailed examination.

Furthermore, the doctor will check whether the patient has tuberculosis and may perform a chest X-ray or lung function test.

During treatment
The doctor may perform the following tests:

• Examination of the mouth and throat to detect mucosal changes such as inflammation or ulceration
• Blood test / complete blood count with assessment of blood cell counts and measurement of methotrexate serum concentration
• Blood test to monitor liver function
• Imaging test to monitor liver condition
• Examination of a small liver tissue sample for more detailed analysis
• Blood test to monitor kidney function
• Respiratory system examination and, if necessary, lung function tests.

It is very important that the patient attends all scheduled examinations.
If any of these test results are abnormal, the doctor will adjust the treatment accordingly.

Elderly patients
Elderly patients receiving methotrexate should be closely monitored by the doctor to detect any adverse effects as early as possible. Age-related impairments in liver and kidney function, as well as low body stores of folic acid in older patients, require relatively low doses of methotrexate.

Other precautions
Cases of acute pulmonary hemorrhage have been reported in patients with underlying rheumatologic diseases during methotrexate treatment. If the patient develops hemoptysis (coughing up blood-tinged sputum), immediate medical attention must be sought.

Methotrexate may affect the immune system, vaccination outcomes, and immunological test results. It may lead to reactivation of latent chronic infections (e.g., shingles, tuberculosis, hepatitis B or C virus). Vaccines containing live microorganisms must not be used during treatment with Namaxir.

Methotrexate may increase skin sensitivity to sunlight. Exposure to intense sunlight should be avoided, and use of solariums or tanning lamps is not recommended without prior consultation with a doctor. To protect the skin from strong sunlight, appropriate clothing should be worn or a high-protection sunscreen used.

During treatment with Namaxir, recurrence of skin inflammation and radiation-induced sunburn ("radiation recall reaction") may occur. UV exposure during concurrent treatment with Namaxir may worsen psoriatic lesions.

Lymph node enlargement (lymphadenopathy) may occur. In such cases, treatment should be discontinued.

Diarrhea may be a sign of toxic effects of Namaxir and requires discontinuation of treatment. If diarrhea occurs, the patient should inform the doctor.

In cancer patients receiving methotrexate, certain brain disorders (encephalopathy/leukoencephalopathy) have been reported. Such adverse effects cannot be ruled out when methotrexate is used to treat other diseases.

If the patient, their partner, or caregiver notices new onset or worsening of neurological symptoms, including general muscle weakness, visual disturbances, changes in thinking, memory, and orientation leading to disorientation and personality changes, immediate medical attention should be sought, as these may be symptoms of a very rare but serious brain infection called progressive multifocal leukoencephalopathy (PML).

Children
Namaxir is not recommended for children under 3 years of age due to insufficient experience in this age group.

Namaxir and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use. This includes all prescription and over-the-counter medicines.

Particular attention should be paid to the following medicines:

• Antibiotics, such as: tetracyclines, chloramphenicol, non-absorbable broad-spectrum antibiotics, penicillins, glycopeptides, sulfonamides, ciprofloxacin and cephalothin (medicines used to prevent and treat certain infections)
• Penicillins may reduce methotrexate excretion, potentially increasing adverse effects
• Non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates (pain-relieving and/or anti-inflammatory medicines, such as: acetylsalicylic acid, diclofenac, ibuprofen or pyrazolones)
• Probenecid (used in the treatment of gout)
• Weak organic acids such as loop diuretics (diuretic medicines)
• Medicines that may adversely affect bone marrow function, e.g. trimethoprim-sulfamethoxazole (a bactericidal agent) or pyrimethamine
• Other medicines used in the treatment of rheumatoid arthritis, such as: leflunomide, sulfasalazine and azathioprine
• Cyclosporine (used for immunosuppression)
• Mercaptopurine (a cytostatic medicine)
• Retinoids (medicines for psoriasis and other skin diseases)
• Theophylline (a medicine for bronchial asthma and other lung diseases)
• Some medicines used for stomach disorders, such as omeprazole and pantoprazole
• Hypoglycemic agents (medicines used to lower blood glucose levels)
• Metamizole (synonyms: novaminsulfone and dipyrone) (strong analgesic and/or antipyretic medicine).

Vitamin supplements containing folic acid should only be used if specifically recommended by a doctor, as they may reduce the effectiveness of methotrexate.

Live vaccines must not be administered.

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

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Do not use Namaxir if the patient is pregnant or trying to become pregnant. Methotrexate may cause congenital malformations, harm the unborn child, or cause miscarriage. This is associated with developmental abnormalities of the skull, face, heart and blood vessels, brain, and limbs. Therefore, it is extremely important that women who are pregnant or planning pregnancy do not take methotrexate. If the patient is of childbearing age, pregnancy must be definitively ruled out before starting treatment, using appropriate measures such as a pregnancy test. The patient must avoid becoming pregnant during methotrexate treatment and for at least 6 months after treatment ends, using reliable contraception methods throughout this period (see also section "Warnings and precautions").

If the patient becomes pregnant during treatment or suspects she may be pregnant, she should consult her doctor immediately. The patient should seek advice regarding the potential harmful effects of treatment on the child.

If the patient plans to become pregnant, she should consult her treating doctor, who may refer her to a specialist for advice before planned initiation of treatment.

Breastfeeding
Breastfeeding should not be continued during treatment, as methotrexate passes into breast milk. If the doctor considers continued treatment with Namaxir necessary, breastfeeding must be discontinued.

Male fertility
Available evidence does not indicate an increased risk of developmental abnormalities or miscarriages following paternal methotrexate exposure at doses below 30 mg/week. However, the risk cannot be completely excluded. Methotrexate may be genotoxic, meaning it may cause genetic mutations. Methotrexate may affect sperm and cause congenital malformations. Therefore, the patient should avoid impregnating his partner and must not donate sperm during methotrexate treatment and for at least 3 months after its completion.

Driving and operating machinery
During treatment with Namaxir, adverse effects on the central nervous system may occur, such as fatigue and dizziness. Therefore, the ability to drive motor vehicles and/or operate machinery may be reduced in some cases. If drowsiness or fatigue occurs, the patient should not drive or operate machinery.

Namaxir contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Namaxir

Important warning regarding Namaxir (methotrexate) dosing:
In the treatment of rheumatoid arthritis, juvenile idiopathic arthritis,
psoriasis, psoriatic arthritis, and Crohn's disease, Namaxir must be used once a week only.
Taking more Namaxir (methotrexate) than prescribed may result in death. Please read section 3 of this leaflet carefully. If you have any questions, consult your doctor or pharmacist before taking the medicine.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will determine the dosage, which is individually adjusted for each patient.
Therapeutic effects are usually observed only after 4–8 weeks.
Namaxir should be administered by a doctor or healthcare professional, or under their supervision, as subcutaneous injections once a week only. The day for injection should be agreed upon by the patient and the doctor.

Use in children and adolescents
The doctor will decide on the appropriate dose for children and adolescents with polyarticular juvenile idiopathic arthritis.
The use of Namaxir is not recommended in children under 3 years of age due to insufficient experience in this age group.

Method and timing of administration
Namaxir is administered subcutaneously once a week only!
The duration of treatment is determined by the treating physician. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, and Crohn's disease with Namaxir is long-term therapy.
At the beginning of treatment, Namaxir may be administered by medical personnel. However, the doctor may decide that the patient is capable of self-administering subcutaneous injections of Namaxir. The patient will be properly trained accordingly. Never attempt to self-inject without prior training.
Please refer to the instructions provided at the end of this leaflet.
Remember to use the entire contents of the syringe.
The technique for handling and disposal of the medicine must be consistent with that used for other cytotoxic drugs and in accordance with local regulations. Pregnant healthcare workers should not prepare or administer Namaxir.
Avoid contact of methotrexate with skin surfaces or mucous membranes. In case of contamination, the affected area should be immediately and thoroughly rinsed with water.

Accidental overdose of Namaxir
Follow your doctor's instructions regarding dosage. Do not change the dose without medical advice.
If you suspect that a patient has taken more Namaxir than prescribed, contact your doctor immediately. The doctor will decide on appropriate treatment measures depending on the severity of poisoning.

Missed dose of Namaxir
Do not take a double dose to make up for a missed dose. Consult your doctor for advice.

Stopping treatment with Namaxir
Do not interrupt or discontinue treatment with Namaxir without consulting your doctor.
If you suspect severe adverse reactions, seek medical advice immediately.
If the patient feels that Namaxir is too strong or not effective enough, they should inform their doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency and severity of adverse effects depend on the dose size and frequency of administration.
Since serious adverse effects may occur even after administration of small doses, regular medical examinations are necessary. Your doctor will order tests to rule out abnormalities in blood parameters (e.g. low white blood cell count, platelets and lymphocytes) and changes in the liver and kidneys.
You must inform your doctor immediately if the patient experiences any of the following symptoms, as they may indicate serious, potentially life-threatening adverse effects requiring urgent treatment:

• persistent dry cough without sputum, shortness of breath, and fever; these may be symptoms of lung inflammation [common]
• haemoptysis, i.e. coughing up blood-stained sputum, which may indicate bleeding from the lungs [frequency unknown]
• signs of liver damage, such as yellowing of the skin and whites of the eyes; methotrexate may cause chronic liver damage (liver cirrhosis), scar tissue formation in the liver (liver fibrosis), fatty degeneration of the liver (fatty liver) [all occur uncommonly], liver inflammation (acute hepatitis) [rare], and liver failure [very rare]
• signs of hypersensitivity, such as: skin rash, including red, itchy skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), and feeling faint; these may be symptoms of severe allergic reactions or anaphylactic shock [rare]
• signs of kidney damage, such as: swelling of the hands, ankles or feet, or change in frequency of urination, reduced urine volume (oliguria) or absence of urine (anuria); these may be symptoms of kidney failure [rare]
• signs of infection, e.g. fever, chills, soreness, sore throat; methotrexate may increase susceptibility to infections; severe infections may occur, such as a certain type of pneumonia (pneumonia caused by Pneumocystis jirovecii) or blood infection (sepsis) [rare]
• symptoms such as: weakness on one side of the body (stroke) or pain, swelling, redness and warmth in one leg (deep vein thrombosis); symptoms may occur if a travelling blood clot blocks a blood vessel (thromboembolic event) [rare]
• fever and severe worsening of general health or sudden fever accompanied by sore throat or mouth pain, or urinary tract disturbances; methotrexate may cause a significant decrease in certain white blood cells (agranulocytosis) and severe bone marrow suppression [very rare]
• unexpected bleeding, e.g. bleeding gums, blood in urine, vomiting blood or bruising, which may be symptoms of a significant decrease in platelets due to bone marrow suppression [very rare]
• symptoms such as severe headaches, often accompanied by fever, neck stiffness, nausea, vomiting, disorientation and sensitivity to light, which may indicate meningitis (acute aseptic meningitis) [very rare]
• in cancer patients receiving methotrexate, certain brain disorders (encephalopathy/leukoencephalopathy) have been reported; such adverse effects cannot be ruled out when methotrexate is used to treat other diseases; symptoms of these brain disorders may include: disturbance of consciousness, movement disorder (ataxia), visual disturbances or memory impairment [frequency unknown]
• severe skin rash or blisters on the skin (may also occur in the mouth, eyes and genital organs); these may be symptoms of conditions called Stevens-Johnson syndrome or toxic epidermal necrolysis (burn-like skin syndrome/Lyell’s syndrome) [very rare]

Below are other adverse effects that may occur:
Very common (may affect more than 1 in 10 people)

• inflammation of the mucous membrane of the mouth, indigestion, nausea, loss of appetite, abdominal pain
• abnormal liver function test results (AspAT, AlAT, bilirubin, alkaline phosphatase)

Common (may affect up to 1 in 10 people)

• ulceration of the mucous membrane of the mouth, diarrhoea
• rash, skin redness, itching
• headache, fatigue, drowsiness
• reduced blood cell production, leading to decreased numbers of white and/or red blood cells and/or platelets

Uncommon (may affect up to 1 in 100 people)

• sore throat
• intestinal inflammation, vomiting, pancreatitis, black or tarry stools, gastrointestinal ulceration and gastrointestinal bleeding
• sunburn-like reactions due to increased skin sensitivity to sunlight, hair loss, increased number of rheumatoid nodules, skin ulcers, shingles, vasculitis, herpes-like rash, urticaria
• onset of diabetes
• dizziness, confusion, depression
• decreased serum albumin concentration
• decreased number of all blood cells, including platelets
• inflammation and ulceration of the bladder or vagina, impaired kidney function, urinary disturbances
• joint pain, muscle pain, decreased bone mass

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

• gingivitis, increased skin pigmentation, acne, small blue spots on the skin due to bleeding from blood vessels (petechiae), allergic vasculitis
• decreased level of antibodies in the blood
• infection (including reactivation of inactive chronic infection), eye redness (conjunctivitis)
• mood disturbances
• visual disturbances
• pericarditis, fluid accumulation in the pericardium, restricted filling of the heart chamber due to fluid accumulation in the pericardium
• low blood pressure
• formation of scar tissue in the lungs (pulmonary fibrosis), shortness of breath and bronchial asthma, fluid accumulation in the pleura
• stress fracture
• electrolyte disturbances
• fever, impaired wound healing

Very rare (may affect up to 1 in 10,000 people)

• acute toxic dilation of the large intestine (toxic megacolon)
• lymphoproliferative disorders (overproduction of white blood cells)
• increased nail pigmentation, inflammation of the skin around the nails (acute paronychia), deep infection of hair follicles (furunculosis), visible enlargement of small blood vessels
• local tissue damage (formation of sterile abscess, changes in fatty tissue) at the injection site
• pain, loss of muscle strength or numbness or tingling sensation/weak response to stimuli, taste disturbances (metallic taste), seizures, paralysis, meningeal symptoms
• worsening of vision, non-inflammatory eye disease (retinopathy)
• decreased libido, impotence, breast enlargement in men (gynaecomastia), disturbances in sperm production (oligospermia), menstrual disorders, vaginal discharge
• enlarged lymph nodes (lymphadenopathy)

Frequency unknown (cannot be determined from available data)

• increased number of certain white blood cells
• jaw bone damage (due to overproduction of white blood cells)
• nosebleeds
• protein in urine
• weakness
• redness and peeling of the skin
• swelling
• tissue necrosis at the injection site

Subcutaneous doses of Namaxir are generally well tolerated locally. Usually, only mild, local skin reactions (such as burning sensation, erythema, swelling, discoloration, intense itching, pain) have been observed, which tend to diminish during treatment.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Namaxir

Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep the pre-filled syringe ampoules in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the stated month.
This medicine is for single use only. Any unused solution should be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Namaxir contains

• The active substance is methotrexate.
• Namaxir 7.5 mg: Each pre-filled syringe containing 0.30 ml of solution contains 7.5 mg of methotrexate.
• Namaxir 10 mg: Each pre-filled syringe containing 0.40 ml of solution contains 10 mg of methotrexate.
• Namaxir 15 mg: Each pre-filled syringe containing 0.38 ml of solution contains 15 mg of methotrexate.
• Namaxir 20 mg: Each pre-filled syringe containing 0.50 ml of solution contains 20 mg of methotrexate.
• Namaxir 25 mg: Each pre-filled syringe containing 0.63 ml of solution contains 25 mg of methotrexate.
• The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment) and water for injections.

What Namaxir looks like and contents of the pack
The pre-filled syringes of Namaxir contain a clear, yellowish-orange solution, free from visible particles.

Pack sizes
Namaxir 7.5 mg, 10 mg, 20 mg, 25 mg
Namaxir is available in packs containing 1 or 4 pre-filled syringes, or in multipacks containing 3 boxes each with 4 pre-filled syringes, each of 1 ml capacity made of colourless type I glass with a plunger made of chlorobutyl rubber and a polystyrene hub, fitted with a fixed needle and alcohol-impregnated swabs, with or without a needle safety device (which protects against accidental needlestick injury).

Namaxir 15 mg
Namaxir is available in packs containing 1 or 4 pre-filled syringes, or in multipacks containing 3 boxes each with 4 pre-filled syringes or 6 boxes each with 1 pre-filled syringe, each of 1 ml capacity made of colourless type I glass with a plunger made of chlorobutyl rubber and a polystyrene hub, fitted with a fixed needle and alcohol-impregnated swabs, with or without a needle safety device.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

For further information regarding this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland, tel. (22) 345 93 00.

Manufacturer
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
Via Morolense 87
03013 Ferentino (FR)
Italy

S.C. Sindan-Pharma S.R.L.
11 Ion Mihalache Blvd.
011171 Bucharest
Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: MTX-ratiopharm 7.5 mg Injection solution in a pre-filled syringe
MTX-ratiopharm 10 mg Injection solution in a pre-filled syringe
MTX-ratiopharm 15 mg Injection solution in a pre-filled syringe
MTX-ratiopharm 20 mg Injection solution in a pre-filled syringe
MTX-ratiopharm 25 mg Injection solution in a pre-filled syringe

Germany: MTX-ratiopharm 7.5 mg Injection solution in a pre-filled syringe
MTX-ratiopharm 10 mg Injection solution in a pre-filled syringe
MTX-ratiopharm 15 mg Injection solution in a pre-filled syringe
MTX-ratiopharm 20 mg Injection solution in a pre-filled syringe
MTX-ratiopharm 25 mg Injection solution in a pre-filled syringe

Bulgaria: Namaxir 7.5 mg injection solution in a pre-filled syringe
Namaxir 10 mg injection solution in a pre-filled syringe
Namaxir 15 mg injection solution in a pre-filled syringe
Namaxir 20 mg injection solution in a pre-filled syringe

Croatia: Namaxir 7.5 mg otopina za injekciju u napunjenoj štrcaljki
Namaxir 10 mg otopina za injekciju u napunjenoj štrcaljki
Namaxir 15 mg otopina za injekciju u napunjenoj štrcaljki
Namaxir 20 mg otopina za injekciju u napunjenoj štrcaljki
Namaxir 25 mg otopina za injekciju u napunjenoj štrcaljki

Hungary: Namaxir 15 mg oldatos injekció előretöltött fecskendőben
Namaxir 20 mg oldatos injekció előretöltött fecskendőben
Namaxir 25 mg oldatos injekció előretöltött fecskendőben

Poland: Namaxir

Romania: Namaxir 7.5 mg soluţie injectabilă în seringă preumplută
Namaxir 10 mg soluţie injectabilă în seringă preumplută
Namaxir 15 mg soluţie injectabilă în seringă preumplută
Namaxir 20 mg soluţie injectabilă în seringă preumplută
Namaxir 25 mg soluţie injectabilă în seringă preumplută

Instructions for use
Before starting self-injections, carefully read the instructions below and always follow the injection technique recommended by your doctor, pharmacist or nurse.
This medicine is for single use only. Any unused solution must be discarded.
The solution should be clear and free from solid particles.
If you have any problems or questions, consult your doctor, pharmacist or nurse.

Preparation
Choose a well-lit, clean and flat working surface.
Before starting, prepare the necessary items:

• 1 pre-filled syringe of Namaxir
• 1 alcohol-impregnated swab (supplied in the pack)

Wash your hands thoroughly. Before use, inspect the Namaxir pre-filled syringe for any visible defects (or cracks).

Injection site
The best places for injection are:

• The upper thigh,
• The abdomen, except the area around the navel.

If another person is assisting the patient with the injection, it may also be administered into the back of the upper arm.
Always choose a different injection site each time. This helps reduce the risk of irritation at the injection site.
Never inject the medicine into areas that are painful, bruised, red, hardened, scarred or have stretch marks. In psoriasis, do not inject the medicine directly into raised, thickened, red, flaky skin areas or skin lesions.

Injecting the solution

1. Remove the Namaxir pre-filled syringe from its packaging and read the leaflet carefully. The pre-filled syringe should be removed from the packaging at room temperature.
2. Cleaning the injection site
   Select the injection site and clean it with an alcohol-impregnated swab. Wait at least 60 seconds for the area to dry.

3. Remove the plastic protective cap.
   Carefully pull off the plastic protective sheath in a straight motion. If the sheath is difficult to remove, gently twist while pulling.
   Important: Do not touch the needle of the pre-filled syringe!

4. Inserting the needle
   Using two fingers, pinch a fold of skin and quickly insert the needle at a 90-degree angle.

Note: The presence of a small air bubble in the syringe is normal. Do not attempt to remove it before injection, as this may result in loss of some of the medicine.

< Pre-filled syringes without needle safety device: >

5. Injection
   Insert the entire needle into the skin fold. Inject the solution subcutaneously by slowly pressing the plunger fully down. Keep the skin fold firmly pinched until the injection is complete.
   Carefully withdraw the needle from the skin with a straight motion.

To avoid needlestick injury, carefully use one hand to slide the needle back into the protective cap and gently press the cap into place.

< Pre-filled syringes with needle safety device: >

5. Injection
   Namaxir pre-filled syringes are equipped with a needle safety device designed to protect against accidental needlestick injury. The following instructions apply specifically to syringes with this device and may differ from instructions for other injection systems.
   Insert the entire needle into the skin fold. Inject the solution subcutaneously by slowly pressing the plunger fully down. Keep the skin fold firmly pinched until the injection is complete.
   Carefully withdraw the needle from the skin with a straight motion, keeping your finger on the plunger.

Activate the safety mechanism by firmly pressing the plunger, ensuring the needle is not directed toward the patient or any other person. The protective shield will automatically cover the needle, producing an audible click.

6. Immediately dispose of the syringe into a sharps container.

Avoid contact of Namaxir with the skin surface or mucous membranes. If contamination occurs, immediately rinse the affected area thoroughly with water.
In case of accidental needlestick injury to the patient or another person, seek immediate medical advice and do not use that pre-filled syringe.

Disposal and preparation of the medicine for use
The handling and disposal of this medicine must be carried out in the same manner as for other cytotoxic medicines and in accordance with local regulations. Pregnant healthcare personnel should not prepare or administer Namaxir.