Namaxir

Package leaflet: Information for the user

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

• Keep this leaflet. 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform 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 using 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 defense 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 appropriate 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. Inflammation 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 five or more joints are affected within the first six months of the disease.
Psoriatic arthritis is joint inflammation, particularly affecting 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, diarrhea, 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 liver function disorders
• 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 sperm and egg cell production, an effect which in most cases is reversible. Methotrexate may cause miscarriage and serious congenital malformations. Women must avoid becoming pregnant during methotrexate treatment 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 tests and safety measures
Severe adverse effects may occur even after low doses of methotrexate. To detect them early, your doctor must perform laboratory tests and examinations.

Before treatment
Prior to initiating treatment, blood samples will be taken to confirm adequate blood cell counts. Blood will also be tested to assess liver function and to check for hepatitis. Additionally, serum albumin levels (a blood protein), signs of liver inflammation (liver infection), and kidney function will be evaluated. Your doctor may also decide to perform other liver function tests, some of which may involve imaging studies, while others may require taking a small tissue sample from the liver for further examination.

Furthermore, your doctor will check whether you have tuberculosis and may perform a chest X-ray or lung function test.

During treatment
Your doctor may carry out the following tests:

• Examination of the mouth and throat to detect mucosal changes such as inflammation or ulceration
• Blood test / complete blood count to assess blood cell counts and measure methotrexate serum concentration
• Blood test to monitor liver function
• Imaging test to monitor liver status
• Examination of a small liver tissue sample for 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 tests.
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 a doctor to detect any adverse effects as early as possible. Age-related impairments in liver and kidney function, as well as low folate stores in older patients, require relatively low doses of methotrexate.

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

Methotrexate may affect the immune system, vaccine responses, and immunological test results. It may reactivate latent chronic infections (e.g. shingles, tuberculosis, hepatitis B or C). Vaccines containing live microorganisms should not be used during treatment with Namaxir.

Methotrexate may increase skin sensitivity to sunlight. Exposure to intense sunlight should be avoided, and use of sunlamps or tanning beds is not recommended without consulting a doctor. To protect the skin from strong sunlight, wear appropriate clothing or use a high-protection sunscreen.

During treatment with Namaxir, skin flare-ups and radiation-induced sunburn ("recall reaction") may recur. UV irradiation 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, inform your 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 conditions.

If the patient, their partner or caregiver notices new onset or worsening neurological symptoms, including general muscle weakness, visual disturbances, changes in thinking, memory and orientation leading to disorientation and personality changes, medical advice should be sought immediately, 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
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take, including any future medications.

Particular attention should be paid to informing the doctor about the use of:

• 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 or salicylates (pain-relieving and/or anti-inflammatory medicines such as: acetylsalicylic acid, diclofenac and 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 (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 sugar levels)
• metamizole (synonyms: novaminsulfone and dipyrone) (strong analgesic and/or antipyretic).

Vitamin preparations containing folic acid should only be used if prescribed 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 a pregnancy, 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, e.g. a pregnancy test. The patient should 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 use at doses below 30 mg/week. However, a 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 be a sperm donor 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 the dosing of Namaxir (methotrexate):
In the treatment of rheumatoid arthritis, juvenile idiopathic arthritis,
psoriasis, psoriatic arthritis, and Crohn's disease, Namaxir must be used only once a week.
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 decide on the appropriate dose, which will be individually adjusted to the patient.
Therapeutic effects are usually noticeable only after 4–8 weeks.
Namaxir should be administered by a doctor or healthcare professional, or under their supervision, as subcutaneous injections only once a week. The day for administration should be agreed upon by the patient and the doctor.

Use in children and adolescents
The doctor will determine 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!
The duration of treatment is determined by the treating physician. Treatment with Namaxir for rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, and Crohn's disease is long-term.
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 pre-filled syringe.
The technique of administration 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
Always follow your doctor's instructions regarding dosage. Do not change the dose on your own.
If you suspect that a patient has taken more Namaxir than prescribed, contact a doctor immediately. The doctor will decide on the appropriate treatment 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 stop or discontinue treatment with Namaxir without consulting your doctor.
If you suspect serious 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency and severity of adverse reactions depend on the dose and frequency
of administration of the medicine. Since severe adverse reactions may occur even after administration of small
doses, regular medical examinations are necessary. Your treating physician will order
tests to rule out abnormalities in blood parameters (e.g. low
white blood cell count, platelets, and lymphoma) as well as changes in the liver and kidneys.
You should immediately inform your doctor if the patient experiences any of the following
symptoms, as they may indicate severe, potentially life-threatening adverse reactions
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 not known]
• symptoms of liver damage, such as yellowing of the skin and whites of the eyes; methotrexate may cause chronic liver damage (liver cirrhosis), formation of scar tissue in the liver (liver fibrosis), fatty degeneration of the liver (fatty liver) [all occur not very commonly], liver inflammation (acute hepatitis) [rare], and liver failure [very rare]
• symptoms 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]
• symptoms 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]
• symptoms 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 (Pneumocystis jirovecii pneumonia) or blood infection (septicaemia) [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 moving 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 symptoms; methotrexate may cause a marked decrease in certain white blood cells (agranulocytosis) and severe suppression of bone marrow function [very rare]
• unexpected bleeding, e.g. bleeding gums, blood in urine, vomiting blood, or bruising, which may be symptoms of a significant decrease in platelet count due to bone marrow suppression [very rare]
• symptoms such as severe headaches, often combined with 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 reactions cannot be excluded 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 problems [frequency not known]
• 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 (Lyell’s syndrome) [very rare]

Below are other adverse reactions 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
• enteritis, vomiting, pancreatitis, black or tarry stools, gastrointestinal ulceration and gastrointestinal bleeding
• sunburn-like reactions due to increased skin sensitivity to sunlight, hair loss, increase in number of rheumatoid nodules, skin ulcers, herpes zoster, vasculitis, herpes-like rash, urticaria
• onset of diabetes
• dizziness, confusion, depression
• decreased serum albumin concentration
• decreased number of all blood cells, including platelets
• inflammatory condition and ulceration of the bladder or vagina, impaired kidney function, urinary disorders
• joint pain, muscle pain, decreased bone mass

Rare (may affect up to 1 in 1000 people)

• gingivitis, increased skin pigmentation, acne, pinpoint skin bleeding spots (petechiae), allergic vasculitis
• decreased level of antibodies in blood
• infection (including reactivation of latent 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
• scarring of lung tissue (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, reduced response to stimuli, taste changes (metallic taste), seizures, paralysis, meningeal symptoms
• worsening of vision, non-inflammatory eye disease (retinopathy)
• decreased libido, impotence, breast enlargement in men (gynaecomastia), disturbances in semen production (oligospermia), menstrual disorders, vaginal discharge
• enlarged lymph nodes (lymphoma)

Frequency not known (cannot be estimated 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 damage at the injection site

Subcutaneous doses of Namaxir are generally well tolerated locally.
Mild local skin reactions (such as burning sensation, erythema, swelling,
discoloration, intense itching, pain) that diminish during treatment are usually observed.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
at the 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Namaxir

Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep the pre-filled syringes 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 specified month.
This medicine is for single use only. Any unused solution must 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
Namaxir pre-filled syringes 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 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 swabs, with or without a needle safety device (which protects against accidental needlestick injury).

Not all pack sizes may be marketed.

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

For further information about this medicine, contact the local 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 medicine is authorised for sale in the European Economic Area 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 15 mg injection solution in a pre-filled syringe

Croatia: Namaxir 7.5 mg solution for injection in a pre-filled syringe
Namaxir 10 mg solution for injection in a pre-filled syringe
Namaxir 15 mg solution for injection in a pre-filled syringe
Namaxir 20 mg solution for injection in a pre-filled syringe
Namaxir 25 mg solution for injection in a pre-filled syringe

Hungary: Namaxir 15 mg solution for injection in a pre-filled syringe
Namaxir 20 mg solution for injection in a pre-filled syringe
Namaxir 25 mg solution for injection in a pre-filled syringe

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

• 1 pre-filled syringe of Namaxir
• 1 alcohol 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 sites for injection are:

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

If another person is assisting the patient with the injection, the injection may also be given 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 directly into raised, thickened, red, flaky, or diseased skin areas.

Injecting the solution

1. Remove the Namaxir pre-filled syringe from its packaging and carefully read the leaflet. 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 swab. Wait at least 60 seconds for the area to dry.

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

4. Inserting the needle
   Use two fingers to create a skin fold and quickly insert the needle at a 90-degree angle into the skin.

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. Hold the skin fold firmly until the injection is complete.
   Carefully withdraw the needle from the skin in a straight motion.

To avoid needlestick injury, carefully use one hand to slide the needle back into the 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 that protects against accidental needlestick injury. The following instructions apply specifically to pre-filled 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. Hold the skin fold firmly until the injection is complete.
   Carefully withdraw the needle from the skin in a straight motion, keeping your finger on the plunger.

Activate the safety mechanism by firmly pressing the plunger, ensuring the needle is not pointing toward the patient or anyone else. The protective shield will automatically cover the needle, producing an audible click.

6. Immediately dispose of the syringe in 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.