Namaxir

Leaflet accompanying the packaging: information for the user

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

Methotrexate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Namaxir and what is it used for
• 2. Important information before using Namaxir
• 3. How to use Namaxir
• 4. Possible side effects
• 5. How to store Namaxir
• 6. Contents of the packaging and other information

1. What is Namaxir and what is it used for

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

• it disrupts the growth of some rapidly dividing cells in the body
• it reduces the activity of the immune system (the body's defense mechanism)
• it has anti-inflammatory effects.

Indications for use of Namaxir:

• active rheumatoid arthritis in adult patients
• polyarticular forms of severe, active juvenile idiopathic arthritis, if the response to non-steroidal anti-inflammatory drugs (NSAIDs) is insufficient
• severe, disabling psoriasis, if an adequate response has not been achieved with phototherapy, PUVA therapy, and retinoids, and severe psoriatic arthritis in adult patients
• Crohn's disease with a mild to moderate course in adult patients, when treatment with other drugs is not possible.

Rheumatoid arthritis (RA) is a chronic disease classified as collagenosis, characterized by inflammation of the synovial membranes lining the joints. The synovial membranes produce fluid that acts as a lubricant for many joints. The inflammatory state causes thickening of the membranes and swelling of the joints.
Juvenile arthritis occurs in children and adolescents under the age of 16. The polyarticular form is diagnosed if the disease affects 5 or more joints within the first 6 months.
Psoriatic arthritis is inflammation of the joints, especially of the fingers and toes, with psoriatic skin and nail changes.
Psoriasis is a common chronic skin disease characterized by red patches covered with thick, dry, silvery, tightly adhering scales.
Namaxir modifies and slows down 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 large amounts of alcohol
• if the patient has severe infections, such as tuberculosis, HIV infection, or other immunodeficiency syndromes
• if the patient has stomach or intestinal ulcers
• if the patient is pregnant or breastfeeding (see "Pregnancy, breastfeeding, and fertility")
• if the patient is receiving a vaccine containing live microorganisms at the same time.

Warnings and precautions

Before starting treatment with Namaxir, the patient should discuss the following with their 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 been diagnosed with dehydration (lack of water in the body).

Special precautions for use of Namaxir
Methotrexate temporarily disrupts sperm and egg production, in most cases, this effect disappears. Methotrexate can cause miscarriage and severe birth defects. Women should avoid becoming pregnant while taking methotrexate and for at least 6 months after stopping treatment. Men taking methotrexate should avoid fathering a child while taking methotrexate and for at least 3 months after stopping treatment. See also "Pregnancy, breastfeeding, and fertility".
Recommended tests and safety measures
Severe side effects can occur even at low doses of methotrexate. To detect them in time, the doctor must perform tests and laboratory tests.
Before treatment
Before starting treatment, blood samples will be taken to confirm a sufficient number of blood cells. The blood will also be tested to check liver function and to see if the patient has hepatitis. Additionally, the level of albumin (a blood protein) in the serum, liver inflammation (liver infection), and kidney function will be checked. The doctor may also decide to perform other liver function tests, some of which may require imaging tests, and others may require taking a small tissue sample from the liver for further examination.
The doctor will also check if 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 changes in the mucous membranes such as inflammation or ulcers
• Blood test/morphology with blood cell count and measurement of methotrexate levels in the serum
• Blood test to monitor liver function
• Imaging test to monitor liver condition
• Examination of a small tissue sample taken from the liver for further examination
• Blood test to monitor kidney function
• Examination of the respiratory system and, if necessary, lung function test.

It is very important for the patient to attend all scheduled tests.
If the result of any of these tests is abnormal, the doctor will modify the treatment accordingly.
Elderly patients
Patients over 65 years of age treated with methotrexate should be closely monitored by their doctor to detect any adverse effects as early as possible.
Age-related disorders of liver and kidney function, as well as low folate stores in the elderly patient's body, require relatively low doses of methotrexate.
Other precautions
During treatment with methotrexate, cases of acute bleeding from the lungs have been reported in patients with underlying rheumatologic disease. If the patient experiences hemoptysis (coughing up blood), they should immediately consult their doctor.
Methotrexate may affect the immune system, vaccination results, and immunological test results. It may lead to the reactivation of latent chronic diseases (e.g., shingles, tuberculosis, hepatitis B or C). During treatment with Namaxir, vaccines containing live microorganisms should not be used.
Methotrexate may increase skin sensitivity to sunlight. The patient should avoid intense sun exposure and not use a sunbed or sunlamp without consulting their doctor. To protect the skin from intense sunlight, the patient should wear appropriate clothing or use a sunscreen with a high protection factor.
During treatment with Namaxir, a recurrence of radiation-induced skin inflammation and sunburn ("recall reaction") may occur. Exposure to UV radiation during concurrent use of Namaxir may exacerbate psoriatic lesions.
Lymph node enlargement (lymphoma) 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 the patient experiences diarrhea, they should inform their doctor.
In patients with cancer 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 or worsening neurological symptoms, including general muscle weakness, vision disturbances, changes in thinking, memory, and orientation leading to disorientation and personality changes, they should immediately consult their doctor, as these may be symptoms of a very rare, serious brain infection called progressive multifocal leukoencephalopathy (PML).

Children

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

Namaxir and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take in the future.
It is especially important to inform 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)
• penicillinsmay decrease methotrexate excretion, potentially increasing the risk of side effects
• non-steroidal anti-inflammatory drugs (NSAIDs)or salicylates(pain-relieving and/or anti-inflammatory medicines, such as acetylsalicylic acid, diclofenac, and ibuprofen or pyrazole)
• probenecid(used to treat gout)
• weak organic acids, such as loop diuretics(diuretics)
• medicines that may harm bone marrow, such as trimethoprim-sulfamethoxazole (an antibacterial agent) or pyrimethamine
• other medicines used to treat rheumatoid arthritis, such as leflunomide, sulfasalazine, and azathioprine
• mercaptopurine (a cytostaticmedicine)
• retinoids (medicines used to treat psoriasisand other skin diseases)
• theophylline (a medicine used to treat asthmaand other lung diseases)
• certain medicines used to treat stomach diseases, such as omeprazole and pantoprazole
• medicines that lower blood sugar levels(used to treat diabetes)
• metamizole (synonyms: novaminsulfone and dipyrone) (a strong pain-relievingand/or antipyreticmedicine).

Vitamin products containing folinic acidshould only be used if recommended by a doctor, as they may reduce the effect of methotrexate.

Do not receive live vaccinations.

Namaxir with food, drink, and alcohol

During treatment with Namaxir, the patient should avoid drinking alcohol and large amounts of coffee, caffeinated beverages, and black tea.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 birth defects, 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 very important that female patients of childbearing age do not take methotrexate if they are pregnant or plan to become pregnant. Before starting treatment, it must be confirmed that the patient is not pregnant, by taking appropriate measures, such as a pregnancy test. The patient should avoid becoming pregnant while taking methotrexate and for at least 6 months after stopping treatment, using reliable contraception methods during this time (see also "Warnings and precautions").
If the patient becomes pregnant during treatment or suspects they may be pregnant, they should consult their doctor as soon as possible. The patient should receive advice on the potential harmful effects of treatment on the child.
If the patient plans to become pregnant, they should consult their treating doctor, who may refer them to a specialist for advice before planned treatment begins.
Breastfeeding
Do not breastfeed during treatment, as methotrexate passes into breast milk. If the doctor considers continued treatment with Namaxir necessary, breastfeeding should be discontinued.
Male fertility
Available data do not indicate an increased risk of birth defects or miscarriages after the father has taken methotrexate at a dose below 30 mg/week. However, this risk cannot be entirely ruled out. Methotrexate may have genotoxic effects, meaning it may cause genetic mutations. Methotrexate may affect sperm and cause birth defects. Therefore, men should avoid fathering a child and should not donate sperm during treatment with methotrexate and for at least 3 months after stopping treatment.

Driving and using machines

During treatment with Namaxir, side effects such as fatigue and dizziness may occur. Therefore, the ability to drive vehicles or operate machinery may be impaired in some cases. If the patient experiences drowsiness or fatigue, they should not drive or operate machinery.

Namaxir contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to use Namaxir

Important warning regarding Namaxir dosing (methotrexate):

For the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, and Crohn's disease, Namaxir should be used only once a week.Using more Namaxir (methotrexate) than prescribed can be fatal. The patient should read section 3 of this leaflet carefully. If they have any questions, they should consult their doctor or pharmacist before taking the medicine.
This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The doctor will decide on the dosage, which is individualized for each patient.
The effects of treatment are usually visible only after 4-8 weeks.
Namaxir should be administered by a doctor or healthcare professional, or under their supervision, by subcutaneous injection only once a week. The day of injection should be determined by the patient in consultation with their doctor.

Use in children and adolescents

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

Method and time of administration

Namaxir is injected subcutaneously once a week!
The duration of treatment is determined by the doctor. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, and Crohn's disease with Namaxir is long-term.
Initially, Namaxir may be administered by medical personnel. However, the doctor may decide that the patient is able to self-administer subcutaneous injections of Namaxir. The patient will be properly trained in this regard. The patient should never attempt to self-administer the injection without prior training.
The patient should read the instructions at the end of the leaflet.
The patient should remember to use the entire contents.
The technique for handling and disposing of the medicine must be the same as for other cytostatic medicines and in accordance with local regulations. Pregnant healthcare workers should not prepare or administer Namaxir.
Avoid contact between methotrexate and skin or mucous membranes. In case of contamination, the affected area should be rinsed immediately with water.

Using more Namaxir than prescribed

The patient should follow the doctor's instructions regarding dosage. The patient should not change the dose of the medicine on their own.
If the patient suspects they have used more Namaxir than they should, they should immediately consult their doctor. The doctor will decide on the type of treatment to be taken, depending on the severity of the overdose.

Missing a dose of Namaxir

The patient should not take a double dose to make up for a missed dose. The patient should consult their doctor for advice.

Stopping treatment with Namaxir

The patient should not stop or discontinue treatment with Namaxir without consulting their doctor.
If the patient suspects severe side effects, they should immediately consult their doctor.
If the patient feels that Namaxir is too strong or too weak, they should inform their doctor or pharmacist.

4. Possible side effects

Like all medicines, Namaxir can cause side effects, although not everybody gets them.
The frequency and severity of side effects depend on the dose and frequency of administration of the medicine. Since severe side effects can occur even at low doses, regular medical check-ups are necessary. The doctor will order tests to rule out abnormalities in blood parameters (e.g., low white blood cell count, platelet count, and lymphoma) and changes in liver and kidney function.
The patient should immediately tell their doctorif they experience any of the following symptoms, as they may indicate severe, potentially life-threatening side effects that require urgent treatment:

• persistent dry cough without expectoration, shortness of breath, and fever; these may be symptoms of pneumonia [common]
• hemoptysis (coughing up blood), which may indicate pulmonary bleeding [unknown]
• symptoms of liver damage, such as yellowing of the skin and whites of the eyes; methotrexate may cause chronic liver damage (liver cirrhosis), scarring of liver tissue (liver fibrosis), fatty liver degeneration [all uncommon], acute liver inflammation (acute hepatitis) [rare], and liver failure [very rare]
• allergic reaction symptoms, such as skin rash, including red, itchy skin, swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and a feeling of impending fainting; these may be symptoms of severe allergic reactions or anaphylactic shock [rare]
• symptoms of kidney damage, such as swelling of hands, feet, or ankles, or changes in urine frequency, decreased urine output (oliguria), or absence of urine (anuria); these may be symptoms of kidney failure [rare]
• infection symptoms, such as fever, chills, pain, or sore throat; methotrexate may increase the risk of infections; severe infections, such as a certain type of pneumonia (Pneumocystis jirovecii pneumonia) or blood infection (sepsis), may occur [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 blood clot blocks a blood vessel (thromboembolic event)[rare]
• fever and severe deterioration of general health or sudden fever, which may be accompanied by sore throat or mouth and urinary disorders; methotrexate may cause significant reduction in the number of certain white blood cells (agranulocytosis) and severe bone marrow suppression [very rare]
• unexpected bleeding, such as gum bleeding, blood in urine, vomiting blood, or bruising, which may be symptoms of severe bone marrow suppression [very rare]
• symptoms such as severe headaches, often accompanied by fever, stiff neck, nausea, vomiting, disorientation, and sensitivity to light, which may indicate meningitis (aseptic meningitis) [very rare]
• in patients with cancer 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: altered consciousness, movement disorders, vision disturbances, or memory disturbances[unknown]
• severe skin rash or blisters on the skin (which may also occur in the mouth, eyes, and genital areas); these may be symptoms of conditions called Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome) [very rare]

Other side effects that may occur:

• very common(may affect more than 1 in 10 people)
• mouth inflammation, nausea, loss of appetite, abdominal pain
• abnormal liver function test results (ASAT, ALAT, bilirubin, alkaline phosphatase)

• common(may affect up to 1 in 10 people)
• mouth ulcers, diarrhea
• skin rash, redness, itching
• headache, fatigue, drowsiness
• reduced blood cell production, leading to a decrease in the number of white blood cells and/or red blood cells and/or platelets

• uncommon(may affect up to 1 in 100 people)
• pharyngitis
• enteritis, vomiting, pancreatitis, black or tarry stools, gastrointestinal bleeding
• reactions similar to sunburn, increased sensitivity of the skin to sunlight, hair loss, increased number of rheumatoid nodules, skin ulcers, shingles, vasculitis, erythema multiforme, hives
• onset of diabetes
• dizziness, confusion, depression
• decreased serum albumin levels
• decreased production of all blood cells, including platelets
• cystitis, urinary tract infections, kidney dysfunction, urinary disorders
• arthralgia, myalgia, decreased bone density

• rare(may affect up to 1 in 1,000 people)
• gingivitis, increased pigmentation of the nails, inflammation of the nail bed (paronychia), deep infection of the hair follicles (furunculosis), telangiectasia
• decreased levels of certain antibodies in the blood
• infections (including reactivation of latent chronic infections), conjunctivitis
• mood changes
• vision disturbances
• pericarditis, pericardial effusion, restrictive cardiomyopathy
• hypotension
• pulmonary fibrosis, dyspnea, asthma, pleural effusion
• stress fractures
• electrolyte disturbances
• fever, impaired wound healing

• very rare(may affect up to 1 in 10,000 people)
• acute toxic megacolon
• lymphoproliferative disorders (excessive production of white blood cells)
• increased pigmentation of the nails, inflammation of the nail bed (paronychia), deep infection of the hair follicles (furunculosis), visible dilation of small blood vessels
• local tissue damage (abscess formation, changes in fatty tissue) at the injection site
• pain, loss of muscle strength or a feeling of numbness or tingling, changes in taste (metallic taste), seizures, paralysis, meningeal symptoms
• worsening vision, non-inflammatory eye disease (retinopathy)
• decreased libido, impotence, gynecomastia in men, impaired sperm production (oligospermia), menstrual disorders, vaginal discharge
• lymph node enlargement (lymphoma)

• frequency unknown(cannot be estimated from available data)
• increased levels of certain white blood cells in the blood
• jawbone damage (due to excessive production of white blood cells)
• nasal bleeding
• protein in urine
• weakness
• redness and peeling of the skin
• swelling
• tissue destruction at the injection site

Subcutaneous injections of Namaxir are usually well-tolerated locally. Only mild local skin reactions (such as burning, redness, swelling, discoloration, intense itching, pain) that decrease during treatment are usually observed.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Namaxir

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store 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 month.
The medicine is for single use only. Any unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Namaxir contains

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

What Namaxir looks like and contents of the pack

The pre-filled syringes of Namaxir contain a clear, yellow-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 cartons, each with 4 pre-filled syringes, of 1 ml capacity, made of colorless glass type I, with a chlorobutyl rubber stopper and a polystyrene plunger with a fixed needle and alcohol-impregnated swabs with a needle protection system (which protects against accidental needlestick injury) or without a needle protection system.
Namaxir 15 mg
Namaxir is available in packs containing 1 or 4 pre-filled syringes or in multipacks containing 3 cartons, each with 4 pre-filled syringes, or 6 cartons, each with 1 pre-filled syringe, of 1 ml capacity, made of colorless glass type I, with a chlorobutyl rubber stopper and a polystyrene plunger with a fixed needle and alcohol-impregnated swabs with a needle protection system (which protects against accidental needlestick injury) or without a needle protection system.
Not all pack sizes may be marketed.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland
For more information on the medicine, the patient should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, 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 authorized in the Member States of the European Economic Area under the following names:

Austria:
MTX-ratiopharm 7.5 mg Injektionslösung in einer Fertigspritze
MTX-ratiopharm 10 mg Injektionslösung in einer Fertigspritze
MTX-ratiopharm 15 mg Injektionslösung in einer Fertigspritze
MTX-ratiopharm 20 mg Injektionslösung in einer Fertigspritze
MTX-ratiopharm 25 mg Injektionslösung in einer Fertigspritze
Germany:
MTX-ratiopharm 7.5 mg Injektionslösung in einer Fertigspritze
MTX-ratiopharm 10 mg Injektionslösung in einer Fertigspritze
MTX-ratiopharm 15 mg Injektionslösung in einer Fertigspritze
MTX-ratiopharm 20 mg Injektionslösung in einer Fertigspritze
MTX-ratiopharm 25 mg Injektionslösung in einer Fertigspritze
Bulgaria:
Namaxir 7.5 mg инжекционен разтвор в предварително напълнена спринцовка
Namaxir 10 mg инжекционен разтвор в предварително напълнена спринцовка
Namaxir 15 mg инжекционен разтвор в предварително напълнена спринцовка
Namaxir 15 mg инжекционен разтвор в предварително напълнена спринцовка
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 eloretöltött fecskendoben
Namaxir 20 mg oldatos injekció eloretöltött fecskendoben
Namaxir 25 mg oldatos injekció eloretöltött fecskendoben
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

Date of last revision of the leaflet: December 2024

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Instructions for use

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

Preparation

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

• 1 pre-filled syringe of Namaxir
• 1 alcohol swab (supplied with the packaging) Wash hands thoroughly. Before use, inspect the Namaxir syringe for visible defects (or cracks).

Injection Site

The best injection sites are:

• the upper part of the thigh,
• the abdomen, except for the navel area.

If another person is helping the patient with the injection, it can also be administered in the back of the hand, just below the shoulder. Each time, a different injection site should be chosen. This approach helps to reduce the risk of irritation at the injection site. Never inject the drug into a painful, swollen, red, hardened, scarred, or stretch-marked area. In the case of psoriasis, do not inject the drug directly into raised, thickened, red, or scaly skin areas or lesions. Injecting the solution

• 1. Remove the Namaxir drug ampoule-syringe from the packaging and read the leaflet carefully. The ampoule-syringe should be removed from the packaging at room temperature.
• 2. Clean the injection site. Choose an injection site and clean it with a swab moistened with a cleaning agent (e.g., the alcohol swab included in the packaging). Wait at least 60 seconds for it to dry.

• 3. Remove the protective plastic cap.

Gently pull the protective plastic cap off the syringe with a straight motion. If the cap is stuck, pull it off while gently twisting. Important: Do not touchthe ampoule-syringe needle!

• 4. Insert the needle

Using two fingers, create a skin fold and quickly insert the needle into the skin at a 90-degree angle.

Note: The presence of a small air bubble in the syringe is a normal phenomenon. Do not attempt to remove it from the syringe before administering the injection, as this may cause some of the drug to spill. <Ampoule-syringes without a needle protection system:>

• 5. Inject

Insert the entire needle into the skin fold. Inject the liquid under the skin, slowly pushing the plunger to the end of the syringe. Hold the skin fold stable until the injection is complete. Carefully withdraw the needle from the skin with a straight motion.

To avoid cutting yourself, carefully insert the needle back into the protective cap with one hand and gently press the cap into place. <Ampoule-syringes with a needle protection system:>

• 5. Inject

The Namaxir drug ampoule-syringes have a needle protection system that protects against accidental needlestick injury. The following instructions apply to ampoule-syringes equipped with this system and may differ from the instructions for other injection systems. Insert the entire needle into the skin fold. Inject the liquid under the skin, slowly pushing the plunger to the end of the syringe. Hold the skin fold stable until the injection is complete. Carefully withdraw the needle from the skin with a straight motion, keeping your finger on the plunger.

Activate the protection system by firmly pressing the plunger, making sure the needle is not pointing towards the patient or others. The protective cap will automatically cover the needle, making a clicking sound.

• 6. Immediately dispose of the syringe in a sharps container.

Avoid contact between the Namaxir drug and skin or mucous membranes. In case of contamination, immediately rinse the contaminated surface with plenty of water. If a patient or another person is accidentally stuck with the needle, immediately consult a doctor and do not use that ampoule-syringe.

Disposal and Preparation of the Drug for Use

The technique for handling and disposing of the drug should be similar to that for other cytostatic drugs and in accordance with local regulations. Pregnant medical staff should not prepare or administer the Namaxir drug.