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

Namaxir, 30 mg, solution for injection in a pre-filled syringe

Methotrexate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 side effects not listed in the 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 certain rapidly dividing cells in the body
• it reduces the activity of the immune system (the body's defense mechanism)
• it has an anti-inflammatory effect.

Indications for the 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, refractory, disabling psoriasis, in which a satisfactory response has not been achieved with phototherapy, PUVA therapy, and retinoids, and severe psoriatic arthritis in adult patients
• mild to moderate Crohn's disease in adult patients, when treatment with other medicines 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 the fingers and toes, with psoriatic lesions on the skin and nails.
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 significant 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 section "Pregnancy, breastfeeding, and fertility")
• if the patient is receiving a vaccine containing live microorganisms at the same time.

Warnings and precautions

Before starting to take Namaxir, the patient should discuss with their doctor or pharmacist:

• if the patient is elderly, frail, 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 the use of Namaxir
Methotrexate temporarily disrupts sperm and egg production, in most cases, this effect disappears. Methotrexate may cause miscarriage and severe birth defects. The patient should avoid becoming pregnant while taking methotrexate and for at least 6 months after stopping treatment. See also section "Pregnancy, breastfeeding, and fertility".
Recommended tests and safety measures
Severe side effects may occur even after administration of 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 rule out hepatitis. Additionally, the albumin (blood protein) level in the serum, liver inflammation (hepatitis 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 a small tissue sample to be taken from the liver for further examination.
Furthermore, the doctor will 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
• Respiratory system examination 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
Elderly patients treated with methotrexate should be closely monitored by the doctor to detect any side effects as early as possible.
Age-related liver and kidney function disorders, 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 pulmonary bleeding have been reported in patients with underlying rheumatologic disease. If the patient experiences hemoptysis (coughing up blood), they should immediately consult a 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). While taking Namaxir, live vaccines should not be administered.
During treatment with Namaxir, radiation-induced skin inflammation and sunburn (a "recall" reaction) may occur. Exposure to UV radiation during treatment with 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 side 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 a 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, have recently taken, or plan to take. This includes medicines that the patient will take in the future.
The effect of Namaxir may be influenced by the simultaneous administration of certain medicines, such as:

• antibiotics, such as tetracyclines, chloramphenicol, non-absorbable broad-spectrum antibiotics, penicillins, glycopeptides, sulfonamides, ciprofloxacin, and cephalothin (medicines used to prevent and treat certain infections)
• 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(diuretic medicines)
• 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 used to lower blood sugar levels.

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

Do not receive live vaccines.

Namaxir with food, drink, and alcohol

While taking 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, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before using this medicine.
Pregnancy
Namaxir should not be used if the patient is pregnant or trying to become pregnant. Methotrexate may cause birth defects, harm the unborn baby, 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 planning to become pregnant. If the patient is of childbearing age, it should be definitively confirmed that they are not pregnant before starting treatment, by taking appropriate measures, such as performing 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 throughout this time (see also section "Warnings and precautions").
If the patient becomes pregnant while taking the medicine or suspects they may be pregnant, they should consult a doctor as soon as possible. The patient should receive advice on the potential harmful effects of the treatment on the baby.
If the patient plans to become pregnant, they should consult their doctor, who may refer them to a specialist for advice before planned treatment begins.
Breastfeeding
The patient should not breastfeed while taking the medicine, as methotrexate passes into breast milk. If the doctor considers continued treatment with Namaxir necessary, the patient should stop breastfeeding.
Male fertility
Available evidence does not indicate an increased risk of birth defects or miscarriages after the father has taken methotrexate at a dose below 30 mg/week. However, the risk cannot be completely ruled out. Methotrexate may be genotoxic, meaning it may cause genetic mutations. Methotrexate may affect sperm and cause birth defects. Therefore, the patient should avoid impregnating their partner and should not donate sperm while taking methotrexate and for at least 6 months after stopping treatment.

Driving and using machines

While taking Namaxir, the patient may experience side effects such as fatigue and dizziness. Therefore, their 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 the medicine is considered "sodium-free".

3. How to use Namaxir

Important warning regarding Namaxir dosing (methotrexate):

In 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 may result in death. The patient should carefully read section 3 of this leaflet. 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 tailored to the individual patient.
The effects of the 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 the skin or mucous membranes. In case of contamination, the contaminated surface should be rinsed immediately with water.

Using a higher dose of Namaxir than recommended

The patient should follow the doctor's instructions for dosing. The patient should not change the dose of the medicine on their own.
If the patient suspects they have used a higher dose of Namaxir than they should have, they should immediately consult a 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 a 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 may occur even after administration of low doses of methotrexate, regular medical examinations 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 the liver and kidneys.
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], hepatitis (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 faint; these may be symptoms of severe allergic reactions or anaphylactic shock [rare]

Other side effects that may occur:

• 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, discomfort, pain, or throat soreness; methotrexate may increase the risk of infections; severe infections, such as a 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 sores, or urinary tract disorders; methotrexate may cause a significant decrease 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 side 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 area); 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 ulcers, nausea, vomiting, 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
• decreased blood cell production, leading to a decrease in white blood cells and/or red blood cells and/or platelets

Uncommon (may affect up to 1 in 100 people)

• pharyngitis
• enteritis, vomiting, pancreatitis, gastrointestinal bleeding, or gastrointestinal ulcers
• increased sensitivity to light, hair loss, increased number of rheumatoid nodules, skin ulcers, shingles, vasculitis, rash similar to herpes, hives
• onset of diabetes
• dizziness, confusion, depression
• decreased albumin levels in the blood
• decreased blood cell count, including platelets
• inflammation and ulceration of the bladder or vagina, impaired kidney function, urinary disorders
• joint pain, muscle pain, decreased bone density

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

• gingivitis, increased skin pigmentation, acne, petechiae (small blood spots on the skin), ecchymosis (bruising)
• decreased levels of certain antibodies in the blood
• infections (including reactivation of latent chronic infections), conjunctivitis (redness of the eyes)
• mood disorders
• vision disturbances
• pericarditis, pericardial effusion, or constrictive pericarditis
• low blood pressure
• pulmonary fibrosis, dyspnea, or asthma, pleural effusion
• stress fractures
• electrolyte disturbances
• fever, impaired wound healing

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

• acute toxic dilation of the colon (toxic megacolon)
• lymphoproliferative disorders (excessive production of white blood cells)
• increased nail pigmentation, paronychia (inflammation of the nail bed), severe folliculitis (inflammation of the hair follicles), or telangiectasia (visible small blood vessels)
• local damage (abscess formation, fat tissue changes) at the injection site
• pain, loss of muscle strength, or numbness, tingling, or altered sensation, metallic taste, seizures, paralysis, meningeal symptoms
• impaired vision, non-inflammatory eye disease (retinopathy)
• decreased libido, impotence, gynecomastia (breast enlargement in men), oligospermia (reduced sperm count), menstrual disorders, vaginal discharge
• lymph node enlargement (lymphoma)

Frequency not known (cannot be estimated from the available data)

• increased levels of certain white blood cells
• bone damage in the jaw (as a result of increased white blood cell production)
• nasal bleeding
• protein in the urine
• weakness
• skin redness and peeling
• swelling
• destruction of tissue at the injection site

Usually, the doses of Namaxir administered subcutaneously are well-tolerated locally. Only mild, local skin reactions (such as burning sensation, redness, swelling, discoloration, severe itching, pain) decreasing during treatment are usually observed.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 helps to gather more information on the safety of the medicine.

5. How to store Namaxir

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store the pre-filled syringes in the outer packaging to protect them 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 use. 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 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.
• Namaxir, 30 mg: Each pre-filled syringe containing 0.75 ml of solution contains 30 mg of methotrexate.
• 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, 30 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 type I glass, with a chlorobutyl rubber plunger and a polystyrene barrel with a fixed needle and alcohol pads 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 type I glass, with a chlorobutyl rubber plunger and a polystyrene barrel with a fixed needle and alcohol pads 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.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
To obtain more detailed 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 Warsaw, phone: (22) 345 93 00.

Manufacturer

Actavis Italy S.p.A.
Via Pasteur 10
20014 Nerviano (Milan)
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
MTX-ratiopharm 30 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
Namaxir 30 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: November 2022

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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

The patient should choose a well-lit, clean, and flat work surface.
Before starting, the patient should prepare the necessary items:

• 1 pre-filled syringe of Namaxir
• 1 alcohol pad (supplied with the packaging) The patient should wash their hands thoroughly. Before use, the patient should inspect the Namaxir syringe for visible defects (or cracks).

Injection site

The best injection sites are:

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

If another person is helping the patient with the injection, they can also inject into the back of the arm, just below the shoulder.
The patient should choose a different injection site each time. This helps to reduce the risk of irritation at the injection site.
The patient should never inject the medicine into an area that is painful, hardened, red, swollen, scarred, or stretch marked. In the case of psoriasis, the patient should not inject the medicine directly into raised, thickened, red, or scaly areas of the skin or lesions.
Injecting the solution:

• 1. Remove the pre-filled syringe of Namaxir from the packaging and read the leaflet carefully. The pre-filled syringe should be removed from the packaging at room temperature.
• 2. Clean the injection site. Choose an injection site and clean it with an alcohol pad (e.g., the one supplied with the packaging). Wait at least 60 seconds for it to dry.

• 3. Remove the plastic protective cap.

Carefully pull the plastic protective cap straight off the syringe. If the cap is stuck, the patient should pull it off while gently twisting.
Important:Do not touchthe needle of the Namaxir syringe!

• 4. Insert the needle

Using two fingers, the patient should 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. The patient should not try to remove it from the syringe before injecting, as this may cause some of the medicine to spill.
Pre-filled syringes without a needle protection system:

• 5. Inject the solution

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

To avoid needlestick injury, the patient should immediately put the needle back into its protective cap and gently press the cap into place.
Pre-filled syringes with a needle protection system:

• 5. Inject the solution

Insert the entire needle into the skin fold. Inject the solution under the skin, slowly pushing the plunger to the end of the syringe. Hold the skin fold stable until the injection is complete.
Carefully pull the needle out of the skin with a straight motion, keeping the finger on the plunger.

Activate the needle 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 Namaxir and the skin or mucous membranes. In case of contamination, the contaminated surface should be rinsed immediately with water.
If the patient or another person is accidentally stuck with the needle, they should immediately consult a doctor and not use that pre-filled syringe.

Disposal and preparation for use

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.