Metex

Leaflet accompanying the packaging: information for the user

Metex, 50 mg/ml, 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Metex and what is it used for

Metex contains methotrexate as the active substance.
Methotrexate is a substance with the following properties:

• it disrupts the growth of certain cells in the body that multiply rapidly;
• it limits the activity of the immune system (the body's own defense mechanism);
• it has anti-inflammatory effects.

Indications for use of Metex

• active rheumatoid arthritis in adult patients;
• polyarticular forms of severe, active juvenile idiopathic arthritis, if the response to non-steroidal anti-inflammatory drugs is insufficient;
• severe, refractory psoriasis, in which an satisfactory 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,
which acts as a lubricant for many joints. The inflammatory state causes thickening of the membranes and swelling of the joints.
Juvenile arthritisoccurs in children and adolescents under the age of 16. The polyarticular form is indicated by the involvement of 5 or more joints within the first 6 months
of the disease.
Psoriatic arthritisis a type of arthritis with psoriatic changes
on the skin and nails, which particularly affects the joints of the fingers and toes.
Psoriasis, a common chronic skin disease, is characterized by red patches covered with thick, dry, silvery, tightly adhering scales.
Metex modifies and slows down the progression of the disease.
Crohn's diseaseis 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 Metex

When not to use Metex

• if the patient is allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver, kidney, or blood disease;
• if the patient regularly consumes large amounts of alcohol;
• if the patient has severe infections, such as tuberculosis, HIV infection, or other immune deficiency syndromes;
• if the patient has ulcers in the mouth, stomach, or intestines;
• 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 Metex, 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);
• if the patient has diabetes and is being treated with insulin.

Special precautions for use of Metex
Methotrexate temporarily disrupts the production of sperm and egg cells; in most cases, this effect disappears. Methotrexate may cause miscarriage and severe birth defects. Women should avoid becoming pregnant while taking methotrexate and for at least 6 months after stopping treatment. Men should avoid fertilizing their partner while taking methotrexate and for at least 3 months after stopping treatment. See also "Pregnancy, breastfeeding, and fertility".
Recommended tests and precautions
Severe side effects may occur even after administration of low doses of methotrexate. To detect them in time, the doctor must perform regular check-ups and laboratory tests.
Before starting treatment
Before starting treatment, a blood test will be performed to check if the patient has a sufficient number of blood cells. Blood tests will also be performed to assess liver function and check for hepatitis. Additionally, the level of albumin (a blood protein) in the serum and kidney function will be checked, and an assessment for hepatitis (liver infection) will be performed. The doctor may also decide to perform other liver tests, which may include liver imaging or taking a small tissue sample from the liver for a more detailed assessment. Furthermore, the doctor may 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 for mucosal changes, such as inflammation or ulcers;
• blood tests to monitor the level of methotrexate in the blood;
• blood tests to monitor liver function;
• imaging tests to monitor the condition of the liver;
• taking a small tissue sample from the liver for a more detailed assessment;
• blood tests to monitor kidney function;
• tests to monitor the respiratory system and, if necessary, lung function tests.

It is very important for the patient to attend these scheduled tests.
If the results of any of these tests show abnormalities, the doctor will adjust the treatment accordingly.
Elderly patients
Elderly patients treated with methotrexate should be closely monitored by their doctor to quickly detect any possible side effects.
Age-related disorders of liver and kidney function and low folate reserves in the body of older individuals require the use of 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, they should immediately consult their doctor.
Methotrexate may affect the immune system, vaccination results, and immunological test results. There may be reactivation of latent chronic diseases (e.g., shingles, tuberculosis, hepatitis B or C). During treatment with Metex, live vaccines should not be used.
Methotrexate may increase the sensitivity of the skin 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 methotrexate, radiation-induced skin inflammation and sunburn (recall reaction) may occur. Exposure to UV radiation during methotrexate treatment 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 Metex and requires discontinuation of treatment. If the patient experiences diarrhea, they should tell their doctor.
In patients with cancer receiving methotrexate treatment, certain brain function disorders (encephalopathy/leukoencephalopathy) have been reported. It cannot be excluded that such side effects may occur in the treatment of other diseases. The symptoms of these brain function disorders include altered mental state, movement disorders (ataxia), vision disorders, and memory disorders[unknown frequency].

Metex 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. This includes medicines that will be taken in the future.
Concomitant administration of certain medicines may affect the action of Metex:

• antibiotics, e.g., 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 drugsor salicylates(pain-relieving and/or anti-inflammatory medicines, e.g., acetylsalicylic acid, diclofenac, and ibuprofen or pyrazole);
• metamizole (synonyms: novaminsulfone and dipyrone) (a strong pain-relieving and/or antipyretic medicine);
• probenecid(used to treat gout);
• weak organic acids such as loop diuretics(diuretic medicines);
• medicines that may harm bone marrowfunction, e.g., trimethoprim-sulfamethoxazole (a bactericidal substance) or pyrimethamine;
• other medicines used to treat rheumatoid arthritis, e.g., leflunomide, sulfasalazine, and azathioprine;
• cyclosporine (an immunosuppressive medicine);
• mercaptopurine (a cytostatic medicine);
• retinoids (medicines for psoriasisand other skin diseases);
• theophylline (a medicine for asthmaand other lung diseases);
• certain medicines used to treat stomach diseases, e.g., omeprazole and pantoprazole;
• medicines that lower blood sugar levels (hypoglycemic medicines).

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

Avoid live vaccines.

Metex with food, drink, and alcohol

While taking Metex, the patient should avoid drinking alcohol and large amounts of coffee, caffeinated beverages, and black tea.

Pregnancy, breastfeeding, and fertility

Pregnancy
Metex should not be used if the patient is pregnant or trying to become pregnant. Methotrexate may cause birth defects, harm the unborn child, or cause miscarriage.
This is related to developmental abnormalities of the skull, face, heart, and blood vessels, brain, and limbs. Therefore, it is very important that female patients who are pregnant or planning to become pregnant do not take methotrexate. If the patient is of childbearing age, it must be definitively confirmed that she is not pregnant before starting treatment, by taking appropriate measures, e.g., performing a pregnancy test.
The patient should avoid becoming pregnant while taking methotrexate and for at least 6 months after stopping treatment, using reliable contraceptive methods throughout this time (see also "Warnings and precautions").
If the patient becomes pregnant while taking methotrexate or suspects that she may be pregnant, she should consult her doctor as soon as possible. The patient should receive advice on the possible harmful effects of treatment on the child.
If the patient plans to become pregnant, she should consult her doctor, who may refer her to a specialist for advice before starting treatment.
Breastfeeding
Breastfeeding should be discontinued before starting and during treatment with Metex.
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 entirely excluded. Methotrexate may be genotoxic, meaning it may cause genetic mutations. Methotrexate may affect sperm and cause birth defects. Therefore, the patient should avoid fertilizing their partner and should not donate sperm while taking methotrexate and for at least 3 months after stopping treatment.

Driving and using machines

While taking Metex, the patient may experience side effects from the central nervous system, such as fatigue and dizziness. Therefore, the ability to drive vehicles or operate machines may be impaired in some cases.
In case of drowsiness or fatigue, the patient should not drive vehicles or operate machines.

Metex contains sodium

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

3. How to use Metex

Important warning regarding Metex dosing (methotrexate):

In the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, and Crohn's disease, Metex should be used only once a week. Using more Metex (methotrexate) than prescribed may 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 using the medicine.
This medicine should be used 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 will be tailored to the individual patient.
The effects of treatment are usually visible only after 4-8 weeks.
Metex should be administered by a doctor or medical staff 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.
Metex 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

Metex 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 Metex is long-term.
Initially, Metex may be administered by medical staff. However, the doctor may decide that the patient is able to self-administer Metex subcutaneously. The patient will be properly trained in this regard.
The patient should never attempt to self-administer the medicine without prior training.
The patient should read the instructions at the end of the leaflet.
The technique for administration and disposal must be the same as for other cytostatic medicines and in accordance with local regulations. Pregnant women should not handle or administer Metex.
Avoid contact between methotrexate and skin or mucous membranes. In case of contamination, the affected area should be rinsed immediately with plenty of water.

Using a higher dose of Metex than recommended

If the patient has used a higher dose of Metex than recommended, they should immediately consult their doctor.

Missing a dose of Metex

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Metex

If the patient stops taking Metex, they should immediately inform their doctor.
If the patient feels that the effect of Metex is too strong or too weak, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Metex 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 check-ups are necessary. The treating doctor should 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;this may be a symptom of pulmonary bleeding [unknown frequency]
• symptoms of liver damage, such as yellowing of the skin and 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, ankles, or feet, or changes in urine frequency or volume (oliguria or 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) and sepsis, may occur [rare]
• symptoms such as weakness on one side of the body (stroke) or pain, swelling, redness, and unusual warmth in one leg (deep vein thrombosis) This can 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;methotrexate may cause severe reduction of certain white blood cells (agranulocytosis) and severe bone marrow suppression [very rare]
• unexpected bleeding, such as bleeding from the gums, blood in the urine, or vomiting blood or appearance of blood blisters;these may be symptoms of severe bone marrow suppression [very rare]
• symptoms such as severe headache with fever, stiff neck, nausea, vomiting, disorientation, and sensitivity to lightmay indicate meningitis (aseptic meningitis) [very rare]
• in patients with cancer receiving methotrexate treatment, certain brain function disorders (encephalopathy/leukoencephalopathy) have been reported. It cannot be excluded that such side effects may occur in the treatment of other diseases. The symptoms of these brain function disorders include altered mental state, movement disorders (ataxia), vision disorders, and memory disorders[unknown frequency]
• severe skin rash or blisters on the skin (which may also occur in the mouth, eyes, and genitals);these may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome) [very rare]

Other side effects that may occur:

Very common:may occur in more than 1 in 10 people

• mouth ulcers, nausea, vomiting, decreased appetite, abdominal pain,
• abnormal liver test results (AST, ALT, bilirubin, alkaline phosphatase).

Common:may occur in up to 1 in 10 people

• mouth ulcers, diarrhea,
• skin rash, redness, itching,
• headache, fatigue, drowsiness,
• decreased production of blood cells, leading to a decrease in white blood cells and/or red blood cells and/or platelets.

Uncommon:may occur in up to 1 in 100 people

• pharyngitis,
• enteritis, vomiting, pancreatitis, black or tarry stools, gastrointestinal bleeding and ulcers,
• reactions similar to sunburn, increased sensitivity of the skin to sunlight, hair loss, increased number of rheumatoid nodules, skin ulcers, shingles, vasculitis, rash similar to herpes, hives,
• diabetes mellitus,
• dizziness, confusion, depression,
• decreased serum albumin levels,
• decreased blood cell count and platelet count,
• inflammation and ulcers of the bladder or vagina, kidney function disorders, urinary disorders,
• joint pain, muscle pain, decreased bone density.

Rare:may occur in up to 1 in 1,000 people

• gingivitis,
• increased pigmentation of the skin, acne, blue spots on the skin due to bleeding from blood vessels (petechiae, ecchymoses), allergic vasculitis,
• decreased levels of antibodies in the blood,
• infections (including latent chronic infections), conjunctivitis,
• mood changes (mood swings),
• vision disorders,
• pericarditis, pericardial effusion, constrictive pericarditis,
• low blood pressure,
• pulmonary fibrosis, dyspnea, asthma,
• pleural effusion,
• stress fractures,
• electrolyte disorders,
• fever, impaired wound healing.

Very rare:may occur in up to 1 in 10,000 people

• acute toxic dilation of the intestine (toxic megacolon),
• increased pigmentation of the nails, acute paronychia, deep infection of hair follicles (furunculosis), visible dilation of small blood vessels,
• local damage (formation of a sterile abscess, changes in fatty tissue) at the injection site,
• pain, loss of muscle strength or feeling of numbness or tingling, metallic taste, seizures, paralysis, meningeal reaction,
• impaired vision, non-inflammatory eye disease (retinopathy),
• decreased libido, impotence, gynecomastia in men, disorders of sperm production (oligospermia), menstrual disorders, vaginal discharge,
• lymphoma,
• lymphoproliferative disorders (overproduction of white blood cells).

Frequency not known:frequency cannot be estimated from the available data

• increased white blood cell count,
• nosebleeds,
• proteinuria,
• fatigue,
• bone damage in the jaw (due to overproduction of white blood cells),
• destruction of tissue at the injection site,
• redness and peeling of the skin,
• edema.

Subcutaneously administered doses of methotrexate are generally well tolerated locally. Only mild, local skin reactions have been observed, which decrease during treatment.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309,
website: //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 Metex

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Pre-filled syringes should be stored in the outer carton to protect from light.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Metex contains

• The active substance of Metex is methotrexate. 1 ml of the solution contains methotrexate disodium equivalent to 50 mg of methotrexate.
• The other ingredients are sodium chloride, sodium hydroxide, and water for injections.

What Metex looks like and contents of the pack

Metex pre-filled syringes contain a clear, yellow-brown solution. The syringe is equipped with a safety device that protects against needlestick injury and prevents reuse.
The following pack sizes are available:
Pre-filled syringes with fixed needles for subcutaneous injection and graduation mark, packaged in blisters containing 0.15 ml, 0.20 ml, 0.25 ml, 0.30 ml, 0.35 ml, 0.40 ml, 0.45 ml, 0.50 ml, 0.55 ml, or 0.60 ml of the solution for injection in packs of 1, 4, 5, 6, 10, 11, 12, and 24 pre-filled syringes with a safety device.
Pre-filled syringes with fixed needles for subcutaneous injection and graduation mark, packaged in blisters containing 0.15 ml, 0.20 ml, 0.25 ml, 0.30 ml, 0.35 ml, 0.40 ml, 0.45 ml, 0.50 ml, 0.55 ml, or 0.60 ml of the solution for injection in calendar packs of 6 or 12 pre-filled syringes with a safety device.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Phone:
+49 4103 8006-0
Fax:
+49 4103 8006-100

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Czech Republic, Finland, Greece, Spain, Netherlands, Iceland, Slovakia, Slovenia, Sweden, Hungary: Metoject
Denmark, Estonia, Lithuania, Latvia, Norway, Poland, and Portugal: Metex
Germany: metex
Italy: Reumaflex
Date of last revision of the leaflet:2024-08-28

Instructions for subcutaneous injection

Metex should be administered by subcutaneous injection only once a week. Before starting the injection, the patient should read the instructions below carefully and always follow the injection technique recommended by their doctor, pharmacist, or nurse.
In case of any doubts or questions, the patient should consult their doctor, pharmacist, or nurse.

Preparation

Choose a well-lit, clean, and flat work surface.
Wash hands thoroughly.
Remove the Metex pre-filled syringe from the packaging and read the leaflet carefully. The pre-filled syringe should be removed from the packaging at room temperature.
Before use, inspect the Metex syringe for visible defects (or cracks).
A small air bubble may be visible in the solution, which will not affect the dose or be harmful.

Injection site

The best injection sites are:

Areas for subcutaneous injections

• 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 upper outer part of the arm, just below the shoulder.
• Each time, a different injection site should be chosen.

Abdomen

This approach helps to minimize the risk of irritation at the injection site.

• Never inject the medicine into an area that is painful, bruised, red, hard, scarred, or stretch marked. In the case of psoriasis, do not inject the medicine directly into raised, thickened, red, or scaly areas of the skin or lesions.
  Injecting the solution

  Abdomen

  Thigh

  • 1. Choose the injection site and clean the area around the chosen site with soap and water or a disinfectant.
  • 2. Remove the plastic protective cap Carefully remove the gray plastic protective cap from the syringe by pulling it straight off. If the cap is difficult to remove, twist it slightly while pulling. Important: do nottouch the needle of the pre-filled syringe!

  Warning: the injection should be performed immediately after removing the cap.

  
  • 3. Inserting the needle

  Hold a fold of skin between two fingers and quickly insert the needle into the skin at a 90-degree angle.

  
  • 4. Injection

  Insert the needle fully into the skin fold. Slowly press the plunger and inject the solution under the skin. Hold the skin fold until the injection is complete.
  Carefully pull the needle out of the skin with a straight motion.

  
  • 5. Dispose of the used syringe with the needle in a sharps container. Do not dispose of it in a household waste bin.

  Methotrexate should not come into contact with skin or mucous membranes. In case of contact, the affected area should be rinsed immediately with plenty of water.
  In case of needlestick injury to the patient or another person, they should immediately consult their doctor and not use the pre-filled syringe.

  Disposal and preparation for use

  The method of preparing the medicine for use and disposing of the medicine and pre-filled syringe must be in accordance with local regulations. Pregnant healthcare workers should not prepare or administer Metex.

  Instructions for subcutaneous injection

  Metex should be administered by subcutaneous injection only once a week. Before starting the injection, the patient should read the instructions below carefully and always follow the injection technique recommended by their doctor, pharmacist, or nurse.
  In case of any doubts or questions, the patient should consult their doctor, pharmacist, or nurse.

  Preparation

  Choose a well-lit, clean, and flat work surface.
  Wash hands thoroughly.
  Remove the Metex pre-filled syringe with a safety device from the packaging and read the leaflet carefully. The pre-filled syringe should be removed from the packaging at room temperature.
  Before use, inspect the Metex syringe for visible defects (or cracks).
  A small air bubble may be visible in the solution, which will not affect the dose or be harmful.

  Injection site

  Areas for subcutaneous injections

  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 upper outer part of the arm, just below the shoulder.
  • Each time, a different injection site should be chosen.

  Abdomen

  This approach helps to minimize the risk of irritation at the injection site.

  • Never inject the medicine into an area that is painful, bruised, red, hard, scarred, or stretch marked. In the case of psoriasis, do not inject the medicine directly into raised, thickened, red, or scaly areas of the skin or lesions.
    Injecting the solution

    Abdomen

    Thigh

    • 1. Choose the injection site and clean the area around the chosen site with soap and water or a disinfectant.
    • 2. Remove the plastic protective cap Carefully remove the gray plastic protective cap from the syringe by pulling it straight off. If the cap is difficult to remove, twist it slightly while pulling. Important: do nottouch the needle of the pre-filled syringe!

    Warning: the injection should be performed immediately after removing the cap.

    
    • 3. Inserting the needle

    Hold a fold of skin between two fingers and quickly insert the needle into the skin at a 90-degree angle.

    
    • 4. Injection

    Insert the needle fully into the skin fold. Slowly press the plunger and inject the solution under the skin.

    
    • 5. Removing the needle
    

    Hold the skin fold until the injection is complete.
    Carefully pull the needle out of the skin with a straight motion.
    The protective cap automatically covers the needle.
    Note: The safety mechanism will only work if the syringe is fully emptied by pressing the plunger down to the stop.

    • 6. Dispose of the used syringe with the needle in a sharps container. Do not dispose of it in a household waste bin.

    Methotrexate should not come into contact with skin or mucous membranes. In case of contact, the affected area should be rinsed immediately with plenty of water.
    In case of needlestick injury to the patient or another person, they should immediately consult their doctor and not use the pre-filled syringe.

    Disposal and preparation for use

    The method of preparing the medicine for use and disposing of the medicine and pre-filled syringe must be in accordance with local regulations. Pregnant healthcare workers should not prepare or administer Metex.