Methotrexate ever pharma

Package leaflet: Information for the user

Methotrexate EVER Pharma, 7.5 mg, solution for injection in pre-filled syringe
Methotrexate EVER Pharma, 10 mg, solution for injection in pre-filled syringe
Methotrexate EVER Pharma, 12.5 mg, solution for injection in pre-filled syringe
Methotrexate EVER Pharma, 15 mg, solution for injection in pre-filled syringe
Methotrexate EVER Pharma, 17.5 mg, solution for injection in pre-filled syringe
Methotrexate EVER Pharma, 20 mg, solution for injection in pre-filled syringe
Methotrexate EVER Pharma, 22.5 mg, solution for injection in pre-filled syringe
Methotrexate EVER Pharma, 25 mg, solution for injection in pre-filled syringe
Methotrexatum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Methotrexate EVER Pharma is and what it is used for

Methotrexate EVER Pharma contains the active substance methotrexate, which works by:

• reducing inflammation or swelling, and
• reducing the activity of the immune system (the body's defence mechanism). Excessive immune system activity is associated with inflammatory diseases.

Methotrexate EVER Pharma is used to treat:

• severe active rheumatoid arthritis in adults. Active rheumatoid arthritis is an inflammatory disease affecting the joints;
• severe active juvenile idiopathic arthritis affecting five or more joints (this condition is therefore called polyarticular disease) in patients who have not responded adequately to non-steroidal anti-inflammatory drugs (NSAIDs);
• severe, treatment-resistant psoriasis and severe psoriatic arthritis in adults;

2. Important information before using Methotrexate EVER Pharma

When not to use Methotrexate EVER Pharma

• 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 or active infection
• if the patient has mucositis or gastrointestinal ulceration
• if the patient has severe kidney disease (the physician will assess whether the kidney disease is severe)
• if the patient has severe liver disease (the physician will assess whether the liver disease is severe)
• if the patient has a blood disorder
• if the patient has immune system disorders
• if the patient consumes excessive amounts of alcohol, has alcoholic liver disease, or another chronic liver disease
• if the patient is pregnant or breastfeeding (see section "Pregnancy, breastfeeding and fertility")
• if the patient is simultaneously receiving vaccines containing live organisms.

Warnings and precautions
Important warning regarding dosing of Methotrexate EVER Pharma:
Methotrexate EVER Pharma, used in the treatment of rheumatic diseases or skin disorders,
must be administered once weekly only. Dosing errors during methotrexate therapy
may result in severe adverse reactions, including death.
Please read section 3 of this leaflet carefully.
If you have any questions, consult your doctor or pharmacist before taking this
medicine.
Before starting treatment with Methotrexate EVER Pharma, discuss with your doctor if:

• the patient has diabetes and is treated with insulin
• the patient has inactive, chronic infection (e.g. tuberculosis, hepatitis B or C, shingles)
• the patient has or has previously had kidney or liver disease
• the patient has impaired lung function
• the patient is significantly overweight
• fluid accumulates in the abdominal cavity or in the space between the lungs and the chest wall (ascites, pleural effusion)
• the patient is dehydrated or has conditions leading to dehydration (e.g. vomiting, diarrhoea, mucositis).

If the patient, their partner or caregiver notices new onset or worsening of
neurological symptoms, including general muscle weakness, visual disturbances, changes in thinking, memory, and orientation leading to disorientation and personality changes, contact the doctor immediately, as these may be symptoms of a very rare, serious brain infection called progressive multifocal leukoencephalopathy (PML).
Methotrexate temporarily affects sperm and ovulation production. Methotrexate may cause miscarriage and lead to severe congenital malformations. Women should avoid becoming pregnant during methotrexate treatment and for at least six months after treatment ends. Men should avoid fathering a child during treatment with methotrexate and for at least 3 months after treatment ends. See also section "Pregnancy, breastfeeding and fertility".
During treatment with Methotrexate EVER Pharma, radiation dermatitis (radiation-induced skin inflammation) or sunburn may recur.
Exposure to ultraviolet radiation during therapy with Methotrexate EVER Pharma may exacerbate skin lesions associated with psoriasis.
Cases of acute pulmonary haemorrhage have been reported in patients with underlying rheumatological disorders during methotrexate therapy. If the patient develops haemoptysis (coughing up blood), seek immediate medical attention.
Diarrhoea may occur as an adverse effect of Methotrexate EVER Pharma, which may require discontinuation of treatment. If diarrhoea occurs, consult your doctor.
Lymphadenopathy (lymphoma) may occur in patients receiving low-dose methotrexate. In such cases, treatment should be discontinued.

Recommended monitoring and precautions
Even after administration of low doses of methotrexate, severe adverse effects may occur. To detect these effects early, the physician must perform regular monitoring and laboratory tests.

Before starting treatment:
Prior to initiating therapy, the physician will recommend blood tests to verify adequate blood cell counts before administering the drug. The physician will also order blood tests to evaluate liver function and to rule out hepatitis. Additionally, blood tests will be performed to assess serum albumin levels (a blood protein), degree of liver inflammation (liver infection), and kidney function. The physician may also decide to perform additional liver tests, some of which may include imaging studies of the liver, while others may require a liver biopsy (a small tissue sample taken for detailed examination). The physician may also check for tuberculosis and recommend a chest X-ray or pulmonary function tests.

During treatment:
The physician may recommend the following tests:

• examination of the mouth and throat to check for mucosal changes such as inflammation or ulceration
• blood tests including complete blood count and determination of methotrexate serum levels
• blood tests to monitor liver function
• imaging studies to assess liver status
• liver biopsy for more detailed evaluation
• blood tests to monitor kidney function
• monitoring of the respiratory tract and, if necessary, pulmonary function tests

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

Children, adolescents and elderly patients
Use of this medicine is not recommended in children under 3 years of age due to insufficient experience with its use in this age group.
During treatment with Methotrexate EVER Pharma, children, adolescents, and elderly patients should remain under close medical supervision to detect any adverse effects as early as possible.
In elderly patients, a relatively low dose of methotrexate should be used due to impaired liver and kidney function and reduced folic acid reserves.

Methotrexate EVER Pharma with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, herbal remedies, and dietary supplements such as vitamins.
It is particularly important to inform your doctor if you are taking:

• non-steroidal anti-inflammatory drugs or salicylates (medicines used to treat pain and/or inflammation, such as acetylsalicylic acid, diclofenac, and ibuprofen)
• azathioprine (a medicine used to prevent organ transplant rejection)
• retinoids (medicines used to treat psoriasis and other skin disorders)
• metamizole (a medicine used to reduce pain and fever)
• other medicines used in rheumatoid arthritis or psoriasis, such as leflunomide, sulfasalazine (also used in the treatment of ulcerative colitis), penicillamine, or cyclosporine
• anticonvulsants (medicines used to prevent epileptic seizures), such as phenytoin, valproate, or carbamazepine
• anticancer medicines, such as mercaptopurine or fluorouracil
• barbiturates (sedative drugs administered by injection)
• sedatives
• p-aminobenzoic acid (a medicine used in the treatment of skin disorders)
• hydroxychloroquine (a medicine used to prevent and treat malaria)
• oral contraceptives
• probenecid (a medicine used to treat gout)
• antibiotics and medicines used for infections, such as tetracyclines, chloramphenicol, non-absorbable broad-spectrum antibiotics, trimethoprim with sulfamethoxazole, penicillin, glycopeptides, sulfonamides, ciprofloxacin, and cephalothin. Penicillins may reduce methotrexate excretion, potentially increasing the frequency of adverse effects
• pyrimethamine (a medicine used to prevent and treat malaria)
• folic acid-containing medicines and vitamin preparations
• proton pump inhibitors (medicines that reduce gastric acid production, used to treat severe heartburn or ulcers), such as omeprazole or pantoprazole
• theophylline (a medicine used to treat asthma)
• nitrous oxide (a gas used for general anaesthesia)
• any live vaccines (these should be avoided), such as measles, mumps, or yellow fever vaccines
• cholestyramine (used to reduce blood cholesterol levels)

Methotrexate EVER Pharma, alcohol and caffeine
During treatment with Methotrexate EVER Pharma, alcohol should not be consumed. Also avoid excessive intake of coffee, caffeine-containing beverages, and black tea, as these may exacerbate adverse effects or affect the efficacy of Methotrexate EVER Pharma.
During treatment with Methotrexate EVER Pharma, it is important to drink plenty of fluids, as dehydration (reduced body water) may increase the toxic effects of Methotrexate EVER Pharma.

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

Pregnancy
Methotrexate EVER Pharma must not be used if the patient is pregnant or planning a pregnancy.
Methotrexate may cause congenital malformations, harm the unborn child, or cause miscarriage. It may lead to skull, facial, heart, vascular, brain, and limb abnormalities. Therefore, it is extremely important not to use methotrexate in pregnant women or in women planning pregnancy. In women of childbearing age, pregnancy must be definitively ruled out before starting treatment, for example by performing a pregnancy test. Women should avoid becoming pregnant during methotrexate treatment and for at least 6 months after treatment ends. During this time, effective contraception methods must be used (see also section "Warnings and precautions").
If a woman becomes pregnant during treatment or suspects she may be pregnant, she should contact her doctor immediately. The doctor will advise her on the risks to the fetus associated with the treatment.
If a patient plans pregnancy, the treating physician may refer her for a specialist consultation before initiating treatment.

Breastfeeding
Breastfeeding should be avoided during treatment, as methotrexate passes into breast milk.
If the treating physician considers methotrexate treatment absolutely necessary during this period, breastfeeding must be discontinued.

Male fertility
Available data do not indicate an increased risk of congenital malformations or miscarriage in children fathered by men taking methotrexate at doses below 30 mg per week. However, risk cannot be completely excluded. Methotrexate may have genotoxic effects, meaning it may cause genetic changes. Methotrexate may affect sperm production, potentially leading to congenital malformations. Therefore, patients receiving methotrexate should avoid fathering children or donating sperm during treatment and for at least 3 months after treatment ends.

Driving and operating machinery
During treatment with Methotrexate EVER Pharma, adverse effects on the central nervous system such as fatigue and dizziness may occur, which could impair the ability to drive or operate machinery. If the patient experiences fatigue or dizziness, he or she should not drive or operate machinery.

Methotrexate EVER Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, meaning the medicine is considered "sodium-free".

3. How to use Methotrexate EVER Pharma

Important warning regarding dosing of Methotrexate EVER Pharma (methotrexate)
In the treatment of rheumatoid arthritis, active juvenile idiopathic arthritis, and psoriasis, Methotrexate EVER Pharma must be used only once a week.
Taking more than the prescribed amount of Methotrexate EVER Pharma may result in death. Please read section 3 of this leaflet carefully. If you have any questions, consult your doctor or pharmacist before taking this medicine.
This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Methotrexate EVER Pharma is administered only once a week. Together with your doctor, choose a suitable day of the week for the injection.
Incorrect use of Methotrexate EVER Pharma may lead to severe adverse effects, which may be fatal.

Recommended dosage:
Dosage in patients with rheumatoid arthritis
The recommended starting dose is 7.5 mg of methotrexate once a week.
If the initial dose is not effective and the patient tolerates the medicine well, the doctor may increase the dose by 2.5 mg per week. The average weekly dose of methotrexate is 15–20 mg. Weekly doses higher than 25 mg should generally not be exceeded. Once the desired therapeutic effect has been achieved, the doctor may gradually reduce the dose of Methotrexate EVER Pharma to the lowest effective maintenance dose.
The expected response to treatment usually occurs after 4–8 weeks of therapy. After discontinuation of Methotrexate EVER Pharma, symptoms may return.

Use in children and adolescents (aged 3 years and older) with polyarticular forms of juvenile idiopathic arthritis
The doctor will calculate the required dose based on the child's body surface area (m²). The dose is expressed as mg/m² body surface area.
Use in children under 3 years of age is not recommended due to insufficient experience in this age group.

Adults with severe psoriasis or psoriatic arthritis
The doctor will administer a test dose of 2.5–5 mg to assess possible toxic effects. If the test dose is well tolerated, treatment will continue one week later with a dose of approximately 7.5 mg (for an adult with average body weight of 70 kg). Weekly doses higher than 25 mg should generally not be exceeded. Once the desired therapeutic effect has been achieved, the doctor may gradually reduce the dose of Methotrexate EVER Pharma to the lowest effective maintenance dose.
The expected response to treatment usually occurs after 2–6 weeks. Depending on the severity of symptoms and blood and urine test results, treatment should be continued or discontinued.
In elderly patients, the dose should be reduced due to age-related decline in liver and kidney function and decreased folate stores.

Method of administration and duration of treatment
Methotrexate EVER Pharma is administered by subcutaneous injection (under the skin). The medicine may only be used once weekly by injection. It is recommended to perform the injections of Methotrexate EVER Pharma on the same day each week.
At the beginning of treatment, Methotrexate EVER Pharma may be administered by healthcare professionals. However, the doctor may decide that the patient is capable of self-injecting the medicine. The patient will be properly trained accordingly. Never attempt self-injection without prior training.

The duration of treatment is determined by the treating physician. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, and psoriatic arthritis requires long-term use of Methotrexate EVER Pharma.

How to self-administer the Methotrexate EVER Pharma injection
If you have difficulty handling the syringe, consult your doctor or pharmacist.
Do not attempt self-injection unless you have been properly trained how to do so. If you are unsure what to do, contact your doctor or nurse immediately.

Before self-administering the Methotrexate EVER Pharma injection

• Check the expiry date of the medicine. Do not use the medicine after the expiry date.
• Check whether the syringe is damaged and whether the solution inside is a clear, yellowish liquid. If not, use another syringe.
• Check whether there is redness, skin discoloration, swelling, leakage, or persistent pain at the site of the last injection. If such symptoms are present, consult your doctor or nurse.
• Choose the injection site. The injection site should be changed each time.

Instructions for self-administering the Methotrexate EVER Pharma injection

1. Open the package. Ensure that the packaging is intact.
2. Place the syringe and the needle with protective cap on a clean surface.
3. Wash hands thoroughly with soap and water.
4. Sit or lie down in a relaxed, comfortable position. Make sure you can see the area of skin where the injection will be given. The best sites for injection are the skin of the anterior-lateral abdominal wall or the front part of the thigh.

5. The pre-filled syringe is ready for use. Examine the syringe for visible defects (or cracks). Inspect the solution. A yellowish liquid should be visible. A small air bubble may be visible in the solution, which will not affect the injection and does not pose a risk to the patient. Do not attempt to remove the air bubble before injection – this may lead to loss of part of the medicine.

The pre-filled syringe of Methotrexate EVER Pharma is equipped with a needle safety system preventing accidental needlestick injury after use. The following instructions apply to pre-filled syringes equipped with this system and may differ from instructions for other injection systems.

6. Holding the syringe barrel with one hand, remove the protective cap by pulling it straight off to avoid bending the needle. Be careful not to touch the needle with fingers to maintain sterility.

7. Use two fingers to pinch a skin fold. Creating a skin fold will ensure delivery of the active substance into the subcutaneous fatty tissue. Insert the needle quickly into the skin at the appropriate angle (45° to 90°) and press the plunger all the way down. Visually check whether any solution remains in the syringe. If liquid remains in the syringe,

this means the full dose was not properly administered, and you should consult your doctor.

8. When the plunger is fully depressed, the needle will be safely retracted. Only now release the skin fold.

9. Press a swab gently on the injection site. Do not rub the injection site, as this may cause irritation.
10. Immediately dispose of the syringe in a sharps container. Close the lid tightly and store the container out of reach of children. If accidental contact with methotrexate occurs on the skin or soft tissues, rinse the area thoroughly with plenty of water.

Women who are pregnant or planning to become pregnant should not handle Methotrexate EVER Pharma.
The duration of treatment is determined by the treating physician. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, and psoriatic arthritis requires long-term use of Methotrexate EVER Pharma.
If you feel that the effect of Methotrexate EVER Pharma is too strong or too weak, consult your doctor or pharmacist.

Overdose of Methotrexate EVER Pharma
Use only the dose prescribed by your treating doctor. Do not change the dose without medical advice.
If you suspect that you have taken more Methotrexate EVER Pharma than prescribed, contact your doctor or the nearest hospital emergency department immediately. Patients visiting a doctor or hospital should bring the medicine packaging and this leaflet with them.
Methotrexate overdose may cause severe toxic reactions. Symptoms of overdose may include easy bruising or bleeding, unexplained weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood, vomiting material resembling coffee grounds, or reduced urine output. See also section 4.

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

Stopping Methotrexate EVER Pharma
Do not stop or discontinue treatment with Methotrexate EVER Pharma without consulting your doctor. If you suspect severe adverse effects, seek medical advice immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body)
• lung inflammation (symptoms may include general malaise, dry irritating cough, shortness of breath, breathlessness at rest, chest pain or fever)
• haemoptysis or coughing up blood-stained sputum
• severe skin peeling or formation of blisters on the skin
• unexplained bleeding (including vomiting blood) or bruising
• severe diarrhoea
• mouth mucosal ulcers
• black or tarry stools
• blood in urine or stool
• small red spots on the skin
• fever
• yellowing of the skin (jaundice)
• pain or difficulty urinating
• feeling thirsty and (or) frequent urination
• seizures (convulsions)
• loss of consciousness
• blurred vision or visual disturbances

The following adverse reactions have also been reported:
Very common (may affect more than 1 in 10 people):

• loss of appetite
• nausea
• abdominal pain
• inflammation of the mouth mucosa
• digestive disturbances
• increased liver enzyme activity.

Common (may affect up to 1 in 10 people):

• decreased production of blood cells with reduced numbers of white and (or) red blood cells or platelets (leukopenia, anaemia, thrombocytopenia)
• headache
• feeling tired
• drowsiness
• lung inflammation with dry cough without expectoration, breathlessness and fever
• diarrhoea
• rash
• skin redness
• itching.

Uncommon (may affect up to 1 in 100 people):

• decreased number of blood cells and platelets
• dizziness
• disorientation
• depression
• mouth ulcers
• vasculitis
• gastrointestinal ulcers and haemorrhages
• liver function disorders
• diabetes
• decreased blood protein levels
• urticaria
• skin photosensitivity
• fluid-filled blisters on the skin
• alopecia
• enlargement of rheumatoid nodules
• skin ulcers
• herpes zoster
• joint or muscle pain
• osteoporosis (reduced bone mass)
• bladder inflammation and ulceration (may present with haematuria)
• kidney function disorder
• painful urination
• vaginal inflammation and ulceration.

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

• infection (including reactivation of inactive chronic infection)
• sepsis
• red eyes
• allergic reactions
• anaphylactic shock
• decreased antibody levels in blood
• restricted filling of the heart chamber due to fluid accumulation in the pericardium
• Pneumocystis jiroveci-induced pneumonia
• visual disturbances
• pericarditis
• fluid accumulation in the pericardial sac
• low blood pressure
• blood clots
• lung damage
• breathlessness
• bronchial asthma
• fluid accumulation in the pleural sac
• gingivitis
• acute hepatitis
• brownish skin discoloration
• acne
• presence of red or purple spots due to haemorrhages
• allergic vasculitis
• fever
• bone fractures
• kidney failure
• reduced or absent urine production
• electrolyte disturbances
• slow wound healing.

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

• significant decrease in certain white blood cells (agranulocytosis)
• severe bone marrow failure
• liver failure
• lymph node swelling
• pain
• muscle weakness
• tingling and numbness/less than normal sensitivity to stimuli
• taste disturbances (metallic taste in mouth)
• cramps
• meningitis causing paralysis or vomiting
• worsening of vision
• Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)
• nail discoloration
• retinal eye damage
• vomiting blood
• fever, sore throat, fatigue followed by skin damage
• loss of libido
• problems achieving erection
• paronychia of the hands
• severe gastrointestinal complications
• boils
• visible enlargement of small blood vessels
• hot flushes
• breast enlargement in men (gynecomastia)
• lymphoproliferative disorders (excessive white blood cell proliferation)
• disturbances in semen production
• menstrual disorders.

Unknown (frequency cannot be determined from available data):

• redness and skin peeling
• oedema
• tissue necrosis at the injection site
• increased number of certain white blood cells (eosinophilia)
• certain brain disorders (encephalopathy/leukoencephalopathy)
• nosebleeds
• lung haemorrhage
• presence of protein in urine
• feeling of weakness
• jaw bone damage (secondary to excessive white blood cell proliferation).

Subcutaneous administration of methotrexate is well tolerated locally. Only mild skin reactions (such as burning sensation, erythema, swelling, discolouration, intense itching, pain) have been observed after administration of Methotrexate EVER Pharma, which diminish during the course of treatment.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Methotrexate EVER Pharma

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not store in the refrigerator or freeze.
Keep the pre-filled syringe in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the label of the pre-filled syringe and the cardboard box: Expiry date (EXP). The expiry date refers to the last day of the stated month.
Do not use this medicine if the syringe is damaged or if the solution is not clear and contains precipitated particles.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Methotrexate EVER Pharma contains

• The active substance is methotrexate. One mL of injection solution contains 25 mg of methotrexate.

Methotrexate EVER Pharma, 7.5 mg
Each pre-filled syringe with 0.3 mL of injection solution contains 7.5 mg of methotrexate.
Methotrexate EVER Pharma, 10 mg
Each pre-filled syringe with 0.4 mL of injection solution contains 10 mg of methotrexate.
Methotrexate EVER Pharma, 12.5 mg
Each pre-filled syringe with 0.5 mL of injection solution contains 12.5 mg of methotrexate.
Methotrexate EVER Pharma, 15 mg
Each pre-filled syringe with 0.6 mL of injection solution contains 15 mg of methotrexate.
Methotrexate EVER Pharma, 17.5 mg
Each pre-filled syringe with 0.7 mL of injection solution contains 17.5 mg of methotrexate.
Methotrexate EVER Pharma, 20 mg
Each pre-filled syringe with 0.8 mL of injection solution contains 20 mg of methotrexate.
Methotrexate EVER Pharma, 22.5 mg
Each pre-filled syringe with 0.9 mL of injection solution contains 22.5 mg of methotrexate.
Methotrexate EVER Pharma, 25 mg
Each pre-filled syringe with 1 mL of injection solution contains 25 mg of methotrexate.

• Other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

What Methotrexate EVER Pharma looks like and contents of the pack
Methotrexate EVER Pharma is available in 1 mL pre-filled syringes made of colourless glass (type I), with a fixed stainless steel needle, closed with a bromobutyl rubber stopper, and equipped with a needle safety system.
The pre-filled syringes are equipped with a safety system preventing needlestick injury after use.
Blister made of PET foil.
The following pack sizes are available, with syringes contained in a cardboard box:
1 pre-filled syringe in a blister
4 pre-filled syringes in two double blisters
12 pre-filled syringes in six double blisters
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee
Austria

Manufacturer
EVER Pharma Jena GmbH
Otto-Schott-Strasse 15
07745 Jena
Germany

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
EVER Pharma Poland Sp. z o.o.
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Methotrexat EVER Pharma 7.5 mg, 10 mg, 12.5 mg, 17.5 mg, 20 mg, 22.5 mg, 25 mg Injektionslösung in einer Fertigspritze
Poland: Methotrexate EVER Pharma
Czech Republic: Methotrexát EVER Pharma
Slovakia: Metotrexát EVER Pharma 7.5 mg, 10 mg, 12.5 mg, 17.5 mg, 20 mg, 22.5 mg, 25 mg injekčný roztok v naplnenej injekčnej striekačke