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 all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Methotrexate EVER Pharma is and what it is used for
2. What you need to know 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 polyarthritis (a disease so named because it affects five or more joints) in patients who have not responded adequately to non-steroidal anti-inflammatory drugs (NSAIDs);
• severe psoriasis and severe psoriatic arthritis in adults that are unresponsive to treatment;

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 oral mucositis or gastrointestinal ulceration
• if the patient has severe kidney disease (the physician will assess whether kidney disease is severe)
• if the patient has severe liver disease (the physician will assess whether liver disease is severe)
• if the patient has a blood disorder
• if the patient has immune system dysfunction
• 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 microorganisms.

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 lead to severe adverse reactions, including death.
Please read section 3 of this leaflet very carefully.
If you have any questions, please 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 had kidney or liver disease in the past
• the patient has lung function disorders
• if the patient is significantly overweight
• if the patient has fluid accumulation 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, diarrhea, oral mucositis).

If the patient, their partner, or caregiver notice 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 in the fetus. Women should avoid
becoming pregnant during methotrexate treatment and for at least six months after completion of therapy.
Men should avoid fathering a child during treatment with methotrexate and for at least 3 months
after completion of therapy. See also section "Pregnancy, breastfeeding and fertility".
During treatment with Methotrexate EVER Pharma, radiation-induced dermatitis (radiation dermatitis) 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 hemorrhage have been reported in patients with underlying rheumatic disease receiving methotrexate. If the patient develops hemoptysis (coughing up blood-tinged sputum), seek immediate medical attention.
Diarrhea may occur as an adverse reaction to Methotrexate EVER Pharma, which may require discontinuation of treatment. If diarrhea occurs, consult your doctor.
In patients receiving low-dose methotrexate, lymph node enlargement (lymphoma) may occur. In such cases, treatment should be discontinued.

Recommended monitoring tests and precautions
Even after administration of low doses of methotrexate, severe adverse reactions may occur.
To detect these reactions 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 whether blood cell counts are adequate for treatment. The physician will also recommend blood tests to assess liver function and determine whether hepatitis is present. Additionally, blood tests will be performed to check serum albumin levels (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 liver imaging, while others may require a small liver tissue sample for more detailed examination. The physician may also check for tuberculosis and recommend a chest X-ray or lung 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 / complete blood count including determination of blood cell counts and serum methotrexate concentration
• blood tests to monitor liver function
• imaging tests to assess liver status
• liver biopsy (a small tissue sample taken for detailed examination)
• blood tests to monitor kidney function
• respiratory monitoring and, if necessary, lung 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
The 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 receiving methotrexate should remain under close medical supervision to detect any potential adverse reactions as early as possible.
In elderly patients, a relatively low dose of methotrexate is necessary due to impaired liver and kidney function and reduced folic acid reserves.

Methotrexate EVER Pharma and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, herbal remedies, and dietary supplements such as vitamins.
It is particularly important to inform the doctor about the use of:

• 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
• antineoplastic agents, such as mercaptopurine or fluorouracil
• barbiturates (sedatives administered by injection)
• sedatives
• p-aminobenzoic acid (a medicine used in the treatment of skin disorders)
• hydroxychloroquine (a medicine used for prevention and treatment of 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, which may increase the frequency of adverse reactions
• pyrimethamine (a medicine used for prevention and treatment of malaria)
• medicines containing folic acid 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 anesthesia)
• 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 drinking
During treatment with Methotrexate EVER Pharma, alcohol should not be consumed, and excessive intake of coffee, caffeine-containing beverages, and black tea should be avoided, as they may exacerbate adverse reactions or affect the efficacy of Methotrexate EVER Pharma.
During treatment with Methotrexate EVER Pharma, patients should drink plenty of fluids, as dehydration (reduced body water) may intensify the toxic effects of Methotrexate EVER Pharma.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans 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 pregnancy.
Methotrexate may cause congenital malformations, harm the unborn child, or cause miscarriage. It may lead to malformations of the skull, face, heart, blood vessels, brain, and limbs. Therefore, it is extremely important that methotrexate is not used in pregnant women or women planning pregnancy. In women of childbearing potential, pregnancy must be definitively excluded, for example by performing a pregnancy test before starting treatment. The patient should avoid becoming pregnant during methotrexate treatment and for at least 6 months after its completion. 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 the patient on the risks to the fetus associated with treatment.
If a patient plans pregnancy, the treating physician may refer her for a specialist consultation prior to planned initiation of treatment.

Breastfeeding
Breastfeeding should not be undertaken 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 when the father uses 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 a child or donating sperm during treatment and for at least 3 months after its completion.

Driving and operating machinery
During treatment with Methotrexate EVER Pharma, adverse reactions affecting the central nervous system, such as fatigue and dizziness, may occur, which may impair the ability to drive and/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
an appropriate day of the week for the injection.
Improper use of Methotrexate EVER Pharma may lead to severe adverse reactions, which could
result in death.

Recommended dose:
Dosing in patients with rheumatoid arthritis
The recommended starting dose is 7.5 mg of methotrexate once weekly.
If this dose is not effective and the patient tolerates the medicine well, the doctor may increase the
dose by 2.5 mg per week. The usual weekly dose of methotrexate ranges from 15 to 20 mg.
Generally, the weekly dose should not exceed 25 mg. Once the desired therapeutic effect is achieved,
your 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. 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.
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 an average body weight of 70 kg). Generally, the weekly dose should not exceed 25 mg.
Once the desired therapeutic effect is 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. The medicine should only
be used once a week. It is recommended to administer the injections of Methotrexate EVER
Pharma on the same day each week.
At the beginning of treatment, Methotrexate EVER Pharma may be administered by medical staff.
However, the doctor may decide that the patient is capable of self-injecting Methotrexate EVER
Pharma. The patient will be properly trained accordingly. Never attempt self-injection without prior
training.
The duration of treatment is determined by the treating physician. Long-term treatment with
Methotrexate EVER Pharma is required for rheumatoid arthritis, juvenile idiopathic arthritis,
psoriasis, and psoriatic arthritis.

How to perform self-injection of Methotrexate EVER Pharma
If you have difficulty handling the syringe, consult your doctor or pharmacist.
Do not attempt self-injection unless you have been properly trained in how to do it. If you are
unsure about any step, contact your doctor or nurse immediately.

Before performing self-injection of Methotrexate EVER Pharma

• Check the expiry date of the medicine. Do not use 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 any of these symptoms are present, consult your doctor or nurse.
• Choose the injection site. The injection site should be changed each time.

Instructions for self-injection of Methotrexate EVER Pharma

1. Open the package. Ensure 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 clearly see the area of skin where the injection will be administered. The best injection sites are the skin on the front and side of the abdomen or the front of the thigh.

5. The syringe is pre-filled and ready to 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 result in loss of part of the medicine.

The pre-filled syringe of Methotrexate EVER Pharma is equipped with a needle safety system that prevents accidental needlestick injury after use. The following instructions apply to pre-filled syringes with this safety 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. With two fingers, pinch a fold of skin. Creating a skin fold ensures delivery of the active substance into the subcutaneous fatty tissue. Quickly insert the needle into the skin at the appropriate angle (45° to 90°) and push 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. Once the plunger is fully depressed, the needle will be safely retracted. Only now should you release the skin fold.

9. Press a swab gently against 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 container tightly and store it out of reach of children. If methotrexate comes into accidental contact with the skin or soft tissues, rinse the area thoroughly with plenty of water.

Pregnant women or women planning pregnancy should not handle Methotrexate EVER Pharma.
The duration of treatment is determined by the treating physician. Long-term treatment with
Methotrexate EVER Pharma is required for rheumatoid arthritis, juvenile idiopathic arthritis,
psoriasis, and psoriatic arthritis.
If you feel that the effect of Methotrexate EVER Pharma is too strong or too weak, consult your
doctor or pharmacist.

Taking more than the recommended dose of Methotrexate EVER Pharma
Always use the dose prescribed by your 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 package 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.

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

Stopping treatment with Methotrexate EVER Pharma
Do not stop or discontinue treatment with Methotrexate EVER Pharma without consulting your
doctor. If you suspect severe adverse reactions, 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 everybody will experience 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. Your doctor 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 must inform your doctor immediately if any of the following symptoms occur, as they may indicate serious, potentially life-threatening adverse reactions requiring urgent treatment:

• sudden wheezing, difficulty breathing, eyelid, facial or lip swelling, rash or itching (especially if 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 blistering
• unexplained bleeding (including vomiting blood) or bruising
• severe diarrhoea
• mouth mucosal ulceration
• black or tarry stools
• blood in urine or faeces
• small red spots on the skin
• fever
• yellowing of the skin (jaundice)
• pain or difficulty passing urine
• feeling thirsty and (or) passing urine frequently
• seizures (fits)
• loss of consciousness
• blurred vision or visual disturbances

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

• loss of appetite
• nausea (feeling sick)
• abdominal pain
• inflammation of the mucous membrane in the mouth
• digestive disturbances
• increased liver enzyme activity.

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

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

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

• decreased number of blood cells and platelets
• dizziness
• disorientation
• depression
• mouth ulceration
• vasculitis (inflammation of blood vessels)
• gastrointestinal ulceration and haemorrhage
• liver function disorders
• diabetes
• decreased blood protein levels
• urticaria
• skin photosensitivity
• fluid-filled blisters on the skin
• hair loss
• enlargement of rheumatoid nodules
• skin ulceration
• shingles
• 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 occur in up to 1 in 1,000 people):

• infection (including reactivation of inactive chronic infection)
• sepsis
• redness of the eyes
• allergic reactions
• anaphylactic shock
• decreased antibody levels in blood
• impaired ventricular filling due to fluid accumulation in the pericardium
• Pneumocystis jiroveci-induced pneumonia
• visual disturbances
• pericarditis (inflammation of the sac surrounding the heart)
• 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 occur in up to 1 in 10,000 people):

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

Not known (frequency cannot be estimated from available data):

• redness and peeling of the skin
• swelling
• 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 generally 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 tend to diminish during the course of treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, 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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Methotrexate EVER Pharma

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not store in a refrigerator or freeze.
Keep the pre-filled syringe in its outer packaging to protect from light.
Do not use this medicine after the expiry date stated on 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
particulate matter.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What 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 containing 0.3 mL of injection solution contains 7.5 mg of methotrexate.
Methotrexate EVER Pharma, 10 mg
Each pre-filled syringe containing 0.4 mL of injection solution contains 10 mg of methotrexate.
Methotrexate EVER Pharma, 12.5 mg
Each pre-filled syringe containing 0.5 mL of injection solution contains 12.5 mg of methotrexate.
Methotrexate EVER Pharma, 15 mg
Each pre-filled syringe containing 0.6 mL of injection solution contains 15 mg of methotrexate.
Methotrexate EVER Pharma, 17.5 mg
Each pre-filled syringe containing 0.7 mL of injection solution contains 17.5 mg of methotrexate.
Methotrexate EVER Pharma, 20 mg
Each pre-filled syringe containing 0.8 mL of injection solution contains 20 mg of methotrexate.
Methotrexate EVER Pharma, 22.5 mg
Each pre-filled syringe containing 0.9 mL of injection solution contains 22.5 mg of methotrexate.
Methotrexate EVER Pharma, 25 mg
Each pre-filled syringe containing 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), fitted 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 film.
Pack sizes with syringes in one cardboard box are as follows:
1 pre-filled syringe in a blister
4 pre-filled syringes in two dual blisters
12 pre-filled syringes in six dual 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 further information about this medicinal product, 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