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, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people. 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. 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). Overactivity of the immune system 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 juvenile idiopathic arthritis) in patients who have not responded adequately to non-steroidal anti-inflammatory drugs (NSAIDs);
• severe psoriasis and severe psoriatic arthritis in adults that are resistant 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 doctor will assess whether kidney disease is severe)
• if the patient has severe liver disease (the doctor will assess whether 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 receiving vaccines containing live microorganisms at the same time.

Warnings and precautions
Important warning regarding dosing of Methotrexate EVER Pharma:
Methotrexate EVER Pharma, used in the treatment of rheumatic diseases or skin diseases,
must be administered once weekly only.
Dosing errors during methotrexate use 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, diarrhoea, oral mucositis).

If the patient, their partner or caregiver notice new onset or worsening of neurological symptoms, including general muscle weakness, vision 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 treatment ends. Men should avoid fathering a child during methotrexate treatment and for at least three months after treatment ends. See also section "Pregnancy, breastfeeding and fertility".
During treatment with Methotrexate EVER Pharma, recurrence of radiation-induced skin inflammation (radiation dermatitis) or sunburn may occur.
Exposure to ultraviolet radiation during therapy with Methotrexate EVER Pharma may worsen skin lesions associated with psoriasis.
Cases of acute pulmonary haemorrhage have been reported in patients with underlying rheumatological disease during methotrexate treatment. If the patient develops haemoptysis (coughing up blood-stained sputum), seek immediate medical advice.
Diarrhoea may occur as an adverse effect of Methotrexate EVER Pharma, which may require discontinuation of treatment. If diarrhoea occurs, consult your doctor.
Enlargement of lymph nodes (lymphoma) may occur in patients receiving low-dose methotrexate. 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 enough, the doctor must perform regular clinical and laboratory tests.

Before starting treatment:
Before initiating treatment, the doctor will recommend blood tests to check whether blood cell counts are sufficient for administering the medicine. The doctor will also recommend blood tests to assess liver function and to determine whether hepatitis is present. Additionally, blood tests will be performed to check serum albumin levels (a blood protein), degree of liver inflammation (liver infection), and kidney function. The doctor may also decide to perform other liver tests; some may involve imaging of the liver, while others may require taking a small tissue sample from the liver for more detailed examination. The doctor may also check whether the patient has tuberculosis and recommend a chest X-ray or lung function tests.

During treatment:
The doctor may recommend the following tests:

• examination of the mouth and throat to check for mucosal changes such as inflammation or ulceration
• blood tests/full blood count to determine blood cell counts and serum methotrexate concentration
• blood tests to monitor liver function
• imaging tests to assess liver status
• taking a small tissue sample from the liver for more detailed examination
• blood tests to monitor kidney function
• monitoring of the respiratory tract 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 doctor 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 treated with 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 with other medicines
Tell 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 especially 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 diseases)
• 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 (sedatives administered by injection)
• sedatives
• p-aminobenzoic acid (a medicine used in the treatment of skin diseases)
• hydroxychloroquine (a medicine used to prevent and treat malaria)
• oral contraceptives
• probenecid (a medicine used to treat gout)
• antibiotics and medicines used in 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 to prevent and treat 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 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, drinking and alcohol
During treatment with Methotrexate EVER Pharma, alcohol should not be consumed, and excessive intake of coffee, caffeine-containing beverages and black tea should also be avoided, as they may intensify adverse effects or affect the efficacy of Methotrexate EVER Pharma.
During treatment with Methotrexate EVER Pharma, the patient should drink plenty of fluids, as dehydration (reduced water content in the body) 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 is planning to have a child, 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 cause skull, facial, heart, blood vessel, brain and limb abnormalities. Therefore, it is very important that methotrexate is not used in pregnant women or women planning pregnancy. In women of childbearing age, 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 methods of contraception 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 about the risks to the fetus associated with treatment.
If the patient is planning a pregnancy, the treating doctor may refer her for a specialist consultation before planned initiation of treatment.

Breastfeeding
Breastfeeding should not be performed during treatment, as methotrexate passes into breast milk.
If the treating doctor considers methotrexate treatment absolutely necessary during this time, breastfeeding must be discontinued.

Male fertility
Available data do not indicate an increased risk of congenital malformations in the fetus or miscarriage when the father uses methotrexate at doses below 30 mg per week. However, the risk cannot be completely excluded. Methotrexate may have genotoxic effects. This means 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 using machines
During treatment with Methotrexate EVER Pharma, adverse reactions affecting the central nervous system may occur, such as fatigue and dizziness, which may affect 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 the 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.
Incorrect use of Methotrexate EVER Pharma may lead to severe adverse effects, which may result
in death.

Recommended dosage:
Dosing in patients with rheumatoid arthritis
The recommended starting dose is 7.5 mg of methotrexate once a week.
If the 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
should generally not exceed 25 mg. After achieving the desired therapeutic effect, your doctor may
gradually reduce the dose of Methotrexate EVER Pharma to the lowest effective maintenance dose.
The expected response to treatment usually occurs within 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.
The use of this medicine is not recommended in children under 3 years of age due to insufficient
experience in this age group.

Adults with severe psoriasis or psoriatic arthritis
The doctor will administer an initial 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
(applicable to an adult with an average body weight of 70 kg). Weekly doses should generally not
exceed 25 mg. After achieving the desired therapeutic effect, your doctor may gradually reduce the
dose of Methotrexate EVER Pharma to the lowest effective maintenance dose.
The expected response to treatment usually occurs within 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 reduced folate stores.

Method of administration and duration of treatment
Methotrexate EVER Pharma is administered by subcutaneous injection. The medicine may be used
once weekly by subcutaneous injection. It is recommended to perform Methotrexate EVER Pharma
injections on the same day each week.

At the beginning of treatment, Methotrexate EVER Pharma may be administered by healthcare
personnel. However, your doctor may decide that you are capable of self-injecting Methotrexate
EVER Pharma. You will receive appropriate training in this regard. Never attempt self-injection
without prior training.

The duration of treatment is determined by your 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 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. If you are unsure what to do,
contact your doctor or nurse immediately.

Before self-administering 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 previous injection site. 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 Methotrexate EVER Pharma injection

1. Open the packaging. Ensure the packaging is intact.
2. Place the syringe and needle with protective cap on a clean surface.
3. Wash your hands thoroughly with soap and water.
4. Sit or lie down in a relaxed, comfortable position. Ensure you can see the area of skin where the injection will be given. The best injection sites are the skin on the front and side of the abdomen or the front 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 present 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
designed to prevent needlestick injury after use. The following instructions apply to pre-filled
syringes 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 your fingers to maintain sterility.

7. Using two fingers, create a skin fold. 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. When the plunger is fully depressed, the needle will be safely retracted. Only now should you release the skin fold.

9. Press a swab 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 lid tightly and place 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.

Pregnant women or women planning to become pregnant should not handle Methotrexate EVER
Pharma.
The duration of treatment is determined by your 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.

Taking more than the recommended dose of Methotrexate EVER Pharma
Use only the dose prescribed by your doctor. Do not change the dose without medical advice.
If you suspect that you have taken more than the prescribed dose of Methotrexate EVER Pharma,
contact your doctor or the nearest hospital emergency department immediately. Patients visiting a
doctor or hospital should bring the medicine packaging and 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 interrupt or discontinue treatment with Methotrexate EVER Pharma without consulting your
doctor. If you suspect severe adverse effects, seek immediate medical advice.

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 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. The treating physician should order tests to rule out blood abnormalities (e.g. low white blood cell count, low platelet count, lymphoma) and changes in liver and kidney function.
You should contact 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, swelling of the eyelids, face or lips, 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 ulcers
• black or tarry stools
• blood in urine or faeces
• 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 mucous membrane of the mouth
• digestive disorders
• increased liver enzyme activity.

Common (may affect 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, breathlessness and fever
• diarrhoea
• rash
• redness of the skin
• itching.

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

• decreased number of blood cells and platelets
• dizziness
• disorientation
• depression
• mouth ulcers
• 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 (herpes zoster)
• joint or muscle pain
• osteoporosis (reduced bone mass)
• inflammation and ulceration of the urinary bladder (may occur with haematuria)
• kidney function disorder
• painful urination
• inflammation and ulceration of the vagina.

Rare (may affect 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
• restricted filling of the heart chamber 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 surrounding the lungs
• 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):

• marked decrease in certain white blood cells (agranulocytosis)
• severe bone marrow failure
• liver failure
• swollen lymph nodes
• pain
• muscle weakness
• tingling and numbness/reduced sensitivity to stimuli
• taste disturbances (metallic taste in the 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
• infection of the nail fold of the fingers
• 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.

Unknown (frequency cannot be determined from available data):

• redness and peeling of the skin
• swelling
• tissue damage at the site of injection
• 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 diminish during continued 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, phone: +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.
Reporting adverse reactions helps to 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.
Store 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 particles.
Medicines should 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.

• The 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 an attached 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 needle-stick injury after use.
Blister made of PET foil.
Pack sizes containing syringes in one cardboard box are as follows:
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 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 Member States of the European Economic Area 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