Methotrexate Mylan

Package leaflet: Information for the user

Metotrexato Mylan 5 mg=0.133 mL, solution for injection in pre-filled syringe 37.5 mg/mL, 7.5 mg=0.200 mL, solution for injection in pre-filled syringe 37.5 mg/mL, 10 mg=0.267 mL, solution for injection in pre-filled syringe 37.5 mg/mL

Metotrexato Mylan 12.5 mg=0.333 mL, solution for injection in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 15 mg=0.400 mL, solution for injection in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 17.5 mg=0.467 mL, solution for injection in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 20 mg=0.533 mL, solution for injection in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 22.5 mg=0.600 mL, solution for injection in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 25 mg=0.667 mL, solution for injection in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 27.5 mg=0.733 mL, solution for injection in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 30 mg=0.800 mL, solution for injection in pre-filled syringe 37.5 mg/mL
methotrexate
Please read all of this leaflet carefully before you use 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 only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Metotrexato Mylan is and what it is used for
2. What you need to know before using Metotrexato Mylan
3. How to use Metotrexato Mylan
4. Possible side effects
5. How to store Metotrexato Mylan
6. Contents of the pack and other information

1. What Metotrexato Mylan is and what it is used for

Methotrexate is a substance with the following properties:

• it slows the growth of certain cells in the body that reproduce rapidly;
• it reduces the activity of the immune system (the body's defence mechanism);
• it has anti-inflammatory effects.

Metotrexato Mylan is indicated for the treatment of:

• active rheumatoid arthritis in adult patients;
• severe, active polyarticular forms of juvenile idiopathic arthritis when the response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate;
• severe, recurring and disabling psoriasis that does not respond adequately to other therapies such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients;
• induction of remission in adult patients with moderate steroid-dependent Crohn’s disease, in combination with corticosteroids;
• maintenance of remission in Crohn’s disease in adult patients who have responded to methotrexate monotherapy. In this case, treatment will be with Metotrexato Mylan alone.

Rheumatoid arthritis (RA) is a chronic collagen disease, characterized by inflammation of the synovial membranes (joint membranes). These membranes produce a fluid that acts as a lubricant for many joints. Inflammation causes thickening of these membranes and joint swelling.

Juvenile arthritis affects children and adolescents under the age of 16. Polyarticular forms are those affecting five or more joints within the first six months after onset of the disease.

Psoriatic arthritis is a type of arthritis associated with psoriatic skin and nail lesions, particularly affecting the joints of the fingers and toes.

Psoriasis is a common chronic skin disease, characterized by red patches covered with dry, thick, silvery scales that are difficult to remove.

Metotrexato Mylan modifies and slows the progression of the disease.

Crohn’s disease is a type of inflammatory bowel disease that can affect any part of the gastrointestinal tract, causing symptoms such as abdominal pain, diarrhoea, vomiting, or weight loss.

2. What you need to know before using Metotrexato Mylan

If you, your partner, or your caregiver notice the onset or worsening of neurological symptoms, including general muscle weakness, vision disturbances, changes in thinking, memory, and orientation, leading to confusion and personality changes, contact your doctor immediately, as these may be symptoms of a very rare and serious brain infection called progressive multifocal leukoencephalopathy (PML).
Do not use Metotrexato Mylan

• if you are allergic to methotrexate or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney disease or blood disorders;
• if you regularly consume large amounts of alcoholic beverages;
• if you have a serious infection, e.g., tuberculosis, HIV, or other immunodeficiency syndromes;
• if you have mouth ulcers or gastric or intestinal ulcers;
• if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if you are simultaneously receiving vaccinations with live vaccines. Warnings and precautions Consult your doctor or pharmacist before using Metotrexato Mylan:
• Cases of acute pulmonary hemorrhage have been reported in patients with rheumatological diseases treated with methotrexate. If you notice blood in your saliva or after coughing, contact your doctor immediately;
• if you are elderly or generally feel unwell and weak;
• if you have liver function problems;
• if you are dehydrated (loss of body water). Important warning about the dosage of Metotrexato Mylan

Methotrexate for the treatment of rheumatic diseases, skin diseases, and Crohn's disease must be used only once a week. Incorrect dosing of methotrexate may cause serious, even fatal, adverse effects. Please read section 3 of this leaflet very carefully.
Consult your doctor before using Metotrexato Mylan if:

• you have diabetes mellitus and are being treated with insulin;
• you have inactive or chronic infections (e.g., tuberculosis, hepatitis B or C, shingles [herpes zoster]);
• you have or have had liver or kidney diseases;
• you have lung function problems;
• you are severely overweight;
• you have abnormal fluid accumulation in the abdomen or in the cavity between the lungs and the chest wall (ascites, pleural effusions);
• you are dehydrated or suffer from conditions causing dehydration (e.g., dehydration due to vomiting, diarrhea, or inflammation of the mouth and lips).

Recommended follow-up examinations and precautions
Even though Metotrexato Mylan is used at low doses, serious adverse effects may occur. To detect them early, your doctor must perform monitoring and laboratory tests.
Before starting treatment
Before beginning treatment, a blood test should be performed to check that you have an adequate number of blood cells. Your blood will also be tested to assess liver function and to check for hepatitis. Additionally, serum albumin levels (a blood protein), hepatitis status (liver infection), and kidney function will be evaluated. Your doctor may also decide to perform further liver tests, some of which may include imaging diagnostics of your liver, while others may require small tissue samples from the liver for closer examination. Your doctor may also ensure you do not have tuberculosis and may perform a chest X-ray or lung function tests.
During treatment
Your doctor may perform the following tests:

• examination of the oral cavity and pharynx to check for mucosal changes such as inflammation or ulceration;
• blood tests / complete blood count with measurement of blood cell counts and serum methotrexate levels;
• blood tests to monitor liver function;
• imaging diagnostics to monitor liver condition;
• liver tissue biopsy for further examination;
• blood tests to monitor kidney function;
• respiratory monitoring and, if necessary, lung function tests. It is very important that you attend these scheduled examinations. If any of these test results are significant, your doctor will adjust your treatment accordingly.

Elderly patients
Elderly patients receiving methotrexate must be closely monitored by a doctor so that possible adverse effects can be detected as early as possible.
Age-related impairment of liver and kidney function, as well as reduced body stores of vitamin folic acid in older age, require a relatively low dose of methotrexate.
Methotrexate may affect the immune system and vaccination outcomes. It may also influence the results of immunological tests. Chronic inactive infections (e.g., herpes zoster [shingles], tuberculosis, hepatitis B or C) may reactivate. During treatment with Metotrexato Mylan, vaccination with live vaccines must not be performed.
Radiation dermatitis and sunburn may reappear during methotrexate therapy (recall reaction). Psoriatic lesions may worsen with concomitant use of ultraviolet radiation and methotrexate.
Enlarged lymph nodes (lymphoma) may appear, and treatment should therefore be discontinued.
Diarrhea may be a toxic effect of Metotrexato Mylan and requires discontinuation of therapy. If you experience diarrhea, discuss it with your doctor.
Encephalopathy (a brain disease) and leukoencephalopathy (a specific disease of the brain's white matter) have occurred in cancer patients treated with methotrexate, and it cannot be excluded that they may occur when methotrexate is used to treat other diseases.
Special precautions for treatment with Metotrexato Mylan
Methotrexate temporarily affects sperm and egg production, an effect that in most cases is reversible. Methotrexate may cause miscarriage and severe birth defects. While using methotrexate and for at least six months after treatment ends, you must avoid becoming pregnant.
See also section “Pregnancy, breastfeeding and fertility”.
Children
Metotrexato Mylan must not be used in children under 3 years of age due to insufficient experience in this age group.
Other medicines and Metotrexato Mylan
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
The effect of treatment may be altered if Metotrexato Mylan is administered concomitantly with other medicines such as:

• medicines that may damage the liver or alter blood counts, e.g., leflunomide;
• antibiotics (medicines to prevent/treat certain infections) such as: tetracyclines, chloramphenicol, non-absorbable broad-spectrum antibiotics, penicillins, glycopeptides, sulfonamides (sulfur-containing medicines that prevent/treat certain infections), ciprofloxacin, and cephalothin;
• non-steroidal anti-inflammatory drugs or salicylates (medicines for pain and/or inflammation);
• probenecid (a medicine for gout);
• weak organic acids such as loop diuretics (diuretic medicines) or certain medicines used for pain and inflammatory diseases (e.g., acetylsalicylic acid, diclofenac, and ibuprofen) and pyrazoles (e.g., metamizole for pain treatment);
• medicines that may have adverse effects on bone marrow, e.g., trimethoprim/sulfamethoxazole (an antibiotic) and pyrimethamine;
• other medicines used to treat rheumatoid arthritis, e.g., penicillamine, hydroxychloroquine, sulfasalazine, azathioprine, and cyclosporine;
• mercaptopurine (a cytostatic medicine);
• retinoids (medicines for psoriasis and other dermatological diseases);
• theophylline (a medicine for bronchial asthma and other lung diseases);
• proton pump inhibitors (medicines for stomach problems);
• hypoglycemics (medicines used to lower blood sugar). Vitamin complexes containing folic acid or folinic acid may compromise the treatment effect and should be taken only under medical supervision.

Vaccinations with live vaccines must be avoided during treatment with Metotrexato Mylan.
Metotrexato Mylan with food, drinks, and alcohol
During treatment with Metotrexato Mylan, alcoholic beverages, large amounts of coffee, caffeine-containing drinks, and black tea should be avoided.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Metotrexato Mylan during pregnancy or if you are trying to become pregnant.
Methotrexate may cause birth defects, harm the fetus, or cause miscarriage. It is associated with malformations of the skull, face, heart and blood vessels, brain, and limbs. Therefore, it is very important that pregnant women or women planning pregnancy are not treated with methotrexate. In women of childbearing age, pregnancy must be ruled out using adequate measures, for example, by performing a pregnancy test before starting treatment.
During methotrexate treatment and for at least 6 months after treatment ends, you must avoid pregnancy by using reliable contraceptive methods throughout this period (see also section “Warnings and precautions”).
If you become pregnant during treatment or suspect you are pregnant, contact your doctor as soon as possible. You should receive counseling regarding the risk of harmful effects on the baby due to the treatment.
If you plan to have a baby, you should consult your doctor, who will refer you to a specialist before the planned start of treatment.
Breastfeeding
Breastfeeding must be discontinued before and during treatment with Metotrexato Mylan.
Male fertility
Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes a methotrexate dose below 30 mg/week. However, the risk cannot be completely excluded. Methotrexate may be genotoxic. This means that the medicine may cause genetic mutations. Methotrexate may affect sperm production, potentially causing birth defects. Therefore, while taking methotrexate and for at least 6 months after treatment ends, you must avoid fathering a child or donating semen.
Driving and using machines
Treatment with Metotrexato Mylan may cause adverse reactions affecting the central nervous system, such as fatigue and dizziness. Therefore, the ability to drive vehicles and/or operate machinery may, in some cases, be impaired. If you feel tired or drowsy, you must not drive vehicles or operate machinery.
Metotrexato Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to use Metotrexato Mylan

Important warning regarding the dosage of Metotrexato Mylan (methotrexate)
Use Metotrexato Mylan only once a week for the treatment of active rheumatoid arthritis, severe active polyarticular juvenile idiopathic arthritis, severe recurrent and disabling psoriasis, severe psoriatic arthritis, and moderate Crohn's disease. Excessive use of Metotrexato Mylan (methotrexate) can be fatal. Please read paragraph 3 of this leaflet very carefully. If you have any doubts, consult your doctor or pharmacist before taking this medicine.
Always use this medicine exactly as instructed by your doctor or pharmacist. Always follow exactly the instructions for use provided at the end of this leaflet. If in doubt, consult your doctor or pharmacist.
Metotrexato Mylan is administered under the supervision of a doctor or healthcare professional as an injection only once a week. Decide together with your doctor which day of the week you will receive your weekly injection. Metotrexato Mylan must be administered by subcutaneous injection (under the skin).
Your doctor will determine the appropriate dose for children and adolescents with polyarticular juvenile idiopathic arthritis.
Use in children
Metotrexato Mylan must not be used in children under 3 years of age due to insufficient experience in this age group.
Dosage in adult patients with Crohn's disease:
Your doctor will start with a weekly dose of 25 mg. A response to treatment is generally expected after 8–12 weeks. Depending on the treatment effects over time, your doctor may decide to reduce the dose to 15 mg per week.
Method of administration and duration of treatment
Metotrexato Mylan is injected once a week!
The duration of treatment is determined by your treating physician. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis vulgaris, psoriatic arthritis, and Crohn's disease with Metotrexato Mylan is long-term therapy.
At the beginning of treatment, Metotrexato Mylan may be administered by medical staff. However, your doctor may consider that you are able to learn how to self-administer Metotrexato Mylan injections. In such a case, you will receive adequate training. Under no circumstances should you attempt to self-inject without having received proper training.
Handling and disposal must be carried out as for other cytotoxic preparations, in accordance with local regulations. Healthcare personnel who are pregnant should avoid handling and/or administering Metotrexato Mylan.
Methotrexate must not come into contact with the surface of the skin or mucous membranes. In case of contamination, the affected area must be immediately rinsed thoroughly with abundant water.
If you feel that the effect of Metotrexato Mylan is too strong or too weak, consult your doctor or pharmacist.
If you use more Metotrexato Mylan than you should
Follow your doctor's dosage instructions. Do not change the dosage on your own.
If you suspect that you have used too much Metotrexato Mylan, contact your doctor immediately. Your doctor will decide the appropriate treatment depending on the severity of the poisoning.
If you forget to use Metotrexato Mylan
Do not use a double dose to make up for a missed dose.
Take the dose prescribed by your doctor as soon as possible, and then continue weekly dosing as scheduled.
If you stop using Metotrexato Mylan
Do not stop or discontinue treatment with Metotrexato Mylan without first discussing it with your doctor. If you suspect serious side effects, contact your doctor immediately for advice.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following frequencies are indicated:

very common: may affect more than 1 in 10 people
common: may affect up to 1 in 10 people
uncommon: may affect up to 1 in 100 people
rare: may affect up to 1 in 1,000 people
very rare: may affect up to 1 in 10,000 people
not known: frequency cannot be estimated from the available data

The frequency and severity of side effects depend on the dose level and frequency of administration. Since serious side effects may occur even at low doses, it is important that you are regularly monitored by your doctor. Your doctor should therefore prescribe tests to detect possible abnormalities in the blood (e.g., reduced white blood cell count, reduced platelet count, lymphoma) and changes in kidney and liver function.

Contact your doctor immediately if you notice any of the following symptoms, which may indicate serious, potentially life-threatening side effects requiring urgent specific treatment:

• persistent dry cough without phlegm, shortness of breath, and fever: these may be signs of lung inflammation (pneumonitis) [frequency: common];
• blood in saliva or after coughing;
• signs of liver damage such as yellowing of the skin and whites of the eyes; methotrexate may cause chronic liver damage (hepatic cirrhosis), scarring of the liver (hepatic fibrosis), fatty degeneration of the liver [frequency: uncommon], inflammation of the liver (acute hepatitis) [frequency: rare], and liver failure [frequency: very rare];
• allergic symptoms such as skin rashes including red, itchy skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and feeling faint; these may be signs of severe allergic reactions or anaphylactic shock [frequency: rare];
• signs of kidney damage such as swelling of hands, ankles, feet or changes in frequency of urination or decreased or absent urine output; these may be signs of kidney failure [frequency: rare];
• signs of infection, e.g., fever, chills, aches, sore throat; methotrexate may increase susceptibility to infections. Rarely, serious infections such as a specific type of pneumonia (Pneumocystis carinii pneumonia) or blood poisoning (sepsis) may occur;
• severe diarrhoea, vomiting with blood, black or tarry stools; these symptoms may indicate a rare but serious gastrointestinal complication caused by methotrexate, namely gastrointestinal ulcers;
• symptoms associated with blockage (occlusion) of a blood vessel by a blood clot that has detached (thromboembolic event), such as weakness on one side of the body (stroke) or pain, swelling, redness and unusual warmth in one leg (deep vein thrombosis); methotrexate may cause thromboembolic events [frequency: rare];
• fever and severe worsening of general condition, or sudden fever accompanied by sore throat or mouth inflammation, or urinary problems; very rarely, methotrexate may cause a sudden drop in the number of certain white blood cells (agranulocytosis) and severe bone marrow suppression;
• sudden bleeding, e.g., bleeding gums, blood in urine, vomiting blood or bruising, which may be signs of a severe drop in platelet count due to severe bone marrow depression [frequency: very rare];
• severe skin rash or blistering of the skin (may also affect the mouth, eyes and genitals); these may be signs of very rare conditions called Stevens-Johnson syndrome and toxic epidermal necrolysis.

Other side effects that may occur are:
Very common:

• inflammation of the mouth, indigestion, nausea (feeling unwell), loss of appetite;
• increased liver enzymes.

Common:

• mouth ulcers, diarrhoea;
• skin rash, redness of the skin, itching;
• headache, fatigue, drowsiness;
• reduced production of blood cells with decreased white and/or red blood cells and/or platelets (leucopenia, anaemia, thrombocytopenia).

Uncommon:

• sore throat, intestinal inflammation, vomiting;
• increased sensitivity to light, hair loss, increase in number of rheumatoid nodules, skin ulcers, shingles (herpes zoster), inflammation of blood vessels, herpes-like skin rashes, hives (urticaria);
• onset of diabetes mellitus;
• dizziness, confusion, depression;
• decreased serum albumin;
• decreased number of blood cells and platelets;
• inflammation and ulceration of the bladder or vagina, reduced kidney function, difficulty urinating;
• joint pain, muscle pain, osteoporosis (reduced bone mass).

Rare:

• increased skin pigmentation, acne, bruising of the skin due to bleeding from blood vessels;
• allergic inflammation of blood vessels, fever, red eyes, infection, impaired wound healing, decreased number of antibodies in the body;
• vision disorders;
• inflammation of the membrane surrounding the heart (pericarditis), fluid accumulation in the membrane surrounding the heart (pericardial effusion);
• low blood pressure;
• pulmonary fibrosis, shortness of breath and bronchial asthma, fluid accumulation in the membrane lining the lungs (pleural effusion);
• electrolyte disturbances.

Very rare:

• severe bleeding, toxic megacolon (acute toxic dilation of the intestine);
• increased nail pigmentation, inflammation of the cuticles, furunculosis (deep infection of hair follicles), visible enlargement of small blood vessels;
• local tissue damage (formation of sterile abscesses, changes in fatty tissue) at the injection site following intramuscular or subcutaneous administration;
• vision disturbances, pain, numbness or tingling/lessened sensitivity to stimulation than normal, changes in taste (metallic taste), seizures, paralysis, severe headache accompanied by fever;
• retinopathy (eye disorders of non-inflammatory origin);
• loss of libido, impotence, enlargement of male breast glands (gynaecomastia), abnormal sperm formation, menstrual disorders, vaginal discharge;
• enlarged lymph nodes (lymphadenopathy);
• lymphoproliferative disorders (excessive growth of white blood cells).

Not known:

• leukoencephalopathy (a disease affecting the white matter of the brain);
• bleeding from the lungs;
• redness and peeling of the skin;
• swelling;
• bone damage in the jaw/mandible (secondary to excessive growth of white blood cells).

Subcutaneous administration of methotrexate is well tolerated locally. Only mild local skin reactions have been observed, which decreased during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metotrexato Mylan

Keep this medicine out of the sight and reach of children.
Store below 30°C. Do not refrigerate or freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the label and carton after 'Exp.'. The expiry date refers to the last day of that month.
Metotrexato Mylan is for single use only. Any unused solution remaining in the syringe must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Metotrexato Mylan contains

• The active substance is methotrexate.
• The other components are sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

This medicinal product contains less than 1 mmol (23 mg) of sodium per mL, i.e. essentially ‘sodium-free’.

Description of the appearance of Metotrexato Mylan and contents of the pack

Metotrexato Mylan is supplied in a syringe containing a clear, yellowish solution free from visible particles.

Metotrexato Mylan is supplied in a pre-filled syringe with an injection needle and a safety device, and is available in packs of 1 syringe. Alcohol wipes are included in the pack.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy

Manufacturer
Basic Pharma Manufacturing B.V.
Burgemeester Lemmensstraat 352
6163 JT Geleen
The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:

Austria, Cyprus
Cipro Methotrexate/Viatris 5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 7.5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 10 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 12.5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 15 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 17.5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 20 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 22.5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 25 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 27.5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 30 mg, Solution for injection in pre-filled syringe

Croatia
Kazak 7.5 mg, otopina za injekciju u napunjenoj štrcaljki
Kazak 10 mg, otopina za injekciju u napunjenoj štrcaljki
Kazak 15 mg, otopina za injekciju u napunjenoj štrcaljki
Kazak 20 mg, otopina za injekciju u napunjenoj štrcaljki
Kazak 25 mg, otopina za injekciju u napunjenoj štrcaljki

Greece
Methotrexate/Viatris 5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 7.5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 10 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 12.5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 15 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 17.5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 20 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 22.5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 25 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 27.5 mg, Solution for injection in pre-filled syringe
Methotrexate/Viatris 30 mg, Solution for injection in pre-filled syringe

Italy
Metotrexato Mylan

Netherlands
Methotrexaat Viatris 5 mg = 0.133 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml
Methotrexaat Viatris 7.5 mg = 0.200 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml
Methotrexaat Viatris 10 mg = 0.267 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml
Methotrexaat Viatris 12.5 mg = 0.333 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml
Methotrexaat Viatris 15 mg = 0.400 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml
Methotrexaat Viatris 17.5 mg = 0.467 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml
Methotrexaat Viatris 20 mg = 0.533 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml
Methotrexaat Viatris 22.5 mg = 0.600 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml
Methotrexaat Viatris 25 mg = 0.667 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml
Methotrexaat Viatris 27.5 mg = 0.733 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml
Methotrexaat Viatris 30 mg = 0.800 ml, oplossing voor injectie in een voorgevulde spuit 37.5 mg/ml

Instructions for use

Read these instructions carefully before starting the injection and always use the injection technique recommended by your doctor or pharmacist.

Metotrexato Mylan is for single use only. Any unused solution remaining in the syringe must be discarded.

The solution must be clear and free from particles.

For any problems or questions, contact your doctor or pharmacist.

Preparation

Choose a clean, well-lit, flat working surface.

Before starting, prepare everything you need:

• one pre-filled syringe of Metotrexato Mylan;
• one alcohol wipe, included in the pack.

Wash your hands thoroughly.

Inspect the syringe for any damage to the syringe or safety device, or for loose components. Before use, check that the safety device is in the safety position. Do not use the syringe if it does not match this figure:

Figure 1: Safety device

If you notice that the syringe cannot be used, dispose of it in a sharps and biological hazard waste container.

Injection site

The best sites for injection are:

• the upper thigh,
• the abdomen, excluding the area around the navel.

If you have assistance, the injection may also be administered on the back of the upper arm, just below the shoulder.

Change the injection site with each injection. This way you can reduce the risk of developing irritation at the injection site.

Never inject into areas of delicate, bruised, red, hard, scarred skin or skin with stretch marks. If you suffer from psoriasis, try to avoid injecting directly into lesions or areas of raised, thickened, red, flaky or otherwise affected skin.

Injecting the solution

1. Remove the syringe from the packaging and read the patient information leaflet carefully. Remove the syringe from its packaging at room temperature.

2. Disinfection

Choose an injection site and disinfect it with the alcohol wipe included in the pack.

Allow the disinfected injection site to dry for at least 60 seconds.

3. Removal of the protective cap

Carefully remove the protective cap by pulling it straight off the syringe. Important: Do not touch the needle of the pre-filled syringe! After removing the needle cap, dispose of it in a sharps and biological hazard waste container.

4. Inserting the needle

Using two fingers of one hand, gently pinch a fold of skin at the injection site. With the other hand, insert the needle at the injection site at an angle of 45–90 degrees, without touching the hub of the plunger.

5. Injection and needlestick injury protection

Push the plunger completely forward until it stops. After fully depressing the plunger, the needle will be safely covered.

6. Disposal of the device

After using the syringe, immediately dispose of the device in a sharps and biological hazard waste container. Do not dispose of the used syringe in household waste.

Methotrexate must not come into contact with the skin surface or mucous membranes. In case of contamination, the affected area must be immediately rinsed with abundant water.

If you or someone near you is injured by the needle, seek immediate medical attention and do not use the pre-filled syringe.

Disposal and other handling

Handling and disposal of the medicinal product and the pre-filled syringe must be carried out in accordance with local regulations for cytotoxic preparations. Healthcare personnel who are pregnant should avoid handling and/or administering methotrexate.