METOTREXATO 5 mg Injectable Solution In Pre-Filled Syringe

Зміст інструкції

1. Metotrexato Mylan 5 mg=0.133 mL, injectable solution in pre-filled syringe 37.5 mg/mL, 7.5 mg=0.200 mL, injectable solution in pre-filled syringe 37.5 mg/mL, 10 mg=0.267 mL, injectable solution in pre-filled syringe 37.5 mg/mL
   1. What is Metotrexato Mylan and what is it 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. Package Contents and Other Information

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

Metotrexato Mylan 12.5 mg=0.333 mL, injectable solution in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 15 mg=0.400 mL, injectable solution in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 17.5 mg=0.467 mL, injectable solution in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 20 mg=0.533 mL, injectable solution in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 22.5 mg=0.600 mL, injectable solution in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 25 mg=0.667 mL, injectable solution in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 27.5 mg=0.733 mL, injectable solution in pre-filled syringe 37.5 mg/mL
Metotrexato Mylan 30 mg=0.800 mL, injectable solution in pre-filled syringe 37.5 mg/mL
methotrexate

Read this leaflet carefully before you start using this medicine as 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those 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 you use 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 is Metotrexato Mylan and what is it used for

Methotrexate is a substance with the following properties:

• slows the growth of some cells in the body that reproduce rapidly;
• reduces the activity of the immune system (the body's defense mechanism);
• has anti-inflammatory effects. Metotrexato Mylan is indicated for the treatment of:
• active rheumatoid arthritis in adult patients;
• polyarticular forms of severe juvenile idiopathic arthritis in active phase, when the response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate;
• severe, relapsing and disabling psoriasis, which does not respond adequately to other forms of therapy 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 association with corticosteroids;
• maintenance of remission of Crohn's disease in adult patients who have responded to methotrexate monotherapy. In this case, you will be treated only with Metotrexato Mylan.

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 swelling of the joints.
Juvenile arthritis affects children and adolescents under the age of 16. Polyarticular forms
are those that affect 5 or more joints within the first 6 months from the onset of the disease.
Psoriatic arthritis is a type of arthritis with psoriatic skin and nail lesions, especially at
the level of the joints of the hands and feet.
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, diarrhea, vomiting or weight loss.

2. What you need to know before using Metotrexato Mylan

If you, your partner or the person assisting you notices the appearance or worsening of neurological symptoms, including general muscle weakness, vision disturbances, changes in thinking, memory and orientation, resulting in confusion and personality changes, consult 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 any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe liver or kidney disease or blood disorders;
• if you regularly consume large amounts of alcoholic beverages;
• if you suffer from a severe infection, e.g. tuberculosis, HIV or other immunodeficiency syndromes;
• if you suffer from ulcers in the mouth or gastric or intestinal ulcers;
• if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if you are simultaneously undergoing vaccinations with live vaccines. Warnings and precautions Ask your doctor or pharmacist before using Metotrexato Mylan:
• Cases of acute pulmonary bleeding have been reported in patients with rheumatic disease treated with methotrexate. If you observe blood in your saliva or after coughing, you should contact your doctor immediately;
• if you are elderly or generally feel unwell and weak;
• if you have problems with liver function;
• if you suffer from dehydration (loss of water). Important warning about the dosage of Metotrexato Mylan

Methotrexate for the treatment of rheumatic disease, skin diseases and Crohn's disease can only be used once a week. An incorrect dosage of methotrexate could cause serious, even fatal, side effects. 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 and prolonged infections (e.g., tuberculosis, hepatitis B or C, shingles [herpes zoster]);
• you have/have had liver or kidney disease;
• you have problems with lung function;
• you are severely overweight;
• you have an abnormal accumulation of fluid in the abdomen or in the cavity between the lungs and the chest wall (ascites, pleural effusions);
• you are dehydrated or suffer from conditions that cause dehydration (e.g., dehydration following vomiting, diarrhea or inflammation of the mouth and lips).

Further recommended tests and precautions
Even if Metotrexato Mylan is used at low doses, serious side effects can occur. In order to identify them promptly, the doctor must perform monitoring tests and laboratory tests.
Before starting therapy
Before you start treatment, a blood sample must be taken to check if there are enough blood cells. The blood will also be examined to check your liver function and to see if you have hepatitis. In addition, the amount of serum albumin (a blood protein), the status of hepatitis (liver infection) and kidney function will be checked. The doctor may also decide to perform other liver tests, some of which may be imaging tests of your liver and others may require small tissue samples from the liver to examine it better. The doctor can also make sure that you do not suffer from tuberculosis and may perform a chest X-ray or pulmonary function tests.
During treatment
The doctor may perform the following tests:

• examination of the oral cavity and pharynx to check for changes in the mucosa such as inflammation or ulcerations;
• blood tests/complete blood count with cell count and measurement of serum methotrexate levels;
• blood tests to monitor liver function;
• imaging tests to monitor the condition of the liver;
• taking small samples of liver tissue to examine it better;
• blood tests to monitor kidney function;
• monitoring of the respiratory tract and, if necessary, pulmonary function tests. It is very important that you attend these scheduled tests. If the results of any of these tests are relevant, the doctor will adjust the treatment accordingly.

Elderly patients
Elderly patients treated with methotrexate must be closely monitored by a doctor so that possible side effects can be detected as early as possible.
Age-related impairment of hepatic and renal function, as well as poor vitamin folic acid reserves in old age, require a relatively low dose of methotrexate.
Methotrexate can affect the immune system and the results of vaccination. It can also affect the outcome of immunological tests. Chronic inactive infections can recur (e.g., herpes zoster [shingles], tuberculosis, hepatitis B or C). During therapy with Metotrexato Mylan, vaccination with live vaccines should be avoided.
Radiation dermatitis and sunburn can recur during methotrexate therapy (recall reaction). Psoriatic lesions may worsen following concomitant use of ultraviolet radiation and methotrexate.
Enlarged lymph nodes (lymphoma) may appear and therapy should therefore be discontinued.
Diarrhea can be a toxic effect of Metotrexato Mylan and requires discontinuation of therapy. If you suffer from diarrhea, tell your doctor.
In patients with tumors treated with methotrexate, encephalopathy (a brain disease) and leukoencephalopathy (a particular disease of the white matter of the brain) have occurred and it cannot be ruled out that they may occur when methotrexate is used for the treatment of other diseases.
Particular precautions for treatment with Metotrexato Mylan
Methotrexate temporarily affects the production of sperm and eggs, an effect that is reversible in most cases. Methotrexate can cause miscarriage and serious birth defects. While using methotrexate and for at least six months after the end of treatment, you should avoid becoming pregnant.
See also section “Pregnancy, breastfeeding and fertility”.

Children
Metotrexato Mylan should not be used in children under 3 years of age due to insufficient experience with this age group.

Other medicines and Metotrexato Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of the treatment may be altered if Metotrexato Mylan is administered at the same time as other medicines such as:

• medicines that can damage the liver or alter the blood count, e.g., leflunomide;
• antibiotics (medicines to prevent/fight certain infections) such as: tetracyclines, chloramphenicol and broad-spectrum non-absorbable antibiotics, penicillins, glycopeptides, sulfonamides (medicines containing sulfur, which prevent/fight certain infections), ciprofloxacin and cefalotin;
• non-steroidal anti-inflammatory drugs or salicylates (medicines against pain and/or inflammation);
• probenecid (a medicine against gout);
• weak organic acids such as loop diuretics (diuretic medicines) or some medicines used for the treatment of pain and inflammatory diseases (e.g., acetylsalicylic acid, diclofenac and ibuprofen) and pyrazole (e.g., metamizole for the treatment of pain);
• medicines that can have adverse effects on the 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 against psoriasis and other dermatological diseases);
• theophylline (a medicine against bronchial asthma and other lung diseases);
• proton pump inhibitors (medicines against stomach problems);
• hypoglycemic agents (medicines used to lower blood sugar). Vitamin complexes containing folic acid or folinic acid may compromise the effect of the treatment and should only be taken under the control of the doctor.

Vaccinations with live vaccines should be avoided during the use of Metotrexato Mylan.

Metotrexato Mylan with food, drinks and alcohol
Alcoholic beverages, large amounts of coffee, caffeinated drinks and black tea should be avoided during treatment with Metotrexato Mylan.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Metotrexato Mylan during pregnancy or if you are trying to become pregnant.
Methotrexate can 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 a pregnancy are not treated with methotrexate. In women of childbearing potential, every possibility of pregnancy must be excluded by using appropriate measures, for example by performing a pregnancy test before starting treatment.
During the intake of methotrexate and for at least 6 months after the end of treatment, you should avoid pregnancy using reliable contraceptive methods for the entire period (see also the section “Warnings and precautions”).
If you become pregnant during treatment or suspect you are pregnant, consult your doctor as soon as possible. You should be given advice on the risk of harmful effects on the baby due to the treatment.
If you wish to become pregnant, you should consult your doctor, who will refer you to a specialist before the planned start of treatment.
Breastfeeding
Breastfeeding must be stopped before and during treatment with Metotrexato Mylan.
Male fertility
Available evidence does not indicate an increased risk of malformations or miscarriage if the father takes a dose of methotrexate less than 30 mg/week. However, the risk cannot be completely excluded. Methotrexate can be genotoxic. This means that the medicine can cause genetic mutations. Methotrexate can affect sperm production with the possibility of causing birth defects. Therefore, while taking methotrexate and for at least 6 months after the end of treatment, you should avoid procreation or donating semen.

Driving and using machines
Treatment with Metotrexato Mylan can cause adverse reactions affecting the central nervous system, such as fatigue and dizziness. Therefore, the ability to drive vehicles and/or operate machinery may be impaired in some cases. If you feel tired or drowsy, you should 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 weekfor the treatment of active rheumatoid arthritis, severe active polyarticular juvenile idiopathic arthritis, severe relapsing and disabling psoriasis, severe psoriatic arthritis and moderate Crohn's disease. Excessive use of Metotrexato Mylan (methotrexate) can be fatal. Read section 3 of this medicine very carefully.
Use this medicine following exactly the instructions of your doctor or pharmacist. Follow your doctor or pharmacist.
Metotrexato Mylan is administered by or under the supervision of a doctor or healthcare professional in the form of an injection only once a week. Decide, together with your doctor, the day of the week to have the weekly injection. Metotrexato Mylan must be injected subcutaneously (under the skin).
The doctor will decide the appropriate dose for children and adolescents suffering from polyarticular forms of juvenile idiopathic arthritis.

Use in children
Metotrexato Mylan should 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:
The doctor will start with a weekly dose of 25 mg. A response to treatment is generally expected after 8-12 weeks. Depending on the effects of treatment over time, the 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 decided by the treating physician. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, vulgaris psoriasis, psoriatic arthritis and Crohn's disease with Metotrexato Mylan is a long-term treatment.
At the beginning of treatment, Metotrexato Mylan may be injected by medical personnel. However, the doctor may believe that you are able to learn to administer Metotrexato Mylan injections yourself. In this case, you will receive adequate training. Under no circumstances should you attempt to administer the injection yourself without having received adequate training.
Handling and disposal must be carried out as with other cytostatic preparations in accordance with local regulations. Pregnant healthcare personnel must refrain from 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 with plenty of 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 prescriptions. Do not change the dosage on your own.
If you suspect you have used too much Metotrexato Mylan, contact your doctor immediately. The doctor will decide on the appropriate treatment based on the severity of the intoxication.

If you forget to use Metotrexato Mylan
Do not use a double dose to make up for a missed dose.
Use the dose prescribed by your doctor as soon as possible and then every week.

If you stop using Metotrexato Mylan
You should not stop or discontinue treatment with Metotrexato Mylan without first talking to your doctor. If you suspect serious side effects, contact your doctor immediately for advice.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Below are some frequencies, as defined:
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 the frequency cannot be estimated from the available data
The frequency as well as the severity of side effects depend on the level of the dose and the
frequency of administration. Because some serious side effects can occur even at a
low dose, it is important that you are regularly monitored by your doctor. The doctor will then need to
prescribe you tests to identify any abnormalities in the blood (e.g.,
reduced number of white blood cells, reduced number of platelets, lymphoma) and changes in
kidney and liver function.

Immediately inform your doctorif you notice any of the following symptoms, which may be
indicative of serious side effects, potentially life-threatening, that require
urgent specific treatment:

• persistent dry cough without phlegm, shortness of breath and fever: these may be signs of lung inflammation (pneumonia) [frequency: common];
• blood in saliva or after coughing;
• symptoms of liver damage such as yellowing of the skin and the white of the eyes; methotrexate can cause chronic liver damage (liver cirrhosis), formation of liver scar tissue (liver fibrosis), fatty degeneration of the liver [frequency: uncommon], liver inflammation (acute hepatitis) [frequency: rare] and liver failure [frequency: very rare];
• allergic symptoms such as skin rashes including red and itchy skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing) and feeling faint; these may be signs of severe allergic reactions or anaphylactic shock [frequency: rare];
• symptoms of kidney damage such as swelling of hands, ankles, feet or changes in the frequency of urination or decreased or absent urine; these may be signs of kidney failure [frequency: rare];
• symptoms of infection, e.g., fever, chills, aches, sore throat; methotrexate can make you more susceptible to infections. Rarely, serious infections such as a specific type of pneumonia (Pneumocystis cariniipneumonia) or blood poisoning (sepsis) may occur;
• severe diarrhea, vomiting with blood and black or tarry stools; these symptoms may be indicative of a rare serious complication of the gastrointestinal system caused by methotrexate, namely gastrointestinal ulcers;
• symptoms associated with blockage (occlusion) of a blood vessel by a detached blood clot (thromboembolic event), such as weakness on one side of the body (stroke) or pain, swelling, redness and unusual warmth in a leg (deep vein thrombosis); methotrexate can cause thromboembolic events [frequency: rare];
• fever and severe deterioration of general condition, or sudden fever accompanied by sore throat or inflamed mouth, or urinary problems; very rarely methotrexate can cause a sudden reduction in the number of certain white blood cells (agranulocytosis) and severe suppression of the bone marrow;
• sudden bleeding, e.g., bleeding gums, blood in urine, vomiting with blood or bruising, which may be signs of a severe reduction in the number of platelets caused by severe bone marrow depressions [frequency: very rare];
• severe skin rash or blistering on 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 sick), loss of appetite;
• increased liver enzymes.

Common:

• mouth ulcers, diarrhea;
• skin rash, redness of the skin, itching;
• headache, fatigue, drowsiness;
• reduced formation of blood cells with a decrease in white blood cells and/or red blood cells and/or platelets (leukopenia, anemia, thrombocytopenia). Uncommon:
• sore throat, inflammation of the intestine, vomiting;
• increased sensitivity to light, hair loss, increased number of rheumatic nodules, skin ulcers, shingles, inflammation of blood vessels, herpes-like skin rashes, hives;
• onset of diabetes mellitus;
• dizziness, confusion, depression;
• decreased serum albumin;
• decreased number of blood cells and platelets;
• inflammation and ulceration of the urinary bladder or vagina, reduced kidney function, problems with urination;
• joint pain, muscle pain, osteoporosis (reduced bone mass).

Rare:

• increased skin pigmentation, acne, bruising on 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;
• visual disturbances;
• inflammation of the membrane surrounding the heart, accumulation of fluid in the membrane surrounding the heart;
• low blood pressure;
• pulmonary fibrosis, shortness of breath and bronchial asthma, accumulation of fluid in the membrane lining the lungs;
• electrolyte disturbances.

Very rare:

• profuse bleeding, toxic megacolon (acute toxic dilation of the intestine);
• increased pigmentation of the nails, inflammation of the cuticles, boils (deep infection of hair follicles), visible thickening of small blood vessels;
• local damage (formation of sterile abscesses, changes in adipose tissue) at the injection site after intramuscular or subcutaneous administration;
• visual disturbances, pain, numbness or tingling/decreased sensitivity to stimulation, changes in taste (metallic taste), convulsions, paralysis, severe headache accompanied by fever;
• retinopathy (eye disorders of non-inflammatory origin);
• loss of libido, impotence, enlargement of male breast glands (gynecomastia), abnormal sperm formation, menstrual disorders, vaginal bleeding;
• enlargement of lymph nodes (lymphoma);
• lymphoproliferative disorders (excessive growth of white blood cells).

Not known:

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature 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 which is stated on the label and the carton after
‘Exp.’. The expiry date refers to the last day of that month.
Metotrexato Mylan is for single use only. The unused solution remaining in the syringe must
be discarded.
Do not dispose of any medicine in 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 ingredient is methotrexate.
• The other ingredients are sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

This medicine contains less than 1 mmol (23 mg) of sodium per mL, that is to say, 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. The pack also includes alcohol-soaked wipes.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Cyprus 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.

Preparation
Choose a clean, well-lit and flat work surface.
Before you begin, prepare everything you need:

• a pre-filled syringe of Metotrexato Mylan;
• 1 alcohol-soaked wipe, included in the pack. Wash your hands carefully. Check the syringe for any damage to the syringe or safety device or loosely attached components. Before use, check that the safety device is in the safety position. Do not use the syringe if it does not conform to this figure:

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

Injection Site
The best sites for injection are:

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

If you have the help of another person, the injection can also be given
on the back of the 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 skin, bruised, reddened,
hardened, scarred or with stretch marks. If you suffer from psoriasis, try not to
inject directly onto lesions or areas of skin that are raised, thickened, reddened or showing
skin flaking or lesions.

Injecting the Solution
taken from the pack at room temperature.

• 2. Disinfection Figure 1: Safety device

Choose an injection site and disinfect it with the alcohol-soaked wipe included in the
pack.
Allow the disinfected injection site to dry for at least 60 seconds.

• 3. Removing the Protective Cap Carefully remove the protective cap by pulling it straight off the syringe. Important: do nottouch the needle of the pre-filled syringe! After removing the needle cap, discard it in a sharps and biological risk waste container.

• 4. Inserting the Needle Using two fingers of one hand, gently create a skin fold at the injection site. With the other hand, insert the needle into the injection site at an angle of 45-90 degrees, without touching the head of the plunger rod.
• 5. Injection and Needle Stick Protection Push the plunger completely 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 risk waste container. Do not dispose of the used syringe or device in household waste.

Methotrexate must not come into contact with the surface of the skin or mucous membranes. If
contamination occurs, the affected area must be immediately rinsed with plenty of water.
If you or someone near you is injured with the needle, seek medical attention immediately and
do not use the pre-filled syringe.

Disposal and Other Handling
The handling and disposal of the medicine and the pre-filled syringe must be carried out as
for other cytotoxic preparations in accordance with local regulations. Healthcare professionals who are
pregnant should refrain from handling and/or administering methotrexate.