METOTREXATO 2.5 мг Инъекционный раствор в преднаполненном шприце

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1. METOTREXATO DOC Generici
   1. What is METOTREXATO DOC Generici and what is it used for
   2. What you need to know before using METOTREXATO DOC Generici
   3. How to use METOTREXATO DOC Generici
   4. Possible side effects
   5. How to store METOTREXATO DOC Generici
   6. Contents of the pack and other information
2. METOTREXATO DOC Generici pre-filled syringes with fixed needle for injection, with rigid protection cap and alcohol-soaked pads are available in packs of 1 and 4 syringes.Not all pack sizes may be marketed.

METOTREXATO DOC Generici

2.5mg injectable solution in pre-filled syringe
7.5 mg injectable solution in pre-filled syringe
10 mg injectable solution in pre-filled syringe
12.5 mg injectable solution in pre-filled syringe
15 mg injectable solution in pre-filled syringe
17.5mg injectable solution in pre-filled syringe
20 mg injectable solution in pre-filled syringe
22.5 mg injectable solution in pre-filled syringe
25 mg injectable solution in pre-filled syringe
27.5 mg injectable solution in pre-filled syringe
30 mg injectable solution in pre-filled syringe
Read 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 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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is METOTREXATO DOC Generici and what is it used for

METOTREXATO DOC Generici contains methotrexate as the active ingredient.
Methotrexate is a substance with the following properties:

• interferes with the growth of some cells of the body that reproduce rapidly
• reduces the activity of the immune system (the body's defense mechanism)
• has anti-inflammatory effects.

METOTREXATO DOC Generici is indicated for the treatment of:

• active rheumatoid arthritis in adult patients;
• polyarticular forms of severe active juvenile idiopathic arthritis, when 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;
• mild to moderate Crohn's disease in adult patients, in cases where adequate treatment with other drugs is not possible.

Rheumatoid arthritis (RA)is a chronic connective tissue 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 idiopathic arthritisaffects children and adolescents under the age of 16. The forms
polyarticular are those that affect 5 or more joints within the first six months from the onset
of the disease.
Psoriatic arthritisis a type of arthritis with psoriatic skin and nail lesions, especially at
the level of the joints of the hands and feet.
Psoriasisis a common chronic skin disease, characterized by red patches covered with dry and thick scales,
silver in color, difficult to remove.
METOTREXATO DOC Generici has been shown to be able to modify and slow down the
progression of these diseases.
Crohn's diseaseis 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 DOC Generici

Do not use METOTREXATO DOC Generici

• 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 serious 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 undergoing vaccinations with live vaccines at the same time.

Warnings and precautions
Consult your doctor or pharmacist before using METOTREXATO DOC Generici if:

• you are elderly or generally feel unwell and weak;
• you have problems with liver function;
• you suffer from dehydration (loss of water).

Further tests and recommended safety measures
Even if METOTREXATO DOC Generici is used at low doses, serious side effects can occur.
To identify them promptly, the doctor must perform monitoring tests and laboratory tests.
Before starting therapy
Before you begin 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 whether to perform other liver tests, some of which may be images of your liver and others may require small tissue samples from the liver for better examination. 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 mucous membrane or ulcerations
• Blood tests / complete blood count with blood cell count and measurement of serum methotrexate levels
• Blood tests to monitor liver function
• Imaging tests to monitor the condition of the liver
• Small tissue samples taken from the liver for better examination
• 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 significant, 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 soon as possible.
Age-related impairment of liver and kidney function, as well as poor vitamin folic acid reserves in old age, require a relatively low dose of methotrexate.
Cases of acute pulmonary bleeding have been reported in patients with rheumatic disease treated with methotrexate. If you notice blood in your saliva or after coughing, you should contact your doctor immediately.
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). Do not undergo vaccination with live vaccines during therapy with METOTREXATO DOC Generici.
If you, your partner or the person assisting you notice the appearance or worsening of neurological symptoms, including general muscle weakness, visual 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).
Radiation dermatitis and sunburns 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 DOC Generici and requires discontinuation of therapy. If you suffer from diarrhea, tell your doctor.
Some brain diseases (encephalopathy / leukoencephalopathy) have occurred in patients with tumors treated with methotrexate. It cannot be excluded that these side effects may occur when methotrexate is used to treat other diseases.
Particular precautions for treatment with METOTREXATO DOC Generici
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. If you are a woman, while taking methotrexate and for at least 6 months after the end of treatment, you must avoid pregnancy. If you are a man, you must avoid fathering a child while taking methotrexate and for at least 3 months after the end of treatment. See also the section “Pregnancy, breastfeeding and fertility”.

Other medicines and METOTREXATO DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines. Consider that this applies to medicines you will take in the future.
The effect of treatment may be altered if METOTREXATO DOC Generici is administered concurrently with other medicines such as:

• Antibioticssuch as: tetracyclines, chloramphenicol and broad-spectrum non-absorbable antibiotics, penicillins, glycopeptides, sulfonamides, ciprofloxacin and cephalothin (medicines that prevent / fight some infections).
• Non-steroidal anti-inflammatory drugsor salicylates(pain and / or inflammation medications such as acetylsalicylic acid, diclofenac and ibuprofen or pyrazolone)
• Probenecid(medicine for gout)
• Weak organic acids such as loop diuretics(diuretic drugs)
• Medicines that can have adverse effects on the bone marrow, e.g. trimethoprim-sulfamethoxazole (an antibiotic) and pyrimethamine
• Other medicines used to treat rheumatoid arthritissuch as leflunomide, sulfasalazine and azathioprine
• Mercaptopurine (a cytostaticmedicine)
• Retinoids (medicine for psoriasisand other dermatological diseases)
• Theophylline (medicine for bronchial asthmaand other lung diseases)
• Some medicines for stomach problems such as omeprazole and pantoprazole
• Hypoglycemic agents (medicines used to lower blood sugar)

Vitamin complexes containing folic acidmay compromise the effect of treatment and must be taken only under the control of the doctor.

Penicillins
Penicillins can reduce the excretion of methotrexate causing a potential increase in side effects.
Vaccinations with live vaccinesmust be avoided.

METOTREXATO DOC Generici with food, drinks and alcohol
During treatment with METOTREXATO DOC Generici, alcoholic beverages, large amounts of coffee, caffeinated beverages and black tea should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use METOTREXATO DOC Generici 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 patients or those 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 must avoid pregnancy using reliable contraceptive methods throughout 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 will receive advice on the risk of harmful effects on the baby due to 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 discontinued before and during treatment with METOTREXATO DOC Generici.
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 ruled out. 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 3 months after the end of treatment, you must avoid fathering a child or donating semen.

Driving and using machines
Treatment with METOTREXATO DOC Generici can cause adverse reactions affecting the central nervous system, such as fatigue and dizziness. Therefore, the ability to drive a vehicle and / or use machinery may be impaired in some cases. If you feel tired or sleepy, do not drive or use machinery.

METOTREXATO DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically “sodium-free”.

3. How to use METOTREXATO DOC Generici

Important warning regarding the dose of METOTREXATO DOC Generici:
In the treatment of rheumatoid arthritis, psoriasis, polyarticular forms of juvenile idiopathic arthritis and
Crohn's disease, METOTREXATO DOC Generici must only be taken once a week. Excessive use of METOTREXATO DOC Generici can be fatal. Read paragraph 3 of this leaflet very
carefully. If in doubt, consult your doctor or pharmacist
before taking this medicine.
Use this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
The doctor will decide the dose, to be adapted to the individual patient. In general, the effects of treatment
are noticeable after 4-8 weeks of treatment.
METOTREXATO DOC Generici is administered by a doctor or under his/her supervision or by
healthcare personnel in the form of an injection once a week only. Decide, together with
your doctor, the day of the week to have the weekly injection. METOTREXATO DOC
Generici must be injected subcutaneously (under the skin).

At the beginning of treatment, METOTREXATO DOC Generici will be injected by medical
personnel.
However, the doctor may consider that you are able to learn how to administer METOTREXATO DOC Generici
injections yourself. In this case, you will receive adequate training. In
no case should you attempt to administer the injection yourself without having received adequate
training.
Use in children and adolescents
The doctor will decide the appropriate dose for children and adolescents with polyarticular forms
of juvenile idiopathic arthritis.
METOTREXATO DOC Generici is not recommended in children under 3 years of age due to the
limited experience gained with this age group.

Method of administration and duration of treatment
METOTREXATO DOC Generici is injected once a week!
The duration of treatment is decided by the attending physician. Treatments for rheumatoid arthritis, juvenile
idiopathic arthritis, psoriasis vulgaris, psoriatic arthritis and Crohn's disease with METOTREXATO
DOC Generici are long-term treatments.
Handling and disposal must be carried out as for other cytostatic preparations in
accordance with local regulations. Healthcare personnel who are pregnant should refrain
from handling and/or administering METOTREXATO DOC Generici.
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 use more METOTREXATO DOC Generici than you should
If you use more METOTREXATO DOC Generici than you should, contact your doctor immediately.

If you forget to use METOTREXATO DOC Generici
Do not take a double dose to make up for a missed dose

If you stop using METOTREXATO DOC Generici
If you stop using METOTREXATO DOC Generici, consult your
doctor immediately. If you feel that the effect of METOTREXATO DOC Generici is too strong or too weak,
inform your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The frequency and severity of side effects depend on the dose and frequency of
administration. Because some serious side effects can occur even at a low
dose, it is important that the doctor performs regular monitoring. The doctor will then

prescribe you teststo identify any presence of abnormalitiesin the blood (e.g. reduced number of white blood cells, reduced number of platelets, lymphoma) and alterations in the function of the
kidneys and liver.

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

• dry persistent cough without phlegm, shortness of breath and fever: these may be signs of lung inflammation [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 [all uncommon], liver inflammation (acute hepatitis) [rare] and liver failure [very rare]
• allergic symptoms such as skin rashes including red and itchy skin, swelling ofhands, feet, ankles, face, lips, mouth or throat (which can cause difficulty inswallowing or breathing) and a feeling of fainting: these may be signs of severe allergic reactions or anaphylactic shock [rare]
• symptoms of kidney damage such as swelling of hands, ankles, feet or changes infrequency of urination or decreased (oliguria) or absence of urine (anuria): these may be signs of kidney failure [rare]
• symptoms of infection, e.g. fever, chills, aches, sore throat: methotrexate can make you more susceptible to infections. Serious infections such as a specific type of pneumonia ( Pneumocystis cariniipneumonia) or blood poisoning ( sepsis) [rare]
• symptoms such as weakness on one side of the body (stroke) or pain, swelling, redness andunusual warmth in a leg (deep vein thrombosis); this can occurwhena blood clot breaks loose and causes a blockage of a blood vessel( thromboembolic event) [rare]
• fever and a severe deterioration in general condition, or sudden feveraccompanied by sore throat or inflamed mouth, or urinary problems: methotrexate can cause a sudden reduction in the number of some white blood cells (agranulocytosis) and severe bone marrow depression [very rare]
• sudden bleeding, e.g. bleeding gums, blood in urine,vomiting with blood or bruising: these may be signs of a severe reduction in the number of platelets caused by severe bone marrow depression [very rare]
• symptoms such as severe headache often associated with fever, stiff neck,feeling unwell, vomiting, disorientation and sensitivity to lightmay indicate inflammation of the membranes of the brain (acute aseptic meningitis) [very rare]
• some brain diseases (encephalopathy / leukoencephalopathy) have occurred in patients with tumors treated with methotrexate. It cannot be ruled out that these side effects may occur when methotrexate is used for the treatment of other diseases. Signs of these types of brain disorders may be: altered mental states, movement disorders (ataxia), visual disturbancesor memory disorders[frequency not known]
• severe skin rash or blistering (may also occur on the mouth, eyes andgenitals): these may be signs of a condition called Stevens Johnson syndrome or toxic skin syndrome (toxic epidermal necrolysis / Lyell's syndrome) [very rare].

Other side effects may also occur, listed below:

Very common: may affect more than 1 in 10 people

• Inflammation of the mouth, indigestion, nausea (feeling sick), loss of appetite, abdominal pain.
• Abnormal liver function tests (ASAT, ALAT, bilirubin, alkaline phosphatase).

Common: may affect up to 1 in 10 people

• 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.

Uncommon: may affect up to 1 in 100 people

• Inflammation of the throat.
• Inflammation of the intestine, vomiting, inflammation of the pancreas, black and tarry stools, gastrointestinal ulcers and bleeding.
• Increased sensitivity to light, hair loss, increased number of rheumatic nodules, skin ulcers, shingles, inflammation of blood vessels, skin rashes similar to herpes, hives.
• Onset of diabetes mellitus.
• Dizziness, confusion, depression.
• Decreased serum albumin.
• Reduction in the number of all blood cells and platelets.
• Inflammation and ulceration of the urinary bladder or vagina, reduced kidney function, problems with urination.
• Joint pain, muscle pain, decreased bone mass.

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

• Inflammation of the gums.
• Increased skin pigmentation, acne, bruising of the skin due to bleeding from blood vessels (ecchymosis, petechiae), allergic inflammation of blood vessels.
• Reduction in the number of antibodies in the blood.
• Infection (including reactivation of inactive chronic infection), red eyes (conjunctivitis).
• Mood changes (emotional instability).
• Visual disturbances
• Inflammation of the membrane surrounding the heart, accumulation of fluid in the membrane surrounding the heart, obstruction of cardiac filling due to the presence of fluid in the membrane around the heart.
• Low blood pressure
• Formation of scar tissue in the lungs (pulmonary fibrosis), shortness of breath and bronchial asthma, accumulation of fluid in the membrane lining the lungs.
• Stress fractures.
• Electrolyte disorders.
• Fever, alteration of wound healing.

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

• Toxic acute dilation of the intestine (toxic megacolon).
• Increased pigmentation of the nails, inflammation of the areas around the cuticles, boils (deep infection of hair follicles), visible enlargement of small blood vessels (capillaries).
• Local damage (formation of sterile abscesses, changes in adipose tissue) at the injection site after intramuscular or subcutaneous administration.
• Visual disturbances, pain, loss of strength or numbness/decreased sensitivity to normal 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 discharge.
• Enlargement of lymph nodes (lymphoma).
• Lymphoproliferative disorders (excessive growth of white blood cells).

Frequency not known: cannot be estimated from available data:

• Increased number of some types of white blood cells.
• Nosebleeds.
• Redness and flaking of the skin.
• Protein in the urine.
• Feeling of weakness.
• Bleeding from the lungs.
• Bone damage in the jaw/maxilla (secondary to excessive growth of white blood cells).
• Destruction of tissues at the injection site, swelling.

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 experience any side effects, including 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 DOC Generici

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25  C.
Store the pre-filled syringes in the outer carton 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.
Single use only. Any remaining solution 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. Contents of the pack and other information

What METOTREXATO DOC Generici contains
The active ingredient is methotrexate.
METOTREXATO DOC Generici 2.5 mg:
each pre-filled syringe of 0.33 ml contains 2.5 mg of methotrexate
METOTREXATO DOC Generici 7.5 mg:
each pre-filled syringe of 0.30 ml contains 7.5 mg of methotrexate
METOTREXATO DOC Generici 10 mg:
each pre-filled syringe of 0.40 ml contains 10 mg of methotrexate
METOTREXATO DOC Generici 12.5 mg:
each pre-filled syringe of 0.31 ml contains 12.5 mg of methotrexate
METOTREXATO DOC Generici 15 mg:
each pre-filled syringe of 0.38 ml contains 15 mg of methotrexate
METOTREXATO DOC Generici 17.5 mg:
each pre-filled syringe of 0.44 ml contains 17.5 mg of methotrexate
METOTREXATO DOC Generici 20 mg:
each pre-filled syringe of 0.50 ml contains 20 mg of methotrexate
METOTREXATO DOC Generici 22.5 mg:
each pre-filled syringe of 0.56 ml contains 22.5 mg of methotrexate
METOTREXATO DOC Generici 25 mg:
each pre-filled syringe of 0.63 ml contains 25 mg of methotrexate
METOTREXATO DOC Generici 27.5 mg:
each pre-filled syringe of 0.69 ml contains 27.5 mg of methotrexate
METOTREXATO DOC Generici 30 mg:
each pre-filled syringe of 0.75 ml contains 30 mg of methotrexate.
The other ingredients are sodium chloride, sodium hydroxide for pH adjustment, water for
injectable preparations

Description of the appearance of METOTREXATO DOC Generici and contents of the pack
METOTREXATO DOC Generici syringes contain a clear, yellow-orange solution free of
visible particles.

Packs:

METOTREXATO DOC Generici pre-filled syringes with fixed needle for injection, with rigid protection cap and alcohol-soaked pads are available in packs of 1 and 4 syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
DOC Generici Srl, Via Turati 40, 20121 Milano

Manufacturer:
Actavis Italy S.p.A., Via Pasteur 10, Nerviano (Milano)
S.C. Sindan- Pharma S.R.L, 11 Ion Mihalache Blvd, Bucharest, Romania
---------------------------------------------------------------------------------------------------------------------------

Instructions for Use
Read these instructions carefully before starting the injection and always use the injection technique recommended by your doctor, pharmacist or nurse.
For single use only. Any remaining solution must be discarded.
The solution must be clear and free of particles.
For any problems or questions, contact your doctor, pharmacist or nurse.

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

• 1 pre-filled syringe of METOTREXATO DOC Generici
• 1 alcohol-soaked disinfectant pad (provided in the pack). Wash your hands carefully. Before use, check the METOTREXATO DOC Generici syringe for any visible defects (or cracks).

Injection Site
The best injection sites are:

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

• If you have help from another person for the injection, the injection can also be given in the back of the arm, just below the shoulder.
• Change the injection site for each injection. This way you can reduce the risk of developing irritation at the injection site.
• Never inject into areas of delicate skin, bruising, redness, hardness, scars or stretch marks. If you suffer from psoriasis, try not to inject directly on lesions or areas of raised, thick, red skin or skin scaling or lesions.

Injecting the solution

• 1. Remove the pre-filled methotrexate syringe from the packaging and read the leaflet carefully. Remove the pre-filled syringe from the packaging at room temperature.
• 2. Disinfection Choose an injection site and disinfect it with a disinfectant pad, for example using the alcohol-soaked pad included in the packaging. Allow the disinfectant to dry for at least 60 seconds.

• 3. Remove the plastic protective cap

Carefully remove the plastic protective cap by pulling it straight off the syringe. If the cap is very tight, gently rotate it while pulling.
Important: Do not touchthe needle of the pre-filled syringe!

• 4. Inserting the needle

Using two fingers, pinch up a fold of skin and quickly insert the needle into the skin at a 90-degree angle.
Note: it is normal to have a small air bubble in the syringe. Do not try to remove this air bubble before giving the injection – if you do, you may lose some of the medicine.

• 5. Injection

Insert the needle completely into the skin fold. Inject the liquid subcutaneously by slowly pressing the plunger all the way down into the syringe. Keep a firm hold of the skin fold until the injection is complete.
Carefully withdraw the needle vertically.

To avoid any injury, replace the needle in the protective cap using one hand and gently press the cap back into place.

• 6. Immediately dispose of the syringe in sharps containers.

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 plenty of water.
If you or someone near you is injured with the needle, consult a doctor immediately and do not use the pre-filled syringe.

Disposal and other handling
Handling and disposal 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 METOTREXATO DOC Generici.