100 mg / ml concentrate for solution for infusion solution
methotrexate
What Methotrexate Ebewe is and what it is used for
Methotrexate Ebewe contains the active substance methotrexate. Methotrexate is a so-called cytotoxic drug and is most often used to kill cells in tumors.
Methotrexate Ebewe is used to treat certain types of cancer, e.g. acute lymphocytic leukemia (disease of the blood or bone marrow with an increased number of white blood cells ), breast cancer, and skeletal cancer.
Your doctor may explain how Methotrexate Ebewe can help with your specific illness.
Methotrexate contained in Methotrexate Ebewe may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Methotrexate Ebewe
Do not use Methotrexate Ebewe
- if you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6).
- if you have a serious kidney disease (your doctor will determine the severity of the disease).
- if you have a serious liver disease (your doctor will determine the severity of the disease).
- if you have any defects in your blood formation (eg after previous radiotherapy or chemotherapy ).
- if your immune system is not working properly (eg for AIDS ).
- if you have increased alcohol consumption.
- if you have a severe or ongoing infection .
- if you have sores in your mouth and throat or sores in your stomach and intestines.
- if you are breast-feeding (see section “Pregnancy, breast-feeding and fertility”).
- if you are pregnant and being treated for a disease other than cancer (see section “Pregnancy, breast-feeding and fertility”).
- you should not receive live vaccines (eg for yellow fever) during treatment with Methotrexate Ebewe.
Warnings and cautions
Talk to your doctor or pharmacist before using Methotrexate Ebewe.
Treatment should be performed by a physician experienced in tumor therapy and adequately experienced in methotrexate therapy.
Your doctor will inform you about the benefits and risks of methotrexate as well as early signs and symptoms of harmful side effects ( toxicity ). You will be under close control so that symptoms of harmful side effects are detected early.
If you get any signs and symptoms of harmful side effects (see section 4 “Possible side effects”), you must tell your doctor immediately. The doctor will decide which controls of the symptoms need to be instituted and inform you about further treatment.
Talk to your doctor before using Methotrexate Ebewe
- if you are diabetic and need to take insulin
- if you have an inactive long-term infection (eg tuberculosis , hepatitis B or C, shingles [herpes zoster]). These infections can be reactivated.
- if you have or have had liver or kidney disease
- if you have or have had problems with lung function
- if you are severely overweight
- if you have abnormal accumulation of fluid in the abdomen or in the cavity between the lungs and the chest wall ( ascites , pleural effusion).
Liver function
Methotrexate can damage the liver.
During treatment with Methotrexate Ebewe, you should not use other medicines that can damage the liver and you should not drink alcohol.
Your doctor will take blood samples before and during treatment to check your liver function.
Also read the sections “Other medicines and Methotrexate Ebewe” and “Methotrexate Ebewe with food, drink and alcohol” and section 4.
Renal function
Methotrexate can damage the kidneys.
Your doctor will take blood samples before and during treatment to check your kidney function.
Conditions that can lead to dehydration (insufficient fluid in the body) such as vomiting, diarrhea, and inflammation of the gums, can increase the side effects of methotrexate. In such cases, your doctor may stop your treatment with methotrexate. See also section 4.
Blood-forming organs and the immune system
Treatment with methotrexate may damage bone marrow (bone marrow inhibition).
If bone marrow is damaged, it can lead to infection and/or heavy bleeding and anemia. Your doctor will take blood samples to treat these complications as soon as possible.
Tell your doctor if you get a fever, sore throat, sore mouth, flu-like illness, bruising, bleeding, or feeling very exhausted.
Due to the possible effect on the immune system, methotrexate may lead to incorrect test results (immunological tests to analyze the immune response) and poorer effects of vaccinations.
The nervous system
Fatal brain injury (encephalopathy/leukoencephalopathy) has been reported in patients receiving methotrexate intravenously. There are also reports of encephalopathy in patients who have taken methotrexate orally (orally).
You must be closely monitored if you receive methotrexate intrathecally ( injection into the central nervous system ).
The skin
Methotrexate can make the skin sensitive to sunlight so you should avoid staying in the sun for long periods.
You should also not sunbathe in a solarium without first discussing this with your doctor.
If you have had skin problems after radiation therapy (skin inflammation due to radiation) and sun damage, these may recur during treatment with methotrexate (“recall” reaction).
More about severe skin reactions ( Stevens-Johnson syndrome, erythema multiforme) can be found in section 4.
The gastrointestinal tract
Serious complications can develop in the gastrointestinal tract during treatment with methotrexate. If this happens, treatment must be stopped.
Talk to your doctor if you have problems with your stomach or intestines (see section 4).
Infection is
Infection may occur during treatment with methotrexate. These can be fatal.
Talk to your doctor if you get any signs of infection (see section 4).
The lungs
Serious lung complications can develop during treatment with methotrexate. If this happens, treatment must be stopped.
Talk to your doctor if you have breathing problems or other lung problems (see section 4).
Acute hemorrhage from the lungs of patients with the underlying rheumatic disease has been reported with methotrexate.
The tumor is
If you have a tumor that grows rapidly, you can suffer from so-called tumor lysis syndrome, see also section 4.
Cancer of the lymph nodes (malignant lymphoma ) can occur. In some patients, cancer receded when methotrexate treatment was discontinued. If lymphoma develops, treatment with methotrexate should therefore be discontinued in the first instance, and only if the lymphoma does not disappear should treatment be discontinued.
Recommended controls and precautions
Methotrexate can cause serious side effects, even when given in low doses. For these to be detected early, the doctor must perform certain checks and laboratory tests.
Before treatment
Before starting treatment, the doctor may take blood samples to confirm that you have enough blood cells, check how your kidneys and liver are working, check the amount of albumin (a protein ) in your blood, and if you have hepatitis (liver infection). Your doctor may also check for tuberculosis and perform a lung X-ray and lung function test.
During treatment
Your doctor may perform the following tests:
- Check if you have any changes, inflammation or sores in the oral mucosa or pharynx.
- Take blood samples to check the number of blood cells and the amount of methotrexate in the blood.
- Take blood samples to check liver function.
- Take blood samples to check kidney function.
- Check your breathing and, if necessary, perform a lung function test.
Do not forget to go on all visits for blood tests and other checks!
Your doctor may need to change your treatment depending on the results of these tests.
Use in the elderly
Elderly people treated with methotrexate should be under particularly close medical supervision so that side effects can be detected as early as possible.
The dose may need to be reduced for the elderly due to poorer liver and kidney function and due to low folic acid reserves that may occur with increasing age.
Special treatment protocols (eg for the treatment of acute lymphocytic leukemia ) have been developed for elderly patients (over 55 years of age).
Children and young people
Methotrexate should be used with caution in children.
Appropriate treatment protocol should be considered with dose and use in mind.
Methotrexate temporarily affects sperm and egg production. Methotrexate can cause miscarriage and severe congenital malformations. You and your partner should avoid having children while you are receiving methotrexate and for at least 6 months after stopping treatment with methotrexate. See also section “Pregnancy, breast-feeding and fertility”.
Other medicines and Methotrexate Ebewe
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are using:
- drugs that can damage the liver, e.g.
- azathioprine (used to prevent rejection after organ transplantation)
- leflunomide (used to treat rheumatoid arthritis )
- retinoids (used to treat skin diseases)
- sulfasalazine (used to treat rheumatoid arthritis , and also inflammation of the intestines)
- drugs for the treatment of rheumatoid arthritis or psoriasis such as gold compounds, penicillamine, hydroxychloroquine, sulfasalazine, azathioprine and cyclosporine
- drugs for the treatment of pain and / or inflammation (non-steroidal anti-inflammatory drugs / NSAIDs such as ibuprofen , indomethacin, phenylbutasone, amidopyridines and acetylsalicylic acid ), including over-the-counter
- cancer drugs ( cytostatics , eg doxorubicin, mercaptopurine, procarbazine, cisplatin, L-asparaginase, vincristine, cytarabine and 5-fluorouracil)
- antibiotics (eg penicillins , sulfonamides , trimethoprim / sulfamethoxazole, tetracyclines , ciprofloxacin , pristinamycin and chloramphenicol)
- sedatives (eg benzodiazepines such as lorazepam or alprazolam)
- corticosteroids (for the treatment of various diseases, allergies , respiratory problems and skin diseases)
- 4-aminobenzoic acid (for the treatment of skin diseases)
- birth control pills
- triamterene (eg for the treatment of hypertension and heart failure )
- cholestyramine (for the treatment of high cholesterol)
- phenytoin and phenobarbital (to prevent seizures)
- probenecid (for the treatment of gout )
- aminohippuric acid (used to control kidney function)
- pyrimethamine (to prevent and treat malaria )
- medicines for severe heartburn and stomach ulcers ( proton pump inhibitors , eg omeprazole, pantoprazole, lansoprazole)
- theophylline (for the treatment of asthma and other lung diseases)
- amiodarone (for the treatment of irregular heartbeats)
- anesthetics that contain nitrous oxide (tell your doctor if you are going to have an operation under anesthesia)
- red blood cell concentrate (for blood transfusions )
- medicines and vitamin preparations containing folic acid
- levetiracetam (for the treatment of seizures in epilepsy ).
You should not be vaccinated with live vaccine while you are being treated with methotrexate. Talk to your doctor if you are unsure.
You will be vaccinated against pneumonia and influenza while you are being treated with methotrexate.
Methotrexate Ebewe with food, drink and alcohol
You should not drink alcohol during treatment with Methotrexate Ebewe as it may increase the risk of side effects, especially in the liver.
Your doctor or pharmacist may recommend that you drink plenty of fluids that do not contain alcohol. It can help the drug to be flushed out of the body more quickly and can prevent kidney problems.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Methotrexate Ebewe during pregnancy unless your doctor prescribes it for cancer treatment. Methotrexate can cause congenital malformations, birth defects, and miscarriages. It is associated with malformations of the skull, face, heart and blood vessels, brain arms, and legs. It is therefore very important that methotrexate is not given to pregnant women or to women planning to become pregnant unless used for cancer treatment.
For indications other than cancer, a possible pregnancy in fertile women must be ruled out, e.g. through pregnancy tests, before starting treatment.
Do not use Methotrexate Ebewe if you are trying to conceive. You must avoid becoming pregnant during treatment with methotrexate and for at least 6 months after stopping treatment. Be sure to use effective contraception throughout this time (see also section “Warnings and Precautions”).
If you become pregnant during treatment or suspect you may be pregnant, talk to your doctor as soon as possible. If you become pregnant during treatment, you should be offered medical advice on the risk of harmful effects on the baby due to the treatment.
If you want to get pregnant, talk to your doctor, who can refer you to specialist advice before the planned start of treatment.
Breast-feeding
Because methotrexate passes into breast milk and may have harmful effects on breastfed infants, you should not breastfeed during treatment. If your doctor thinks you must receive treatment with methotrexate during the breastfeeding period, you must stop breastfeeding.
Fertility
Methotrexate may also reduce your ability to conceive during treatment and for a short period after stopping treatment.
If you want to get pregnant, contact a doctor who can refer you to a specialist for advice.
Fertility in men
Available data do not indicate an increased risk of malformations or miscarriages if the father takes less methotrexate than 30 mg/week. However, risk can not be completely ruled out and there is no information on higher doses of methotrexate. Methotrexate may have genotoxic effects. This means that the drug can cause gene mutations. Methotrexate can affect sperm production, which is associated with the risk of congenital malformations.
You should avoid getting a woman pregnant and donating sperm during treatment with methotrexate and for at least 6 months after stopping treatment. Because treatment with methotrexate may cause infertility and gene mutations at higher doses that are common in cancer treatment, male patients treated with methotrexate at doses above 30 mg/week should consider sperm preservation before starting treatment (see also section “Warnings and precautions”).
Driving and using machines
Central nervous system effects, such as fatigue and a tingling sensation, may occur during treatment with Methotrexate Ebewe and impair your ability to drive or use machines. This can get worse if you have been drinking alcohol.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Methotrexate Ebewe contains sodium
This medicine contains 0.43 mmol (or 9.7 mg) sodium per ml.
This medicine contains 48.5 mg sodium (the main ingredient in table salt/table salt) per 5 ml vial. This corresponds to 2.4% of the highest recommended daily intake of sodium for adults.
This medicine contains 97 mg of sodium (the main ingredient in table salt/table salt) per 10 ml vial. This corresponds to 4.85% of the highest recommended daily intake of sodium for adults.
This medicine contains 485 mg of sodium per 50 ml vial.
Talk to your doctor or pharmacist if you need 40 ml (4,000 mg) or more daily for a long period, especially if you have been prescribed a low-salt (sodium-poor) diet.
How to use Methotrexate Ebewe
You will receive Methotrexate Ebewe from your healthcare provider. You should not take it yourself.
The dose of medicine you receive depends on the disease you are being treated for, your medical condition, your age, your body weight or body surface area, and how well your kidneys are functioning.
If you have kidney problems, your doctor may reduce the dose one, depending on how your kidneys work.
If you have liver problems, mainly due to alcohol, your doctor will be very careful about prescribing one of Methotrexate Ebewe or you may not prescribe it at all.
During treatment, your doctor will take blood samples to check your blood cells and to make sure your liver and kidneys are working properly. You must attend all blood tests.
If you have the impression that the effect of Methotrexate Ebewe is too strong or too weak, talk to your doctor or pharmacist.
If you take more Methotrexate Ebewe than you should
Because you are receiving this medicine from a healthcare professional, it is very unlikely that you would receive too much.
Symptoms of overdose are e.g. bruising or bleeding, unusual weakness, sores in the mouth, nausea, vomiting, black or bloody stools, blood cough or vomiting that looks like coffee grounds, decreased amount of urine.
If you have received the medicine intrathecally, symptoms such as headache, nausea, vomiting, and cramps as well as brain damage ( encephalopathy ) may occur.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects are usually dependent on the dose and the duration of treatment, but serious side effects that can lead to the treatment having to be stopped temporarily or stopped completely can occur even at low doses. Side effects can occur at any time during treatment. Most go back if they were discovered early.
The side effects do not always disappear completely if the treatment with methotrexate is stopped.
Some of the serious side effects listed below can in very rare cases lead to sudden death. There is also a risk that some side effects will only appear after a while. Talk to your doctor about this.
Tell your doctor immediately if you get any of the following symptoms as they may be signs of a serious and potentially life-threatening side effect. The doctor decides if the treatment needs to be stopped.
- Allergic reactions such as sudden wheezing and wheezing, difficulty breathing, swelling of the eyelids, face or lips (which can lead to difficulty swallowing), rash or itching (especially if the whole body is affected) as this may be a sign of a severe allergic reaction .
- Lung problems (symptoms such as general malaise, dry / cough, shortness of breath, shortness of breath at rest, chest pain or fever). This may be a sign of an infection in the lungs ( pneumonia , pneumonitis , alveolitis).
- Symptoms of liver damage such as yellowing of the skin and whites of the eyes (jaundice), dark urine, nausea, vomiting, decreased appetite, pain on the right side of the stomach and itching
- Symptoms of kidney damage such as swollen hands, ankles or feet or decreased urine output or no urine at all – this may be a sign of kidney failure .
- Symptoms of infection such as fever, ache, sore throat. Methotrexate may reduce your body’s ability to fight infections . Serious infection is e.g. a specific type of pneumonia ( pneumocystis jirovecii – pneumonia ) and sepsis may occur.
- Fever, sore throat, sore mouth, general malaise and severe fatigue, nosebleeds or small red spots on the skin – can be signs that a bone marrow is not working properly.
- Ulcers in the oral mucosa.
- Abdominal pain (upper abdomen), nausea, vomiting or fever. This can be caused by an inflammation of the pancreas.
- Severe abdominal pain, fever, nausea, vomiting, severe diarrhea, blood in the stool or altered bowel habits. This can be a sign of serious complications in the gastrointestinal tract, e.g. ulcers or perforation in the stomach or intestines.
- Severe skin reactions ( Stevens-Johnson syndrome , toxic epidermal necrolysis , erythema multiforme). These begin with red spots or spots on the body, often with blisters in the middle, and are often accompanied by general malaise and fever. The rash can be aggravated by severe flaking or blistering which can be life threatening.
- Symptoms that may indicate a blood clot (thromboembolism) such as pain or pressure over the chest, pain in the arms, back, neck or jaws, difficulty breathing, numbness or weakness in one side of the body, speech difficulties and dizziness.
- Cough, chest pain, sudden shortness of breath or coughing up blood. This may be a symptom of pulmonary embolism (congestion in the lung).
- Symptoms associated with tumor lysis syndrome, such as various gastrointestinal symptoms (nausea, vomiting, diarrhea), heart (irregular heartbeat), kidneys (decreased amount of urine, blood in the urine) and nerves and muscles (twitching, weakness, cramps).
The following side effects have also been reported:
Very common (may affect more than 1 user in 10):
- altered white blood cell count (leukocytopenia) and platelets ( thrombocytopenia )
- headache, tingling sensation
- cough
- decreased appetite, diarrhea (especially during the first 24-48 hours of treatment with Methotrexate Ebewe), stomach pain, nausea, vomiting, inflammation and sores in the mouth and throat (especially during the first 24-48 hours of treatment with Methotrexate Ebewe)
- increase in liver enzymes
- hair loss
- decreased creatinine secretion (can be measured by a test performed by your doctor and is a sign of impaired kidney function)
- fatigue, general malaise.
Common (may affect up to 1 in 10 people):
- shingles ( herpes zoster)
- altered red blood cell count ( anemia ), bone marrow damage that can lead to a sharp decrease in the number of white blood cells ( agranulocytosis ) or of all blood cells (pancytopenia)
- drowsiness, numbness and tingling
- red eyes ( conjunctivitis )
- skin rash, redness , itching , increased sensitivity to the sun, sores on the skin.
Uncommon (may affect up to 1 in 100 people):
- increased risk of infections / inflammations due to weakened immune system
- certain types of cancer, so-called lymphoma , which can disappear when treatment with methotrexate is stopped
- diabetes
- Depression
- paralysis of one side of the body, confusion, seizures
- inflammation of the blood vessels ( vasculitis ), allergic vasculitis
- increased amount of connective tissue in the lungs ( pulmonary fibrosis ), fluid between the different parts of the lungs (pleural effusion)
- liver damage (hepatotoxicity), fatty liver , fibrosis (increased amount of connective tissue), cirrhosis (transformation of tissue through hardening and reduction of the normal structure of the liver), decreased serum albumin (a type of protein in the blood)
- severe toxic reactions: accumulation of blisters similar to the skin lesions of herpes virus infection (herpetiform rash)
- hives , dark skin, nodules in the skin (nodulos), impaired wound healing
- joint or muscle pain , osteoporosis
- inflammation and ulcers in the bladder (possibly with blood in the urine), problems with emptying the bladder, pain when urinating, little or no urine
- fetal malformations
- inflammation and ulcers in the vagina
- fever.
Rare (may affect up to 1 in 100 people):
- anemia associated with enlarged red blood cells (megaloblastanemia)
- mood swings, transient perception disorders
- paralysis, speech problems, inflammation of the bone marrow (myelopathy)
- visual disturbances (may be severe), clots in the retinal veins ( retinal thrombosis )
- low blood pressure ( hypotension ), complications of blood clots in veins and arteries (thromboembolic events)
- sore throat ( pharyngitis ), respiratory arrest
- inflammation of the gastrointestinal tract, inflamed gums, black or tar-colored stools
- inflammation of the liver ( hepatitis )
- acne , red or purple dots, papular rash, bruising, dark nails, nail loss
- stress fracture
- increased amount of urea , creatinine and uric acid in the blood (signs of kidney problems), increased amount of blood urea (azotemia)
- miscarriage
- altered menstrual cycle and decreased sperm production that return to normal after stopping treatment.
Very rare (may affect up to 1 in 10,000 people):
- inflammation of the liver caused by herpes virus ( herpes simplex hepatitis )
- fungal infections ( histoplasmosis , cryptococcosis ), viral infections ( cytomegalovirus – infection , including pneumonia ), spread herpes simplex, bacterial infection (nocardiosis)
- anemia caused by insufficient production of red blood cells ( aplastic anemia ), decreased white blood cell count ( eosinophilia , neutropenia ), swollen lymph nodes in the head and neck area, in the armpits and groin (may partially return), uncontrolled increase in lymphocytes (may partly go back)
- small number of antibodies in the blood ( hypogammaglobulinemia )
- muscle weakness and pain in arms and legs, metallic taste, acute aseptic meningitis with symptoms such as severe headache, fever, nausea, vomiting and unconsciousness, damage to / problems with cranial nerves
- swelling around the eyes, inflammation of the eyelids, increased tear production, increased photosensitivity, transient blindness, loss of vision
- inflammation of the pericardium (pericarditis), impaired ability to fill the heart properly due to ejaculation in the pericardium (pericardial tamponade), fluid between different parts of the heart (pericardial effusion)
- chronic damage to the lung structure, asthma-like reactions with cough, breathing problems abnormal lung function test
- vomiting blood
- degradation of liver cells ( acute liver necrosis), degradation of liver, liver failure
- infection of the hair follicles ( furunculosis ), visible and prolonged enlargement of the small blood vessels under the skin (telangiectasia), inflammation of the nail bed a
- blood in the urine, increased excretion of protein in the urine
- fetal death
- decreased production of ova and sperm, infertility , disruption of the menstrual cycle, lost sex drive, impotence , discharge from the vagina, enlarged breasts in men ( gynecomastia )
- lymphoproliferative disorders (abnormal growth of white blood cells ).
Has been reported (occurs in an unknown number of users):
- pneumonia , reactivation of hepatitis B infection , exacerbated hepatitis C infection
- damage to the nervous system (neurotoxicity), inflammation of the membranes around the brain (arachnoiditis), paralysis of the legs (paraplegia), stiffness of the whole body ( stupor ), poor muscle coordination, dementia, increased pressure in the cerebrospinal fluid (surrounding the brain and spinal cord) with symptoms such as headache, nausea, vomiting, high blood pressure and confusion
- chest pain
- hypoxia ( hypoxia )
- inflammation of the peritoneum with symptoms such as abdominal pain and pressure soreness; inflammation of the tongue
- drug reaction with rash all over the body and increased number of eosinophils (a type of blood cell ) in the blood (so-called DRESS syndrome); inflammation of the skin
- bone tissue death ( osteonecrosis )
- impaired function of the bladder and genitals ( urogenital dysfunction )
- tremors
- reddening of the skin and scaly skin
- skeletal damage in the jaws (due to abnormal growth of white blood cells ).
Other complications that can occur when methotrexate is given directly in the central nervous system (intrathecal) are arachnoiditis ( inflammation of the spinal cord membrane) in the brain, which causes symptoms such as headache, back pain, neck stiffness, and fever; subacute myelopathy ( inflammation of the bone marrow ) that can cause symptoms such as paresis (extreme muscle weakness in the arms or legs) or paraplegia (paralysis of the legs); chronic leukoencephalopathy leading to confusion, mood swings, drowsiness, coordination problems, dementia, seizures, and coma. The symptoms can worsen and lead to death. There are indications that a combination of radiation to the skull and intrathecal treatment with methotrexate may increase the risk of leukoencephalopathy.
When methotrexate is given into a muscle, it can lead to a burning sensation or the formation of a boil.
How to store Methotrexate Ebewe
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Keep the vial in the outer carton. Sensitive to light.
Waste materials must be disposed of by the hospital’s instructions for chemotherapy and current laws on the disposal of hazardous waste.
Contents of the pack and other information
Content declaration
- The active substance is methotrexate.1 ml concentrate for solution for infusion contains 100 mg methotrexate.
- The other ingredients are sodium hydroxide and water for injections.
What the medicine looks like and contents of the pack
Methotrexate Ebewe is a clear, dark yellow solution.
Pack sizes:
Individual pack containing 1 vial (500 mg / 5 ml, 1,000 mg / 10 ml, 5,000 mg / 50 ml).
Multipack containing 5 vials (500 mg / 5 ml, 1,000 mg / 10 ml, 5,000 mg / 50 ml).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
EBEWE Pharma Ges.mbH Nfg.KG, Mondseestrasse 11, 4866 Unterach, Austria
Manufacturer
Fareva Unterach GmbH, Mondseestrasse 11, 4866 Unterach, Austria