Metex Inject Losung 7, 5 mg / ml

All fields of application by the manufacturer

Application to this, the 7, 5 mg / ml in conjunction with Metex Injektlösung area there is more detailed information:

flammable rheumatic diseases

Drug overview

Metex Injektlösung 7, 5 mg / ml is available in the following variants:

Other components

The following substance not effective components are part of the drug:

• Sodium chloride
• Sodium hydroxide
• Water for injection

So does Metex Injektlösung 7, 5 mg / ml

Metex Injektlösung 7, 5 mg / ml contains the active substance of methotrexate. Learn more about the applications and the action of methotrexate below. Read also the information about the groups of active ingredients of Immunologika, cytotoxic drugs, to which belongs the drug methotrexate. Please note the special effect of Metex Injektlösung 7, 5 mg / ml is also

Fields of application of the active substance: methotrexate

Methotrexate inserted as chemotherapy for various cancers such as the acute Lymphocytic (the lymph related) and myeloblastic (bone marrow related) leukemia, breast cancer, ovarian cancer, tumours in the head and in the neck area, HRPC bronchial tumors and cancers in the brain and in the spinal cord in leukemia.

Methotrexate is used also in not tissue-newly forming diseases such as various forms of psoriasis and flammable rheumatic illnesses.

In-depth information is available to the following application areas of methotrexate:

• Psoriasis
• flammable rheumatic diseases
• Breast cancer
• Cancer (General)

Mode of action of methotrexate

Methotrexate is part of both the drug group of the Immunologika as also the cytostatic drugs. In lower doses, it acts dampening effect on the body’s own defense system, in high doses it inhibits cell growth.

Methotrexate blocks a vital metabolic process as an opponent of folic acid. By inhibiting the enzyme Dihydrofolreduktase, the active ingredient prevents the reduction of Dihydrofolsäure (FH-2) to Tetrahydrofolsäure (FH 4). Reduced Folate but are absolutely necessary for the production of building blocks of genetic material and the proteins in the cells.

In General, strongly growing tissue – such as malignant cells, bone marrow, cells of unborn children, skin and mucous membrane cells – is for these effects of methotrexate sensitive. In psoriasis, the skin of compared to normal skin cell production is greatly increased. This is the starting point for the use of methotrexate in particularly severe General, refractory psoriasis and arthritis psoriatica. So far, it is not clear whether the efficacy of methotrexate in flammable rheumatic diseases such as the Chronic Polyarthritis is based on an anti-inflammatory effect or the Suppression of the immune system of the patient.

The effect of methotrexate can be lifted through administration of folinic acid (as Kalziumfolinat). Folinic acid is converted into cells without the participation of the blocked enzyme in Tetrahydrofolsäure and causes a population of cell memory in reduced folate.

Peculiarities of the action of Metex Injektlösung 7, 5 mg / ml

Notes to the dosage instructions on the packaging and in the patient information:

The medicine contains the active ingredient methotrexate in the form of methotrexate sodium. A milliliter of solution for injection contains always 8.22 mg methotrexate sodium, which is equivalent to 7.5 mg methotrexate. By appropriate choice of fill volume, the doses arise: A glass bottle with 1.34 ml contains 10 mg of methotrexate. A glass bottle with two millilitre contains 15 mg of methotrexate. A glass bottle with a 2.67 milliliter contains 20 mg of methotrexate. A glass bottle with 3,34 millilitre contains 25 mg of methotrexate.

Warnings & precautions

• So far the active ingredient can affect the responsiveness that active participation in road traffic or using machines are dangerous. This is true in a ramped up level in conjunction with alcohol.
• The drug can weaken the vaccination reactions and distort the results of laboratory tests.
• A cancer treatment with the drug should be done only by doctors with experience in tumor therapy and depending on the body surface dose.
• During the treatment, especially with the combination of the drug with the antibiotic trimethoprim the blood count must be checked regularly by doctors.
• Because the liver damage caused by the drug should no other liver incriminating drugs taken during treatment or drunk alcohol.
• The doctor must choose lower dosages and continuously check the kidney function in patients with impaired renal function.
• Ulcers in the mouth, diarrhea, hematemesis, or blood in the stool occur during treatment with the drug, the doctor immediately is to communicate.
• Lack of folic acid increases the toxicity of the drug. During the treatment, therefore the folic acid supply should be ensured.
• Tickly, fever, cough, chest pain or shortness of breath occur during treatment with the drug, the doctor immediately is to communicate.
• The function of the liver and kidneys is to check regularly by doctors during treatment.
• It comes during the treatment with the drug to vomiting or diarrhea, treatment should be interrupted until the end of these complaints.
• At skin and mucous membrane contact with the drug, the bodies concerned should be rinsed immediately with plenty of water.
• The drug may be applied only once a week for the treatment of rheumatic diseases and the psoriasis.
• The drug is to be kept in the master package to protect the contents from light.

Medicines can cause allergic reactions. Evidence for this can be: redness, runny nose, itching, swelling of the mucous membrane, itching and redness of the eyes, narrowing of the Airways (asthma). In rare cases, there may be allergic shock with loss of consciousness.

Should you perceive signs of an allergic reaction, immediately inform a doctor.

Interactions

What interactions of active substance of methotrexate in Metex Injektlösung 7, 5 mg / ml are known? It is important to note that the interactions can be different depending on the pharmaceutical form of the drug (for example, Tablet, syringe, ointment).

Following substances both affect the effect of methotrexate: pain relievers such as aspirin, nonsteroidal anti-inflammatory drugs, Diphenylhydantoin (disambiguation), barbiturates (sedatives), sedative, antibiotics such as the tetracycline, sulfonamides and trimethoprim and chloramphenicol; Doxorubicin (cancer therapy), Probenecid (Rheumamittel), para-aminobenzoic acid (helps in the development of red blood cells), para Aminohippursäure (to the diagnosis), the antibiotics Cefalotin and Penicillins.

Following substances reduce the effect of methotrexate: glucocorticoids, the metabolism of L-Asparaginase, the antibiotics Bleomycin and penicillin; Triamterene (to the Entwässung), which contain Gichtmittel allopurinol, vitamin preparations, the folic acid or its derivatives (in particular, folinic acid).

Due to the increased risk of liver damage is to avoid alcohol, even in small quantities, and active ingredients with a toxic effect on the liver should be administered at the same time by the doctor. In patients who take such means during methotrexate therapy, particularly regular medical monitoring of the blood liver enzyme values should take place.

Occasionally, an increased bone marrow damage occurred during a combination therapy with trimethoprim. This is a danger pronounced errors of the blood-forming system, for longer-running pre-treatment with bone marrow harmful substances (such as the sulfonamides and trimethoprim, chloramphenicol, Pyrazolderivate, the Antirheumatikum of indomethacin, the epilepsy Rd Diphenylhydantoin).

Dosage

Patients who suffer from a Chronic Polyarthritis and psoriatic arthritis should receive 7.5 mg methotrexate as a dose once a week. When a good compatibility the dose can be increased then gradually, at 2.5 mg of methotrexate. This depends on the disease activity. Not more than 20 mg of methotrexate should be injected into the week.

The patient suffers from psoriasis, methotrexate starts with injections from 7.5 25 milligrams up to a week. Here, 30 mg of methotrexate should not be exceeded. The dose increases gradually as long as, until optimal relief occurs. Then is down dose slowly, until the lowest yet effective dose. This is then persisted because of reduced side effects.

People suffering under active juvenile arthritis receive 10 to 15 mg methotrexate per square meter of body surface per week. An adult has an average body surface of approximately 1.73 square meters. Good effect methotrexate can be injected up to 20 milligrams per square meter of body surface in the week.

The drug can be given in the muscles, but also in the veins. The doctor decides on the nature and duration of the application.

Contra-indications

The following information on contra-indications for the purposes of Metex Injektlösung 7, 5 mg / ml in General, pregnancy & lactation, and in children. It is important to note that the contra-indications can be different depending on the pharmaceutical form of the drug (for example, Tablet, syringe, ointment).

When may Metex Injektlösung 7, 5 mg / ml not be used?

• Methotrexate should be prescribed only by doctors who have sufficient experience. Not be applied should methotrexate at
• Renal impairment (creatinine clearance below 60 ml / minute)
• Liver damage
• Diseases of the haematopoietic system (bone marrow)
• increased alcohol consumption
• an immune deficiency disease and severe infections
• Stomach ulcers and intestinal.

Prior to the therapy following examinations shall be performed: complete blood count of blood clotting cells, specific liver function tests, certain red blood supplies, renal function values, and hepatitis blood count. Methotrexate may be given only under strict risk benefit of the doctor when:

• Reduction in lung function
• insulin dependent diabetes mellitus
• dormant chronic infections
• Conditions, leading to a drainage
• Risk factors such as a restricted kidney function
• Patients older
• Folic acid deficiency
• Vaccination with Lebendimpfstoffen.

What must you consider when pregnancy and breast-feeding?

Administration of methotrexate gives in the first third of the pregnancy in humans malformations. Women may be not pregnant during the treatment. There a pregnancy test be required be sure before the treatment. A pregnancy occurs during treatment or keeps the doctor necessarily required the treatment of a pregnant patient, should be a medical advice on the risks associated with the treatment of adverse effects for the child.

Methotrexate damages also the genetic material. Therefore recommend men treated with methotrexate, to witness a child during the treatment and six months thereafter. Because of the possibility of still-acting to serious errors of sperm production by methotrexate should be considered prior to the therapy, to store sperm for a subsequent artificial insemination.

Methotrexate is transferred into breast milk. The doctor considers essential, treatment with the drug should be breastfed off.

What is taken into account in children?

So far, no sufficient experience with the use of methotrexate in children with cancer could be made. For the active substance, there is therefore no binding dosage recommendations for these age groups and therapy.

Only for children and young people under 16 years of age with polyarthritischen forms of juvenile arthritis is there a dosage recommendation.

Side effects

What side effects can the active ingredient methotrexate in Metex Injektlösung 7, 5 mg / ml have? Below, you will learn the most important thing possible, well-known side effects of methotrexate in Metex Injektlösung 7, 5 mg / ml. These side effects should not occur, but can. Because everyone reacts differently to medications. Please also note that the side effects in type and frequency can vary depending on the drug form of the drug (for example, Tablet, syringe, ointment).

Very common side effects: loss of appetite, nausea and vomiting, increase of liver enzymes, abdominal pain.

Common side effects: inflammatory lesions, itching, wound healing disorders, inflammation and Gewebsveränderungen at the injection site, headache, fatigue, dizziness, diarrhea, inflammation of the oral mucosa, Lung complaints, dry tickly, shortness of breath, fever, reduce the number of white blood cells, reduce the number of coagulation cells.

Uncommon side effects: light sensitivity, hives, increased skin color, joint pain, muscle pain, osteoporosis, dizziness, confusion, depression, ulcers, ulcer, diabetic metabolic situation, liver fattening, strong reduction of all blood cells, reduction of granulocytes number, inflammation and ulcers in the bladder or vagina, allergic reactions and anaphylactic shock.

Rare side effects: menstrual disorders, anemia.

Very rare side effects: Stevens-Johnson Syndrome, Lyell Syndrome, increased staining of nails, pain, muscle weakness or numbness in the limbs, acute inflammation of the liver, reactivation of chronic inflammation of the liver, acute liver decay, shortness of breath, asthma bronchial, libido loss, impotence, deficient sperm formation, defective Eibildung, severe processes of bone marrow damage, decreased sperm density, lymph node enlargement, acute inflammation of the dead skin, seizures, paralysis, vomiting, hair loss, increase of rheumatoid nodules, shingles, heart bag effusion, cardiac Tamponade, kidney function disorders to acute renal failure, Fever, blood poisoning and allergic diseases of small arteries.

Specialties: The incorrect dosage of methotrexate may lead to serious, sometimes even fatal side effects. The active ingredient may be used only once a week in psoriasis and flammable rheumatic illnesses. In cancer, the doctor must calculate the dosage according to the surface of the body.