7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, 25 mg, 27.5 mg, 30 mg\u00a0solution for injection\u00a0in pre-filled injector\u00a0methotrexate<\/p>\n\n\n\n
Injexate contains methotrexate as active substance.<\/p>\n\n\n\n
Methotrexate is a substance with the following properties:<\/p>\n\n\n\n
Injexate is for the treatment of:<\/p>\n\n\n\n
Indicate changes and delays in the course of the disease.<\/p>\n\n\n\n
Methotrexate contained in Injexate may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n
Talk to your doctor or pharmacist before taking Injexate if:<\/p>\n\n\n\n
Acute hemorrhage from the lungs of patients with the underlying rheumatic disease has been reported with methotrexate. If you get symptoms such as saliva blood or bloody cough, contact your doctor immediately.<\/p>\n\n\n\n
Special precautions for treatment with Injexate<\/strong><\/p>\n\n\n\n Methotrexate temporarily affects sperm and egg production, an effect that in most cases decreases after the end of treatment. Methotrexate can cause miscarriage and severe congenital malformations. You must avoid becoming pregnant while using methotrexate and for at least 6 months after stopping treatment. See also the section “Pregnancy, breastfeeding and fertility”.<\/p>\n\n\n\n Recommended follow-up examinations and safety measures:<\/strong><\/p>\n\n\n\n Even when Injexate is given in low doses, serious side effects can occur. For them to be detected in time, the doctor must perform checks and laboratory tests.<\/p>\n\n\n\n Before treatment:<\/strong><\/p>\n\n\n\n Before starting treatment, you will be given blood samples to check that you have enough blood cells, test your liver function, check serum albumin (a protein in the blood) and kidney function. The doctor will also check if you have tuberculosis (a contagious disease in combination with small lumps in the affected tissue ) and have you have a lung X-ray.<\/p>\n\n\n\n During treatment:<\/strong><\/p>\n\n\n\n You will undergo the following tests at least once a month for the first six months and at least every three months thereafter:<\/p>\n\n\n\n Inactive, chronic infections (eg herpes zoster [shingles], tuberculosis, hepatitis B or C) may flare up during treatment with methotrexate.<\/p>\n\n\n\n Radiation-induced dermatitis (inflammation of the skin) and sun damage may recur during treatment with methotrexate (recall reaction). Psoriasis lesions can get worse if you are exposed to UV radiation during treatment with methotrexate.<\/p>\n\n\n\n Enlarged lymph nodes ( lymphoma ) can occur and then the treatment must be stopped.<\/p>\n\n\n\n Diarrhea can be a toxic effect of Injexate and requires discontinuation of treatment. If you have diarrhea, you should consult a doctor.<\/p>\n\n\n\n Certain brain diseases (encephalopathy\/leukoencephalopathy) have been reported in cancer patients treated with methotrexate. Such side effects cannot be ruled out when methotrexate is used to treat other diseases.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n The effect of the treatment can be affected if Injexate is given at the same time as certain other medicines:<\/p>\n\n\n\n Vitamins that contain folic acid can weaken the effect of your treatment and should only be taken when your doctor prescribes it.<\/p>\n\n\n\n Vaccination with live vaccines must be avoided.<\/strong><\/p>\n\n\n\n Avoid alcohol and large amounts of coffee, soft drinks containing caffeine<\/a>, and black tea during treatment with Injexate.<\/p>\n\n\n\n Pregnancy<\/strong><\/p>\n\n\n\n Do not use Injexate during pregnancy or if you are trying to get pregnant. Methotrexate can cause congenital malformations, birth defects, and miscarriages. It is associated with malformations of the skull, face, heart and blood vessels, brain and arms, and legs. It is therefore very important that methotrexate is not given to pregnant patients or patients planning to become pregnant. Infertile women, pregnancy must be ruled out by appropriate measures, e.g. a pregnancy test before starting treatment. You must avoid becoming pregnant while taking methotrexate and for at least 6 months after stopping treatment, using reliable contraception during this time (see also section \u201cWarnings and precautions\u201d).<\/p>\n\n\n\n If you become pregnant during treatment or suspect you may be pregnant, talk to your doctor as soon as possible. You should be offered medical advice on the risk of harmful effects on the child due to the treatment.<\/p>\n\n\n\n If you wish to become pregnant, consult your doctor, who may refer you to specialist advice before the planned start of treatment.<\/p>\n\n\n\n Fertility in men<\/strong><\/p>\n\n\n\n Available data do not indicate an increased risk of malformations or miscarriages if the father takes less methotrexate than 30 mg\/week. However, risk cannot be completely ruled out. Methotrexate may be genotoxic. This means that the drug can cause gene mutation. Methotrexate can affect sperm production and can cause congenital malformations. Therefore, you should avoid getting a woman pregnant and donating sperm while taking methotrexate and for at least 6 months after stopping treatment.<\/p>\n\n\n\n Breast-feeding must be stopped before and during treatment with Injexate.<\/p>\n\n\n\n Treatment with Injexate can cause side effects that affect the central nervous system, e.g. fatigue and dizziness. The ability to drive and\/or use machines may in some cases be impaired. If you feel drowsy, do not drive or use machines.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free.<\/p>\n\n\n\n Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n The doctor will decide on a dose, which will be adjusted individually for you. It usually takes 4-8 weeks before you see any effect of the treatment.<\/p>\n\n\n\n Injexate is given subcutaneously (under the skin) as an injection only <\/strong><\/em>once a week. It is given by or under the supervision of a doctor or healthcare professional. Together with the doctor, you decide on a suitable day of the week each week when you receive an injection.<\/p>\n\n\n\n Use for children and adolescents<\/strong><\/p>\n\n\n\n The doctor will determine the appropriate dose for children and adolescents with polyarthritic forms of juvenile idiopathic arthritis.<\/p>\n\n\n\n Injexate is not recommended for children under 3 years of age due to insufficient experience in this age group.<\/p>\n\n\n\n Injexate is given as an injection once a week<\/strong>!<\/p>\n\n\n\n The duration of treatment is determined by the attending physician. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis Vulgaris, psoriatic arthritis, and Crohn’s disease with Injexate is a long-term treatment.<\/p>\n\n\n\n Methotrexate should only be prescribed by a doctor who knows the different properties of the drug and its mechanism of action. If deemed appropriate, the treating physician may, in selected cases, entrust the subcutaneous administration to the patient.<\/p>\n\n\n\n At the beginning of treatment, Injexate can be injected by healthcare professionals. However, your doctor may decide that you can learn to inject Injexate yourself. In that case, you will receive instructions on how to proceed. Under no circumstances should you try to inject yourself, unless you have learned how to do it.<\/p>\n\n\n\n For single use only. Note that all content must be used.<\/p>\n\n\n\n Handling and disposal must be consistent with that of other cytostatic preparations by local requirements. Pregnant healthcare professionals should not handle and\/or administer Injexate.<\/p>\n\n\n\n Methotrexate should not come into contact with the skin surface or mucous membranes. If this happens, immediately flush the area with plenty of water.<\/p>\n\n\n\n Instructions for use:<\/strong><\/p>\n\n\n\n Read the entire instruction manual before using the Injexate pre-filled injector. This injector requires you to be trained by healthcare professionals before using it.<\/p>\n\n\n\n Contact a doctor, pharmacist, or nurse if you have any problems or questions.<\/p>\n\n\n\n Before you begin<\/strong><\/p>\n\n\n\n Preparation<\/strong><\/p>\n\n\n\n 1. Before injection<\/strong><\/p>\n\n\n\n 2. Injection<\/strong><\/p>\n\n\n\n 3. Disposal<\/strong><\/p>\n\n\n\n Methotrexate should not come into contact with skin or mucous membranes. If this happens, immediately flush the area with plenty of water.<\/p>\n\n\n\n If you or anyone close to you is injured by the needle, consult a doctor immediately and do not use the pre-filled injector.<\/p>\n\n\n\n Contact your doctor immediately if you have used too much Injexate.<\/p>\n\n\n\n If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.<\/p>\n\n\n\n Do not take a double dose to make up for a forgotten dose.<\/p>\n\n\n\n Contact your doctor immediately if you stop using Injexate.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them.<\/p>\n\n\n\n How often the side effects occur as well as their severity depends on the dose level and how often the medicine is given. As serious side effects can occur even at low doses, you must be checked regularly by your doctor. Your doctor will take samples to check for any abnormal values in your blood (eg low white blood cell count, low platelet count, lymphoma ) and changes in kidney and liver function.<\/p>\n\n\n\n Contact a doctor immediately<\/strong> if you experience any of the following symptoms as they may be signs of a serious, potentially life-threatening side effect, which requires immediate treatment:<\/p>\n\n\n\n Listed below are other side effects that may occur:<\/p>\n\n\n\n Very common<\/strong>: may affect more than 1 user in 10<\/p>\n\n\n\n Common<\/strong>: may affect up to 1 in 10 users<\/p>\n\n\n\n Uncommon<\/strong>: may affect up to 1 in 100 people<\/p>\n\n\n\n Rare<\/strong>: may affect up to 1 in 1,000 users<\/p>\n\n\n\n Very rare<\/strong>: may affect up to 1 in 10,000 people<\/p>\n\n\n\n Has been reported<\/strong>: occurs in an unknown number of users<\/p>\n\n\n\n Subcutaneous administration of methotrexate is well tolerated locally. Only mild skin reactions (such as burning sensation, reddening of the skin, swelling, discoloration, severe itching, pain) have been observed during treatment.<\/p>\n\n\n\n Reporting of side effects<\/em><\/p>\n\n\n\n If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not store above 30 \u00b0 C.<\/p>\n\n\n\n Store the pre-filled injector in the outer carton. Sensitive to light.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the carton after EXP and on the label after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Do not use Injexate if you notice any color change or visible particles.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n 1 pre-filled injector with 0.15 ml solution contains 7.5 mg methotrexate<\/p>\n\n\n\n 1 pre-filled injector with 0.20 ml solution contains 10 mg methotrexate<\/p>\n\n\n\n 1 pre-filled injector with 0.25 ml solution contains 12.5 mg methotrexate<\/p>\n\n\n\n 1 pre-filled injector with 0.30 ml solution contains 15 mg methotrexate<\/p>\n\n\n\n 1 pre-filled injector with 0.35 ml solution contains 17.5 mg methotrexate<\/p>\n\n\n\n 1 pre-filled injector with 0.40 ml solution contains 20 mg methotrexate<\/p>\n\n\n\n 1 pre-filled injector with 0.45 ml solution contains 22.5 mg methotrexate<\/p>\n\n\n\n 1 pre-filled injector with 0.50 ml solution contains 25 mg methotrexate<\/p>\n\n\n\n 1 pre-filled injector with 0.55 ml solution contains 27.5 mg methotrexate<\/p>\n\n\n\n 1 pre-filled injector with 0.60 ml solution contains 30 mg methotrexate<\/p>\n\n\n\n Injexate contains a clear, yellow to brown solution.<\/p>\n\n\n\n The following pack sizes are available:<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/em><\/p>\n\n\n\n Accord Healthcare BV<\/p>\n\n\n\n Winthontlaan 200<\/p>\n\n\n\n 3526 KV Utrecht<\/p>\n\n\n\n Netherlands<\/p>\n\n\n\n Manufacturer<\/em><\/p>\n\n\n\n Accord Healthcare Limited,<\/p>\n\n\n\n Sage House,<\/p>\n\n\n\n 319, Pinner Road,<\/p>\n\n\n\n North Harrow,<\/p>\n\n\n\n Middlesex HA1 4HF,<\/p>\n\n\n\n UK<\/p>\n\n\n\n Wessling Hungary Kft.,<\/p>\n\n\n\n Anonymous u. 6., Budapest, 1045<\/p>\n\n\n\n Hungary <\/p>\n\n\n\n Accord Healthcare Polska Sp.z oo,<\/p>\n\n\n\n ul. Lutomierska 50,95-200 Pabianice, Poland<\/p>\n","protected":false},"excerpt":{"rendered":" Injexate contains methotrexate as active substance.. Methotrexate is a substance with the following properties:<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,12116],"tags":[12800,12794,12796,12799,12801,4858,4861,12795,12798,12797,4859,12793],"class_list":["post-14311","post","type-post","status-publish","format-standard","hentry","category-medicines","category-i","tag-benefits-of-injexate","tag-benefits-of-methotrexate","tag-injexate","tag-injexate-injection","tag-injexate-side-effects","tag-methotrexate","tag-methotrexate-injection","tag-side-effects-of-methotrexate","tag-what-injexate-is-used-for","tag-what-is-injexate","tag-what-is-methotrexate","tag-what-methotrexate-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14311","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=14311"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14311\/revisions"}],"predecessor-version":[{"id":14927,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14311\/revisions\/14927"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=14311"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=14311"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=14311"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Other medicines and Injexate<\/h2>\n\n\n\n
Inject with food, drink and alcohol<\/h2>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Injexate contains sodium<\/h2>\n\n\n\n
3. How to use Injexate<\/h2>\n\n\n\n
Important warning regarding dosing one of Injexate (methotrexate): <\/strong>Injexate should only be used once a week in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, psoriasis, and Crohn’s disease. Using too much Injexate (methotrexate) can be life-threatening. Read section 3 of this leaflet very carefully. If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Method of administration and duration of treatment<\/h2>\n\n\n\n
<\/a><\/td> Wash your hands with soap under running warm water.<\/td><\/tr> <\/a><\/td> Choose an injection site (abdomen or thigh if the patient injects himself; if the patient is assisted by healthcare professionals or caregivers, the back of the arm is another option).<\/td><\/tr> <\/a><\/td> Clean the injection site: use a spirit dryer to clean the injection site. Allow the area to air dry.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n <\/a><\/td> Inspect the liquid through the window and check that there are no changes in color, turbidity, or large particles.<\/td><\/tr> <\/a><\/td> Remove the clear cover: Rotate and pull off the cover. Do not allow your hands to come close to the needle cover after removing the cover. Do not replace the cover, discard it immediately. Do not inject if you drop the pre-filled injector after removing the capInject within 5 minutes after removing the cap.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n <\/a><\/td> Place the injector directly on the skin (approximately 90 degrees).<\/td><\/tr> <\/a><\/td> Press the white handle straight down. The medicine is injected when you press. Do this at a speed that is comfortable for you. Do not lift the injector during the injection.<\/td><\/tr> <\/a><\/td> Injection one is finished when you have pressed the white handle as far as it will go, you will hear a clicking sound and the orange part of the injector will no longer be visible.<\/td><\/tr> <\/a><\/td> Lift straight up: The yellow band indicates that the needle guard is locked.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n <\/a><\/td> Dispose of used Injexate pre-filled injector: Place the injector in a container approved for sharp objects. The regulations vary between different areas. Ask your doctor or pharmacist for proper disposal instructions. Do not throw the injector into the household waste.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n If you use more Injexate than you should<\/h2>\n\n\n\n
If you forget to use Injexate<\/h2>\n\n\n\n
If you stop using Injexate<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
5. How to store Injexate<\/h2>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n