\n\npowder and liquid for intravesical suspension
(Bacillus Calmette-Gu\u00e9rin)<\/p>\n\n\n\n
The complete name of this medicine is BCG \u2011 medac, powder, and liquid for intravesical suspension. Hereinafter referred to as BCG \u2011 medac in this leaflet.
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BCG medac contains attenuated (attenuated) Mycobacterium Bovis<\/em> bacteria with little potential<\/em> for infection. BCG-medac stimulates the immune system and is used to treat several types of bladder cancer. It is effective if the cancer is confined to the cells that make up the lining of the bladder (urothelium) and has not invaded the bladder’s internal tissue.<\/p>\n\n\n\n BCG-medac is given directly into the bladder by instillation (treatment with a fluid in a limited area). For the form of bladder cancer with a flat tumor (cancer in situ<\/em> ), BCG-medac is used to treat a disease that is limited to the inner lining of the bladder. There are different degrees of cancer that can affect the inner lining of the bladder and the cell layers closest to the lining (lamina propria). BCG-medac is also used to prevent cancer from returning ( prophylactic treatment). BCG contained in BCG medac may also be approved for the treatment of other diseases 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. BCG-medac must not be given under the skin or into the skin, in a muscle or vein, or for vaccination. It must be given directly into the bladder by instillation.<\/p>\n\n\n\n Your doctor will give you a patient card, which you should always have with you (see also section 4).<\/strong> Talk to your doctor or pharmacist before using BCG –<\/strong> medac<\/p>\n\n\n\n General hygiene<\/em><\/strong><\/p>\n\n\n\n After installation , sit down on the toilet seat before urinating so as not to spread the urine and to prevent contamination of the toilet seat and the toilet with BCG bacteria.<\/p>\n\n\n\n We recommend that you wash your hands and genitals after urinating. This is especially true during the first urination after BCG treatment. If damaged skin becomes contaminated, use a suitable disinfectant (ask a doctor or pharmacist). Discovered by Bacillus Calmette \u2011 Gu\u00e9rin<\/em><\/strong><\/p>\n\n\n\n It is generally difficult to detect BCG bacteria. A negative test result does not rule out an infection with BCG outside the bladder. Urinary tract infection<\/em><\/strong><\/p>\n\n\n\n Your doctor must determine that you do not have an acute urinary tract infection before each bladder treatment with BCG. If an acute urinary tract infection is diagnosed during treatment with BCG, treatment should be discontinued until the urine test is normal and antibiotic treatment is completed. Patients who have contact with people with weakened immune systems<\/em><\/strong><\/p>\n\n\n\n If you are being treated with BCG \u2011 medac, you must follow the general hygiene advice given above. This is extremely important when in contact with people with weakened immune systems as BCG bacteria can be harmful to patients with a weak immune system. However, a transmission of the bacterium between humans has not yet been reported. Sexual transmission<\/em><\/strong><\/p>\n\n\n\n You should use condoms during intercourse for one week after BCG treatment to be sure that no sexual transmission of BCG bacteria takes place.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important with the following medicines, as BCG bacteria are sensitive to<\/p>\n\n\n\n BCG bacteria are resistant to pyrazinamide and cycloserine.<\/p>\n\n\n\n Pregnancy<\/em><\/strong><\/p>\n\n\n\n Do not use BCG-medac if you are pregnant or think you may be pregnant. Breast-feeding<\/em><\/strong><\/p>\n\n\n\n Do not take BCG-medac while breast-feeding. Fertility<\/em><\/strong><\/p>\n\n\n\n BCG has been shown to have a negative effect on the production of sperm and can lead to low concentrations or lack of sperm in the semen. This effect was reversible in animals. However, men should seek advice on the possibility of preserving sperm before starting treatment.<\/p>\n\n\n\n This medicine may affect your ability to drive or use machines. Do not drive or use machines until you know what effect BCG \u2011 medac has on you. 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, nurse, or pharmacist. Dosage<\/strong><\/p>\n\n\n\n BCG \u2011 medac is prepared and given only by trained health care professionals. The contents of one vial are sufficient for blister treatment. Administration<\/strong><\/p>\n\n\n\n The BCG medac is inserted into the bladder at low pressure using a catheter.<\/p>\n\n\n\n If possible, the medicine should remain in the bladder for two hours. To allow for this, do not drink anything for four hours before treatment and two hours after treatment. While suspension one remains in the bladder, it must come into adequate contact with the entire surface of the mucosa. By moving, you facilitate the treatment. After two hours, empty the bladder, in a sitting position, to avoid spillage. Unless you are on treatment with limited fluid intake, you should drink plenty for 48 hours after each treatment. Use for children<\/strong><\/p>\n\n\n\n The safety and efficacy of BCG Medac in children have not been established. Use for the elderly<\/strong><\/p>\n\n\n\n There are no specific instructions for use in the elderly, but liver function should be considered before administering BCG. Length of treatment<\/strong><\/p>\n\n\n\n As a standard treatment regimen (induction therapy), you will receive an intravesical(bladder delivery) treatment with BCG-medac per week for six consecutive weeks. After a period of four weeks without treatment, you may receive additional intravesical administration called maintenance treatment for at least one year as described below. Your doctor will talk to you about this. Induction treatment<\/em><\/strong><\/p>\n\n\n\n Maintenance treatment<\/em><\/strong><\/p>\n\n\n\n If necessary, your doctor will discuss the need for maintenance treatment with you every 6 months after the first year of treatment. Although maintenance treatment reduces the risk of cancer returning and may slow its progression, the side effects and discomfort of treatment may outweigh the benefits for some patients. It is therefore important that you and the doctor discuss the disadvantages of the treatment and your own wishes before starting or continuing the treatment.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects of BCG treatment are common but generally mild and temporary. Side effects usually increase with the number of BCG treatments. The most serious side effect is a severe systemic infection. Tell your doctor immediately if you get the following symptoms, which can occur at any time and sometimes be delayed, and may develop weeks, months, or even years after your last dose.<\/p>\n\n\n\n Show your patient card to the attending physician.<\/strong><\/p>\n\n\n\n Systemic BCG infection \/ reaction<\/em><\/strong><\/p>\n\n\n\n If the bladder is accidentally damaged during treatment with BCG medac or if BCG medac is given into a muscle or vein, this can lead to a severe general BCG\u2011 infection. Severe systemic BCG\u2011 infection may lead to BCG\u2011 sepsis. BCG sepsis is a life-threatening condition. Talk to a doctor immediately if you get a symptom or sign that worries you or contact an infection doctor! However, infection one is not virulent (pathogenic). Your doctor will prescribe medication for your side effects and BCG treatment may be discontinued. In contrast to a BCG infection, the BCG response often manifests as low-grade fever, flu-like symptoms, and general discomfort for 24-48 hours as the onset of an immune response. Your doctor may prescribe certain medicines to treat your symptoms. Talk to your doctor if symptoms worsen. Delayed BCG\u2011 infection<\/em><\/strong><\/p>\n\n\n\n In some cases, BCG bacteria can remain in the body for several years. This infection can appear at any time and sometimes symptoms and signs of an infection may appear later, even years after the last dose of one of the BCG medac has been administered. Signs of inflammation may be similar to those of severe BCG infection\/reaction mentioned above. Problems with implants or grafts can also be a side effect of BCG treatment and require urgent treatment.<\/p>\n\n\n\n Thus, it is very important that you have your patient card with you and show it to all doctors who treat you to ensure an appropriate treatment in the event of a delayed BCG\u2011 infection. Your doctor will also be able to assess whether the symptoms are a side effect of your BCG treatment or not.<\/strong> The following is a complete list of side effects that may occur: Very common: <\/strong> may affect more than 1 user in 10<\/strong><\/p>\n\n\n\n Common: may affect up to 1 in 10 users<\/strong><\/p>\n\n\n\n Uncommon: may affect up to 1 in 100 people<\/strong><\/p>\n\n\n\n Rare: <\/strong> may affect up to 1 in 1,000 users<\/strong><\/p>\n\n\n\n Very rare: may affect up to 1 in 10,000 people<\/strong><\/p>\n\n\n\n Has been reported: occurs in an unknown number of users<\/strong><\/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 includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address<\/p>\n\n\n\n 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 label and carton after EXP. Store in a refrigerator (2-8 \u00b0 C).<\/p>\n\n\n\n Do not freeze. Store in the original package. Sensitive to light. After reconstitution, the product should be used immediately.<\/p>\n\n\n\n The active substance is live BCG bacteria (Bacillus Calmette \u2011 Gu\u00e9rin) (strain RIVM derived from strain 1173 \u2011 P2). After reconstitution, a vial contains:<\/p>\n\n\n\n BCG \u2011 strain RIVM derived from strain 1173 \u2011 P2 2 x 10 8<\/sup> to 3 x 10 9<\/sup> living units The other ingredients in the powder are: polygeline, anhydrous glucose, and polysorbate 80.<\/p>\n\n\n\n The other ingredients in the liquid are: sodium chloride and water for injections.<\/p>\n\n\n\n BCG \u2011 medac consists of a white powder and a colorless, clear solution used as a liquid. There are packs of 1, 3, 5, or 6 vials. Not all pack sizes may be marketed.<\/p>\n\n\n\n medac<\/p>\n\n\n\n Society for<\/p>\n\n\n\n clinical specialties mbH<\/p>\n\n\n\n Theaterstr. 6<\/p>\n\n\n\n 22880 Wedel<\/p>\n\n\n\n Germany The complete name of this medicine is BCG \u2011 medac, powder, and liquid for intravesical suspension. Hereinafter referred to as BCG \u2011 medac in this leaflet.<\/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":[2202,2200],"tags":[9236,9239,9251,9241,9255,9240,9237,9252],"class_list":["post-5906","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-bacillus-calmette-guerin","tag-bacillus-calmette-guerin-powder","tag-bcg-medac","tag-side-effects-of-bacillus-calmette-guerin","tag-side-effects-of-bcg-medac","tag-what-bacillus-calmette-guerin-is-used-for","tag-what-is-bacillus-calmette-guerin","tag-what-is-bcg-medac"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5906","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=5906"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5906\/revisions"}],"predecessor-version":[{"id":12150,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5906\/revisions\/12150"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5906"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5906"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5906"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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<\/p>\n\n\n\n2. What you need to know before using BCG medac<\/h2>\n\n\n\n
Do not use BCG-medac<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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<\/p>\n\n\n\nOther medicines and BCG \u2011 medac<\/h2>\n\n\n\n
<\/p>\n\n\n\nPregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
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<\/p>\n\n\n\n3. How to use BCG \u2011 medac<\/h2>\n\n\n\n
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<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store BCG medac<\/h2>\n\n\n\n
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<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
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<\/p>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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