15,000 IU, powder for solution for injection / infusion, bleomycin solution

Read all of this leaflet carefully before you start using this medicine.

– Save this leaflet, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist or nurse. If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Bleomycin Baxter is and what it is used for 
2. What you need to know before you use Bleomycin Baxter 
3. How to use Bleomycin Baxter 
4. Possible side effects 
5. How to store Bleomycin Baxter 6. Contents of the pack 
and other information 

1. What Bleomycin Baxter is and what it is used for

Bleomycin Baxter is an anti-cancer agent and damages the genetic material in the cells in a way that inhibits the cell division in the diseased cells and the cells die. Bleomycin Baxter is used in various forms of cancer.

2. What you need to know before you use Bleomycin Baxter

Do not use Bleomycin Baxter

  • if you are allergic (hypersensitive) to bleomycin sulfate.
  • if you have an ongoing lung infection, severe lung function, or circulatory disorders in the respiratory system, e.g. pulmonary fibrosis (a lung disease in which the lung tissue is transformed into connective tissue) or a blood clot in the lung.
  • if you are breast-feeding

Warnings and cautions

Talk to your doctor before taking Bleomycin Baxter:

  • If you receive or have previously received radiotherapy of the chest, this gives a greatly increased risk of lung effects.
  • If you have other ongoing lung diseases as it increases the risk of lung effects.
  • If you are older, you should pay extra attention to signs of lung effects as sensitivity to Bleomycin Baxter increases with age. The risk of lung impact is then greater.
  • If you have impaired kidney function, the risk of lung damage increases.
  • If you are going to be anesthetized in connection with, for example, an operation, it is important that you inform the anesthetist that you are being treated with Bleomycin Baxter, as too much oxygen increases the risk of lung changes.
  • If you have joint problems. Rheumatic joint problems may be exacerbated by treatment with Bleomycin Baxter.
  • If you are a man or woman of childbearing potential :
    • Because Bleomycin Baxter can be harmful to sperm, eggs, and the fetus, women, and men should use an effective method of contraception during and at least 6 months after stopping treatment. See Pregnancy, breast-feeding, and fertility.
    • Treatment with Bleomycin Baxter can make it difficult for men and women to have children. There is a risk that the treatment will cause a lack of sperm in the sperm. Men should therefore be informed about the possibility of preserving semen.

Talk to your doctor if you get these symptoms during treatment with Bleomycin Baxter:

  • If you experience difficulty breathing or pain when inhaling, during, or after treatment with Bleomycin Baxter, contact your doctor immediately.
  • If you have a fever, chills, wheezing, or wheezing and may feel confused, contact a doctor immediately. It may be a sign of a hypersensitivity reaction. Such a reaction can occur up to several hours after receiving Bleomycin Baxter.
  • If you get nausea because you can get medication that counteracts this. Loss of appetite and weight loss are common and may persist for some time after treatment is completed.
  • If you get a fever on the day of injection, it is because Bleomycin Baxter has a cell-damaging effect. The incidence of fever decreases with the number of injections. If the fever is high and it takes time before it drops, your doctor may prescribe antipyretics.
  • If you have AIDS and have skin problems. Your doctor will discontinue treatment due to the risk of recurring skin problems,
  • If you are receiving concomitant treatment with other anticancer medicines, or radiation therapy, ulceration of the mucous membranes may worsen. Such reactions may occur late in treatment, usually during the second to the third week of treatment.

Children and young people

No data are available for children and adolescents.

Other medicines and Bleomycin Baxter

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

When Bleomycin is used at the same time as other medicines, the effect can affect or be affected by the other medicine/medicines, which increases the risk of side effects and other unwanted effects.

Examples of drugs that affect or are affected by Bleomycin are:

  • Some other anticancer medicines (eg cyclophosphamide, carmustine, gemcitabine, methotrexate, or mitomycin). Concomitant treatment with bleomycin increases the risk of lung changes.
  • Some other anticancer medicines (eg cisplatin, vinblastine). Concomitant treatment increases the risk of kidney effects.
  • Some other medicines (vinca alkaloids) increase the risk of poor blood circulation in the fingers, toes, and nasal tips during concomitant treatment with bleomycin. Therefore, tell your doctor if you get cold and white fingers and toes.
  • Some medicines for epilepsy ( phenytoin ).
  • Other drugs that also have a negative effect on mucous membranes, as well as radiation therapy, can aggravate the problems with sore mucous membranes
  • Oxygen treatment increases the risk of lung effects.
  • The live vaccine, concomitant treatment may cause the vaccine to cause an infection.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Risk of birth defects. Use therefore not Bleomycin Baxterunder pregnancy except on certain prescription from the doctor. Women and men of childbearing potential must use an effective method of contraception during and at least 6 months after stopping treatment.

Breast-feeding

It is unknown whether bleomycin passes into breast milk, but due to the risk of serious toxic effects in breast-fed infants, breastfeeding should be discontinued while using bleomycin.

Fertility

Treatment with Bleomycin Baxter can make it difficult for men and women to have children.

There is a risk that the treatment will cause a lack of sperm in the sperm. Men should therefore be informed about the possibility of preserving semen.

Driving and using machines

Certain side effects, such as nausea and vomiting, can indirectly affect the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

3. How to use Bleomycin Baxter

Dose one is determined by the doctor, who adjusts it individually for you.

Bleomycin Baxter is usually injected intramuscularly, exceptionally intravenously(also as a long-term infusion), or intraarterially. Can also be given as an intrapleural instillation, ie in the alveoli.

Bleomycin Baxter solution for injection/infusion should only be given by hospital staff, who can provide further information.

4. Possible side effects

Like all medicines, Bleomycin Baxter can cause side effects, although not everybody gets them.

Contact a doctor immediately if you notice any of the following side effects:

Lung changes

The most serious side effects are lung changes, usually in the form of a special type of pneumonia (interstitial pneumonia ). It is therefore important to contact a doctor as soon as possible in case of breathing difficulties or pain when inhaling, as this may be a symptom of this pneumonia. Untreated interstitial pneumonia can lead to the transformation of the lung tissue into the connective tissue ( lung fibrosis ), which is a serious disease condition. Lung changes are more common in patients over 70 years of age.

Hypersensitivity s

About one in a hundred patients with lymphoma treated with Bleomycin Baxter develop a hypersensitivity reaction (idiosyncratic reaction). This reaction is similar to an allergy and shock may occur immediately or up to several hours after administration of the drug ended. Therefore, seek medical attention immediately if you experience symptoms such as extensive skin rash, itching, swelling of the face, swollen mucous membranes in the mouth and throat, wheezing, confusion, and/or rapidly rising fever.

Skin-related side effects ar

If you have AIDS and have skin-related side effects, contact your doctor immediately. Your doctor will stop the treatment and not resume it.

Other side effects are:

Very common (may affect more than 1 in 10 people ): Reddening of the skin, itching, stretch marks (looks like streaks on the skin), blisters. Color change in the skin. Swollen and sore fingertips.

Common (may affect up to 1 in 10 people): Headache. Loss of appetite. Weight loss. Nausea and vomiting. Inflammation of the mouth and mucous membranes. Skin rash, hives, severe redness of the skin. Hardening and thickening of the skin, swelling. Hair loss. Fever on the day of injection, stiffness, malaise.

Uncommon (may affect up to 1 in 100 people): Impaired bone marrow function which may reduce the number of blood cells and platelets. Bleeding. Dizziness, confusion. Low blood pressure. Fungal infection in the mouth pores. Diarrhea. Nail problems. Blistering over points exposed to pressure (eg elbows). Muscle pain, joint pain, and joint pain. Pain in tumor one. Local reactions at the injection site such as inflammation of the blood vessel.

Rare (may affect up to 1 in 1,000 people): Febrile neutropenia (increased body temperature due to decreased white blood cell count ). Pericarditis, chest pain, heart attack. Changes in the blood vessels can cause bleeding between the meninges, cerebral hemorrhage or clot in the brain ( stroke ), blood clots in small vessels, anemia with acute renal failure ( hemolytic uremic syndrome ), inflammation of blood vessels in the brain. The significant feeling of freezing around fingers and toes in combination with these becoming remarkably pale (Raynaud’s phenomenon). A blood clot in an artery(a large blood vessel). Disrupted liver function. Connective tissue disease that makes the skin hard and thickened (systemic sclerosis).

Very rare in up to 1 in 10,000 people): Severe metabolic disorder and salt balance due to rapid tumor degradation (Tumor lysis syndrome).

Has been reported (occurs in an unknown number of users): Severe allergic reaction. A blood clot in the leg. Breathing does not work satisfactorily and the body, therefore, does not receive a normal supply of oxygen and removal of carbon dioxide. Acute respiratory distress syndrome (a disease that affects breathing and lung function). A blood clot in the lung. Pneumonia, lung disease of the lower respiratory tract that mainly affects the walls of the alveoli. Liver inflammation. Skin inflammation, itching which coincides with the appearance of red linear stripes most often on the back and flanks. Red, annular, and blister-like rashes (erythema multiforme). Fetal death. Overindulge. Diseased accumulation of fluid in the feet and lower legs. Injection site pain.

Nausea and vomiting are most common at high doses.

Skin and mucosal changes are very common, occurring in up to half of all patients receiving Bleomycin Baxter. It is common for these side effects to occur only after a period of treatment.

Some side effects may occur after treatment with Bleomycin Baxter is stopped. Therefore, also contact the hospital staff or your doctor if you suspect that you have experienced side effects after the end of treatment.

Reporting of side effects

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. 

5. How to store Bleomycin Baxter

Keep out of sight and reach of children.

Store in a refrigerator (2 ° C – 8 ° C).

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.

Reconstituted solution for injection and infusion has a chemical and physical in-use stability of 12 hours at 15 o C-25 o C under the protection of light. From a microbiological point of view, the ready-to-use product should be used immediately. If the ready-to-use product is not used immediately, the user is responsible for the storage time after preparation and storage conditions before use.

6. Contents of the packaging and other information

Content declaration

  • The active substance is bleomycin sulfate. Each vial contains 15,000 IU bleomycin.
  • Bleomycin Baxter does not contain any excipients

What the medicine looks like and contents of the pack

White or yellow-white powder in a stained glass vial. Pack size 10×15,000 IU.

SE- 164 94 Kista

Manufacturer:

Baxter Oncology GmbH 
Kantstrasse 2 
DE-33790 Halle-Künsebeck 
Germany

Muhammad Nadeem

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