TSIMTSIA 200 mg vial. 1 ml
TSIMTSIA 200 mg vial. 1 ml
What Cimzia is and what it is used
Cimzia contains the active substance certolizumab pegol, a human antibody fragment. Antibodies are proteins that specifically recognize and bind to other proteins. Cimzia binds to a particular protein called tumor necrosis factor-alpha (TNF?). So that TNF? is blocked by Cimzia, which reduces inflammation in rheumatoid arthritis. Drugs that bind to TNF?, are called TNF blockers.
Cimzia is used for treating moderate to severe rheumatoid arthritis in adults when other medications fail to control your symptoms. Cimzia is usually administered with another drug called methotrexate. If your doctor determines that methotrexate is inappropriate, Cimzia can be given alone.
What you should know before using Cimzia
Do NOT use Cimzia
If you are allergic (hypersensitive) to the active substance or to any other ingredients of this medicine (listed in Section 6).
If you have a severe infection, including active tuberculosis (TB).
If you have moderate to severe HEART FAILURE. Tell your doctor if you have a serious heart condition.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Cimzia. 32
Before starting treatment with Cimzia, tell your doctor if any of the following apply to you:
If you develop Allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash, stop using Cimzia and tell your doctor immediately.
If you have had repeated or opportunistic infections or other conditions that increase the risk of infections (such as immunosuppressive therapy - drugs that can reduce your ability to fight infections).
If you have an infection or develop symptoms such as fever, sores, fatigue, or dental problems. During treatment with Cimzia, you can more easily develop infections, including severe, and in rare cases, life-threatening infections.
Saobshteni cases of tuberculosis (TB) in patients treated with Cimzia. Your doctor will examine you for signs and symptoms of tuberculosis before starting treatment with Cimzia. This will include taking a detailed medical history, chest radiograph and tuberculin skin test. Conduct of these tests should be recorded on your Patient Alert Card. If diagnosed latent (inactive) TB, you may be asked to take appropriate antituberculous medications before starting treatment with Cimzia. It is important to tell your doctor if you have ever had tuberculosis or have been in close contact with someone who has had TB. Tell your doctor if during or after treatment with Cimzia symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or other infection.
If you are at risk or are a carrier or have an active infection with hepatitis B (HBV), Cimzia may increase the risk of reactivation in people who are carriers of this virus. If this happens, you should stop using Cimzia. Your doctor will examine you for HBV before taking Cimzia.
If you have mild heart failure and was treated with Cimzia, state of heart failure should be closely monitored by your doctor. It is important to tell your doctor if you have a serious heart condition. If you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of the ankles), you should tell your doctor immediately. Your doctor may decide to stop treatment with Cimzia.
Although not common in patients treated with Cimzia or other TNF blockers have been reported incidents of certain cancers. Patients with severe rheumatoid arthritis related disease for a long time may have a higher than average risk of occurrence of a certain type of cancer affecting the lymphatic system, called lymphoma. If you take Cimzia, your risk for developing lymphoma or other cancers may be increased. In addition, uncommon cases of non-melanoma skin cancer were observed in patients receiving Cimzia. Tell your doctor if during treatment with Cimzia and then develop new skin lesions or existing skin lesions change their appearance. Patients with chronic obstructive pulmonary disease (COPD) or heavy smokers, may have an increased chance of developing cancer treatment with Cimzia. If you have COPD or addicted smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
There are cases of cancers, including unusual types, in children and tiinendzhari patients taking TNF blockers, which sometimes lead to death (see below "Youths").
If you have a nervous system disorder, such as multiple sclerosis, your doctor will decide whether you should use Cimzia.
In some patients the body may fail to produce enough blood cells involved in the body's fight infections or help stop bleeding. If there is persistent fever, bruising, bleeding easily or look very pale, call your doctor immediately. Your doctor may decide to stop treatment with Cimzia.
In rare cases, you may develop symptoms of the disease called lupus (eg, persistent rash, fever, joint pain and fatigue). If these symptoms occur to you, contact your doctor. Your doctor may decide to stop treatment with Cimzia.
Tell your doctor if you are vaccinated or to be vaccinated. To you should you not be doing a live vaccine while using Cimzia.
Certain vaccines can cause infections. If you use Cimzia during pregnancy, your baby may be at higher risk of developing such an infection nearly five months after the last dose that you take during pregnancy. It is important to tell your baby's doctor and other health professionals that you used Cimza, they can decide when your baby needs to be made a vaccine.
Surgical or dental procedures
Tell your doctor if you are planning surgical and dental procedures. Inform your surgeon or dentist performing the procedure that you are treated with Cimzia, and show your Patient Alert Card.
Children and adolescents
Cimzia is not recommended for use in children and adolescents under the age of 18 years.
Other medicines and Cimzia
You should not take Cimzia, if you use the following medications used to treat rheumatoid arthritis:
If you have questions, please consult your doctor.
Cimzia can be given together with:
Pain medications, including nonsteroidal anti-inflammatory drugs (also called NSAIDs).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Pregnancy and lactation
If you are pregnant or nursing, you think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist before taking this medicine.
No experience with Cimzia in pregnant women. Therefore, it is recommended to use Cimzia during pregnancy. Women of childbearing potential must use adequate contraception while using Cimzia, and at least 5 months after the last dose of Cimzia.
If you use Cimzia during pregnancy, your baby may be at higher risk of infection. It is important to tell your baby's doctor and other health professionals that you used Cimzia, before your baby to make a vaccine (for more information see the section on vaccinations).
It is not known whether Cimzia passes into breast milk. Consult your doctor before breast-feeding during treatment with Cimzia.
Driving and operating machinery
Cimzia may have little influence on the ability to drive and use machines. With the use of Cimzia may appear dizziness (including vertigo, blurred vision and tiredness).
Cimzia contains sodium acetate and sodium chloride
This product contains less than 1 mmol sodium (23 mg) to 400 mg, ie essentially 'sodium-free'.
How to use Cimzia
Always use this medicine exactly as your doctor or nurse or pharmacist. If you're not sure, ask your doctor or pharmacist.
The initial dose for adults with rheumatoid arthritis is 400 mg, given at weeks 0, 2 and 4. Followed by a maintenance dose of 200 mg every 2 weeks starting at week 6. Methotrexate is continued with the use of Cimzia. If your doctor determines that methotrexate is inappropriate, Cimzia can be given alone.
Cimzia will usually be given by a doctor or medical specialist. Cimzia will be administered subcutaneously in the form of one (at a dose of 200 mg) or two (at a dose of 400 mg) injections. They are usually placed in the thigh or abdomen.
Instructions for preparation and injection of Cimzia
After proper training, your doctor may also allow you to inject Cimzia.
If your doctor is allowed to self-inject after the 7th dose, you should review it to assess whether there is an effect or Cimzia should be another treatment.
If you use more than the amount of Cimzia
If your doctor is allowed to self-inject and you accidentally inject Cimzia more often than prescribed, tell him. Always carry a patient alert card and outer carton Cimzia, even if it is empty.
If you forget to use Cimzia
If your doctor has allowed you to self-inject and you forget to inject Cimzia, you should take the next dose as soon as you remember. Then inject the following doses every two weeks, as originally.
If you stop using Cimzia
Do not stop using Cimzia, without first you consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of these side effects:
severe rash, hives or other signs of allergic reaction (hives)
swelling of the face, hands and feet (angioedema)
difficulty breathing, swallowing (multiple causes for these symptoms)
shortness of breath with exertion or when lying down or swelling of the feet (heart failure)
symptoms of disorders of the blood, prolonged fever, bruising, bleeding, pallor (pancytopenia, anemia, decrease in platelets and white blood cells)
Notify AS SOON AS POSSIBLE your doctor if you notice any of these side effects:
signs of infection such as fever, malaise, wounds, dental problems, burning on urination
weakness or tiredness
weakness in arms and legs
secreted or open sore that does not heal
The above symptoms can be caused by any of the following side effects observed during treatment with Cimzia:
Common: may affect up to 1 in 10 people
Bacterial infections anywhere (formation of pus)
Viral infections (including colds, flu, and herpes zoster)
High blood pressure
Rash or itching
Headache (including migraine)
Sensory disturbances such as numbness, stiffness, burning
Feeling of weakness and malaise
Reactions at the injection site
Uncommon: may affect up to 1 in 100 people
Allergic conditions, including allergic rhinitis and allergic drug reactions (including anaphylaxis)
Cancer of the blood and lymphatic system, lymphoma and leukemia
Malignancies of the dense bodies
Skin cancer and the cancer
Benign (nezlokachestveni) tumors and cysts (including the skin)
Heart disease, including weakness of the heart muscle, heart failure, heart attack, chest discomfort or pressure in the chest, heart rhythm disturbances, including irregular heartbeat
Edema (swelling of the face and legs)
Symptoms of lupus (immune or connective tissue disease) (joint pain, skin rash, photosensitivity and fever)
Inflammation of the blood vessels
Sepsis (serious infection that can lead to organ failure, shock and death)
Fungal infections (occurring in weakened defenses against infection)
-Respiratory disorders and inflammation (including asthma, shortness of breath, coughing, sinus congestion, pleurisy, inflammation of the throat or difficulty breathing)
Diseases of the stomach, including the collection of fluid in the abdominal cavity ulcers (including ulcers of the mouth), perforation, bloating, acid reflux, indigestion, dry mouth
Diseases of bile
Muscle diseases, including increased muscle enzymes
Changes in the levels of different salts in the blood
Changes in cholesterol and fat levels in the blood
Blood clots in the veins and lungs
Bleeding or bruising
Altered blood counts, including low red blood cells (anemia), low platelet count, increased platelet
Swelling of the lymph nodes
Flu-like symptoms, chills, sensation of fever, night sweats, hot flashes
Anxiety and mood disorders such as depression, impaired appetite, change in weight
Feeling of weakness, including loss of consciousness
Neurological disorders of the extremities, including symptoms of numbness, tingling, burning sensation, loss of reflexes, dizziness, tremor
Skin disorders, such as new or worsening psoriasis, disorders of the sweat glands, ulcers, photosensitivity, acne, bruising, hair loss, discolored, brittle nails, dry skin and injuries
Diseases of the kidneys and urinary tract, including renal function, blood in the urine and urinary disorders
Disturbances of the menstrual cycle (monthly malaise), including no heavy bleeding or irregular bleeding
Violations of the chest
Inflammation of the eyes, visual disturbances, difficulty in tears
Prolonged coagulation time (blood clotting)
Rare: may affect up to 1 in 1,000 people
Gastrointestinal cancer, melanoma
Inflammation of the lung
Stroke, blockage of blood vessels, poor circulation which makes the fingers and toes numb and pale (Raynaud's phenomenon), change in skin color - purple spots, small veins near the surface of the skin may become visible
Increase of spleen
Formation of gallstones
Immune system disorders, such as sarcoidosis (rash, joint pain, fever), serum sickness, inflammation of adipose tissue, angioneurotic edema (swelling of the lips, face and throat)
Thyroid gland (goiter, fatigue, weight loss)
Changes in blood levels of uric acid (increase)
Attempted suicide, mental disorder, delirium
Inflammation of the auditory, visual or facial nerves, impaired coordination or balance
Ringing in the ears
Increased bowel movement
Fistula (connecting one body to another) (anywhere)
Violations of the oral cavity, including pain on swallowing
Skin peeling, blistering, abnormal hair structure
Other side effects
With administration of Cimzia for the treatment of other diseases are not observed following common side effects:
Gastro-intestinal stenosis (narrowing of a part of the digestive system).
Gastro-intestinal blockage (obstruction of the digestive system).
Violation of the general physical condition.
Azoospermia (absence of sperm).
In other TNF blockers to treat rheumatoid arthritis, there is risk of multiple sclerosis or Guillain-Barré syndrome. The risk of multiple sclerosis or Guillain-Barré syndrome with Cimzia is unclear.
If you experience any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet.
How to store Cimzia
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and syringe after "EXP". The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C).
Do not freeze.
Keep the pre-filled syringe in the outer carton to protect from light.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Package Contents and more information
The active substance is certolizumab pegol. Each pre-filled syringe contains 200 mg certolizumab pegol in one ml.
The other ingredients are: sodium acetate, sodium chloride and water for injection (see "Cimzia contains sodium acetate and sodium chloride" in Section 2).
Cimzia looks like and contents of pack
One Cimzia pack contains:
Two pre-filled syringes of solution, and two alcohol swabs (for cleaning the areas chosen for injection).
None of the components of the syringe contains latex.