CIMZIA. 200 mg. 1 ml. 2 ampules
CIMZIA. 200 mg. 1 ml. 2 ampules
What is Cimzia and what it is used
Cimzia contains the active substance certolizumab pegol , a fragment of a human antibody. Antibodies are proteins that specifically recognize and bind to other proteins. Cimzia binds to a specific protein , called tumor necrosis factor - alpha (TNF?). So that TNF? is blocked by Cimzia, which leads to a reduction of inflammation in rheumatoid arthritis . Drugs that bind TNF?, are also 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 applied independently.
2 . What you should know before using Cimzia
DO NOT use Cimzia
- If you are allergic (hypersensitive ) to the active substance or to any of the 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 or have had severe heart disease .
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 these following apply to you :
- If you develop allergic reactions such as chest tightness, wheezing , dizziness, swelling or rash , stop taking Cimzia and tell your doctor immediately.
- If you had recurrent 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, wounds, fatigue or dental problems . During treatment with Cimzia, you can develop more easily infections, including severe and in rare cases, life -threatening infections.
- Saobshteni are 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 X-ray and a tuberculin test. Conduct of these tests should be recorded on your Patient Alert Card . If diagnosed latent ( inactive ) TB, you may need to take appropriate anti-tuberculosis drugs before 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 immediately if during or after treatment with Cimzia symptoms of tuberculosis ( persistent cough , weight loss, listlessness , mild fever ) or other infections.
- 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 taking Cimzia. Your doctor will examine you for HBV before taking Cimzia.
- If you have mild heart failure and was treated with Cimzia, state of cardiac failure should be monitored regularly by your doctor. It is important to tell your doctor if you have or have had severe heart disease . If you develop new or worsened symptoms of heart failure (such as shortness of breath or swelling of the feet), you should tell your doctor immediately. Your doctor may decide to stop treatment with Cimzia.
Malignancy ( cancer)
- Although not common in patients treated with Cimzia or other TNF blockers have been reports of the occurrence of certain cancers. Patients with more severe forms of rheumatoid arthritis , having a disease for a long time may have a higher than average risk of occurrence of a particular type of cancer affecting the lymph system, called lymphoma. If you are taking 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 you during treatment with Cimzia and then develop new skin lesions or existing skin lesions change appearance. Patients with chronic obstructive pulmonary disease ( COPD) or heavy smokers, may have an increased chance of developing cancer by treatment with Cimzia. If you have COPD or heavy smoker , you should discuss with your doctor whether treatment with TNF blocker is appropriate for you.
- There have been cases of cancers , including unusual species in children and patients tiinendzhari taking TNF blockers, which sometimes lead to death ( see below " Children and Youth " ) .
- If you have a nervous system disorder , such as multiple sclerosis , your doctor will decide whether you should take 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 will decide whether 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 will decide whether to stop treatment with Cimzia.
- Tell your doctor if a vaccination or to be vaccinated. To you should you not be doing a live vaccine while using Cimzia.
- Certain vaccines may cause infections. If you used Cimzia during pregnancy , your baby may be at higher risk of such infection approximately 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. Tell your surgeon or dentist performing the procedure that you are being treated with Cimzia, and show your Patient Alert Card .
Children and adolescents
Cimzia is not recommended for use in children and adolescents under 18 years.
Other medicines and Cimzia
You should not take Cimzia, if you use these drugs used to treat rheumatoid arthritis :
If you have questions , please consult your doctor.
Cimzia can be given at the same time :
- Corticosteroids or
- 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 breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.
There is 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 five months after the last Cimzia.
If you used 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 the baby to make a vaccine ( for more information see the section on vaccination).
It is not known whether Cimzia passes into breast milk . Consult your doctor before breast-feeding during treatment with Cimzia.
Driving and using machines
Cimzia may have a minor influence on the ability to drive and use machines. With the use of Cimzia may appear dizziness (including vertigo, blurred vision and fatigue ) .
Cimzia comprises sodium acetate and sodium chloride
This product contains less than 1 mmol sodium (23 mg) at 400 mg, the essentially ' sodium-free ' .
3 . How to use Cimzia
Always use this medicine exactly as your told your doctor or pharmacist. If you are 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 administration of Cimzia. If your doctor determines that methotrexate is inappropriate , Cimzia can be applied independently.
Cimzia will usually be given by a doctor or medical specialist . Cimzia will be administered subcutaneously in the form of a ( 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 allow you to inject Cimzia.
If your doctor has allowed you to 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 has allowed you to 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 inject and you forget to inject Cimzia, you should inject the next dose as soon as you remember. Continue injecting subsequent doses every 2 weeks as originally .
If you stop using Cimzia
Do not stop taking 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.
4 . 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 the following 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 of these symptoms)
shortness of breath with exertion or when lying down or swelling of the feet (heart failure )
symptoms of violations by blood, prolonged fever, bruising , bleeding, pallor ( pancytopenia , anemia, decrease in platelets and white blood cells)
Tell 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 fatigue
weakness in arms and legs
secretion or open sore that does not heal
Described above symptoms can be caused by any of the following adverse reactions observed during treatment with Cimzia:
Common: may affect up to 1 in 10 people
- Bacterial infections at any location (the formation of pus )
- Viral infections (including colds, flu and shingles )
- High blood pressure
- Rash or itching
- Headache (including migraine)
- Sensory disturbances such as numbness , cramping , burning
- A feeling of weakness and malaise
- Diseases of the liver
- Reactions at the injection site
Uncommon : may affect up to 1 in 100 people
- Allergic conditions , including allergic rhinitis and allergic reactions to the drug ( including anaphylactic shock )
- Malignant diseases of the blood and lymphatic system , such as lymphomas and leukemia
- Cancer of solid organ
- Malignant diseases of the skin and to malignancies
- Benign ( non-malignant ) 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 ( severe infection which can lead to organ failure , shock, and death )
- Tuberculosis infection
- Fungal infections (occurring in weakened ability to fight 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 oral ulcers ) , perforations , swelling , acid reflux , diarrhea , dry mouth
- Diseases of the bile
- Muscle diseases, including increased muscle enzymes
- Changes in the levels of various salts in the blood
- Change in the cholesterol and fat levels in the blood
- Blood clots in the veins and lungs
- Bleeding or bruising
- Altered blood counts , including low numbers of red blood cells ( anemia ), low platelet count , increased platelet count
- 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 , weight change
- Vertigo ( dizziness )
- A sense of weakness, including loss of consciousness
- Neurological disorders from the extremities, including symptoms of numbness, tingling , burning sensation , loss of reflexes, dizziness , tremor
- Skin disorders such as new or worsening psoriasis violations by sweat glands , ulcers , photosensitivity , acne , bruising, hair loss , discoloration, brittle nails , dry skin and injuries
- Impaired wound
- Diseases of the kidneys and urinary tract, including renal function , blood in the urine and urinary disorders
- Disorders of the menstrual cycle ( monthly malaise ), including the absence of severe bleeding or irregular bleeding
- Violations by chest
- Inflammation of the eyes, visual disturbances , problems with tears
- Prolonged coagulation time ( coagulation time of blood)
Rare: may affect up to 1 in 1000 people
- Gastrointestinal carcinoma, melanoma
- Inflammation of the lung
- Stroke, blockage of blood vessels , poor circulation which makes the fingers and toes numb and pale ( Raynaud's phenomenon ), changes in skin color - purple spots , small veins near the surface of the skin can become visible
- Enlarged spleen
- Formation of gallstones
- Immune disorders, such as sarcoidosis (rash, joint pain, fever) , serum sickness , inflammation of adipose tissue, angioneurotic edema (swelling of the lips, face and throat)
- Disorders of the thyroid ( 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 by mouth, including pain on swallowing
- Flaking , blistering , with the structure of the hair
- Sexual Dysfunction
Other side effects
With the use of Cimzia for the treatment of other diseases are not observed following common side effects:
- Gastrointestinal stenosis (narrowing of a particular part of the digestive system).
- Gastro- intestinal blockage ( obstruction of the digestive system).
- General physical condition.
- Miscarriage .
- Azoospermia (absence of sperm ) .
In other TNF blockers for the treatment of rheumatoid arthritis is observed onset of multiple sclerosis or Guillain- Barre syndrome . The occurrence of multiple sclerosis or Guillain -Barré syndrome with Cimzia is not known .
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet .
5 . How to store Cimzia
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the pack 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.
6 . Package Contents and more information
What does Cimzia
- The active substance is certolizumab pegol . Each pre -filled syringe contains 200 mg of 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 the pack
One Cimzia pack includes:
- Two pre-filled syringes of solution, and two alcohol swabs ( for cleaning the areas chosen for injection) .
None of the components of the syringe contain latex .