Pegasys 180 micrograms solution for injection. 0.5 ml. syringe
Pegasys 180 micrograms solution for injection. / 0.5 ml. syringe
PEGASYS WHAT IS AND WHAT IT IS USED
Pegasys is a solution for injection in pre-filled syringe (0.5 ml) with a separate injection needle and comes in packs of 1,4 or 12 pre-filled syringes.
Pegasys is a long-acting interferon . Interferon is a protein that modifies the response of the body's immune system , as it helps to fight off infections and severe diseases . Pegasys is used for the treatment of chronic hepatitis B or C, which are viral infections of the liver.
Chronic hepatitis B: Pegasys is usually used alone.
Chronic hepatitis C : In this treatment is best Pegasys be administered in combination with ribavirin.
If you receive combination therapy with Pegasys and ribavirin , you should read the leaflet ribavirin.
Pegasys is used alone only if you can not take ribavirin for some reason.
2 . BEFORE YOU USE PEGASYS
Do not use Pegasys:
if you are allergic to peginterferon alfa -2a, to any interferon or any of the other ingredients of Pegasys;
if you have ever had a heart attack or suffer from other cardiac disease , if you have a so-called autoimmune hepatitis ;
If you have advanced liver disease ( eg skin is yellowed ) if the patient is a child under 3 years of age.
Take special care with Pegasys:
If you are planning to become pregnant , talk to your doctor before you start using Pcgasys ( see Pregnancy )
If you have psoriasis , it may get worse during treatment with Pegasys; If you have another liver problem except hepatitis B or C ;
if you have diabetes or high blood pressure , your doctor may advise you to undergo examination by an eye doctor if you notice changes in your vision ;
when taking Pegasys, may temporarily 're at greater risk of infection. Ask your doctor if you think you have developed an infection (eg pneumonia) ;
If you develop symptoms associated with colds or other respiratory infection ( such as cough , fever or any difficulty breathing ) ;
if you get unusual bleeding or bruising , consult with your doctor ;
if you develop signs of a severe allergic reaction (such as difficulty in breathing , wheezing or hives) while taking this drug , seek immediate medical attention ;
if you have thyroid disease that is not well controlled with medication , if you have had a severe nervous or mental disorder;
if you have ever had depression or develop symptoms associated with depression ( eg feelings of sadness , depression , etc.). while being treated with Pegasys ( see section 4 ) if you have ever had anemia ;
If you are co-infected with HIV and treated with anti- HIV. Taking other medicines:
Inform your doctor if you are taking medicines for asthma, because you may need to change the dose of medication for asthma.
Patients who are infected with HIV. Tell your doctor if you are given treatment against HIV. Lactic acidosis and worsening liver function are side effects associated with highly active antiretroviral therapy ( HAART ) to treat HIV. If you are receiving HAART , the addition of Pegasys + ribavirin may increase the risk of lactic acidosis or liver failure. Your doctor will monitor you for signs and symptoms of these conditions. Please be sure to read the leaflet and ribavirin .
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Driving and using machines:
You should not drive or operate machinery if you feel drowsy , tired , or confused while taking Pegasys .
3 . HOW TO USE PEGASYS
Always use Pegasys exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist. Your doctor has prescribed Pegasys specifically to you and your condition at the moment , does not share this medicine with anyone else .
Dosing of Pegasys
Your doctor has determined the exact dose of Pegasys and tell you how often to apply it . If necessary, the dose may be changed during treatment . Do not exceed recommended dose.
Pegasys, alone or in combination with ribavirin , is usually administered at a dose of 180 micrograms once a week.
The duration of the combination treatment varied from 6 months to 1 year, depending on the nature of the virus , which are infected . Please consult your doctor and follow the recommended duration of treatment. Usually Pegasys injection is done at bedtime.
Pegasys with intended to be administered subcutaneously ( under the skin) . This means that Pegasys is injected with a short needle in the tissue under the skin of the abdomen or thigh. If we inject this medicine will explain how to do it . Detailed instructions are given at the end of this leaflet.
Apply Pegasys exactly as your doctor has told you and as long as prescribed . If you feel that the effect of Pegasys is too strong or too weak, talk to your doctor or pharmacist.
Combination therapy with ribavirin in chronic hepatitis C
In case of combination therapy with Pegasys and ribavirin , please follow the dosing schedule recommended by your doctor .
If you take more dose Pegasys: Contact your doctor or pharmacist as soon as possible quickly.
If you forget to take Pegasys:
If you remember that you missed your injection 1 or 2 days after it was supposed to do, you need to inject the recommended dose as possible quickly. Next injection the next regularly scheduled day.
If you remember that you missed your injection 3 to 5 days after it was supposed to do, you need to inject the recommended dose as possible quickly.
Rights after injections with an interval of 5 days until you return to the regularly scheduled day of the week.
For example : Your regular weekly Pegasys injection is on Monday. On Friday, you know, that you forgot to give an injection on Monday ( 4 days late ) . Need to inject regularly scheduled dose immediately on Friday and the next injection on Wednesday (5 days after injection Friday ) . Your next injection will be on Monday , five days after the injection on Wednesday. You are now returned to your regularly scheduled day and should continue with injections every Monday.
If you remember that you missed your injection 6 days after it was supposed to do, have to wait and inject the dose the next day , your regularly scheduled day.
Contact your doctor or pharmacist if you need help to determine how to handle the missed dose Pegasys.
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product , ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines , Pegasys can cause side effects, although not everybody gets them .
Some people get depressed when taking Pegasys alone or in combination therapy with ribavirin and sometimes people have had suicidal thoughts or aggressive behavior (sometimes directed against others ) . Some patients have actually committed suicide . Be sure to seek emergency care if you notice that you become depressed or having thoughts about suicide or have a change in behavior. You can ask a family member or close friend to help you look out for signs of depression or changes in your behavior.
During treatment, your doctor just take regular blood tests to check for changes in white blood cells ( cells that fight infection ) , red blood cells ( cells that carry oxygen ) , platelets ( blood clotting cells) , liver function or changes in other laboratory values .
Tell your doctor immediately if you notice any of the following side effects : severe chest pain , persistent cough , irregular heartbeat , difficulty breathing , confusion , depression, severe stomach pain , blood in the stool (or black tarry colored stools ), bleeding from the nose , fever or chills, vision problems . These side effects may be serious and need urgent medical attention.
Very common side effects of Pegasys in combination with ribavirin (which occur in more than 10 100 patients ) are:
- Flu-like symptoms such as headache, fever , weakness , fatigue , tremors and chills ;
- Cough , difficulty in breathing ;
- Pain in joints and muscles ;
- Nausea, diarrhea , abdominal pain , loss of appetite, weight loss;
- Difficulty in sleeping, irritability , difficulty concentrating , anxiety , depressed mood ;
- Hair loss , irritation at the injection site skin reactions (including itching, dermatitis and dry skin ) .
Common side effects that occurred in more than 5 100 patients are: changes in mood / emotions , poor memory , vomiting, dry mouth , indigestion , rash , increased sweating and back pain.
Other less common side effects ( occurring in more than 1 in 100 patients) are: infection of the nose , sinuses , throat or respiratory tract inflammation of the mouth , lips, tongue , nose or throat , sinus congestion , fungal infection mouth , sore throat , difficulty swallowing, taste disturbance , fever , ulcers in the mouth, nose bleeds, bleeding gums , ear pain , flatulence or burping, blurred vision , eye irritation , dry eyes , eye pain, numbness or tingling , tremors , migraine , drowsiness , nightmares , night sweats , nervousness , decreased sex drive , impotence, seizures , acute sensitivity , muscle weakness, convulsions , bone pain , arthritis , anemia, low platelet count , thyroid gland swollen glands , dizziness , swelling , rapid pulse , palpitations , flushing , shortness of breath on exertion , eczema , psoriasis , increased sensitivity to light, itchy rash .
Uncommon to rare side effects ( which are observed in less than 1 out of 100 patients) are the following: pneumonia , external ear infections , inflammation of the lining of the lungs , blood clots in the lungs , severe allergic reactions , skin infections , diabetes ; coma , eye problems ( wounds, bleeding , swelling ), the loss of vision or hearing , heart disease ( such as myocardial infarct , rhythm disorders us or cardiac inflammation ), hypertension , cerebral hemorrhage , gastrointestinal disorders ( such as peptic ulceration and bleeding from the gastrointestinal tract ), or liver problems (such as impaired liver function or liver failure, cholangitis ) , tumor in the liver , muscle inflammation , hallucinations and psychotic disorders ( severe personality disorders and deterioration of normal social activity) .
Rarely, autoimmune phenomena (when the body attacks its own cells) as idiopathic (or thrombotic ) thrombocytopenic purpura ( frequent bruising , bleeding, low platelet count , anemia and severe weakness ) , thyroiditis ( inflammation of the thyroid gland ), systemic lupus sritsmatodes , rheumatoid arthritis, sarcoidosis and ( inflamed tissue areas in the body).
Very rarely , Pegasys treatment alone or in combination with ribavirin may cause aplastic anemia (inability of the bone marrow to produce red blood cells , white blood cells and platelets) .
When Pegasys was used alone in patients with hepatitis B or C, the probability as any of these effects is small. If any of the side effects gets serious , or you notice other effects not listed in this leaflet, tell your doctor or pharmacist.
5 . STORAGE PEGASYS
Keep out of reach of children.
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 use Pegasys after the expiry date stated on the label . The expiry date refers to the last day of that month.
Do not use Pegasys, if the packaging of the syringe or needle is damaged, if the solution is cloudy, contains particles , or if the drug has a different color besides colorless to pale yellow .
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.
6 . ADDITIONAL INFORMATION
What does Pegasys
The active component is peginterferon alfa- 2a (recombinant interferon alfa- 2a > conjugated bis ( monomethoxypolyethylene glycol) with a molecular weight Ma 40,000 ) , 180 micrograms in a prefilled syringe.
The other ingredients are sodium chloride , polysorbate 80 , benzyl alcohol , sodium acetate , acetic acid and water for injection.
Pegasys looks like and contents of pack
Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa -2a
How to inject PEGASYS ALONE
The following instructions explain how to use Pegasys prefilled syringes to inject themselves . Please read the instructions carefully and follow the step by step. Your doctor or his / her assistant will explain how to inject .
Wash hands carefully before you start using any of the things .
Before you start , get necessary things : Included in the package:
prefilled syringe Pegasys injection needle included in the pack : cleaning pad small bandage or sterile gauze bandage adhesive waste container
Preparation of a syringe and injection needle
Remove the protective cover that covers the needle ( 1-2).
Remove the rubber cap from the syringe ( 3 ) . Do not touch the syringe tip .
Firmly on the top and the needle of the syringe ( 4 ) .
Remove the needle guard from the syringe ( 5).
To remove air bubbles from the syringe , hold the syringe with the needle pointing upwards . Tap the syringe to move the bubbles to the top. Push the plunger slowly up to the correct dose . Reinstall the cover on the needle and leave the syringe in a horizontal position until ready to use .
Allow the solution to reach room temperature before injection or warm the syringe between your palms .
Examine the solution before injection: do not use it if it appears discolored or has particles in it.
You are now ready to inject the dose.
Injecting the solution
Choose an injection site on the abdomen or thigh ( except for the area around the navel or waistline) . Change the injection site each time.
Cleaning pad clean and disinfect the skin where you will put the injection.
Wait until the skin dry.
Remove the needle guard .
With one hand, pinch a fold of skin. With your other hand , hold the syringe as you got a pencil.
Insert the needle fully into the skin fold under agyl 45 ° degrees.
Inject the solution by gently pushing the plunger to the end.
Remove the needle from the skin.
If necessary, the press for a few seconds at the injection site with a small bandage or sterile gauze .
Do not massage the injection site. If there is bleeding , cover with an adhesive bandage .
Disposal of materials from the injection
Syringe needle and all materials used for injection are intended for single use and must be discarded after injection. Discard the syringe and needle safely in a closed container . Request a suitable container by your doctor or hospital pharmacist .