Pegasys 135 micrograms solution for injection. syringe
Pegasys 135 micrograms solution for injection. syringe
What is Pegasys and what it is used
Pegasys contains the active substance peginterferon alfa- 2a , which is 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 to treat chronic hepatitis C or chronic hepatitis C in adults. It is also used for the treatment of chronic hepatitis C in children and adolescents aged 5 years and older , who have not been treated before . As chronic hepatitis B and chronic hepatitis C viral infection is a liver.
Chronic hepatitis B: Pegasys is usually used alone.
Chronic hepatitis C : In this treatment is best Pegasys be administered in combination with ribavirin. Pegasys is used alone only if you can not take ribavirin for some reason.
If you receive combination therapy with Pegasys and ribavirin , you should read the package leaflet of ribavirin.
2 . What you should know before using Pegasys
Do not use Pegasys
if you are allergic to peginterferon alfa -2a, to any interferon or any of the other ingredients of this medicine (listed in Section 6) ;
if you have ever had a heart attack or have been admitted to hospital because of severe chest pain in the last six months;
if you have a so-called autoimmune hepatitis ;
If you have advanced liver disease and your liver is not working properly (eg skin is yellowed ) ;
if the patient is a child under 3 years of age;
if the patient is a child who had a serious mental illness such as severe depression or suicidal thoughts ;
If you are co-infected with hepatitis C virus and human immunodeficiency virus, and your liver is not working properly (eg skin is yellowed ) ;
If you are treated with telbivudine drug for hepatitis B infection ( see " Other medicines and Pegasys").
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Pegasys:
if you 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.). during treatment with Pegasys ( see section 4 ) ;
if you plan on becoming pregnant, discuss this with your doctor before you start using Pegasys ( see " Pregnancy, lactation and fertility " ) ;
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 ophthalmologist ;
if you notice changes in your vision ;
in the implementation of 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 experience any signs of bleeding or unusual 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 been told you have VKH syndrome or a combination of symptoms of stiff neck , headache , loss of skin color or hair , eye disorders (eg blurred vision ) and / or hearing abnormalities (eg tinnitus ) ;
if you have thyroid disease that is not well controlled with medication ;
if you have ever had anemia ;
if you have a transplanted organ (liver or kidney) transplant or have planned in the near future;
If you are co-infected with HIV and treated with drugs against HIV;
have stopped previous treatment for hepatitis C due to anemia or low blood counts .
During treatment, your doctor will order 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 .
There are reports of violations of the teeth and the gums which can lead to tooth loss , in patients receiving combination therapy with Pegasys and ribavirin. In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Pegasys and ribavirin. You should brush your teeth thoroughly twice daily and have regular dental examinations . Some patients may experience vomiting . If you receive such a reaction , necessarily rinse your mouth thoroughly afterwards.
Children and adolescents
Do not give this medicine to children under 5 years of age. It has not been studied in combination with ribavirin in these children. Pegasys should not be given to children under 3 years as it contains benzyl alcohol and may cause toxic reactions and allergic reactions in these children.
If your child has or has ever had a mental disorder , talk to your doctor who will monitor your child for signs or symptoms of depression ( see section 4 ) ;
In applying Pegasys, your child may have delayed growth and development (see section 4 ) .
Other medicines and Pegasys
Do not use Pegasys, if you are taking telbivudine ( see " Do not use Pegasys"), as the combination of these drugs increases the risk of developing peripheral neuropathy ( numbness, tingling and / or burning sensation in the hands and / or feet ) . Therefore , the combination of Pegasys with telbivudine is contraindicated. Tell your doctor or pharmacist if you are treated with telbivudine.
Tell your doctor if you are taking medicines for asthma, because you may need to change the dose of the drug for asthma.
Patients also had an HIV infection . 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) treatment for 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. Patients receiving zidovudine with ribavirin and alpha interferons, are at increased risk of developing anemia. Patients receiving azathioprine with ribavirin and peginterferon are at increased risk of developing serious blood disorders . Please be sure to read the package leaflet and ribavirin .
Tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines.
Pregnancy, lactation and fertility
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. When Pegasys is given in combination with ribavirin , patients - both men and women need to take special precautions in their sexual activity even in the most unlikely of pregnancy as ribavirin can be very harmful to an unborn baby :
if you are a woman of childbearing potential and taking Pegasys in combination with ribavirin , have to take pregnancy tests and they are negative before treatment, every month during treatment and for 4 months after stopping treatment. Need to use effective methods of birth control during treatment and for 4 months after that. These issues can be discussed with your doctor ;
if you are male and taking Pegasys in combination with ribavirin , you should not have sex with a pregnant woman unless you use a condom. This will reduce the likelihood ribavirin pass into the body of the woman. If your partner is not pregnant now but is of childbearing potential , she should be tested for pregnancy each month during treatment and for 7 months after stopping treatment. You and your partner must use effective methods of birth control during treatment and for 7 months after that. These issues can be discussed with your doctor.
Ask your doctor or pharmacist before taking any medicine . It is not known whether this drug is excreted in human milk . Therefore , you should not breastfeed your baby if you are treated with Pegasys. In combination with ribavirin note of the information on medicinal products containing ribavirin.
Driving and using machines
You should not drive or operate machinery if you feel drowsy , tired , or confused while taking Pegasys.
Pegasys contains benzyl alcohol
Not be used in premature babies, infants or children under 3 years of age. May cause toxic reactions and allergic reactions in infants and children up to age 3 .
3 . How to use Pegasys
Always use this medicine exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
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 the 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 therapy ranges from 4 to 18 months, depending on the type of virus which are infected , the response to treatment , and whether you have been treated before . Please consult your doctor and follow the recommended duration of treatment.
Usually Pegasys injection is done at bedtime.
Use in children (aged 5 years and over) and adolescents
Your doctor has determined the exact dose of Pegasys for your child and tell you how often to use it. The usual dose of Pegasys, alone or in combination with ribavirin , is calculated based on the size and weight of your child. If necessary, the dose may be changed during treatment . Recommended for children and adolescents to use pre-filled syringe Pegasys, as they allow for dose adjustment . Do not exceed the recommended dose.
The duration of the combination therapy in children 6 to 12 months, depending on the type of virus which is infected with your child and the response to the applied therapy . Please check with your doctor and follow the recommended duration of treatment. Injection of Pegasys is usually at bedtime.
Pegasys is 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 ( see " How to inject Pegasys").
Use Pegasys exactly as your doctor tells 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 regimen recommended by your doctor.
If you use more than the amount of Pegasys
Contact your doctor or pharmacist as soon as possible quickly.
If you forget to use 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 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 .
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 , eg . Thoughts about threatening the lives of 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.
Growth and development (children and adolescents ):
During treatment with Pegasys in combination with ribavirin , lasting up to one year , some children and adolescents did not grow or gain weight as expected. Some of the children do not reach the intended growth within two years after completion of treatment , and this may affect their final adult height .
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 (may affect more than 1 in 10 people) :
Metabolic disorders : Loss of appetite;
Psychiatric disorders and nervous system disorders : Depressed mood ( dejection , self-pity or despair ) , anxiety, insomnia , headache , difficulty concentrating and dizziness ;
Respiratory disorders : cough , shortness of breath ;
Disorders of the digestive system : diarrhea , nausea, abdominal pain;
Skin : Hair loss and skin reactions (including itching, dermatitis and dry skin ) ;
Disorders of muscle and bone : Pain in joints and muscles ;
General: fever, weakness , fatigue , tremors , chills , pain , irritation at the injection site and irritability (easy temper ) .
Common side effects of combination therapy of Pegasys and ribavirin (may affect up to 1 in 10 people) :
Infections: fungal, viral and bacterial infections. Infection of the upper respiratory tract infection , bronchitis, a fungal infection of the mouth and herpes ( viral infection , which occurs periodically with the frequency and affect the lips, mouth) ;
Blood : Decreased platelet count (which affects the ability of blood clotting ), anemia (low red blood cells) and swollen lymph glands ;
Hormonal disorders: Hyper - and hypofunction of the thyroid gland ;
Psychiatric disorders and nervous system disorders : Changes in mood / emotions , aggression , nervousness , decreased libido , memory loss , seizures , muscle weakness , migraine, numbness, tingling , burning , shaking, taste disturbance , nightmares, drowsiness ;
Eye disorders : Blurred vision , eye pain, eye inflammation and dry eye;
Ear : dizziness, ear pain ;
Disorders of the heart and blood vessels : Fast heart rate , palpitations, swelling of the extremities , redness of the skin;
Respiratory disorders : Breathlessness on exertion , nose bleeds, inflammation of the nose and throat , infection of the nose and sinuses ( cavities in the skull and facial bones ) , runny nose , sore throat ;
Disorders of the digestive system : Vomiting, indigestion , difficulty swallowing, mouth ulcers , bleeding gums , sore tongue and mouth , flatulence ( excessive amount of air or gas), dry mouth and weight loss;
Skin : rash, increased sweating , psoriasis , urticaria, eczema , sensitivity to light , night sweats ;
Disorders of muscle and bone : back pain , joint inflammation , muscle weakness , bone pain , neck pain , muscle pain , muscle cramps ;
Reproductive system : Impotence (inability to maintain an erection ) ;
General disorders : chest pain , influenza like illness , malaise (when not feeling well ) , lethargy , flushing, thirst.
Uncommon side effects of combination therapy of Pegasys and ribavirin (may affect up to 1 in 100 people) :
Infections : Pulmonary infection , skin infections ;
Neoplasms - benign and malignant disorders liver tumors ;
Immune system disorders : Sarcoidosis ( inflamed tissue areas of the body) , inflammation of the thyroid gland ;
Hormonal disorders: Diabetes (high blood sugar ) ;
Metabolic disorders: dehydration;
Psychiatric disorders and nervous system disorders : suicidal thoughts, hallucinations ( severe personality disorders and deterioration of normal social activity) , peripheral neuropathy (a disorder of the nerves of the limbs) ;
Eye disorders : Bleeding in the retina ( posterior segment of the eye) ;
Ear : Hearing Loss ;
Disorders of the heart and blood vessels : Increased blood pressure;
Respiratory disorders : wheezing ;
Disorders of the digestive system : bleeding from the gastrointestinal tract ;
Liver disorders : Abnormal liver function.
Rare side effects of combination therapy of Pegasys and ribavirin (may affect up to 1 in 1000 people) :
Infections : cardiac infection , infection of the external ear ;
Blood : Strong decrease in red blood cells, white blood cells and platelets ;
Immune system disorders : Severe allergic reaction , systemic lupus erythematosus (a disease in which the body attacks its own cells) , rheumatoid arthritis ( an autoimmune disease) ;
Hormonal disorders: Diabetic ketoacidosis , a complication of uncontrolled diabetes ;
Psychiatric disorders and nervous system disorders : suicide , psychotic disorders ( severe personality disorders and deterioration of normal social activity) , coma ( severe and prolonged loss of consciousness) , seizures , facial palsy ( a weakening of the facial muscles ) ;
Eye disorders : inflammation and edema of the optic nerve , retinal inflammation , corneal ulcer ;
Disorders of the heart and blood vessels : Heart attack , heart failure , heart pain, palpitations , arrhythmias , or inflammation of the lining of the heart and cardiac muscle, brain hemorrhage and inflammation of blood vessels;
Respiratory disorders : Interstitial pneumonitis (lung inflammation, including fatal outcome ) , blood clots in the lungs ;
Disorders of the digestive system : Stomach ulcer , inflammation of the pancreas;
Hepatic impairment : Hepatic failure, inflammation of the bile duct , fatty liver degeneration;
Disorders of muscle and bone disorders: muscle inflammation ;
Renal : renal failure ;
Injury or poisoning : Overdose of substance.
Very rare side effects of combination therapy of Pegasys and ribavirin (may affect up to 1 in 10 000 people) :
Blood : aplastic anemia (insufficient production by the bone marrow of the red blood cells, white blood cells and platelets) ;
Immune system disorders : Idiopathic (or thrombotic ) thrombocytopenic purpura (increased bruising , bleeding, low platelet count , anemia, and pronounced weakness ) ;
Eye disorders : Loss of vision ;
Skin : Toxic epidermal necrolysis / syndrome Stevens-Johnson/eritema multiforme ( range from rashes of varying severity , including leading to death, can occur with the formation of blisters in the mouth , nose , eyes and other mucous membranes and peeling the affected area of skin), angioedema ( swelling of the skin and mucosa ) .
Side effects with unknown frequency:
Blood : pure red blood cells ( a severe form of anemia where red blood cells is reduced or stopped ), it may cause symptoms such as fatigue in the absence of power ;
Immune system : Disease Vogt-Koyanagi-Harada - a rare disorder characterized by the loss of sight, hearing , and skin pigmentation , rejection of a liver or renal transplant ;
Psychiatric disorders and nervous system disorders : mania ( episodes of strong elevated mood ) and bipolar disorder ( episodes of strong elation alternating with sadness and despair ) , thoughts about threatening the life of others , stroke ;
Eye disorders : rare form of detachment of the retina with the fluid in the retina ;
Disorders of the heart and blood vessels : Peripheral ischemia (insufficient blood supply to the limbs) ;
Disorders of the digestive system : Ischemic colitis (insufficient blood supply to the intestine ) ;
Disorders of muscle and bone : Serious muscle damage and pain.
When Pegasys was used alone in patients with hepatitis B or C, the probability as any of these effects is small. If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet .
5 . How to store Pegasys
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze . Keep the vial in the outer carton to protect from light.
Do not use this medicine if you notice that the vial or the package is damaged , if the solution is cloudy, contains particles , or if the drug has a different color besides colorless to pale yellow.
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 Pegasys
The active substance is peginterferon alfa- 2a . Each vial of 1,0 ml of solution contains 135 micrograms of peginterferon alfa- 2a .
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 is injectable solution in a vial ( 1 ml). Available in packs of 1 or 4 vials of a single dose.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Roche Registration Limited, United Kingdom.
Manufacturer : Roche Pharma AG, Germany.
How to inject Pegasys
The following instructions explain how to use Pegasys single dose vials to inject yourself or your child . Please read the instructions carefully and follow them 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:
Pegasys vial with injection.
Included in the package:
syringe of 1 ml;
long needle to withdraw from the vial Pegasys ;
short needle for subcutaneous injection ;
cleaning pad ;
small bandage or sterile gauze ;
adhesive bandage ;
waste container .
Measuring the dose of Pegasys:
Remove the protective cap from the vial Pegasys;
Clean the rubber stopper of the vial with a cleansing swab . You can save the swab to clean the area of skin where you inject Pegasys;
Remove the syringe from the package. Do not touch the tip of the syringe ;
Take the long needle and secure it firmly to the syringe ;
Remove the needle guard without touching the needle and hold the syringe with the needle in his hand ;
Insert the needle through the rubber stopper into the vial Pegasys;
Hold the vial and syringe in one hand and turn the vial and syringe upside down ;
When the syringe pointing upwards , make sure that the needle tip is in solution Pegasys. Your other hand will be free to move the plunger .
Slowly pull the plunger into the syringe by downloading a bit more than the dose prescribed by your doctor ;
Hold the syringe with the needle in the vial facing up , remove the syringe from the long needle and continue to hold the needle in the vial without touching the tip of the syringe ;
Take the short needle and secure it firmly to the syringe ;
Remove the needle guard ;
Check for air bubbles in the syringe. If you see bubbles , pull the plunger back a little . 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 ;
With a cleaning pad clean and disinfect skin where you will put the injection ;
Wait until dry place ;
Remove the needle guard ;
With one hand, pinch a fold of skin. With your other hand hold the syringe as you would a pencil caught ;
Insert the needle fully into the skin fold at an angle of 45 ° to 90 °;
Inject the solution by gently pressing the plunger until 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 . Ask your doctor , hospital or pharmacist for an appropriate container.