SILGARD WHAT IS AND WHAT IT IS USED
Silgard vaccine . Vaccination with Silgard is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18.
These diseases include cancer of the cervix, precancerous lesions of the female genital organs (cervix , vulva and vagina ) and genital warts in males and females . HPV types 16 and 18 are responsible for approximately 70% of cases of carcinoma of the cervix , and 70 % of the HPV-related lesions of the vulva and vagina . HPV types 6 and 11 are responsible for approximately 90% of cases of genital warts .
Silgard is intended to prevent these diseases. The vaccine is not used for the treatment of HPV- associated diseases . Silgard no effect in individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine. However, for individuals who are already infected with one or more of the vaccine types HPV, Silgard may still prevent a disease associated with other HPV types in the vaccine.
Silgard can not cause the diseases it protects against.
Silgard produces type -specific antibodies in clinical trials has been shown to prevent HPV 6 -, 11 -, 16 - and 18 - related diseases in women aged 16-45 years and men aged 16-26 years. The vaccine produces type-specific antibodies and 9 - to 15 - year-old children and adolescents.
Silgard should be used in accordance with official guidelines.
2 . BEFORE YOU RECEIVE SILGARD
You should not receive Silgard, if:
You or your child are allergic (hypersensitive ) to the active substances or to any of the ingredients of Silgard ( listed under "other ingredients" - see section 6) ;
You or your child has an allergic reaction after a dose of Silgard;
You or your child suffer from an illness with fever . At the same time , a mild fever or infection of the upper respiratory tract (eg , cold) itself is not a reason to delay vaccination .
Take special care with Silgard:
You must tell your doctor if you or your child :
have a bleeding disorder (a disease that makes you bleed more than normal) , for example haemophilia ;
have a weakened immune system , for example due to a genetic defect, HIV infection , or drugs which affect the immune system .
After each injection needle fainting may occur , sometimes accompanied by a fall (especially in adolescents ) . Therefore tell your doctor or nurse if you have a seizure in past injection.
As with any vaccine , Silgard may not protect 100% of those vaccinated .
Silgard not protect against all types of Human Papillomavirus. Should therefore continue to take measures against the transmission of sexually transmitted diseases .
Silgard not protect against other diseases that are not caused by human papillomavirus .
Vaccination is not a substitute for routine cervical cancer . You should continue to follow the doctor's advice to study smear of the cervix, as well as preventative and protective measures.
What other important information should Silgard you or your child to know
The duration of protection is currently unknown. Carry out extensive studies to determine the need for a booster (booster ) dose.
Taking other medicines:
Silgard can be given with hepatitis B vaccine or diphtheria (d) and tetanus (T ) combined or pertussis [ acellular, component ] (ap ) and / or poliomyelitis ( inactivated ) (IPV) (dTap, dT-IPV, dTap-IPV vaccines) at a separate injection site (another part of the body , eg . other arm or leg ) at the same visit .
Silgard may not have an optimal effect if:
be used with medicines that suppress the immune system.
In clinical trials, oral or other contraceptives did not reduce the protection of Silgard .
Please tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and lactation :
Consult your doctor if the person to be vaccinated is pregnant, trying to become pregnant or becomes pregnant during the course of vaccination .
Silgard can be given to women who are breastfeeding or plan to breastfeed.
Driving and using machines:
No studies on the effects on the ability to drive or operate machinery.
3 . HOW TO USE SILGARD
Silgard is administered by your doctor as an injection . Silgard is intended for adolescents and adults over 9 years. Vaccinated will receive three doses of vaccine.
First injection : at chosen date;
Second injection: ideally 2 months after first injection ;
Third injection : ideally 6 months after first injection.
If you need an alternate vaccination schedule , the second dose should be administered at least one month after the first dose and the third dose should be administered at least S months after the second dose. Three doses should be given within 1 year. Please talk to your doctor for more information.
Vaccinated should complete the full course of vaccination with three doses ; otherwise the protection of vaccination may be incomplete.
Silgard is administered by injection through the skin into the muscle ( preferably the muscle of the arm or leg) .
The vaccine should not be mixed in the same syringe with any other vaccines or solutions.
If you forget to take Silgard:
If you miss a scheduled injection, your doctor will decide when to give the missed dose.
It is important to follow your doctor or nurse regarding return visits for the next dose . If you forget or are unable to visit your doctor at the scheduled time , seek advice from him. When Silgard administered the first dose, after two doses to complete the course of vaccination with three doses should also be Silgard, a not another HPV vaccine.
If you have any further questions on the use of this product , ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines , Silgard can cause side effects, although not everybody gets them .
In applying Silgard can be observed following side effects:
Very common (more than 1 in 10 patients) , side effects found at the injection site include : pain, swelling and redness. It has been observed , and headache .
Common (greater than 1 in 100 patients) , side effects found at the injection site include : bruising , itching, pain in extremity . Have also been reported fever and nausea.
Rare (less than 1 in 1000 patients): hives ( urticaria) .
Very rarely (less than 1 in 10,000 patients) reported wheezing (bronchospasm ) .
Silgard when used with a combined diphtheria , tetanus, pertussis ( acellular, component ) and poliomyelitis ( inactivated ) during the same visit, there was more headache and swelling at the injection site .
Adverse reactions reported during the period in which the product is on the market include:
Fainting , sometimes accompanied by shaking or stiffening . Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Allergic reactions that may include difficulty breathing, wheezing (bronchospasm ) , hives and rash. Some of these reactions are severe.
As with other vaccines , reported during general use side effects include: swollen glands (neck , armpit, or groin) , Guillain -Barré syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body), dizziness , vomiting , joint pain, muscle pain, unusual tiredness or weakness, chills , malaise, bleeding or bruising more easily than normal , and infections of the skin at the injection site.
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
5 . HOW TO STORE SILGARD
Keep out of reach of children.
Do not use vaccine after the expiry date stated on the vial label and carton (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 vial in the outer carton to protect from light.
Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
6 . FURTHER INFORMATION
If you have any further issues Silgard, please ask your doctor or pharmacist.
What does Silgard
The active substances are : highly purified non-infectious protein for each type of human papillomavirus (6, 11, 16 and 18).
1 dose (0,5 ml) contains approximately:
Human Papillomavirus1 type 6 L1 protein2 3 20 micrograms.
Human Papillomavirus1 type 11 L1 protein2 3 40 micrograms.
Human Papillomavirus1 type 16 L1 protein2 3 40 micrograms.
Human Papillomavirus1 type 18 L1 protein2 3 20 micrograms.
1Choveshki Papillomavirus = HPV.
2L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C -5 ( Strain 1895 ) ) by recombinant DNA technology.
3adsorbed on amorphous aluminum hydroxyphosphate sulphate adjuvant (225 micrograms AL).
The other ingredients in the vaccine suspension are:
sodium chloride , L-histidine , polysorbate 80 , sodium borate and water for injection.
Silgard looks like and contents of the pack
1 dose of Silgard suspension for injection contains 0,5 ml.
Before shaking Silgard may appear as a clear liquid with a white precipitate. After agitation, a white, cloudy liquid.
Silgard is available in packs of 1, 10 or 20 vials .
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Merck Sharp & Dohme Ltd, United Kingdom.
Manufacturer : Merck Sharp and Dohme, BV, the Netherlands.
The following information is intended for healthcare professionals only :
The vaccine should be used as supplied ; does not need to be diluted or dissolved . Should apply recommended dose of the vaccine.
Shake well before use. The vaccine should be kept suspended by agitation immediately prior to use .
Medicinal products for parenteral administration must first be inspected visually for particulate matter and discoloration. Discard the product if it contains particulate matter or looks different in color.