Sinobioway Group Co., Ltd.
We are professional supplier of Mouse nerve growth factor,Somatropin,EPO,GCSF,Insulin,monoclonal antibody drugs,Interferon,Peptide,Hepatitis A vaccine,Enterovirus Type 71 Vaccine.
Business Type:Manufacturer
Country/Region:China
Ddu Verified
HOT Rank
Excipients: Aluminiumhydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, and water for injection.
Free of Preservative and Stabilizer
Target Groups for VaccinationSusceptible children aged from 6 months to 3 years of age.
Therapeutic IndicationInlive® can induce body to generate immunoreaction against EV71 virus, and can be used to prevent Hand-Foot-Month Disease (HFMD) caused by EV71 virus. Inlive® cannot be used to prevent HFMD caused by enterovirus other than EV71 (such as CoxA 16 etc.).
PresentationEach package contains 0.5ml. Single dose of 0.5ml contains EV71 neutralizing antibody titer no less than 3.0EU (EU: NAT Unit).
Administration and DosageAdministration: Ready-to use suspension for intramuscular injection. The preferred site is the deltoid muscle of the upper arm.Schedule and dosage: primary immunization series of Inlive® consists of two doses of 0.5ml each, at 1-month interval.
Adverse ReactionsThe number of total clinical trial subjects was 12185, and 6634 subjects were inoculated Inlive®.Expected frequency of adverse reactions is presented in CIOMS frequency categonies:Very common (≥10%): Systemic adverse reactions: Fever, DiarrheaCommon (≥1% and<10%): Local adverse reactions: Redness, Induration, Pain, Itching Systemic adverse reactions: Loss of Appetite, Irritability, Nausea, Fatigue, AllergyUncommon (≥0.1% and <1%): Local adverse reactions: Rash Systemic adverse reactions: Rash, Coughing, Runny nose, Flu syndrome Phase Ⅲ clinical efficacy trial was carried out in 10,007 healthy infants (6 to 35 months of age) and the subjects were divided randomly into vaccine(400U) team or placebo team who were inoculated two doses with a 28-day interval apart. The safety monitoring lasted for one year. The frequency of adverse reaction(AE) of control group and Inlive group were 51.70% and 52.77% respectively within 56 days after vaccination. The solicited systemic reactions rates were 45.56% and 46.53% respectively, such as fever, diarrhea, loss of appetite, nausea, irritability, mainly temporal fever and diarrhea. The solicited local adverse reactions frequency were 13.88% and 13.59%, respectively, such as redness, induration, pain, swelling and itching. Most of cases were mainly rated as Grade I, lasting for less than 3 days and self-remission. The rates of non-solicited reactions were less than 1% for both groups. All AEs, which were rated as Grade III, had no significantly statistic differences between vaccine group and control group. The rates of AEs were higher after inoculation of the first dose, and no increase was observed when given more doses. The following AEs have been observed during the application of other inactivated viral vaccines: 1) lymph node enlargement on the injection site; 2) urticaria, allergic rash or purpura, allergic shock caused by any component of vaccine (3) seizures (with or without fever). Although the mentioned AEs above were not found during clinical trials of the vaccine, cautions should be takenwhile using Inlive®.If any recipient has unexpected adverse reactions which are not mentioned above, please contact doctor immediately.
Contraindications(1) Allergic to any component of vaccine, including gentamycin sulfate.(2) Fever, acute diseases and acute paroxysm of any chronic disease.(3)Seriously chronic diseases, allergic constitution.
Precautions(1) Must not be intravenous injection.(2) Adrenalin and other first aid medicine should be prepared at the vaccination place, in case of serious allergy reactions. The vaccinated children should not leave until 30 minutes after vaccination.(3) Be cautious when using Inlive® in the following circumstances： 1) Bleeding is possible after intramuscular injection if the recipients suffer from thrombocytopenia or hemorrhagic disease. 2) The immune response of vaccination may be attenuated, if patients are receiving immunosuppressive therapy or the patients are immune deficiency. Patients who are receiving immunosuppressive therapy should get vaccination after therapy. Although immune response may be limited for patients with chronic immune deficiency, the vaccination of Inlive® is still recommended. 3) The patients who are suffering from epilepsia or nervous system diseases, such as Guillain-Barre Syndrome.(4) Like other vaccines, the protective efficacy of Inlive® may not reach 100% for all recipients.(5) Put the vaccine out of children’s reach.(6) Shake scattered before use. Do not use the product ifany crack of the container, unclear tags, foreign matter.(7) Do not let disinfectant contact vaccine during injection or when the vial was opened.(8) Do not freeze. Use immediately after open.(9) To make sure the immunization effectiveness, the person who receives human Immunoglobulin and gets vaccination should conduct these two activities at least 1 month apart.
Drug Interactions(1) Co-administration with other vaccines: The clinical research of simultaneous inoculation with other vaccines has not been conducted yet. No results support the interaction. (2) Drug of immunosuppresion: Immune response may be reduced by immunosuppressant, chemical therapy drug, anti-metabolic drug, alkylating agent, cytotoxin, corticosteroids, etc.(3) Being treated patients: Consult the doctor before inoculation.StorageStore and transport refrigerated at +2℃to +8℃, protected from light. PackagePrefilled syringe or vial. The package unit is one syringe or one vial. Shelf Life36 months. Authorization NumberGuo Yao Zhun Zi S20150017
