Questionnaire for a Preliminary Examination before

Transcription

1 Questionnaire for a Preliminary Examination before Vaccination of ActHIB Vaccine For arbitrary vaccination. This leaflet contains 3 sheets to make a set: the information for persons who desire the inoculation of the Hib vaccine; questionnaire for a preliminary examination before vaccination for Hib vaccine (copy for medical institution); and questionnaire for a preliminary examination before vaccination for Hib vaccine (copy for guardian).

2 To health professionals who administer ActHIB vaccine As described in the package insert at the beginning of the text and in Important precautions, ingredients derived from the liver and lung of cattle of French origin, ingredients derived from the milk of cattle of Europe origin, and ingredients derived from the blood, heart and skeletal muscle of cattle of US origin, and ingredients derived from the heart of cattle of Brazil origin are used in the manufacturing process of ActHIB vaccine. The possibility that a person could contract transmissible spongiform encephalopathy (TSE) due to the inoculation of ActHIB vaccine is theoretically considered very low. However, before inoculation of ActHIB vaccine, please thoroughly consider the need and explain the risk to the vaccinee or his/her guardian (hereafter, guardian) as part of informed consent. To help you provide explanation to guardian, the attached information for guardian and preliminary examination form were prepared. Please use them to obtain informed consent from the guardian and to check the pre-inoculation condition of the vaccinee. Excerpt from the package insert Information on ActHIB Vaccine - Transmissible spongiform encephalopathy (TSE) - [Beginning of the text] In the manufacturing process of ActHIB vaccine, ingredients from cattle (ingredients derived from the liver and lung of cattle of French origin, ingredients derived from the milk of cattle of Europe origin, and ingredients derived from the blood, heart and skeletal muscle of cattle of US origin, and ingredients derived from the heart of cattle of Brazil origin) are used. The possibility that a person could contract transmissible spongiform encephalopathy (TSE) due to the inoculation of ActHIB vaccine is theoretically considered very low. However, before inoculation of ActHIB vaccine, the need should be considered (see Important precautions section). [[Cautions for inoculation] 2. Important precaution (excerpt) ] (4)The manufacturing processes of the master seed lots of ActHIB use ingredients derived from the liver and lung of cattle of French origin, ingredients derived from the milk of cattle of European except UK origin and ingredients derived from the heart and skeletal muscle of cattle of US origin. The manufacturing processes of the working seed lots of ActHIB use ingredient derived from the heart and skeletal muscle of cattle of US origin. The cultivation processes of ActHIB use the ingredients derived from the blood, heart and skeletal muscle of cattle of US origin and ingredients derived from the heart of cattle of Brazil origin. The ingredients derived from cattle of US origin originate from cattle that has verified healthy and are manufactured in compliance with the guidelines from the European Medicines Evaluation Agency. The evaluation of theoretical risk has ascertained that ActHIB reached the target of ensuring a given level of safety. foreign countries have reported the transmission of TSE to humans through the vaccination of ActHIB. The above facts are considered to indicate that the risk of ActHIB of inducing the transmission of TSE is very low. However, consider the explanation of this risk to the vaccinee or to his/her guardians..

3 To persons who desire the inoculation of the Hib vaccine - Read this leaflet carefully. It contains information indispensable for the vaccination - For arbitrary vaccination 1. Bacterial meningitis in infants and young children, as well as Hib (Haemophilus influenzae type b) 1) The membranes that enfold the brain and the spinal cord - which may be considered most important of the body, are called the meninges. A disease, by which bacteria and viruses infect these meninges and provoke inflammation, is meningitis. Meningitis has two types: bacterial meningitis caused by bacteria; and abacterial meningitis of causes other than bacteria (such as virus). Bacterial meningitis elicits particular problems because the clinical course after treatment is poor, sequelae persist, and other problems occur. Initial symptoms of bacterial meningitis include fever, vomiting, moroseness, and convulsions. Since the symptoms are very similar to those of other diseases such as cold, bacterial meningitis is a disease whose diagnosis at an early stage is very difficult to make. 2) There are several bacteria that cause bacterial meningitis in infants and young children. A bacteria accounting for more than half of causes is termed Haemophilus influenzae type b ; it is abbreviated to Hib. Hib is completely different from influenza virus responsible for influenza (flu) that goes around in winter. Furthermore, unlike many other bacteria and viruses, Hib does not lead to the production of antibodies (immunity) when infecting infants and young children. Therefore, Hib may cause repeated infections. 3) Infants and young children < 5 years of age, especially those 3 months to 2 years of age, are predisposed to bacterial meningitis by Hib (Hib meningitis), and caution is required. The annual number of patients in Japan has been reported to be at least 600 before vaccination was introduced, implying that one every 2,000 infants and young children are affected with Hib meningitis by age 5. 4) When contracting Hib meningitis, hospitalization of about 1 month duration and treatment with antibiotics are required. However, of affected infants and young children, approximately 5% die and approximately 25% suffer from growth impairments (e.g., impaired intelligence) and sequelae (e.g., auditory disorder and epilepsy). Furthermore, bacteria to which antibiotics are ineffective (resistant bacteria) have increased recently, making their treatment difficult. 5) Hib also causes serious generalized diseases including pneumonia, epiglottitis and sapraemia. 2. About Hib vaccine to prevent infectious diseases caused by Hib 1) Inoculation is admitted when the infant becomes 2 months of age. The vaccine is inoculated 4 times in total: for the primary inoculation, 3 times (at 4- to 8-week intervals) at the age of 2 to 7 months old; and for the booster inoculation, once at approximately 1 year after the third dose. 2) When inoculation is started at the age of 7 months to less than 12 months, the vaccine is inoculated 3 times in total: twice at a 4- to 8-week interval; and for the booster inoculation, once at approximately 1 year after the second dose. When inoculation is started at the age of 1 year to less than 5 years, the vaccine is inoculated once. 3) Those who started inoculation at the age of 2 months to less than 12 months and could not complete designated number of shots before being 1 year old, booster shot is to be done in a 4 week interval from the last inoculation. [The Guidance of Vaccination (issued on April 1, 2014)] 4) The Hib vaccine induces the production of antibodies (immunity) in nearly 100% of persons who underwent 4 inoculations and has shown a high preventive effect on Hib meningitis. 5) After the inoculation of the Hib vaccine, side reactions similar to those observed with the inoculation of other vaccines may be found. However, they are usually transient and disappear in several days. The most frequently observed side reactions are reddening (redness) and swelling (tumescence). Furthermore, fever develops in several percent of vaccinees. As serious adverse reactions, which are very rare, the following cases are reported abroad: (1) shock and anaphylactic reactions (urticaria, breading difficulty, etc) (2) convulsion (including

4 febrile convulsion) (3) thrombocytopenia purpura. 6) Ingredients of cattle (ingredients derived from the liver and lung of cattle of French origin, ingredients derived from the milk of cattle of Europe origin, and ingredients derived from the blood, heart and skeletal muscle of cattle of US origin, and ingredients derived from the heart of cattle of Brazil origin) were used in the early manufacturing stage of this vaccine. However, little ingredients remain eventually because the subsequent manufacturing processes purify them. This vaccine is already used in not less than 100 countries overseas, and more than 150 million doses of this vaccine have been given. However, there has been no report that describes that a person contracted TSE due to the inoculation of this vaccine. Therefore, theoretical risk may not be denied, but the possibility that a person to whom this vaccine was inoculated contracts transmissible spongiform encephalopathy (TSE) is very low. 3. The following persons should not undergo the inoculation: 1) Person with an obvious fever (usually, > 37.5 C). 2) Person affected by a severe acute disease. 3) Person who has developed anaphylaxis (severe allergic reactions such as breathing difficulty and utter urticaria of the whole body that usually develop within 30 minutes after inoculation) due to the ingredient of this vaccine or to tetanus toxoid. 4) Person who was advised by his/her personal physician not to receive the Hib vaccine. 4. The following persons should consult the physician before the inoculation: 1) Person with underlying diseases such as cardiovascular disorder, renal disorder, hepatic disorder, hematologic disorder, and growth impairment. 2) Person who showed symptoms suspected of allergy, such as fever and systemic rash, within 2 days after inoculation in the past vaccination. 3) Person who has developed convulsions (seizures) in the past. 4) Person who has been indicated to have an immune state abnormality in the past or who has a close relative with congenital immunodeficiency. 5) Person who has a risk to develop allergic reactions to the ingredient of this vaccine or to tetanus toxoid 5. Caution should be exercised to the following points after inoculation: 1) Be ready to make immediate contact with the physician for 30 minutes after inoculation because shock and anaphylaxis may develop. 2) Undergo a medical examination by the physician without delay in the case that abnormalities, such as high fever and convulsion, developed after inoculation. 3) Be cautious to physical condition for 1 week after inoculation. Consult the physician when swelling of the inoculation site is salient or your child becomes morose after inoculation. 4) It is necessary to place a 6-day interval when inoculating another vaccine after the inoculation of this vaccine. Consult the physician when there is a necessity for the inoculation in a hurry. 5) Keep the inoculation site clean. There is no problem in bathing, but do not rub the injection site. 6) Avoid vigorous exercise on the day of inoculation. Your child can lead a common life as for the rest. Undergo a medical examination by the physician after filling out the Questionnaire for a preliminary examination before vaccination for Hib vaccine. If you found something out of the ordinary, consult a physician. When health problems are caused by inoculation of Hib vaccine, financial support for the treatment maybe provided in accordance with Relief System for Sufferers from Adverse Drug Reactions. Please refer website of Pharmaceuticals and Medical Devices Agency. Scheduled date of inoculation Name of medical institution

5 <Keep this sheet in medical institution and give a copy for guardian > Questionnaire for a preliminary examination before vaccination for Hib Vaccine * Fill out and answer the questions. Body temperature before medical checkup Number of inoculations Primary inoculation (1st dose/2nd dose/3rd dose) Booster inoculation Address Phone ( ) - For Arbitrary vaccination C Name of vaccinee Male / Female Name of guardian Date of birth ( yr mth) Question Answer Physician s comment Did you read the expository writing about the vaccination that will be administered today (including an explanation on the use of components of bovine)? Please answer the following questions about the child. Body weight at birth ( ) g Did the child have any abnormal findings at delivery? Did the child have any abnormal findings after birth? Has the child ever been indicated to have an abnormality in a medical checkup for infants? Is there anything wrong with your child today? Symptoms ( ) Has your child been ill in the past 1 month? Was there any family member or friend of the child who had a disease, including measles (rubeola), rubella, vericella (chickenpox), and mumps, within the past 1 month? Was your child vaccinated in the past 1 month? Name of vaccination ( ) Has the child ever contracted a special disease (congenital abnormality, heart disease, renal disease, liver disease, neurologic disease, immunodeficiency, and other disease) from birth to now? And is your child attended by a physician? Did the physician attending the disease agree with today s vaccination? Has the child ever had a seizure (convulsion)? Approximately ( ) years old If yes, did your child have fever at that time? Has the child ever experienced rash or urticaria on the skin, or become ill as a reaction to. medications or food? Is there any close relative who was diagnosed with congenital immunodeficiency? Has the child ever had serious reaction to a vaccine in the past? Name of vaccination ( ) Is there any close relative who had serious reaction to a vaccine in the past? Has the child received blood transfusion or the injection of gamma globulin in the past 6 months? Do you have any question about the vaccination of today? Physician s comment Based on the above answers and the results of the medical examination, I consider that the vaccination of today is (possible / postponed). I have explained to the guardian the information concerning the benefits and side effects of vaccination, the use of components of bovine and the Relief Services for Adverse Health Effects. Signature or Name and Seal of physician [ ] Guardian s comment Do you desire the inoculation after receiving the medical examination and explanation including the use of components of bovine by the physician and understanding the effects and side effects of the vaccination? (I desire the inoculation/i do not desire the inoculation) Signature of guardian [ ] (The manufacturing number seal on the Name of vaccine used Dose Place/name of physician/date of inoculation outer box can be attached.) Name: Lyophilized Haemophilus type b vaccine (tetanus toxoid conjugate) Name of manufacturer: Sanofi Manufacturing.: Subcutaneous inoculation:0.5 ml Inoculation Site: Left/Right Arm Name of medical institution: Name of physician: Date of inoculation: This preliminary examination form aims to ensure the safety of the vaccination. Private information that was described is used only for the preliminary examination on the vaccination.