Continuous Professional Education Programme for Registered Nurses and Midwives to Administer Gardasil Vaccine

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1 Continuous Professional Education Programme for Registered Nurses and Midwives to Administer Gardasil Vaccine Under the Medicine Protocol to Girls in Second Level Schools (or equivalent) through a Schools Immunisation Programme

2 Medicine Protocol This Medicine Protocol is a specific written instruction for the administration of Gardasil Vaccine to girls who may not be individually identified before presentation for treatment. 11/07/2018 2

3 Clinical Criteria Active immunisation against and prevention of: Premalignant genital lesions (cervical, vulvar and vaginal) Cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18 External genital warts (condyloma acuminata) causally related to HPV types 6 and 11 11/07/2018 3

4 Circumstances in which the Medicine Protocol applies HPV immunisation programme will be delivered annually by the Health Service Executive (HSE) mainly via school based immunisation programme. All 12 to 13 year old girls in first year in second level schools or age equivalent (in special schools and home schooled), as recommended by NIAC in a 0, and 6 month schedule within the academic year. unisationguidelines/ 11/07/2018 4

5 Circumstances in which the Medicine Protocol applies 2018/2019 for mop up clinics For girls 15 years and older Gardasil should be administered according to a 3-dose schedule at 0, 6 months and a 3 rd dose at least 3 to 4 months after the 2nd dose If possible all 3 doses should be given within a period of one year. 11/07/2018 5

6 Interrupted immunisation schedule If an immunisation course is interrupted, it should be resumed as soon as possible. It is NOT necessary to repeat an interrupted immunisation schedule er2.pdf 11/07/2018 6

7 Inclusion Criteria for Gardasil Vaccine Girls in first year of second level schools or age equivalent e.g. home schooled special schools Girls in school outside 1 st year whose parents request the vaccine or girls 16 yrs. of age who request the vaccine (2018/2019). Girls with valid consent 11/07/2018 7

8 Exclusion Criteria for Gardasil Vaccine Any girl who has had an anaphylactic or hypersensitivity reaction to a previous dose of Gardasil or any of its constituents. Pregnancy Contraindication to intramuscular injection (haematological disorder/coagulation disorder) 11/07/2018 8

9 Exclusion Criteria cont. Acute febrile illness. The presence of a minor infection such as a mild upper respiratory infection or low grade fever is not a contraindication for immunisation Girls who are immunocompromised either due to disease or treatment 11/07/2018 9

10 Gardasil Vaccine: Product Information Details of the most current and update information of the SmPC and other data is available on the website /07/

11 Possible Side Effects - Gardasil Very Common: (more than 1 per 10 doses of vaccine) Pain, swelling and redness at injection site Headache Common: (more than 1 in 100 doses and less than 1 in 10 doses) Itching and bruising at the injection site Pain in extremity Fever Nausea Rare: (more than 1 in 10,000 doses and less than 1 in 1000)) Urticaria (Hives) Very Rare: Bronchospasm (wheeze) For a full list of side effects refer to /07/

12 Gardasil Constituents Virus: HPV Type 6 L1 protein (20 micrograms) HPV Type 11 L1 protein (40 micrograms) HPV Type 16 L1 protein (40 micrograms) HPV Type 18 L1 protein (20 micrograms) Other Constituents: Sodium chloride; L-histidine; Polysorbate 80;Sodium borate; Water for injection; Traces of Yeast protein which is used in the manufacturing process Adjuvant used is Amorphous Aluminium hydroxphosphate sulphate 11/07/

13 Nature and Contents of Pack- Gardasil Gardasil is only available in single packs of prefilled syringes ready for use for intramuscular injection Vaccine contains two needles 23G x 25mm should be used, 25G x 16mm Prior to agitation, Gardasil may appear as a clear liquid with a white precipitate. After thorough agitation, it is a white, cloudy liquid 11/07/

14 Frequency of Administration The person to be vaccinated will receive 2 or 3 individual doses of the vaccine. All 2 or 3 doses should aim to be given within a 12-month period. 1 st dose: 0 month (Sept./Oct) 2 nd dose: 6 months (March/April) after first injection If a 3 rd dose of vaccine is required it should be given at least 3 to 4 months after the 2 nd dose or in school the following September. 11/07/

PACKAGE LEAFLET: INFORMATION FOR THE USER

PACKAGE LEAFLET: INFORMATION FOR THE USER Gardasil, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) Read all of this leaflet