SOME THINGS ARE JUST PART OF GROWING UP WITH VARIVAX [VARICELLA VACCINE (LIVE*)], CHICKENPOX DOESN’T ALWAYS HAVE TO BE ONE OF THEM.
A FLEXIBLE APPROACH TO ADMINISTRATION 1 VARIVAX can be administered intramuscularly or subcutaneously †
VARIVAX IS NOW AVAILABLE TO ORDER PRIVATELY FROM MSD. MSD@UNITED-DRUG.COM FREEPHONE ORDERLINE 1800 200 845 FREEFAX ORDERLINE 1800 200 846
to 12 years of age (2 doses received ≥ 3 months apart): The following serious side effects temporally associated with the vaccination were reported in individuals 12 months to 12 years of age given varicella vaccine (live) (Oka/Merck strain): Diarrhoea, febrile seizure, fever,post-infectiousarthritis,vomiting. Healthy individuals13yearsofageandolder (majority received2doses4 to8weeksapart): Very common side effects: Fever ≥ 37.7°C oral, injection-site erythema, soreness and swelling. Common side effects: varicella-like rash (generalised median 5 lesions), injection-site rash, pruritus and varicella-like rash (injection site median 2 lesions). Other report- ed adverse events (during post-marketing surveillance) that may potentially be serious include thrombocytopenia, pneumonia, en- cephalitis, anaphylaxis, cerebrovascular accident, febrile and non-febrile convulsions, Guillain-Barré syndrome, transverse myelitis, ataxia,Stevens-Johnsonsyndrome,erythemamultiformeHenoch-Schönleinpurpuraandherpeszoster.Varicella (vaccinestrain)has been reportedduringmarketeduseof thevaccine.Thevaccinevirusmay rarelybe transmitted tocontactsofvaccineeswhodevelop or do not develop a varicella-like rash. Complications of varicella from vaccine strain, including herpes zoster and disseminated disease such as aseptic meningitis and encephalitis, have been reported in immunocompromised or immunocompetent individuals. Necrotizing retinitis has been reported post-marketing in immunocompromised individuals. For a complete list of undesirable effects please refer to the Summary of Product Characteristics. PACKAGE QUANTITIES Single vial of vaccine and prefilled syringe of dilu- ent with two unattached needles. Legal category: POM Marketing authorisation number: PA 1286/057/001 Marketing Authorisation holder: MerckSharp&Dohme Ireland (HumanHealth)Limited,RedOakNorth,SouthCountyBusinessPark,Leopardstown,Dublin18, Ireland. Date of revision: November 2018. © Merck Sharp & Dohme Ireland (Human Health) Limited 2018. All rights reserved. Further information isavailableon request from:MSD,RedOakNorth,SouthCountyBusinessPark,Leopardstown,Dublin18D18X5K7or from www.medicines.ie. Date of Preparation: February 2019.
VARIVAX® powder and solvent for suspension for injection [Varicella Vaccine (live)]
ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing. PRESENTATION Vial con- taining a lyophilised preparation of live attenuated varicella virus (Oka/Merck strain) and a prefilled syringe containing Water for Injections. After reconstitution, one dose (0.5 mL) contains no less than 1350 PFU (Plaque-forming units) varicella virus (Oka/Merck strain). INDICATIONS VARIVAX is indicated for vaccination against varicella in individuals from 12 months of age. VARIVAX can be administered to infants from9monthsofageunderspecialcircumstances,suchas toconformwithnationalvaccinationschedulesor inoutbreaksituations.VARIVAXmayalsobeadministered tosusceptible individualswhohavebeenexposed tovaricella.Vaccination within 3 days of exposure may prevent a clinically apparent infection or modify the course of the infection. Limited data indicate that vaccination up to 5 days after exposure may modify the course of the infection. The use of VARIVAX should be based on official recommendations. DOSAGE AND ADMINISTRATION The vaccine should be injected intramuscularly or subcutaneously. The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder. Do not inject intravascularly. Individuals from 9 to 12 months of age should receive 2 doses, a minimum of 3 months apart. Individuals from 12 months to 12 years of age should receive 2 doses, a minimum of 1 month apart. Individuals 12 months to 12 years of age with asymptomatic HIV infection [CDC Class 1] with an age-specific CD4+ T-lymphocyte percentage ≥25% should receive two doses given 12 weeks apart. Individuals from 13 years of age and older should receive 2 doses, given 4-8 weeks apart. If the interval between doses exceeds 8 weeks, the seconddoseshouldbegivenassoonaspossible. CONTRAINDICATIONS Historyofhypersensitivity toanyvaricellavaccine, toanyof theexcipientsor togelatinorneomycin.Blooddyscrasias, leukaemia, lymphomasofany type,orothermalignantneoplasmsaffecting the hemic or lymphatic systems. Individuals receiving immunosuppressive therapy. Severe humoral or cellular immunodeficiency. Individuals with a family history of congenital or hereditary immunodeficiency unless immune competence has been demonstrated. Active untreated tuberculosis. Any illness with fever >38.5ºC. Pregnancy. Furthermore, pregnancy should be avoided for 1 month followingvaccination. PRECAUTIONSANDWARNINGS Appropriatemedical treatmentandsupervisionshouldalwaysbeavailable in the rare event of anaphylaxis. Vaccine recipients should avoid salicylates for 6 weeks after vaccination. Vaccination may be consid- ered in patients with selected immune deficiencies where the benefits outweigh the risks. Immunocompromised patients who have no contraindication for this vaccination may not respond as well as immunocompetent subjects; therefore, some of these patients may acquire varicella in case of contact, despite appropriate vaccine administration. These patients should be monitored carefully forsignsofvaricella.Transmissionof thevaccinevirusmay rarelyoccurbetweenhealthyvaccineeswhodevelopordonotdevelopa varicella-like rash and healthy susceptible contacts, pregnant contacts and immunosuppressed contacts. Vaccine recipients should therefore avoid close association with susceptible high-risk individuals for up to 6 weeks after vaccination. If varicella vaccine (live) (Oka/Merck strain) is not given concomitantly with measles, mumps, and rubella virus vaccine live, a 1-month interval between the 2 live virus vaccines should be observed. PREGNANCY AND LACTATION Pregnant women should not be vaccinated with VARIVAX. Studies have not been conducted with VARIVAX in pregnant women. However, foetal damage has not been documented when var- icella vaccines have been given to pregnant women. It is not known whether VARIVAX can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay. VARIVAX is not generally recommended for breastfeeding mothers. SIDE EFFECTS Healthy individuals 12 months to 12 years of age (1 dose): Very common side effects: Fever. Common side effects: Upper respiratory infection, rash,measles /rubella-like rash,varicella-like rash (generalisedmedian5 lesions), injectionsiteerythema, rash, pain/tenderness/soreness, swelling and varicella-like rash (injection site median 2 lesions), irritability. Healthy individuals 12 months
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie Adverse events should also be reported to MSD (Tel: 01-299 8700)
WS098 (CRN008R8M)
* VARIVAX is a live attenuated vaccine contraindicated in certain patients. See prescribing information. 1 † VARIVAX should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder. 1 Reference 1. VARIVAX Summary of Product Characteristics. November 2018.
Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7 Ireland
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