Seres Rotarix Oral Suspension Rotavirus Vaccine User Manual & Service Guide PDF (EN)

521788 There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or growth retardation. Administration of Rotarix may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk. As a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever) since data from observational safety studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination (see section Side effects ).

Parents/guardians should be advised to promptly report such symptoms to their healthcare provider. For subjects with a predisposition for intussusception, see section Contraindications . Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy of Rotarix. A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive infants showed no apparent safety problems (see section Side effects ). Administration of Rotarix to infants who have known or suspected immunodeficiency, including in utero exposure to an immunosuppressive treatment, should be based on careful consideration of potential benefits and risks.

Excretion of the vaccine virus in the stools is known to occur after vaccination with peak excretion around the 7th day. Viral antigen particles detected by ELISA were found in 50% of stools after the first dose of Rotarix lyophilised formulation and 4% of stools after the second dose. When these stools were tested for the presence of live vaccine strain, only 17% were positive. In two comparative controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable to that observed after vaccination with Rotarix lyophilised formulation.

Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptom. Rotarix should be administered with caution to individuals with immunodeficient close contacts, such as individuals with malignancies, or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy. Contacts of recent vaccinees should observe personal hygiene (e.g. wash their hands after changing child’s nappies).

The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed. A protective immune response may not be elicited in all vaccinees (see section Pharmacological properties ). The extent of protection that Rotarix might provide against other rotavirus strains that have not been circulating in clinical trials is currently unknown.

Clinical studies from which efficacy data were derived were conducted in Europe, Central, South America, Africa and Asia (see section Pharmacological properties ). Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus. No data are available on the use of Rotarix for post-exposure prophylaxis. ROTARIX SHOULD UNDER NO CIRCUMSTANCES BE INJECTED. This vaccine contains sucrose and glucose as excipients. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine. This vaccine contains 0.15 microgram phenylalanine in each dose.

Phenylalanine may be harmful for patients with phenylketonuria (PKU). This vaccine contains 32 mg sodium in each dose. Pregnancy and lactation Rotarix is not intended for use in adults. There are no data on the use of Rotarix during pregnancy and lactation. Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the vaccination schedule. Preclinical safety data Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity. Overdose Some cases of overdose have been reported.

In general, the adverse event profile reported in these cases was similar to that observed after administration of the recommended dose of Rotarix. Incompatibilities This medicinal product must not be mixed with other medicinal products. PHARMACOLOGICAL PROPERTIES For this section see WHO Product Information on the WHO website STORAGE The expiry date of the vaccine is indicated on the label and packaging. The vaccine should be used immediately after opening. Store in a refrigerator (2 ° C – 8 ° C). Freezing is not recommended for storage.

Nevertheless if the vaccine has been accidentally stored for a maximum of 12 hours at -20 ° C, stability data generated indicate that the vaccine retains its potency. Store in the original package, in order to protect from light. PRESENTATION 1.5 mL of oral suspension in a squeezable tube (polyethylene) fitted with a membrane and a tube cap (polypropylene) in pack sizes of 1, 10 or 50. Not all pack sizes may be marketed. Instructions for administration of the vaccine (see at the end of the leaflet). Discard the empty tube and cap in approved biological waste containers according to local regulations.

Vaccine Vial Monitor (see VVM infographic at the end of the leaflet) The Vaccine Vial Monitor (VVM) is part of the label used for all Rotarix batches supplied by GlaxoSmithKline Biologicals. The colour dot that appears on the label of the tube is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the tube has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level. The interpretation of the VVM is simple. Focus on the inner square. Its colour will change progressively.

As long as the colour of this square is lighter than the colour of the outer circle, then the vaccine can be used. As soon as the colour of the inner square is the same colour as the outer circle or of a darker colour than the outer circle, then the tube should be discarded. It is absolutely critical to ensure that the storage conditions specified above (in particular the cold chain) are complied with. GlaxoSmithKline Biologicals will assume no liability in the event Rotarix has not been stored in compliance with the storage instructions. For further information, please contact the manufacturer. Trade marks are owned by or licensed to the GSK group of companies. Excipients а effet notoire :

ce produit contient 1 073 mg de saccharose, 32 mg de sodium, 10 microgrammes de glucose et 0,15 microgrammes de phйnylalanine par dose (voir rubrique Prйcautions ). ADMINISTRATION Rotarix doit ktre administrй par voie orale uniquement. ROTARIX NE DOIT JAMAIS ETRE INJECTE. Le vaccin se prйsente sous forme d’un liquide limpide et incolore, exempt de particules visibles, pour administration orale. Le vaccin est prkt а l’emploi (aucune reconstitution ou dilution n’est requise). Le vaccin doit ktre administrй par voie orale et ne doit pas ktre mйlangй а d’autres vaccins ou solutions.

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Nгo se espera que infecзxes por HIV assintomбticas ou com leves sintomas afetem a seguranзa ou a eficбcia da Rotarix. Um estudo clнnico realizado com um nъmero limitado de lactentes HIV positivos assintomбticos ou com leves sintomas nгo mostrou problemas aparentes de seguranзa (ver seзгo Reaзxes adversas ). A administraзгo de Rotarix em lactentes com suspeita ou confirmaзгo de imunodeficikncia, incluindo a exposiзгo in ъtero a um tratamento imunossupressor, deve ser baseada em uma anбlise cuidadosa dos potenciais riscos e benefнcios. Sabe-se que a excreзгo do vнrus da vacina nas fezes ocorre apys a vacinaзгo, sendo atingida a excreзгo mбxima por volta do 7є dia.

Partнculas antigknicas virais, detectadas por ELISA, foram encontradas em 50% das fezes apys a primeira dose da formulaзгo liofilizada de Rotarix e em 4% das fezes apys a segunda dose. Quando estas fezes foram analisadas para detectar a presenзa da cepa da vacina viva, apenas 17% foram positivas. Em dois ensaios controlados comparativos, a eliminaзгo da vacina apys a vacinaзгo com a formulaзгo lнquida de Rotarix foi comparбvel а observada apys a vacinaзгo com a formulaзгo liofilizada de Rotarix. Foram observados casos de transmissгo deste vнrus da vacina excretado em contatos soronegativos de vacinados sem causar sintomas clнnicos.

Rotarix deve ser administrada com precauзгo a indivнduos que tenham contatos pryximos com imunodeficientes, tais como indivнduos com neoplasias malignas ou com qualquer outro tipo de imunodeficikncia ou que estejam sendo submetidos a terapkutica imunossupressora. As pessoas em contacto com crianзas vacinadas recentemente devem ter cuidados de higiene pessoal (p. ex., lavar as mгos depois de trocar as fraldas da crianзa).

Deve levar em consideraзгo o risco potencial de apneia e a necessidade de monitoramento respiratyrio durante 48-72 horas quando se administra a primo-imunizaзгo a lactentes muito prematuros (nascidos com ≤ 28 semanas de gestaзгo) e, especialmente, nos que apresentam antecedentes de imaturidade respiratyria. Como o benefнcio da vacinaзгo й elevado neste grupo de lactentes, a vacinaзгo nгo deve ser suspensa ou adiada. Uma resposta imunolygica protetora pode nгo ser obtida em todos os vacinados (ver seзгo Propriedades farmacolygicas ).

Nгo se conhece atualmente o grau de proteзгo que a Rotarix pode conferir contra outras cepas de rotavнrus que nгo estavam previamente incluнdas nos estudos clнnicos. Os estudos clнnicos, nos quais foram obtidos os dados de eficбcia, foram realizados na Europa, Amйrica Central e do Sul, Бfrica e Бsia (ver seзгo Propriedades farmacolygicas ). Rotarix nгo protege contra a gastroenterite causada por outros agentes patogйnicos diferentes do rotavнrus. Nгo existem dados sobre a utilizaзгo de Rotarix para profilaxia pys-exposiзгo. ROTARIX NГO DEVE SER INJETADA EM CIRCUNSTBNCIA ALGUMA. Esta vacina contйm sacarose e glicose como excipientes.

Doentes com problemas hereditбrios raros de intolerвncia а frutose, com malabsorзгo de glucose-galactose ou com insuficikncia de sacarase-isomaltase nгo devem tomar esta vacina. Esta vacina contйm 0,15 µg de fenilalanina em cada dose. A fenilalanina pode ser prejudicial para pacientes com fenilcetonъria (FCN). Esta vacina contйm 32 mg de sydio em cada dose. Gravidez e aleitamento Rotarix nгo se destina a ser administrada em adultos. Portanto, nгo estгo disponнveis dados sobre a utilizaзгo de Rotarix durante a gravidez e o aleitamento. Com base na evidkncia obtida em ensaios clнnicos, a amamentaзгo nгo diminui a proteзгo proporcionada por Rotarix contra gastroenterites por rotavнrus.

Por conseguinte, a amamentaзгo pode continuar durante o esquema de imunizaзгo. Dados de seguranзa prй-clнnica Os dados nгo clнnicos nгo revelam riscos especiais para o ser humano, segundo estudos convencionais de toxicidade de dose repetida. Sobredosagem Foram notificados alguns casos de sobredosagem. No geral, o perfil de eventos adversos notificados nestes casos foi semelhante ao observado apys a administraзгo da dose recomendada de Rotarix. Incompatibilidades Este medicamento nгo deve ser misturado com outros medicamentos. PROPRIEDADES FARMACOLYGICAS Para esta seзгo, consulte as Informaзxes sobre o produto - OMS no site da OMS.

ARMAZENAGEM A data de validade estб indicada na etiqueta e na embalagem. A vacina deve ser utilizada imediatamente apys sua abertura. Conservar na geladeira (2 ° C – 8 ° C). O congelamento nгo й recomendado para a conservaзгo. No entanto, se a vacina tiver sido conservada acidentalmente durante um mбximo de 12 horas a -20 ° C, os dados de estabilidade obtidos indicam que ela mantйm sua potkncia. Conserve na embalagem de origem para proteger da luz. APRESENTAЗГO 1,5 mL de suspensгo oral numa bisnaga (polietileno) com uma membrana e uma tampa da bisnaga (polipropileno) em apresentaзxes de 1, 10 ou 50. Й possнvel que nгo sejam comercializadas todas as apresentaзxes.

Instruзxes para administraзгo da vacina (ver no fim do folheto). Descarte o tubo vazio e a tampa em recipientes de resнduos biolygicos aprovados de acordo com as regulamentaзxes locais. Monitor de Frasco de Vacina (consulte o infogrбfico do MFV no final do folheto) O Monitor de Frasco de Vacina (MFV) faz parte do rytulo utilizado para todos os lotes de Rotarix fornecidos pela GlaxoSmithKline Biologicals. O ponto colorido que aparece no rytulo do tubo й um MFV. Este й um ponto sensнvel а temperatura-perнodo de tempo que fornece a indicaзгo do calor cumulativo ao qual a bisnaga esteve exposta.

Ele informa ao usuбrio final quando existe a possibilidade de a exposiзгo ao calor ter degradado a vacina para alйm do nнvel aceitбvel. A interpretaзгo do MFV й simples. Olhe atentamente para o quadrado interior. A cor do quadrado muda progressivamente. Enquanto a cor do quadrado for mais clara do que a cor do cнrculo exterior, a vacina pode ser utilizada. Logo que a cor do quadrado interior tiver a mesma cor que o cнrculo exterior ou uma cor mais escura do que o cнrculo exterior, a bisnaga deve ser eliminada. Й absolutamente essencial assegurar que as condiзxes de conservaзгo acima especificadas (em especial a cadeia de frio) sejam observadas.

A GlaxoSmithKline Biologicals nгo assume qualquer responsabilidade se Rotarix nгo tiver sido conservada de acordo com as instruзxes de conservaзгo. Para mais informaзxes, favor entrar em contato com o fabricante. Marcas registradas sгo detidas ou licenciadas pelo grupo de empresas GSK. ОПИСАНИЕ Rotarix суспензия для перорального введения Живая ротавирусная вакцина Одна доза (1,5 мл) содержит: Ротавирус человека штамм RIX4414 (живой, ослабленный)* Сообщалось о следующих частотах нежелательных реакций:

Очень частые (≥ 1/10) Частые (≥ 1/100, Нечастые (≥ 1/1 000, Редкие (≥ 1/10 000, Очень редкие ( Описана экскреция вакцинного вируса с калом после вакцинации; пик экскреции наблюдается примерно на 7-й день. Вирусные антигенные частицы обнаруживаются методом ELISA в 50 % образцов кала после первой дозы лиофилизированной формы Rotarix и в 4 % образцов кала после второй дозы. Исследование этих образцов кала на присутствие живого вакцинного штамма дало положительные результаты лишь в 17 % случаев. В двух сравнительных контролируемых исследованиях обнаружены сравнимые величины выделения вакцины после применения жидкой и лиофилизированной форм Rotarix.

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