Bristol-Myers Squibb Farmacêutica S.A.

MODELO DE BULA DERMODEX TRATAMENTO pomada

DERMODEX TRATAMENTO
nistatina + óxido de zinco
USO TÓPICO
APRESENTAÇÃO
DERMODEX TRATAMENTO pomada é apresentada em tubo de 60 g.
USO PEDIÁTRICO E ADULTO
COMPOSIÇÃO
Cada 1 g de DERMODEX TRATAMENTO contém:
óxido de zinco: 200 mg
nistatina: 100.000 U.I.
Veículo emoliente q.s.p.: 1 g
O veículo emoliente é composto pelos ingredientes: Parafina Líquida, Resina de Polietileno
(petrolato) e Óleo de Perfume.


INFORMAÇÕES AO PACIENTE

AÇÃO DO MEDICAMENTO
Diversos trabalhos mostram que em assaduras de bebês é comum a infecção pelo fungo
conhecido como Cândida (é o mesmo fungo que aparece na boca de bebês com o nome de
sapinho e em inúmeros corrimentos vulvovaginais). DERMODEX TRATAMENTO tem na sua
fórmula duas substâncias, uma que age eliminando esse fungo e a outra cicatrizando e
protegendo a pele, através da formação de uma camada protetora que reduz a fricção entre a
pele e as fraldas e impede o contato da pele com urina e fezes.
Geralmente as assaduras das crianças regridem após 24 a 48 horas de tratamento.
Mantenha o tratamento até o total desaparecimento dos sintomas.

INDICAÇÕES DO MEDICAMENTO
A indicação principal de DERMODEX TRATAMENTO é para assadura de bebês, principalmente
relacionadas ao uso de fraldas. Além dessa indicação, DERMODEX TRATAMENTO pode ser
usada em crianças maiores e adultos, no tratamento de irritações na região dos órgãos genitais
e das nádegas, entre os dedos, axilas, sob os seios ou em outras áreas da pele que sofrem
atrito.

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RISCOS DO MEDICAMENTO
Contra-indicações
DERMODEX TRATAMENTO não deve ser utilizado se o paciente for alérgico à nistatina, ao
óxido de zinco ou aos demais ingredientes do produto.

Advertências
Raramente você poderá apresentar irritação da pele com o uso do produto.

Precauções

Uso em idosos
Não há recomendações especiais para pessoas idosas.

Não há contra-indicação relativa a faixas etárias.

Interações medicamentosas
Não são conhecidas interações de DERMODEX TRATAMENTO com outros medicamentos ou
com alimentos.
Informe ao seu médico se você está fazendo uso de algum outro medicamento

MODO DE USO

Aspecto físico e características organolépticas
DERMODEX TRATAMENTO é uma pomada amarelada, com perfume suave.
Como usar
Para aplicar DERMODEX TRATAMENTO na pele da área em contato com as fraldas, siga as
instruções abaixo:
1. Limpe bem a pele da área coberta pela fralda para eliminar qualquer resíduo de urina ou
fezes, que pode agir como irritante para a pele do bebê. Quando houver somente urina, lave
a região apenas com água morna. Se houver fezes, lave com água morna e sabonete
neutro, ou sabonete suave para bebês, e enxague bem.
2. Em seguida, seque delicadamente, usando uma toalha macia. É importante evitar limpeza e
esfregação exageradas, pois, além de desnecessárias, podem causar irritação da pele do
bebê.
3. Após a secagem cuidadosa, aplique uma camada fina de DERMODEX TRATAMENTO em
toda a região da pele coberta pelas fraldas.
4. Você deve lavar bem as toalhas do bebê (e também as fraldas de pano) de preferência com
sabão de coco e enxaguando-as com água para que não fiquem resíduos de sabão. Não
use produtos para amaciar roupas ou outros produtos químicos.

Posologia
Você deve aplicar DERMODEX TRATAMENTO depois do banho e a cada troca de fraldas,
após a lavagem e secagem cuidadosa da pele, como indicado acima. Quando usada para
irritação em outras regiões da pele, aplique duas ou mais vezes ao dia nas áreas afetadas.

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SIGA CORRETAMENTE O MODO DE USAR. NÃO DESAPARECENDO OS SINTOMAS,
PROCURE ORIENTAÇÃO MÉDICA.

NÃO USE O MEDICAMENTO COM O PRAZO DE VALIDADE VENCIDO. ANTES DE USAR
OBSERVE O ASPECTO DO MEDICAMENTO.


REAÇÕES ADVERSAS
Raramente você poderá apresentar irritação da pele com o uso do produto.

INFORME AO MÉDICO O APARECIMENTO DE REAÇÕES INDESEJÁVEIS.


CONDUTA EM CASO DE SUPERDOSE
Não são conhecidos casos de superdose do produto.


CUIDADOS DE CONSERVAÇÃO
Você deve manter DERMODEX TRATAMENTO em temperatura ambiente (entre 15º e 30ºC).
Durante a fabricação do produto é possível a entrada de ar na bisnaga, porém isto não afeta o
peso final nem a qualidade do produto.
Para melhor conservação, você deve manter o tubo armazenado no cartucho com a tampa para
baixo.


TODO MEDICAMENTO DEVE SER MANTIDO FORA DO ALCANCE DAS CRIANÇAS.


INFORMAÇÕES AO PROFISSIONAL DE SAÚDE

CARACTERÍSTICAS FARMACOLÓGICAS
DERMODEX TRATAMENTO é uma pomada que associa em sua fórmula a nistatina, óxido de
zinco e petrolato, que formam uma camada protetora, reduzindo a fricção entre a pele e as
fraldas e impedindo o contato da pele com urina e fezes, além de auxiliar a cicatrização de
irritações da pele e combater a infecção pela Cândida, fungo freqüentemente presente em
assaduras mais intensas ou de maior duração.

RESULTADOS DE EFICÁCIA
A nistatina é um antibiótico polieno macrolídeo fungistático e fungicida contra uma variedade de
fungos, principalmente Candida sp. É pouco absorvida pela pele, tendo demonstrado baixa
toxicidade e baixo potencial de sensibilização alérgica. Na concentração de 100 U.I./mL é eficaz
in vitro contra várias cepas de Candida sp.; concentração inibitória mínima (MIC) de 20 U.I./mL
para C. albicans foi demonstrada em teste com 332 isolados de C. albicans provenientes de
diferentes locais de infecção humana, sem registro de resistência. Aplicada topicamente na
concentração de 100.000 U.I./g, a nistatina demonstrou eficácia para erradicar C. albicans em
vários estudos, promovendo melhora das lesões em 2 a 3 dias e cura em 10 a 20 dias; in vitro
demonstrou eficácia semelhante a dos imidazóis e da amorolfina, ou foi o agente mais eficaz
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contra Candida sp. A associação com óxido de zinco a 20% não diminuiu a atividade
antifúngica da nistatina, na concentração de 100.000 U.I./g, em cobaias.
O óxido de zinco funciona como protetor mecânico da barreira da pele, não apresentando
efeitos tóxicos ou adversos conhecidos; além da sua ação farmacológica, agiria também
através da correção de um déficit local de zinco, quando aplicado topicamente. Demonstrou-se
in vitro que o óxido de zinco promove degradação do colágeno nos tecidos necróticos de
crostas de pele, provavelmente pelo aumento da atividade de metaloproteinases: esse pode ser
um dos mecanismos que explicam sua ação antiinflamatória e o efeito positivo na cicatrização
de úlceras da pele. Provavelmente o óxido de zinco acelera o processo de cicatrização através
do aumento da expressão dos genes para o fator de crescimento IGF-1 (insulina like) no tecido
de granulação. Demonstrou-se ação do óxido de zinco estimulando a re-epitelização: em
células basais da epiderme, tanto de pele íntegra como não íntegra de ratos, aumento o índice
mitótico, quando empregado em concentração de 25%. Além desses, há também um efeito
antibacteriano indireto atribuído ao óxido de zinco, que seria mediado pelos sistemas locais de
defesa e não por ação direta contra bactérias.
A aplicação de petrolato puro sobre a pele provoca redução de aproximadamente 50% na perda
de água da pele medida após 40 minutos da aplicação, devido à propriedade oclusiva do
petrolato, e resulta em ação emoliente que melhora a função de barreira mecânica da pele. O
petrolato é um veículo altamente lipofílico e hidrofóbico que, quando associado ao óxido de
zinco, rodeia as partículas do pó desse último, impedindo a absorção de água ou de exsudatos.
Preparações contendo dois componentes imiscíveis, como pó de óxido de zinco suspenso em
um veículo lipofilíco como petrolato, não têm características absortivas, sendo altamente
oclusivas. O petrolato pode se incorporar à camada externa do estrato córneo da pele durante o
processo de cicatrização e auxilia na diminuição do processo inflamatório, até que se complete
a migração das células epiteliais para a superfície da pele lesada.

INDICAÇÕES
DERMODEX TRATAMENTO tem como indicação principal o tratamento das assaduras infantis
(dermatite das fraldas, dermatite amoniacal). Outras indicações são os intertrigos (mamário,
perineal, interdigital, axilar ou outros) e as paroníquias por fungos do gênero Candida.

CONTRA-INDICAÇÕES
O produto está contra-indicado em casos de hipersensibilidade à nistatina, ao óxido de zinco
ou aos demais ingredientes do produto.

MODO DE USAR E CUIDADOS DE CONSERVAÇÃO DEPOIS DE ABERTO

DERMODEX TRATAMENTO é uma pomada amarelada, com perfume suave.
Para aplicar DERMODEX TRATAMENTO na pele da área em contato com as fraldas, siga as
instruções abaixo:
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Bristol-Myers Squibb Farmacêutica S.A.

1) A pele da área coberta pela fralda deve ser bem limpa, para eliminar qualquer resíduo de
urina ou fezes, que pode agir como irritante para a pele do bebê. Quando houver somente
urina, a região deve ser lavada apenas com água morna. Se houver fezes, lavar com água
morna e sabonete de glicerina, ou sabonete suave para bebês, e enxaguar bem.
2) Em seguida, secar delicadamente, usando uma toalha macia. É importante evitar limpeza e
esfregação exageradas, pois, além de desnecessárias, podem causar irritação da pele.
3) Após a secagem cuidadosa, aplicar uma camada fina de DERMODEX TRATAMENTO em
toda a região da pele coberta pelas fraldas.
4) As toalhas do bebê (e também as fraldas de pano) devem ser lavadas de preferência com
sabão de coco e enxaguadas com água em abundância para que não fiquem resíduos de
sabão. Não usar produtos para amaciar roupas ou outros produtos químicos.
Durante a fabricação do produto é possível a entrada de ar na bisnaga, porém isto não afeta o
peso final nem a qualidade do produto. Para melhor conservação, o tubo deve ser armazenado
no cartucho com a tampa para baixo.


POSOLOGIA

DERMODEX TRATAMENTO deve ser aplicada depois do banho e a cada troca de fraldas, após
a lavagem e secagem cuidadosa da pele, como indicado no MODO DE USAR. Quando usada
nas demais indicações (intertrigos e paroníquias), aplicar duas ou mais vezes ao dia nas áreas
afetadas.

ADVERTÊNCIAS

Em casos raros, pode haver irritação da pele com o uso do produto.

USO EM IDOSOS, CRIANÇAS E OUTROS GRUPOS DE RISCO

Uso pediátrico
Não há advertências ou recomendações especiais para crianças.
Uso geriátrico
Não há advertências ou recomendações especiais para pessoas idosas.

INTERAÇÕES MEDICAMENTOSAS

Não são conhecidas interações de DERMODEX TRATAMENTO com outros medicamentos ou
com alimentos.

REAÇÕES ADVERSAS

Em casos raros, pode haver irritação da pele com o uso do produto.

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Bristol-Myers Squibb Farmacêutica S.A.

SUPERDOSE

Não são conhecidos casos de superdose com o produto.

ARMAZENAGEM

A conservação do produto deverá ser à temperatura ambiente (entre 15ºC e 30ºC). Para melhor
conservação, o tubo deve ser armazenado no cartucho com a tampa para baixo.
Todo medicamento deve ser mantido fora do alcance das crianças.
***nº do lote, data de fabricação e validade: vide cartucho.
VENDA SOB PRESCRIÇÃO MÉDICA
REFERÊNCIAS
1. Dobias B, hazen EL. Nystatin. Chemotherapia 3:108-19, 1961.
2. Cooper SM, Shaw S. Contact allergy to nystatin: an unusual allergen. Contact Dermatitis
41:120, 1999.
3. Boyce ST, Holder IA. Selection of topical antimicrobial agents for cultured skin for burns by
combined assessment of cellular cytotoxicity and antimicrobial activity. Plast Reconstr Surg
92:493-500, 1993.
4. Hamra LK, Pankiewicz IJ. The susceptibility of Candida albicans to amphotericin B, nystatin,
and 5-fluorocytosine. Med J Aust 2:749-50, 1977.
5. Witten VH, Katz SI. Nystatin. Med Clin N Am 54:1329-37, 1970.
6. Alban J. Efficacy of nystatin topical cream in the management of cutaneous candidiasis in
infants. Curr Therap Res 14:158-61, 1972.
7. de Wet PM, Rode H, van Dyk A, Millar AJ. Perianal candidosis: a comparative study with
mupirocin and nystatin. Int J Dermatol 38:618-22, 1999.
8. Hoppe JE. Treatment of oropharyngeal candidiasis and candidal diaper dermatitis in
neonates and infants: review and reappraisal. Pediatr Infect Dis J 16:885-94, 1997.
9. Kwok YKC, Tay YK, Goh CL, Kamarudin A, Koh MT, Seow CS. Epidemiology and in vitro
activity of antimycotics against candidal vaginal/skin/nail infections in Singapore. Int J
Dermatol 37:145-9, 1998.
10. Abu-Elteen KH. Incidence and distribution of Candida species isolated from human skin in
Jordan. Mycoses 42:311-7, 1999.
11. Auger P, Colin P, Joly J, Poirier S, Colin D. Treatment of cutaneous candidosis in guinea
pigs: effect of zinc oxide on the antifungal efficacy of nystatin. Mycoses 32:455-60, 1989.
Informação Confidencial De Propriedade Da Bristol-Myers
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Squibb Farmacêutica S.A. – Uso E Reprodução Proibidos.


Bristol-Myers Squibb Farmacêutica S.A.

12. Agren MS. Studies on zinc in wound healing. Acta Derm Venereol Suppl (Stockh) 154:1-36,
1990.
13. Tarnow P, Agren M, Steenfos H, Jansson JO. Topical zinc oxide treatment increases
endogenous gene expression of insulin-like growth factor-1 in granulation tissue from
porcine wounds. Scand J Plast Reconstr Hand Surg 28:255-9, 1994.
14. Jin L, Murakami TH, Janjua NA, Hori Y. The effects of zinc oxide and diethyldithiocarbamate
on the mitotic index of epidermal basal cells of mouse skin. Acta Med Okayama 48:231-6,
1994.
15. Lodén M. The increase in skin hydration after application of emollients with different amounts
of lipids. Acta Derm Venereol 72:327-30, 1992.
16. Juch RD, Rufli Th, Surber C. Pastes: what do they contain? How do they work? Dermatology
189:373-7, 1994.
17. Lodén M, Bárány E. Skin-identical lipids versus petrolatum in the treatment of tape-stripped
and detergent-perturbed human skin. Acta Derm Venearol 80:412-5, 2000.

Reg. MS – 1.0180.0014
Farm. Bioq. Resp.: Dra. Tathiane Aoqui de Souza
CRF-SP n° 26.655

Fabricado por, distribuído por:
Bristol-Myers Squibb Farmacêutica S.A.
Rua Carlos Gomes, 924 ­ Santo Amaro ­ São Paulo ­ SP
CNPJ 56.998.982/0001-07 ­ Indústria Brasileira

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    {I will|I’ll} {right away|immediately} {take hold of|grab|clutch|grasp|seize|snatch}
    your {rss|rss feed} as I {can not|can’t} {in finding|find|to find} your {email|e-mail} subscription {link|hyperlink} or {newsletter|e-newsletter} service.

    Do {you have|you’ve} any? {Please|Kindly} {allow|permit|let} me {realize|recognize|understand|recognise|know} {so that|in order that} I {may just|may|could}
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    {It is|It’s} {appropriate|perfect|the best}
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    happy. {I have|I’ve} read this post and if I could I {want to|wish to|desire to} suggest you {few|some} interesting things or
    {advice|suggestions|tips}. {Perhaps|Maybe} you {could|can} write
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    {I have|I’ve} been {surfing|browsing} {online|on-line}
    {more than|greater than} {three|3} hours {these days|nowadays|today|lately|as of late}, {yet|but} I {never|by no
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    {It’s|It is} {lovely|pretty|beautiful} {worth|value|price} {enough|sufficient}
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    if all {webmasters|site owners|website owners|web
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    Ahaa, its {nice|pleasant|good|fastidious} {discussion|conversation|dialogue} {regarding|concerning|about|on
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    I am sure this {article|post|piece of writing|paragraph} has touched all the
    internet {users|people|viewers|visitors}, its really really {nice|pleasant|good|fastidious} {article|post|piece of writing|paragraph}
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    Wow, this {article|post|piece of writing|paragraph} is {nice|pleasant|good|fastidious}, my
    {sister|younger sister} is analyzing {such|these|these kinds of} things, {so|thus|therefore} I am going to {tell|inform|let know|convey} her.|
    {Saved as a favorite|bookmarked!!}, {I really like|I like|I love} {your blog|your site|your web
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    Way cool! Some {very|extremely} valid points!
    I appreciate you {writing this|penning this} {article|post|write-up} {and the|and also the|plus the} rest of the {site is|website is} {also very|extremely|very|also really|really} good.|
    Hi, {I do believe|I do think} {this is an excellent|this is a great}
    {blog|website|web site|site}. I stumbledupon
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    {once again|yet again} {since I|since i have} {bookmarked|book marked|book-marked|saved as a favorite} it.
    Money and freedom {is the best|is the greatest} way to change, may you
    be rich and continue to {help|guide} {other people|others}.|
    Woah! I’m really {loving|enjoying|digging} the template/theme of this {site|website|blog}.
    It’s simple, yet effective. A lot of times it’s {very
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    and {visual appearance|visual appeal|appearance}.
    I must say {that you’ve|you have|you’ve} done a {awesome|amazing|very good|superb|fantastic|excellent|great} job with this.
    {In addition|Additionally|Also}, the blog loads {very|extremely|super} {fast|quick} for me on {Safari|Internet explorer|Chrome|Opera|Firefox}.

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    These are {really|actually|in fact|truly|genuinely} {great|enormous|impressive|wonderful|fantastic} ideas in {regarding|concerning|about|on the
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    Any way keep up wrinting.|
    {I love|I really like|I enjoy|I like|Everyone loves} what you
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    {exposure|coverage|reporting}! Keep up the {superb|terrific|very good|great|good|awesome|fantastic|excellent|amazing|wonderful} works guys I’ve {incorporated||added|included} you guys to {|my|our||my personal|my own} blogroll.|
    {Howdy|Hi there|Hey there|Hi|Hello|Hey}! Someone in my {Myspace|Facebook} group shared this
    {site|website} with us so I came to {give it a look|look it
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    I’m {book-marking|bookmarking} and will be tweeting this to my followers!
    {Terrific|Wonderful|Great|Fantastic|Outstanding|Exceptional|Superb|Excellent} blog and {wonderful|terrific|brilliant|amazing|great|excellent|fantastic|outstanding|superb} {style and design|design and style|design}.|
    {I love|I really like|I enjoy|I like|Everyone loves} what you guys {are|are usually|tend to be} up too.
    {This sort of|This type of|Such|This kind of} clever work and {exposure|coverage|reporting}!
    Keep up the {superb|terrific|very good|great|good|awesome|fantastic|excellent|amazing|wonderful} works guys
    I’ve {incorporated|added|included} you guys to {|my|our|my personal|my own}
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    {Howdy|Hi there|Hey there|Hi|Hello|Hey} would you mind
    {stating|sharing} which blog platform you’re {working with|using}?
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    P.S {My apologies|Apologies|Sorry} for {getting|being} off-topic but
    I had to ask!|
    {Howdy|Hi there|Hi|Hey there|Hello|Hey} would
    you mind letting me know which {webhost|hosting company|web
    host} you’re {utilizing|working with|using}?

    I’ve loaded your blog in 3 {completely different|different} {internet browsers|web browsers|browsers} and I must say
    this blog loads a lot {quicker|faster} then most. Can you {suggest|recommend} a good {internet hosting|web hosting|hosting} provider at
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    {I love|I really like|I like|Everyone loves} it {when people|when individuals|when folks|whenever people} {come together|get together}
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    Thank you for the {auspicious|good} writeup.
    It in fact was a amusement account it. Look advanced to {far|more} added agreeable from you!
    {By the way|However}, how {can|could} we communicate?|
    {Howdy|Hi there|Hey there|Hello|Hey} just
    wanted to give you a quick heads up. The {text|words} in your {content|post|article} seem to be running off the screen in {Ie|Internet
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    Hope you get the {problem|issue} {solved|resolved|fixed}
    soon. {Kudos|Cheers|Many thanks|Thanks}|
    This is a topic {that is|that’s|which is} {close
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    wishes|Take care|Thank you}! {Where|Exactly where} are
    your contact details though?|
    It’s very {easy|simple|trouble-free|straightforward|effortless} to find out any {topic|matter} on
    {net|web} as compared to {books|textbooks}, as I found this
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    site|site|web page}.|
    Does your {site|website|blog} have a contact page? I’m having {a tough
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    I’ve got some {creative ideas|recommendations|suggestions|ideas} for
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    for {a long time|a while|some time} now and finally got the {bravery|courage} to go ahead and give you a shout out from {New Caney|Kingwood|Huffman|Porter|Houston|Dallas|Austin|Lubbock|Humble|Atascocita} {Tx|Texas}!
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    I’m {bored to tears|bored to death|bored} at work so I decided to
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    {Howdy|Hi there|Hi|Hello}, i read your blog {occasionally|from time to time} and i own a similar one and i was just {wondering|curious} if you get a lot of
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    changes {that make|which will make|that produce|that will make} {the biggest|the largest|the
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    {I really|I truly|I seriously|I absolutely} love {your blog|your site|your website}..
    {Very nice|Excellent|Pleasant|Great} colors & theme.
    Did you {create|develop|make|build} {this website|this site|this web site|this amazing site} yourself?
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    {Hi there|Hello there|Howdy}! This {post|article|blog post} {couldn’t|could
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    {Wow|Whoa|Incredible|Amazing}! This blog looks {exactly|just} like my old
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    {There is|There’s} {definately|certainly} {a lot to|a great
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    Keep on posting!|
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    {Hello|Hi|Hello there|Hi there|Howdy|Good day}! I could have sworn
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    {A person|Someone|Somebody} {necessarily|essentially} {lend a hand|help|assist} to make {seriously|critically|significantly|severely} {articles|posts} {I would|I might|I’d}
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    {Hello|Hi|Hello there|Hi there|Howdy|Good day|Hey there}!
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