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Infants (6 months of age and younger) are People with pertussis are most infectious during the the children most likely to anxiety ocd order generic tofranil canada die from this disease anxiety 8dpo 25 mg tofranil sale. Rates catarrhal period and during the frst two weeks after of hospitalization and complications increase with onset of the cough (approximately 21 days) anxiety emoji order 50mg tofranil amex. Before a vaccine against pertussis was available anxiety rash buy tofranil 50mg without a prescription, per tussis (whooping cough) was a major cause of child How are vaccines made that prevent diphtheria, hood illness and death in the United States. With the introduction of a vaccine in the late these vaccines are made by chemically treating the 1940s, the number of reported pertussis cases in the diphtheria, tetanus, and pertussis toxins to render U. They are known as inactivated vaccines because they do not contain live Since the 1980s, the number of cases of pertussis has bacteria and cannot replicate themselves, which is why increased, especially among babies younger than 6 multiple doses are needed to produce immunity. In recent years, several states have reported a signifcant increase in cases, with out Whats the diference between all the vaccines breaks of pertussis reaching epidemic levels in some containing diphtheria and tetanus toxoids and states. The frst inactivated toxin, or toxoid, against diphtheria was developed around 1921, but it was not widely used Tdap: Tetanus and diphtheria toxoids with acellular until the 1930s. In 1924, the frst tetanus toxoid (inac pertussis vaccine; adolescents and adults. Pregnant tivated toxin) was produced and was used successfully women should receive Tdap during each pregnancy. The frst pertussis vaccine was developed in the and adults ages 7 years and older. In tion in the anterolateral thigh muscle (for infants and 1991, concerns about safety led to the development young toddlers) or in the deltoid muscle (for older chil of more purifed (acellular) pertussis vaccines that are dren and adults). In 2005, two new vaccine products were licensed for All children, beginning at age 2 months, and adults use in adolescents and adults that combine the tetanus need protection against these three diseasesdiphthe and diphtheria toxoids with acellular pertussis (Tdap) ria, tetanus, and pertussis (whooping cough). These vaccines are the frst acellular pertussis booster doses are also needed throughout life. What side efects have been reported with these At least one of the doses, preferably the frst, should be vaccines Local reactions, such as redness and swelling at the Because immunity to diphtheria and tetanus wanes injection site, and soreness and tenderness where the with time, boosters of Td or Tdap are needed every ten shot was given, as well as mild systemic reactions such years. When adolescents and adults are scheduled for Side efects following Td or Tdap in older children and their routine tetanus and diphtheria booster, adults include redness and swelling at the injection site (following Td) and generalized body aches, and tired should they get vaccinated with Td or Tdap Older children and adults who Immunization experts recommend that a dose of received more than the recommended doses of Td/ Tdap be given to all adolescents at age 1112 years as Tdap vaccine can experience increased local reactions, a booster during the routine adolescent immuniza such as painful swelling of the arm. This is due to the tion visit if the adolescent has fnished the childhood high levels of tetanus antibody in their blood. If the levels of diphtheria antitoxin and 100% will have protec catch-up dose is given at age 10, it can count as the tive levels of tetanus antitoxin in their blood. Then, subsequent booster doses of mates of acellular pertussis vaccine efcacy range from Td or Tdap should be given every ten years. Pregnant 80% to 85%, but protection declines as the time since teens and women should receive Tdap during each the dose increases. Adolescents and adults who have recently received Td vaccine can be given Tdap without any wait Can a pregnant woman receive Tdap vaccine All pregnant women should receive Tdap during If someone experiences a deep or puncture wound, or each pregnancy, preferably early in the time period a wound contaminated with dirt, an additional booster between 27 and 36 weeks gestation. Recent studies dose of either Td or Tdap may be given if the last dose show that vaccination during pregnancy reduces a was more than fve years ago. Because infants are not adequately protected Tdap since their 7th birthday, give Tdap. If a new mother hasnt been vac continued on the next page Immunization Action Coalition Saint Paul, Minnesota 651-647-9009 A precaution means that a person would usu ally not receive the vaccine but there may be occasions Who should not receive these vaccines Precautions include: Guillain-Barre syndrome vaccine should not receive another dose of the same (a rare type of neurological condition) within 6 weeks vaccine. Order of Drug Choice Where there is no preferred 1st line agent provided, the drug choice appears in alphabetical order. Options include preparations containing: both a non-aminoglycoside antibiotic and a corticosteroid. The anti-infective product (clioquinol) in locorten-vioform is considered a reasonable first choice as it is not used systemically and resistance is growing to topical aminoglycoside preparations. Topical aminoglycoside antibiotics are contra-indicated in patients with tympanic perforation; however many specialists do use these drops cautiously in the presence of a perforation Note also a proprietary preparation containing acetic acid 2% (Earcalm spray) is available over the counter and may be considered for mild otitis externa. Refer to local antibiotic guidelines Additional Notes Topical treatment is ineffective and there is no place for drops containing a local anaesthetic. Xylometazoline and ephedrine nasal conditions which are self sprays and drops limiting or amenable to self care. Additional notes Xylometazoline is only suitable for short term use (for acute sinusitis up to 7 days), to avoid the development of tolerance and rebound congestion associated with overuse. Steam inhalation may be beneficial and may be more attractive to use if given an aromatic odour (with menthol and eucalyptus). Glandosane is acidic and may hasten demineralisation of teeth used long term or intensively. The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment. This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Stephanie Chang, M. Data Sources and Study Selection: Searches of PubMed and the Cochrane databases were conducted from January 1998 July 2010 using the same search strategies used for the 2001 report, with the addition of terms not considered in the 2001 review. The Web of Science was also searched for citations of the 2001 report and its peer-reviewed publications. Data Extraction: After review by two investigators against pre-determined inclusion/exclusion criteria, we included existing systematic reviews and randomized controlled clinical trials for assessment of treatment efficacy and safety. Adverse events were generally more frequent for amoxicillin-clavulanate than for cefdinir, ceftriaxone, or azithromycin. What is the Comparative Effectiveness of Different Treatment Options for Treating Uncomplicated Acute Otitis Media in Average Risk Children. What Is the Comparative Effectiveness of Different Management Options for Recurrent Otitis Media (Uncomplicated) and Persistent Otitis Media or Relapse of Acute Otitis Media What Adverse Effects Have Been Observed for the Treatments Whose Outcomes Are Addressed in Key Questions 3 and 4 Prevention or Treatment of Acute Otitis Media in Children with Recurrent Otitis Media. Placebo for Treatment Success (Included Studies with Quality Score 3, 4, or 5 (Excluded Halsted 1967 Study). Shrinkage Plot for Amoxicillin-Clavulanate (7-10 days) vs, Azithromycin (5 days) for Treatment Success (Excluded Pestalozza 1992 Study). Randomized Controlled Trials from Marcy (2001) Addressing Comparative Effectiveness of Different Treatment Options for Treating Uncomplicated Acute Otitis Media in Average Risk Children. Randomized Controlled Trials from Marcy (2001) Addressing High-Dose Amoxicillin vs. Randomized Controlled Trials from Marcy (2001) Addressing Twice a Day High-Dose Amoxicillin Therapy vs. Comparative Effectiveness of Different Treatment Options for Treating Uncomplicated Acute Otitis Media in Average Risk Children in the 2001 Report and the Present Report. Review Articles Examining Comparative Effectiveness of Treatment Strategies in a Uncomplicated Acute Otitis Media.

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Of interest anxiety feels like order tofranil american express, in this respect anxiety job buy discount tofranil online, are studies suggesting to anxiety oils cheap tofranil online amex signifcant attenuation of the hypertensive response anxiety causes discount tofranil 50 mg free shipping. However, studies in the past these fndings, taken together, make heme oxygenase two decades have now established that magnesium a potential target for studies to improve the treatment sulfate can be used safely, including administering it in of preeclampsia. The pavaStatin to Ameliorate Early this has had a major efect on modifying treatment Onset Pre-eclampsia trial is underway to address this outside the United States. In the United States magne and, if positive, its outcome could lead to therapeutic sium sulfate is accepted as the drug of choice but the intervention to prolong afected pregnancies. As noted, there has been enormous progress toward At times empirically guided, but also guided by understanding the pathophysiology of preeclampsia research results, a plethora of potential predictive tests during the past two decades, but many unresolved and have been examined. The full elucidation of the to be clinically useful, although current investigations molecular and cellular mechanisms involved in the using combinations of tests has engendered cautious various stages of the disease process will hopefully optimism that clinically useful ways to predict pre lead to a more complete understanding of the etiology eclampsia may be on the horizon (35, 36). In this of preeclampsia and eventually lead to successful ther respect, the use of combinations of analytes and bio apeutic intervention through the targeted disruption physical testing (eg, uterine artery Doppler velocime of new and novel pathways. Several strategies have been tested, retested, or years: reanalyzed with, at best, minimal evidence of success. The presence of oxidative stress in preeclampsia has been evident for many years in malities of angiogenic signaling pathways during multiple tissues (although there has been some contro pregnancy and preeclampsia, is needed. By the late 1990s the evidence seemed Continued research on the role of genetic and epi sufcient to warrant a trial of the antioxidants vitamin genetic factors in preeclampsia is warranted. C and vitamin E, to modify the pathophysiology of pre Research on the molecular mechanisms involved in eclampsia. In a small pilot study, performed in England, the regulation of proangiogenic and antiangiogenic vitamin C and vitamin E were administered in phar factors also is needed. The fndings stimulated large trials in Clinical research stimulated by and performed follow England, Canada, Australia, and the United States and ing the last National High Blood Pressure Education in developing countries. Both low-risk and high-risk Program report also has led to important advances in women were studied. In this study, it the fndings with vitamin C and vitamin E mirror was not possible to identify any subset of patients in the fndings of studies that used low-dose aspirin and whom therapy was uniquely efective (48). In all studies, these did confrm the signifcant efects of aspirin therapy agents were successful in initial small studies, but that reported in standard meta-analysis to prevent pre success was not validated in larger trials (4145). The eclampsia, and to reduce prematurity and perinatal most likely explanation for this discrepancy is that the mortality. However, the efects of aspirin were not clin small studies are underpowered and refect publica ically useful in these analyses because the usual preva tion bias. That is, small studies that are successful are lence of preeclampsia in low-risk populations was reported, whereas small studies that do not succeed 23%; therefore, 500 women would need to be treated are not likely to be reported and published. One treatment may not it is important to remember that as the prevalence of a be efective for all cases of preeclampsia. Thus, suc disease increases, the number of patients necessary to cesses in small studies in homogenous populations are treat for a successful outcome reduces. Thus, in indi not substantiated in larger studies, which characteris viduals who have preexisting risk factors that increase tically are not only larger but also more heterogeneous preeclampsia prevalence to 20%, it would only require because they are usually performed in several centers. For this reason the task force suggests low-dose prevent preeclampsia where the early small successful aspirin prophylaxis in patients at high risk of pre trials largely took place in developing countries where eclampsia. Specifcally, low-dose aspirin is recom many women had low calcium intake, whereas the mended beginning late in the frst trimester for women large unsuccessful trial was conducted in the United with a medical history of preeclampsia in more than States where the vast majority of women had ade one prior pregnancy or in whom preeclampsia in a quate calcium intake (40, 41). The World Health Orga prior pregnancy resulted in the birth of an infant at nization tested this possibility in a study in which less than 34 weeks of gestation. These women have a calcium was supplemented in pregnant women from prevalence of preeclampsia of at least 40%. However, the frequency of treatment of 35,000 women with low-dose aspirin in severe adverse outcomes, including eclampsia and the numerous previous trials indicated no acute severe hypertension was lower. How reduced a composite outcome of adverse maternal ever, there is no information on the long-range safety outcomes. Based on this information, it would seem supports the concept of prevention with a particular reasonable to discuss the possibility of low-dose aspi agent being pertinent in some, but not all, popula rin therapy with an individual woman at less extreme tions, it also indicates calcium supplementation is not risk, pointing out the potential beneft to her and the useful in a population with adequate calcium intake as established safety of the drug acutely, but also the occurs in the United States. The decision for therapy An attempt was made to evaluate the efcacy of would then be based on the importance of these par low-dose aspirin by meta-analysis of approximately ticular factors to the particular woman. There was no evi predictors to predict preeclampsia and therapy based dence of signifcant reduction in preeclampsia in any on well-established pathophysiology to prevent pre of the large individual trials. However, in the eclampsia is that preeclampsia may actually be more meta-analysis of this large number of participants, than one disease. This possibility certainly is supported there was a signifcant reduction in the frequency of by clinical and epidemiologic data, which indicate pro preeclampsia, premature births, and perinatal mortal foundly diferent efects of the disorder in diferent ity with low-dose aspirin therapy (47). The women who only have preeclampsia in their frst preg analogy of diabetes in which the disease is recognized nancies (55). There was no increase the challenge is to determine how to use this informa in neonatal morbidity. Nonetheless, this study should be repli In reviewing the recommendations that the task cated in a U. There is abundant evi Therefore, the task force has prepared the following dence that gestational hypertension is not simply a lists of research recommendations to attempt to mild form of preeclampsia. It also is likely Research that another portion of the women have preeclampsia Prediction and Risk Stratifcation without developing proteinuria by the time they give birth. This is evident velop preeclampsia from those who will not at a from studies of women with mild gestational hyper period during gestation when available inter tension in whom, as the components of the syndrome ventions will improve outcome. Thus, a target for research rec serve as a biomarker given its ease and minimal ommended by the task force is to develop tests that cost of its measurement. Additional research is needed to help this to be an approximate twofold increase for all verify and characterize the subsets of the disease in a women with a history of preeclampsia (54). However, manner that helps clarify morbidity and mortality women with preeclampsia who give birth before 34 risks as well as specifc management options. Work is needed to develop efective therapeutic in Future research on more novel technologies, such terventions to safely prolong pregnancy to viability as plasma or urine metabolite profles and circulat of the fetus without endangering maternal welfare. It should be determined whether or not prospective clinical trial that is appropriately struc women with preeclampsia and milder cerebrovas tured to include only patients who do not require cular symptoms (headache or visual disturbances) corticosteroids for fetal indications (greater than also have posterior reversible encephalopathy syn 34 weeks of gestation). The poten weeks of gestation requires further investigation to tial role of any of these agents to beneft patients determine if delay of delivery for 2472 hours may with eclampsia or patients developing cerebral signifcantly improve perinatal outcome without edema or posterior reversible encephalopathy syn adversely afecting maternal outcome. Specif Research on the molecular mechanisms involved in ically, it is not known whether lowering moderate the regulation of proangiogenic and antiangiogenic chronic hypertension (greater than 150 mm Hg sys factors is needed. Placental debris and the pathophysiology of pre Program Working Group on High Blood Pressure in Preg eclampsia. Infammatory cytokines in the pathophysiology of [PubMed] [Full Text] ^ hypertension during preeclampsia. Am J Hypertens 2011;24: ward the understanding of the pathophysiology of hyper 9649. The role of the spi ed access to the fetal compartment during chronic ral arteries in the pathogenesis of preeclampsia. Hypoxia and reoxygenation: a pos sis: faking it with endothelial adhesion receptors. Curr sible mechanism for placental oxidative stress in pre Opin Cell Biol 1998;10:6606. Maternal-placental interactions of oxidative in trophoblast endovascular invasion and in the patho stress and antioxidants in preeclampsia. How oxynitrite formation in the vasculature of women with does variability of immune system genes afect placenta preeclampsia. Pathophysiology of hypertension during pre pathogenesis of early-onset pre-eclampsia. Pregnancy eclampsia: linking placental ischemia with endothelial Hypertens 2011;1:728. Molecular mechanisms of during pregnancy and preeclampsia risk: efects of ciga preeclampsia. Negative regulation of soluble Flt-1 removal of soluble fms-like tyrosine kinase 1 in pre and soluble endoglin release by heme oxygenase-1.

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The fitting of the transducer takes place 6 to anxiety cures order 75 mg tofranil with visa 10 weeks after the procedure to anxiety symptoms 8 weeks discount 25 mg tofranil with amex allow time for osseointegration to anxiety disorder in children buy cheap tofranil 75mg online take place anxiety pregnancy buy tofranil 25mg amex. Healing is allowed to take place after the second procedure and the transducer is fitted approximately four weeks later. It also has a new snap on coupling, replacing the bayonet coupling on Classic 300, making it easier for patients to attach it to the abutment. Bone Anchored Hearing Aid Ontario Health Technology Assessment Series 20022(3) 11 Method Search Strategy Due to time constraints, it was not feasible to conduct a formal systematic review. Key words and phrases used included: Bone anchored hearing aid, tissue-integrated implants, effectiveness, cost effectiveness, and quality of life. Databases Searched Published literature was obtained through a search of the following databases for the period of January 1990 to May 2002. Other clinical guidelines clearinghouses Inclusion and Exclusion Criteria the following are the inclusion and exclusion criteria used for the selection of articles. The study was a systematic reviews, a randomized controlled trial, a non-randomized controlled study, or a case series! The data had not been published before or since unless it addresses different outcomes. English language articles on other forms of bone conduction devices were also included to provide a basis for comparison. Bone Anchored Hearing Aid Ontario Health Technology Assessment Series 20022(3) 12 Inclusion criteria for studies Subjects in the studies: individuals with conduction or mixed hearing loss or other hearing loss who were not eligible for air conduction hearing aid or surgical correction. Studies that solely focused on technical procedure without information on patient outcomes were also excluded. Some review articles were included to provide an understanding of the subject matter but were excluded from the analysis Results of the Literature Search the search yielded 141 citations articles. One researcher reviewed the abstract of each citation and determined whether the article has met the inclusion criteria and exclusion criteria. The Level of evidence was assigned according to the following scale that is based on the hierarchy by Goodman. Data extraction and synthesis A tool (Appendix 6) was used to extract data from the selected articles. Common end points (success rates, extrusion rates, adverse skin reactions and audiometric measures were summarized in Appendices 2 and 3. Bone Anchored Hearing Aid Ontario Health Technology Assessment Series 20022(3) 14 Summary of Studies Most of the studies were conducted in Goteborg (Sweden), Nijmegen (Netherlands) and Birmingham (The United Kingdom). The studies consisted entirely of level 4 case series and non-randomized comparative studies in which the subjects acted as their own controls. Most of the studies had small samples (less than 200), but generally involved lengthy follow-up. The procedures for achieving a stable skin-periosteum interface varied among and within the studies. Success Rates Success is defined as the achievement of a stable implant without loss of fixture due to trauma or failed osseointegration. No significant difference was found in fixture survival rates with either the one-stage or two-stage procedure. Despite a relatively short follow-up period, Bonding (13) found a total extrusion rate of 25%, more than twice as high as that found by Tjellstrom et al. The reported rate of fixture loss as a result of failed osseointegration ranged from 0. Failed osseointegration has been partly attributed to bone resorption around the implanted fixture. In addition to bone resorption, frequent causes for the loss of fixtures included trauma, infection, Bone Anchored Hearing Aid Ontario Health Technology Assessment Series 20022(3) 15 malignant diseases, and poor hygiene. Reported causes for the removal of implants were poor hearing, psycho-cosmetic reasons, discomfort and mechanical failure. In the studies, the tissues surrounding the penetration sites were closely monitored, usually at three-month intervals for the first year and every six months thereafter. The percentage of patients who did not have any episode of adverse skin reactions varied among studies. The reported rates of patients who were free of adverse skin reactions included 70% (14), 79% (10); (18), 90% (19), and 92. Table 2: Grading System for Adverse Skin Reactions Grade Skin Reaction 0 No irritation; Epithelial debris removed if necessary 1 Slightly redness. Epithelial debris removed if necessary 2 Red and slightly moist tissue; no granulation formation. The reported percentage of skin assessments (observations) that showed no adverse skin reactions (grade 0) ranged from 91% to 97%. Grade 4 skin reactions that required removal of the fixture were reported to be less than 1%. It was postulated that these cells form a protective cellular defense barrier in the site of the skin breach to the implant. The study also showed the presence of large numbers of polymorphonuclear positive cells, B lymphocytes and plasma cells when clinically apparent graft reaction occurred, indicating bacterial infection superimposed on chronic inflammatory process. Aerobic and anaerobic bacteria were isolated from patients with and without clinical signs of infection. For patients without any sign of infection, the bacterial flora contained a higher variety of species than in the group with signs of infection. Holgers and Ljungh (21) also studied the cell surface hydrophobicity and the binding of immobilized fibronectin, vitronectin and collagen of the isolated bacteria because this could mediate adhesion. Expression of protein binding was found to be similar in strains isolated from the 2 groups. It was concluded that the microenvironment around a titanium implant promotes expression of a hydrophilic rather than a hydrophobic cell surface. This, in turn, makes many infections around the titanium implant curable by local treatment. The Rothera method (10) that uses a free local skin graft harvested from the transplant site. In a retrospective, multicenter series of 41 patients, patients with ostosclersosis or congenital conductive hearing loss had the greatest average improvement in sound field threshold (42dB) over unaided patients. Patients with combined otitis media and otorrhea or cholesteatoma had an average improvement of 33dB. Patients with congenital auditory canal atresia or stenosis showed the lowest average improvement of 22 dB. As sound vibrations are transmitted to the skull more efficiently, the amplifier is less readily saturated by loud sounds, and a higher volume setting can be used. Change in Speech Recognition in quiet and in noise Bone Conduction Hearing Aid Compared to Conventional Bone Conduction Hearing Aid Snik et al. Therefore, in case of a pure sensorineural hearing loss, the performance of even a powerful bone conduction device may be poorer than that of an air conduction hearing aid. Conversely, if an airbone gap is present, the amplification of an air conduction hearing aid needs to be increased substantially to compensate for this gap, and the increased amplification might lead to problems such as feedback and saturation of the amplifier. The most frequently reported advantage was speech recognition (72%), sound quality (38%), and reduced ear infection (32%). One hundred and sixty-five (165) benefits and 105 problems were listed and classified. The main reported benefits were similar to those found by Tjellestrom and Hakansson. There were no major agreement on medical and psychological shortcomings that included sore scar tissue and difficulty in keeping the abutment free from infection. The results showed that 84% of the patients reported significant reduction in discharge, 16% reported no change, and no one reported worsening of discharge. This pattern was found to be similar to findings of studies on other ear interventions. Improvement in quality of life was greater than that achieved with middle ear surgery, but slightly less than that achieved with cochlear implant. Patients with discharge otitis media showed the greatest improvement in the physical domain. On a scale of 1 to 5 (with 5 as the best), 24 patients gave an average score of 2. About 84% of the patients had chronic ear disease, and the remainder had congenital abnormalities.

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In healthy subjects anxiety symptoms muscle weakness buy tofranil 25 mg visa, the average total body clearance estimated from whole blood concentrations was 2 anxiety fatigue buy tofranil 50 mg visa. Factors such as low haematocrit and protein levels anxiety zone symptoms discount tofranil 75 mg, which result in an increase in the unbound fraction of tacrolimus anxiety keeps me from sleeping cheap 50 mg tofranil amex, or corticosteroid-induced increased metabolism, are considered to be responsible for the higher clearance rates observed following transplantation. Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces. Less than 1% of unchanged tacrolimus was detected in the urine and faeces, indicating that tacrolimus is almost completely metabolised prior to elimination: bile being the principal route of elimination. Reversible cardiotoxic effects were observed in rabbits following intravenous administration of tacrolimus. When tacrolimus is administered intravenously as rapid infusion/bolus injection at a dose of 0. Peak blood concentrations achieved with these doses were above 150 ng/mL which is more than 6-fold higher than mean peak concentrations observed with Advagraf in clinical transplantation. Embryofoetal toxicity was observed in rats and rabbits and was limited to doses that caused significant toxicity in maternal animals. In rats, female reproductive function including birth was impaired at toxic doses and the offspring showed reduced birth weights, viability and growth. A negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats. Capsule shell: Titanium dioxide (E 171) Yellow iron oxide (E 172) Red iron oxide (E 172) Sodium laurilsulfate Gelatin. Printing ink (Opacode S-1-15083): Shellac Lecithin (soya) Simeticone Red iron oxide (E 172) Hydroxypropylcellulose. Advagraf 1 mg prolonged-release hard capsules Pack sizes: 30, 50, 60 and 100 prolonged-release hard capsules in blisters or 301, 501, 601 and 1001 prolonged-release hard capsule in unit-dose perforated blisters. Advagraf 3 mg prolonged-release hard capsules Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 301, 501 and 1001 prolonged-release hard capsules in unit-dose perforated blisters. Advagraf 5 mg prolonged-release hard capsules Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 301, 501 and 1001 prolonged-release hard capsules in unit-dose perforated blisters. What Advagraf is and what it is used for Advagraf contains the active substance tacrolimus. Following your organ transplant (liver, kidney), your bodys immune system will try to reject the new organ. Advagraf is used to control your bodys immune response, enabling your body to accept the transplanted organ. You may also be given Advagraf for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation. What you need to know before you take Advagraf Do not take Advagraf if you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Advagraf (see section 6). Warnings and precautions Prograf and Advagraf both contain the active substance, tacrolimus. This is because Advagraf capsules allow for a prolonged release (more slow release over a longer period) of tacrolimus. Tell your doctor if any of the following apply to you: if you are taking any medicines mentioned below under Other medicines and Advagraf. Tell your doctor immediately if during treatment you suffer from: problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted. From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Advagraf. Wear appropriate protective clothing and use a sunscreen with a high sun protection factor. Children and adolescents the use of Advagraf is not recommended in children and adolescents under 18 years. Other medicines and Advagraf Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal preparations. It is not recommended that Advagraf is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection). Advagraf blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Advagraf, which may require interruption, an increase or a decrease in Advagraf dose. In particular, you should tell your doctor if you are taking or have recently taken medicines like: antifungal medicines and antibiotics, particularly so-called macrolide antibiotics, used to treat infections. Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation and pain), amphotericin B (used to treat bacterial infections) or antivirals (used to treat viral infections. These may worsen kidney or nervous system problems when taken together with Advagraf. Your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, hypertension and kidney disease. Advagraf with food and drink Avoid grapefruit (also as juice) while on treatment with Advagraf, since it can affect its levels in the blood. Pregnancy and breast-feeding If you are, think you might be or are planning to become pregnant, ask your doctor for advice before using Advagraf. Driving and using machines Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Advagraf. Advagraf contains lactose, sodium and lecithin (soya) Advagraf contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially sodium free. If you are allergic to peanut or soya, talk to your doctor to determine whether you should use this medicine. This medicine should only be prescribed to you by a doctor with experience in the treatment of transplant patients. Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine. If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine. The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight. Initial daily doses just after transplantation will generally be in the range of 0. Following the initiation of your treatment with Advagraf, frequent blood tests will be taken by your doctor to define the correct dose. Afterwards regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time. Your doctor will usually reduce your Advagraf dose once your condition has stabilised. You will need to take Advagraf every day as long as you need immunosuppression to prevent rejection of your transplanted organ. If you take more Advagraf than you should If you have accidentally taken too much Advagraf, contact your doctor or nearest hospital emergency department immediately. If you forget to take Advagraf If you have forgotten to take your Advagraf capsules in the morning, take them as soon as possible on the same day. If you stop taking Advagraf Stopping your treatment with Advagraf may increase the risk of rejection of your transplanted organ. Possible side effects Like all medicines, Advagraf can cause side effects, although not everybody gets them. Advagraf reduces your bodys defence mechanism (immune system), which will not be as good at fighting infections. Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), agranulocytosis (a severely lowered number of white blood cells), haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) and febrile neutropenia (a decrease in the type of white blood cells which fight infection, accompanied by fever) have been reported. Do not use Advagraf after the expiry date which is stated on the carton after Exp. Use all the prolonged-release hard capsules within 1 year of opening the aluminium wrapping. Contents of the pack and other information What Advagraf contains the active substance is tacrolimus.

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