16 minute read
Over 152,000 Wait for Care
¤300,000 in Professor Kieran Taaffe Research Bursaries
The Charitable Infirmary Charitable Trust (CICT), Ireland’s oldest charity, has awarded two medical research bursaries to teams at Beaumont Hospital to fund scientific and medical research and simultaneously support education and development through pursuit of MD or PhD qualifications. Each award is for two years and has an annual value of up to ¤75,000. Following an open competition, the Medical Group of CICT awarded the bursaries to: Dr Christina Campbell, Respiratory Department, Beaumont Hospital and Dr Olufemi Olumide Aoko, Hepatology Unit, Beaumont Hospital. Dr Campbell is a specialist trainee in Pulmonary Medicine in Beaumont hospital. She will evaluate susceptibility to obstructive sleep apnea in a post SARS-CoV-2 infection population. She hopes to establish the relationship between this condition and the upper airway microenvironment utilizing state-of-the-art next-generation sequencing. She will be working directly under the supervision of the chief investigator for this study, Dr Imran Sulaiman. Dr Sulaiman has recently been appointed as a consultant physician to Beaumont hospital, having worked for many years in New York University, NYC, the United States. He has an international reputation in the area of profiling the microbiome of the upper and lower airways, in addition to acknowledged expertise in the diagnosis and management of obstructive sleep apnea. Dr Aoko is a specialist trainee in Hepatology. He will study the impact of bariatric endoscopy on non-alcoholic fatty liver disease (NAFLD). This is a novel clinical approach to treating the most common cause of liver disease in Ireland and internationally. He will specifically evaluate the impact of this novel technique on metabolic and histologic parameters in obese patients with NAFLD. He will be working directly under the supervision of the Chief investigator for this study, Dr John Ryan, Consultant Hepatologist, Beaumont Hospital. Dr Ryan has recently been appointed as a consultant physician to Beaumont Hospital, having worked for many years in the Royal Free hospital London and Oxford University, United Kingdom. He has an international reputation in the area of non-alcoholic fatty liver disease (NAFLD) and has pioneered new diagnostic and therapeutic interventions in this area. Commenting on the awards, Michael Patten, Chairman of the CICT said, “The CICT goes back to the foundation in 1718 of the Charitable Infirmary (better known as Jervis St Hospital), the first voluntary hospital in the British Isles. Today the Trust continues its focus on serving Dublin by supporting medical excellence at Beaumont Hospital and giving financial aid to Dublin charities serving the poor and underprivileged. “These new bursaries are designed to promote talent development and scientific/ medical research and discovery at Beaumont and are open to all the caring professions based on the hospital campus. We were delighted with the sheer quality of applications for these inaugural bursaries which bodes well for medical discovery at Beaumont. We wish the recipients well in the coming years and will track their progress with great interest”, Mr Patten concluded. The Bursaries are named in honour of Professor Kieran Taaffe, a long serving and inspirational member of the CICT Managing Committee, who was a passionate advocate of education and research. Staff at Beaumont Hospital are welcome to apply to become members of the Trust at any time. Since 1987, the Trust has donated over ¤5 million to research and teaching projects at Beaumont Hospital and at its medical school, the Royal College of Surgeons of Ireland (RCSI) and to Dublin charities.
New findings from OCTAVE trial
The ongoing OCTAVE study has published its first results on vaccine effectiveness in people with impaired immune systems. The study found that a significant proportion of people with immunosuppression have a low or undetectable antibody response after two doses of the covid vaccine. The study is important because it is one of the largest studies in the world so far into covid vaccine efficacy in immunosuppressed patients. It looked at both antibody response and T cell response to the covid vaccine. The OCTAVE trial includes over 2,500 people from across the UK, recruited between February and August 2021, with conditions that affect the immune system (or have treatments that do). Conditions include arthritis, inflammatory bowel disease, end stage kidney disease, solid tumour cancers, blood cancer, and people who’ve had a stem cell transplant. This includes 139 cancer patients (solid tumour patients and blood cancer patients) and 160 people who’ve had a stem cell transplant. The blood cancer patients had acute myeloid leukaemia or myeloma. The results released today are only based on 455 people from the trial, for whom all the necessary blood test results are available. This includes 18 blood cancer patients (acute myeloid leukaemia or myeloma) and 42 people who’ve had a stem cell transplant. Everyone’s antibody response to the covid vaccine was measured 4 weeks after their second vaccine dose. Where possible, people’s antibody response was also measured in between their first and second dose, and before their first dose. Most people had either the Pfizer or AstraZeneca jab. These results were compared against 93 healthy individuals. Read about the findings here: These are only the first set of results to come out of OCTAVE. The study is ongoing and will publish more data in the future. We are cautious about drawing conclusions from this very small sample, but the results do confirm that even when blood cancer and stem cell transplant patients do produce antibodies after vaccination, the quantity of antibodies is lower. It’s positive to see a good T cell response, although we don’t know what this means alongside a poorer antibody response. This study reinforces the need to find alternative methods to protect people with blood cancer from covid, through extra vaccinations or alternative preventative methods such as antibody treatments.
Launching Launching Flucloxacillin Powder Flucloxacillin Powder for solution for injection/infusion for solution for injection/infusion
Launching 500mg 1000mg500mg 1000mg
2000mg 2000mg
500mg PRESCRIBING INFORMATION: 1000mg 2000mg Consult the Summary of Product Characteristics for further information. Additional information is available upon request. Flucloxacillin 500mg, 1000mg and 2000mg powder for solution for injection/infusion. Active ingredients: As flucloxacillin sodium, each 10mL vial contains 500mg flucloxacillin (25.5mg sodium approximately), 20mL vial contains 1000mg flucloxacillin (51mg sodium approximately), 50mL vial contains 2000mg flucloxacillin (102mg sodium approximately). Indications: For the treatment of the following infections due to beta-lactamase producing staphylococci and other sensitive Gram-positive organisms such as streptococci – skin and soft tissue infections (like abscesses, cellulitis, infected burns, impetigo), upper respiratory tract infections (like pharyngitis, tonsillitis, sinusitis), lower respiratory tract infections (like pneumonia, bronchopneumonia, pulmonary abscess), bone and joint infections (like osteomyelitis and arthritis), endocarditis. Prophylaxis in cardiovascular surgery (valve prostheses, artery prostheses) and orthopedic surgery (arthroplasty, osteosynthesis and arthrotomy). Consideration should be given to official guidance on appropriate use of antibacterial agents. Posology and method of administration: Parenteral therapy is indicated if oral route impracticable or unsuitable as in the case of severe diarrhoea or vomiting and particularly for urgent treatment of severe infection. Routes of administration: 500mg vial - Intramuscular (im), intravenous (iv), intrapleural and intraarticular. 1000mg vial and 2000mg vial – intramuscular and intravenous routes only. Intravenous injection/ infusion should be administered slowly. Dosage depends on age, weight and renal function as well as the severity and nature of the infection. Adults and adolescents ≥ 12 years – Total daily dosage of 1g to 4g, administered in three to four divided doses, by iv or im injection. Severe infections: up to 8g per day administered in four infusions (over 20 to 30 min). No single bolus injection or infusion should exceed 2g. Maximum dose of 12g per day should not be exceeded. In surgical prophylaxis: 2g iv (bolus or infusion) upon induction of anesthesia, to be repeated every 6h for 24h in vascular and orthopedic surgery, and for 48h in cardiac or coronary surgery. Methicillin-susceptible Staphylococcus aureus. Endocarditis: 2g every 6h, increasing to 2g every 4h in patients weighing >85kg. Children under 12 years of age – In mild to moderate infections: 25 to 50mg/kg/24 hours administered in three to four equally divided doses by im or iv injection. Severe infections: Up to 100mg/kg/24 hours in three to four divided doses. No single bolus injection or infusion should exceed 33mg/kg. Methicillin-susceptible Staphylococcus aureus. Endocarditis: 200mg/kg/24 hours in three to four divided doses. Premature infants, neonates, sucklings and infants – Risk of kernicterus; only use in premature infants and neonates after rigorous risk-benefit assessment. Treatment is generally with 25mg to 50mg/kg/24 hours divided into three or four equal doses. Maximum daily dose 100mg/kg/24 hours. Abnormal renal function – Renal excretion slowed in patients with renal insufficiency. In severe renal insufficiency (creatinine clearance <10ml/min) consider dose reduction or extension of dose interval. Maximum recommended dose in adults is 1g every 8 to 12 hours. In anuric patients maximum dosage is 1g every 12 h. Flucloxacillin not significantly removed by dialysis hence no supplementary dosages need be administered either during or at end of dialysis period. Hepatic impairment – Dose reduction not necessary. Intrapleural and intraarticular – Usual dose is 250mg to 500mg once daily. Contraindications: Hypersensitivity to the active substance or excipients, should not be given to patients with history of hypersensitivity to beta-lactam antibiotics, patients with previous history of flucloxacillin-associated jaundice/hepatic dysfunction. Not suitable for ocular or subconjunctival administration or intrathecal injection. Special warnings and precautions for use: Before initiating therapy with flucloxacillin check patient history concerning previous hypersensitivity reactions to beta-lactams. Cross sensitivity between penicillins and cephalosporins is well documented. Serious and
PRESCRIBING INFORMATION: Consult the Summary of Product Characteristics for further information. Additional occasionally fatal hypersensitivity reactions have been reported in patients receiving beta-lactam antibiotics, information is available upon request. Flucloxacillin 500mg, 1000mg and 2000mg powder for solution for occurrence more frequent with parenteral compared to oral therapy. Reactions more likely to occur in patients injection/infusion. Active ingredients: As flucloxacillin sodium, each 10mL vial contains 500mg flucloxacillin with history of beta-lactam hypersensitivity. If allergic reaction occurs discontinue flucloxacillin and institute (25.5mg sodium approximately), 20mL vial contains 1000mg flucloxacillin (51mg sodium approximately), 50mL vial appropriate therapy. Feverish generalized erythema associated with pustula occurring at treatment initiation may contains 2000mg flucloxacillin (102mg sodium approximately). Indications: For the treatment of the following be a symptom of acute generalised exanthematous pustulosis (AGEP); in case of AGEP diagnosis discontinue infections due to beta-lactamase producing staphylococci and other sensitive Gram-positive organisms such as flucloxacillin and subsequent administration is contraindicated. Use with caution in patients with evidence of streptococci – skin and soft tissue infections (like abscesses, cellulitis, infected burns, impetigo), upper respiratory hepatic dysfunction, patients ≥50 years of age and those with serious underlying disease; hepatic events may be tract infections (like pharyngitis, tonsillitis, sinusitis), lower respiratory tract infections (like pneumonia, severe and in extremely rare circumstances deaths have been reported. Flucloxacillin solutions reconstituted with bronchopneumonia, pulmonary abscess), bone and joint infections (like osteomyelitis and arthritis), endocarditis. local anesthetics (lidocaine) should not be given by iv administration. Adjust dose in renal impairment. Special Prophylaxis in cardiovascular surgery (valve prostheses, artery prostheses) and orthopedic surgery (arthroplasty, caution essential in newborns due to risk of hyperbilirubinaemia and potential for high serum levels of osteosynthesis and arthrotomy). Consideration should be given to official guidance on appropriate use of flucloxacillin due to reduced rate of renal excretion. Regular monitoring of blood count, hepatic and renal function antibacterial agents. Posology and method of administration: Parenteral therapy is indicated if oral route recommended during prolonged treatment. Pseudomembranous colitis can occur; if this develops discontinue impracticable or unsuitable as in the case of severe diarrhoea or vomiting and particularly for urgent treatment flucloxacillin and initiate appropriate therapy. Prolonged use may occasionally result in overgrowth of nonof severe infection. Routes of administration: 500mg vial - Intramuscular (im), intravenous (iv), intrapleural and susceptible organisms. Caution when administered concomitantly with paracetamol due to increased risk of high intraarticular. 1000mg vial and 2000mg vial – intramuscular and intravenous routes only. Intravenous injection/ anion gap metabolic acidosis (HAGMA). High risk of HAGMA particularly in patients with severe renal impairment, infusion should be administered slowly. Dosage depends on age, weight and renal function as well as the severity sepsis or malnutrition especially if maximum daily doses of paracetamol used. Following co-administration close and nature of the infection. Adults and adolescents ≥ 12 years – Total daily dosage of 1g to 4g, administered in three monitoring recommended to detect the appearance of HAGMA (including testing for urinary 5-oxoproline). If to four divided doses, by iv or im injection. Severe infections: up to 8g per day administered in four infusions (over flucloxacillin is continued after paracetamol cessation, it is advisable to ensure no HAGMA signals. Particular 20 to 30 min). No single bolus injection or infusion should exceed 2g. Maximum dose of 12g per day should not be caution with drug-induced liver injury in patients with HLA-B*5701 haplotype; frequency of these disorders exceeded. In surgical prophylaxis: 2g iv (bolus or infusion) upon induction of anesthesia, to be repeated every 6h increasing in HIV-infected patients who may be at increased risk of exposure to flucloxacillin. Hypokalaemia for 24h in vascular and orthopedic surgery, and for 48h in cardiac or coronary surgery. Methicillin-susceptible Staphylococcus aureus. Endocarditis: 2g every 6h, increasing to 2g every 4h in patients weighing >85kg. Children under 12 years of age – In mild to moderate infections: 25 to 50mg/kg/24 hours administered in three to four equally divided doses by im or iv injection. Severe infections: Up to 100mg/kg/24 hours in three to four divided doses. No single bolus injection or infusion should exceed 33mg/kg. Methicillin-susceptible Staphylococcus aureus. Endocarditis: 200mg/kg/24 hours in three to four divided doses. Premature infants, neonates, sucklings and infants – Risk of kernicterus; only use in premature infants and neonates after rigorous risk-benefit assessment. Treatment is generally with 25mg to 50mg/kg/24 hours divided into three or four equal doses. Maximum daily dose 100mg/kg/24 hours. Abnormal renal function – Renal excretion slowed in patients with renal insufficiency. In severe renal insufficiency (creatinine clearance <10ml/min) consider dose reduction or extension of dose interval. Maximum recommended dose in adults is 1g every 8 to 12 hours. In anuric patients maximum dosage is 1g every 12 h. Flucloxacillin not significantly removed by dialysis hence no supplementary dosages need be administered either during or at end of dialysis period. Hepatic impairment – Dose reduction not necessary. Intrapleural and intraarticular – Usual dose is 250mg to 500mg once daily. Contraindications: Hypersensitivity to the active substance or excipients, should not be given to patients with history of hypersensitivity to beta-lactam antibiotics, patients with previous history of flucloxacillin-associated jaundice/hepatic dysfunction. Not suitable for ocular or subconjunctival administration or intrathecal injection. Special warnings and precautions for use: (potentially life threatening) can occur especially at high doses and may be resistant to potassium supplementation. Regularly measure potassium levels during high dose flucloxacillin therapy. Attention warranted when combining flucloxacillin with hypokalaemia inducing diuretics or when other risk factors for development of hypokalaemia present. Contains sodium, consider in patients on a sodium controlled diet. Undesirable effects: Common (>1/100 to <1/10): Minor gastrointestinal disturbances. Uncommon (>1/1000 to <1/100): Rash, urticaria, purpura. Very rare (<1/10,000): Neutropenia (including agranulocytosis), thrombocytopenia, eosinophilia, haemolytic anaemia, anaphylactic shock, angioneurotic oedema, high anion gap metabolic acidosis, pseudomembranous colitis, neurological disorders with convulsions possible with high dose iv injection in patients with renal failure, hepatitis, cholestatic jaundice, changes in liver function laboratory test results, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, arthralgia, myalgia, interstitial nephritis, fever sometimes develops more than 48 hours after start of treatment. Frequency not known: Acute generalized exanthematous pustulosis, phlebitis. Legal Category: POM Marketing Authorisation Numbers: PA2059/069/001, PA2059/069/002, PA2059/069/003. Marketing Authorisation Holder: Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, Bad Homburg v.d.H 61352, Germany Further Information: See the SmPC for further details. Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517. Before initiating therapy with flucloxacillin check patient history concerning previous hypersensitivity reactions Website: www.hpra.ie, E-mail: medsafety@hpra.ie. Adverse events should also be reported to Fresenius Kabi Limited to beta-lactams. Cross sensitivity between penicillins and cephalosporins is well documented. Serious and via email Pharmacovigilance.GB@Fresenius-Kabi.com. Date of Preparation: August 2021 IE-IVF-2100004
occasionally fatal hypersensitivity reactions have been reported in patients receiving beta-lactam antibiotics, occurrence more frequent with parenteral compared to oral therapy. Reactions more likely to occur in patients with history of beta-lactam hypersensitivity. If allergic reaction occurs discontinue flucloxacillin and institute appropriate therapy. Feverish generalized erythema associated with pustula occurring at treatment initiation may be a symptom of acute generalised exanthematous pustulosis (AGEP); in case of AGEP diagnosis discontinue flucloxacillin and subsequent administration is contraindicated. Use with caution in patients with evidence of hepatic dysfunction, patients ≥50 years of age and those with serious underlying disease; hepatic events may be severe and in extremely rare circumstances deaths have been reported. Flucloxacillin solutions reconstituted with local anesthetics (lidocaine) should not be given by iv administration. Adjust dose in renal impairment. Special caution essential in newborns due to risk of hyperbilirubinaemia and potential for high serum levels of flucloxacillin due to reduced rate of renal excretion. Regular monitoring of blood count, hepatic and renal function recommended during prolonged treatment. Pseudomembranous colitis can occur; if this develops discontinue flucloxacillin and initiate appropriate therapy. Prolonged use may occasionally result in overgrowth of nonsusceptible organisms. Caution when administered concomitantly with paracetamol due to increased risk of high anion gap metabolic acidosis (HAGMA). High risk of HAGMA particularly in patients with severe renal impairment, sepsis or malnutrition especially if maximum daily doses of paracetamol used. Following co-administration close monitoring recommended to detect the appearance of HAGMA (including testing for urinary 5-oxoproline). If flucloxacillin is continued after paracetamol cessation, it is advisable to ensure no HAGMA signals. Particular caution with drug-induced liver injury in patients with HLA-B*5701 haplotype; frequency of these disorders increasing in HIV-infected patients who may be at increased risk of exposure to flucloxacillin. Hypokalaemia (potentially life threatening) can occur especially at high doses and may be resistant to potassium supplementation. Regularly measure potassium levels during high dose flucloxacillin therapy. Attention warranted when combining flucloxacillin with hypokalaemia inducing diuretics or when other risk factors for development of hypokalaemia present. Contains sodium, consider in patients on a sodium controlled diet. Undesirable effects: Common (>1/100 to <1/10): Minor gastrointestinal disturbances. Uncommon (>1/1000 to <1/100): Rash, urticaria, purpura. Very rare (<1/10,000): Neutropenia (including agranulocytosis), thrombocytopenia, eosinophilia, haemolytic anaemia, anaphylactic shock, angioneurotic oedema, high anion gap metabolic acidosis, pseudomembranous colitis, neurological disorders with convulsions possible with high dose iv injection in patients with renal failure, hepatitis, cholestatic jaundice, changes in liver function laboratory test results, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, arthralgia, myalgia, interstitial nephritis, fever sometimes develops more than 48 hours after start of treatment. Frequency not known: Acute generalized exanthematous pustulosis, phlebitis. Legal Category: POM Marketing Authorisation Numbers: PA2059/069/001, PA2059/069/002, PA2059/069/003. Marketing Authorisation Holder: Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, Bad Homburg v.d.H 61352, Germany Further Information: See the SmPC for further details. Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517. Website: www.hpra.ie, E-mail: medsafety@hpra.ie. Adverse events should also be reported to Fresenius Kabi Limited via email Pharmacovigilance.GB@Fresenius-Kabi.com. Date of Preparation: August 2021 IE-IVF-2100004
