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Royal free hospital shared care guidelines

Shared Care Guideline
TACROLIMUS
(Prograf , Adoport , Tacni , Vivadex , Advagraf )
in Renal Transplants
Prepared by Caroline Ashley, Lead Renal Pharmacist, Royal Free Hospital,
In agreement with NHS North Central London (Camden Borough), July 2011, review June 2013.

SHARED CARE CRITERIA
Patients will have been stabilised, receiving a therapeutic dose of a specified brand of tacrolimus with time allowed for
common adverse events and side effects to have occurred before referral to the GP. A minimum period of 3 months
stabilisation is necessary prior to sharing care.
RESPONSIBILITIES

Consultant and Specialist Nurse
1. Ensure that patient is fully counselled and educated regarding transplantation and immunosuppression
2. Supply the specified brand of tacrolimus until the patient is clinically stable.
3. Send a letter to the GP suggesting that shared care is agreed for this patient.
4. Clinical and laboratory supervision (including therapeutic drug monitoring) of patient by routine 1-3 monthly clinic
5. Alterations to tacrolimus brand, and alterations to, or re-titration of dosage, and communication of these and other changes to patient’s therapy to the GP as soon as possible. 6. Institution and communication of other significant changes in patient’s therapy To provide a record card on which details of drug therapy will be kept and advise the patient to take this to any GP or secondary care appointment. 7. Evaluation of adverse effects reported by the GP or patient (if applicable). 8. Communicating the results of all clinical and laboratory tests performed in secondary care to GP within 5 days. 9. Provide a review date and identify whether specialist doctor or nurse will perform this 10. Provide back-up advice at all times (see below). General Practitioner
1. To reply to the Consultant, accepting or declining shared care for tacrolimus within 2 weeks of receiving the
2. Monitoring the patient’s overall health and well being. 3. Adverse drug reaction/ drug interaction monitoring. 4. Prescribing (though not altering dose or updating the patient held record card) of the specified brand of 5. Reporting to and seeking advice from the specialist on any aspect of patient care which is of concern to the GP. Patient
1. Report to the specialist or GP if he or she does not have a clear understanding of the treatment.
2. Share any concerns in relation to treatment with tacrolimus.
3. Inform specialist or GP of any other medication being taken, including over-the-counter products.
4. Report any adverse effects or warning symptoms (sore throat, mouth ulcers, nausea, vomiting, fever, abdominal
discomfort, shortness of breath) to the specialist or GP whilst taking tacrolimus. PCT
1. To support GPs in making the decision over whether or not to accept clinical responsibility for prescribing.
2. To support Trusts in resolving issues that may arise as a result of shared care.
LICENSED INDICATIONS
Prevention of graft rejection following renal transplant.
DOSE AND ADMINISTRATION
Starting dose usually 0.15mg/kg-body weight daily in 2 divided doses taken 12 hours apart. Dose is adjusted
according to blood levels (target range – 8-12ng/ml reducing to 5-8 ng/ml at 1 year), renal and liver function, presence
of infection and length of time post transplant.
FORMULATION
Numerous formulations of tacrolimus are now available:-
Prograf®, Adoport®, Tacni® and Vivadex® are all standard-release formulations, with other generic formulations
expected soon. They are prescribed as a twice-daily dose, and patients must not be switched between brands
except under the supervision of the Renal Transplant Unit.
Advagraf® is a modified release preparation and is prescribed as a once-daily dose.
It is imperative that tacrolimus is prescribed by BRAND name, due to the associated risk of either toxicity
or rejection should the patient receive the wrong formulation.
The information contained in this guideline is issued on the understanding that it is accurate based on the resources at the time of issue. For
further information please refer to the relevant data sheet or contact a member of the transplant team.
Page 1 of 2
The Royal Free Renal Transplant unit will specify the brand of tacrolimus to be prescribed for each patient.
MONITORING
The following will be monitored on a routine basis in secondary care at clinic visits to the Transplant
Centre: blood pressure, neurological and visual status, fasting blood glucose levels, electrolytes, liver
and renal function tests, full blood count, coagulation status, and blood tacrolimus levels. It is not
necessary for GPs to duplicate these tests
.
• The results of tests performed in secondary care to be communicated to the GP within 5 days. SIDE EFFECTS
• Tremor and burning sensation in hands and feet • Malignancies and lymphoproliferative disorders DRUG INTERACTIONS
Drugs that induce/inhibit microsomal P450 oxidation system:
Drugs that reduce blood levels
Drugs that increase blood levels
• Calcium-channel blockers (diltiazem, nicardipine, verapamil) Note – nifedipine and amlodipine are not known to have this effect • Triazole antifungals (e.g. fluconazole) • Nephrotoxic agents – increased risk of nephrotoxicity • HMG-CoA-reductase inhibitors – increased risk of myopathy • Grapefruit/grapefruit juice should be avoided as they may raise tacrolimus levels • Live vaccinations contraindicated due to immunosuppression PREGNANCY AND LACTATION
Human data show that tacrolimus is able to cross the placenta. Limited data from organ transplant recipients show no
evidence of an increased risk of adverse effects on the course and outcome of pregnancy under tacrolimus treatment
compared with other immunosuppressive medicinal products. To date, no other relevant epidemiological data are
available. Due to the need of treatment, tacrolimus can be considered in pregnant women when there is no safer
alternative and when the perceived benefit justifies the potential risk to the foetus.
In case of in utero exposure, monitoring of the newborn for the potential adverse effects of tacrolimus is recommended
(in particular the effects on the kidneys). There is a risk for premature delivery (<37 week) as well as for hyperkalaemia
in the newborn, which, however, normalizes spontaneously.
Human data demonstrate that tacrolimus is excreted into breast milk. As detrimental effects on the newborn cannot be
excluded, women should not breast-feed whilst receiving tacrolimus.
COST
One month’s therapy with tacrolimus (Prograf®) at a dose of 4mg BD - £382.34
One month’s therapy with tacrolimus (Adoport®) at a dose of 4mg BD - £314.50 CONTACT NUMBERS

Royal Free Hospital Renal Unit
Switchboard
020 7794 0500
Renal Transplant Consultants
Dr G.Jones
Ext 36847
Specialist Pharmacists
Caroline Ashley
Bleep 1409
Bleep 1650
Pharmacy Medicines Information
020 7830 2983 (Mon-Fri - 9.00-5.30)
Transplant Sisters
The information contained in this guideline is issued on the understanding that it is accurate based on the resources at the time of issue. For
further information please refer to the relevant data sheet or contact a member of the transplant team.
Page 2 of 2

Source: http://www.camdenccg.nhs.uk/gpdownloads/Shared%20Care%20Guideline%20TACROLIMUS%20-%20Prograf%20-%20in%20Renal%20Transplants.pdf

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