While administration of amprenavir with food results in a 25 % reduction in AUC, it had no effect on the concentration of amprenavir 12 hours after dosing (C12).

An interruption of dosing should be considered if intense local inflammatory reactions occur (see section 4.4) or if infection is observed at the treatment site.

Evidence of efficacy for the once weekly dosing regimen in this patient population has been based on data from the study in patients with ankylosing spondylitis.

The first 37 patients were started at 400 mg, the protocol was subsequently amended to allow higher dosing and the remaining 223 patients were started at 600 mg.

The starting dose and the frequency of dosing depend on whether MIRCERA is replacing another medicine used to stimulate the production of red blood cells or not.

If you cannot easily pull out the dosing button or dial the dose, do not use excessive force and do not use this pen because it may not deliver the correct dose.

If you have a kidney or liver disease, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly.

Place the caps provided on the dosing cups and turn each cap clockwise (to the right) until it clicks and locks into its child-resistant position (See Figure 4).

If you forget to take Aerius oral lyophilisate If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.

After a single oral dose of 5 g of sodium phenylbutyrate, in the form of tablets, measurable plasma levels of phenylbutyrate are detected 15 minutes after dosing.

If you forget to take Azomyr oral lyophilisate If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.

Once daily dosing (300 mg once a day): a clinical study has demonstrated the non inferiority between Epivir once a day and Epivir twice a day containing regimens.

Adefovir is eliminated by renal excretion and adjustments of the dosing interval are required in patients with a creatinine clearance < 50 ml/ min or on dialysis.

NeoRecormon dosing The dose of NeoRecormon depends on your disease condition, the way the injection is given (under the skin or into a vein) and your body weight.

After 28 weeks treatment following the dosing guideline outlined in section 4.2, the mean reduction in HbA1c was 2.8 % with NovoMix 30 (mean at baseline = 9.7 %).

Due to the low plasma concentrations and rapid elimination following topical dosing, the elimination half-life of active free acid in man could not be determined.

After multiple oral administration, steady state is reached after the first or second dosing and no accumulation or induction of biotransformation enzymes occurs.

After a single oral dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylbutyrate are detected 15 minutes after dosing.

For specific dosing information in patients with renal impairment, refer to the Summary of Product Characteristics (SPC) of the co-administered protease inhibitor.

In the first study of continuous 20 mg daily dosing for 6 cycles, improvement was observed in the primary efficacy parameter (irritability, anxiety and dysphoria).

The dosing pipette has a gradation in body weight: • up to 36 kg for the 55 ml bottle • up to 36 kg for the 120 ml bottle • up to 48 kg for the 210 ml bottle

The primary analysis of data from study BM16550 at one year and the confirmatory analysis at 2 years demonstrated the non-inferiority of 3 mg every 3 months injection dosing regimen compared to 2.5 mg oral daily dosing regimen, in terms of mean increases in BMD at lumbar spine, total hip, femoral neck and trochanter (Table 3).

Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle.

2 Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.

If this was noticed later than 6 hours of the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.

Increased absolute counts were apparent within 24 hours of the first dose, remained elevated with weekly dosing, and returned to baseline after treatment cessation.

Daily dosing of 1250 mg produces steady state geometric mean (coefficient of variation) Cmax values of 2.43 (76 %) µg/ ml and AUC values of 36.2 (79 %) µg*hr/ ml.

A greater than dose-proportional increase in nelfinavir plasma concentrations was observed after single doses; however, this was not observed after multiple dosing.

3 * Generally, once weekly dosing assuming three haemodialysis sessions per week, each of approximately 4 hours duration or after 12 hours cumulative haemodialysis.

Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.

30 ml and 150 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe.

This helps prevent contamination and/ or infection as well as entry of air into the insulin reservoir and leakage, of the insulin, which can cause inaccurate dosing.

Dosages of the above studies, covering 83 patients, indicate that dosing guidelines for adult subjects are also valid for neonatal and paediatric patient population.

Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/ or other myelosuppressive treatments.

occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.

Upon multiple dosing, ritonavir accumulation is slightly less than predicted from a single dose due to a time and dose-related increase in apparent clearance (Cl/F).

Following oral dosing with 600 mg BID, steady-state was reached by approximately four weeks, with mean steady state plasma concentrations approximately 2,200 ng/ ml.

Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty.(A residual drop may remain in the tip of the tube.)

If you forget to take Aerius orodispersible tablet If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.

If you forget to take Azomyr orodispersible tablet If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.

Given the difference in pharmacokinetic profiles and dosing schedules, Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride.

Place the PegIntron pre-filled pen upright in the holder of the tray provided in the pack (the dosing button will be on the bottom) on a hard, flat, non-slip surface.

The pharmacokinetics of ropinirole are linear overall (Cmax and AUC) in the therapeutic range between 0.25 mg and 4 mg, after a single dose and after repeated dosing.

After repeated oral administration, steady state is reached after the first dosing and no accumulation occurs in dogs whereas modest accumulation is observed in cats.

Upon multiple dosing, there is an accumulation of immunoreactive interferons.There is, however, only a modest increase in biologic activity as measured by a bioassay.

If you forget to take Neoclarityn oral lyophilisate If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.

Oral anticoagulants Gemfibrozil may potentiate the effects of oral anticoagulants, which necessitates careful monitoring of the anticoagulant dosing (see section 4.4).

If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.05 mg/ kg/ day should be administered as a continuous 24-hour infusion.

The justification was considered acceptable, but the dosing section of the SPC should be amended to better reflect the use as proposed and documented by the applicant.

in the specific case of Pseudomonas chlororaphis, and in the light of the results of the available studies, repeated dosing is not necessary to assess hazard to humans;