Your doctor will calculate the dose of Helixate NexGen 2000 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood.

Scoops of 3 sizes are provided for measuring the correct amount of Aivlosin 8. 5 mg/g Oral Powder for mixing with the daily ration, according to the schedule below.

Powder (10 doses) in vial (type I glass), with a stopper (chlorobutyl) + 5 ml of solvent in a vial (type I glass), with a stopper (chlorobutyl)– Pack size of 1, 10 or 20.

Scoops of 3 sizes are provided for measuring the correct amount of Aivlosin 8.5 mg/g Oral Powder for mixing with the daily ration, according to the schedule below.

Thereafter, a descending sequence of dose levels should be selected with a view to demonstrating any dosage related response and no-observed-adverse effects at the lowest dose level (NOAEL).

In CSF the peak concentrations of 18 mg/ l are achieved, after a 50– 100 mg/ kg intravenous dose, in about four hours.

A common side effect in the high dose group of 8 mg/ kg (motion sickness) was vomiting before the car journey started.

Two dose levels (3.75 µg and 7.5 µg) of both the A/ Vietnam/ 1203/ 2004 and A/ Indonesia/ 05/ 2005 strain vaccines were investigated for the booster vaccination.

Any size vial may be used to measure the required dose; however, final concentration of interferon in sodium chloride solution must be not less than 0.3 million IU/ml.The appropriate dose of

Thereafter, a descending sequence of dose levels should be selected with a view to demonstrate any dose-related response and no-observed-adverse effects at the lowest dose level.

The exact magnitude of the risk associated with a single dose has not been determined, nor has the exact duration of therapy associated with increased risk.

Any size vial may be used to measure the required dose; however, final concentration of interferon in sodium chloride solution must be not less than 0.3 million IU/ml.

At that dose-level, in 12 volunteers given Carbaglu tablets, plasma concentration peaked at 2.6 µg/ ml (median; range 1.8-4.8) after 3 hours (median; range 2-4).

In the posterior segment, there were vitreal cell infiltration and floaters, which also tended to be dose-dependent and generally persisted to the end of the treatment period.

There may be a moderate dose-dependent increase in the platelet count within the normal range during treatment with Abseamed, which gradually regresses during the course of continued therapy.

There may be a moderate dose-dependent increase in the platelet count within the normal range during treatment with Binocrit, which gradually regresses during the course of continued therapy.

Pharmacodynamic effects After administration of tenecteplase dose dependent consumption of α 2-antiplasmin (the fluid-phase inhibitor of plasmin) with consequent increase in the level of systemic plasmin generation have been observed.

At the end of the recovery period, tibial and femoral changes were minimal although generally statistically significant compared to controls in males at all dose levels and in females dosed with the two highest doses compared to controls.

On the other hand, the availability of data on functional observations from the repeated dose study may enhance the ability to select dose levels for a subsequent subchronic study.

Dose levels should be selected taking into account three results from an acute test on delayed neurotoxicity and any other existing toxicity or kinetic data available for the test compound.

Linearity / non-linearity The Cmax for vildagliptin and the area under the plasma concentrations versus time curves (AUC) increased in an approximately dose proportional manner over the therapeutic dose range.

Linearity / non-linearity The C max for vildagliptin and the area under the plasma concentrations versus time curves (AUC) increased in an approximately dose proportional manner over the therapeutic dose range.

There may be a moderate dose-dependent increase in the platelet count within the normal range during treatment with Epoetin alfa HEXAL, which gradually regresses during the course of continued therapy.

tabulation of response data by sex and dose level (i.e. number of animals that died or were killed during the test, number of animals showing signs of toxicity, number of animals exposed),

Bilateral intravitreal administration of ranibizumab to cynomolgus monkeys at doses between 0.25 mg/ eye and 2.0 mg/ eye once every 2 weeks for up to 26 weeks resulted in dose-dependent ocular effects.

s Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/ kg), and was statistically

The CHMP considered also that bioequivalence between test and reference medicinal product has been sufficiently characterised in 2 studies (single and multiple dose) performed with a reduced patch size (7.5 cm²).

If a test at one dose level of at least 2000 mg/kg body weight using a single treatment, or as two treatments on the same day, produces no observable toxic effects, and if genotoxicity would not be expected based upon data from structurally related substances, then a fully study using three dose levels may not be considered necessary.

If a test at one dose level of at least 2000 mg/kg body weight using a single treatment, or as two treatments on the same day, produces no observable toxic effects, and if genotoxicity would not be expected based on data from structurally related substances, then a fully study using three dose levels may not be considered necessary.

In comparative trials with different doses of Ovitrelle, the following undesirable effects were found to be associated with Ovitrelle in a dose-related fashion: ovarian hyperstimulation syndrome, and vomiting and nausea.

No clear evidence of teratogenic activity was found in rats and in rabbits at doses of approximately 3 and 10 times the maximum recommended human dose, based on body surface area.

In patients with severe sepsis, the plasma clearance of drotrecogin alfa (activated) was significantly decreased by renal impairment and hepatic dysfunction, but the magnitude of the differences in clearance (< 30 %) does not warrant any dosage adjustment.

If a test at one dose level of at least 2000 mg/kg body weight/day using a single treatment, or as two treatments on the same day, produces no observable toxic effects, and if genotoxicity would not be expected based upon data from structurally related substances, then a full study using three dose levels may not be considered necessary.

dose levels in medical radiodiagnostic practices or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of standard-sized patients or standard phantoms for broadly defined types of equipment.

Pegaptanib 0.3mg showed treatment benefit regardless of baseline lesion subtype, lesion size and visual acuity as well as age, gender, iris pigmentation and prior and/ or baseline PDT usage.

In chronic renal failure patients there may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with NeoRecormon, especially after intravenous administration.

Two to four fold intervals are frequently optimal for setting the descending dose levels and addition of a fourth test group is often preferable to using very large intervals (e.g. more than a factor of 10) between dosages.

Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/ kg), and was statistically significant versus control at the mid- and high-dose groups (corresponding to 90 and 180 times the lp

Rats treated with Luminity for 1 month exhibited dose-related, reversible perivascular and peribronchiolar eosinophil infiltration, alveolar macrophage accumulation and increased goblet cell size and number in the lungs.

Female rats dosed intravenously once weekly at 1.2 mg/ kg/ week or higher for up to 6 weeks prior to mating and for 2 weeks post mating had decreased litter sizes and live births per litter and increased early resorptions per litter.

The sample size of the KLIM/ PD/ 11/ USA study may be considered too small to draw any definite conclusion regarding endometrial safety of E2 0,5 mg, even for 2 year- treatment.

As with other HMG-CoA reductase inhibitors, a dose-related increase in transaminases has been observed in a small number of patients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient.

Except for irritating or corrosive substances, which will normally reveal exacerbated effects with higher concentrations, variability in test volume should be minimised by adjusting the concentration to ensure a constant volume at all dose levels.

Intravenous single dose administration in rats, rabbits and dogs resulted only in dose-dependent and reversible alterations of the coagulation parameters with local haemorrhage at the injection site, which was regarded as a consequence of the pharmacodynamic effect of tenecteplase.

Reports in summary form of preliminary tests, including glasshouse and field studies, used to assess the biological activity and dose range finding of the plant protection product and of the active substance(s) it contains, must be submitted when requested by the competent authority.

Clinical effects Patency data from the phase I and II angiographic studies suggest that tenecteplase, administered as a single intravenous bolus, is effective in dissolving blood clots in the infarct-related artery of subjects experiencing an AMI on a dose related basis.

If a test at one dose level of at least 1 000 mg/kg body weight/day or, for dietary or drinking water administration, an equivalent percentage in the diet or drinking water (based upon body weight determinations), using the procedures described for this study, produces no observable toxic effects and if toxicity would not be expected based upon data from structurally related substances, then a full study using three dose levels may not be considered necessary.

Except for irritating or corrosive substances which will normally reveal exacerbated effects with higher concentrations, variability in test volume should be minimised by adjusting the concentration to ensure a constant volume at all dose levels.

When doses higher than 9.5 mg/ 24 h were used in the above-mentioned study, dizziness, insomnia, agitation, decreased appetite, atrial fibrillation and cardiac failure were observed more frequently than

Paediatric pharmacokinetics: in 49 paediatric patients receiving the equivalent of a 600 mg dose of efavirenz (dose adjusted from calculated body size based on weight), steady state Cmax was 14.1 μ M, steady state Cmin was 5.6 μ M, and AUC was 216 μ M·h.