th For any information about this medicinal product, please contact the local representative of the

th The effect of treatment with Protopy ointment on the developing immune system of children, especially the young, has not yet been established and this should be taken into account when

or The use of Protopy at the same time as other preparations to be used on the skin or while taking oral

is that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face),

Common (≥ 1/ 100 to < 1/ 10) but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture, including some fatal cases, have been reported following administration of

is or Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.

is 0.6 ml of solution for injection in a pre-filled syringe (Type I glass), with a rubber stopper, and with a

ris Insulin antibodies may develop during treatment with all insulins including EXUBERA.

PR = total normal static reaction of road surface on wheels of trailer or semi-trailer

th Like all medicines, Protopy can cause side effects, although not everybody gets them.

ris The most common side effects of Exubera are hypoglycaemia (low blood glucose) and cough.

or Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to

ed To give yourself a subcutaneous injection you will need a new pre-filled syringe of Dynepo with needle guard.

In this case, the Insulin Release Unit (IRU) must be changed prior to the next inhalation (see section 4.4).

ed chemotherapy, the main measure of effectiveness was the reduction in number of patients who needed a blood transfusion.

is Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80,

The IRU must be changed after accidental exposure to extremely moist conditions, e.g. steamy bathroom.

• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON

er Your Dynepo syringe is provided with a needle guard to prevent needle stick injuries after use, so no special disposal precautions are required. ng lo no ct du ro ed M

ed Protopy was significantly more effective than either of the 2 hydrocortisone preparations at producing improvements in the modified Eczema Area and Severity Index, although it also produced more burning than hydrocortisone.

au to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25 % lower than the previous dose.

elimination of Nespo and r-HuEPO, Nespo should be used with caution in patients with liver disease.

th take blood samples to make sure that your anaemia is still being managed correctly.

au Excipients: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, polysorbate 20 and water for injections.

481 Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect.

If your blood sugar is too low (hypoglycaemia) Your blood sugar levels may fall too much, if for example: – you take too much insulin, – you miss meals or delay them,

Active smoking greatly enhances whereas passive exposure to tobacco smoke in non-smokers decreases the rate and extent of absorption of EXUBERA (see sections 4.3 and 5.2).

au four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.

is adjust your dose as necessary.Your treatment will continue until approximately four weeks after the

In a second study (n=310), which used a weight-adjusted dose (100 micrograms/ kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7

Five blister cards are in a clear plastic (PET) thermoformed tray with a desiccant and covered with a clear plastic (PET) lid.

ris elevated protein/albumin in the urine), monoamine oxidase (MAO) inhibitors (used for the treatment of depression), certain beta-blockers (used for the treatment of certain heart

Over the entire study, the rate of febrile neutropenia was 13 % of pegfilgrastim-treated patients compared with 20 % of filgrastim-treated patients

er possibility of interactions cannot be ruled out and the concomitant systemic administration of known CYP3A4 inhibitors (e. g. erythromycin, itraconazole, ketoconazole and diltiazem) in patients with ng widespread and/ or erythrodermic disease should be done with caution. lo A potential interaction between vaccination and application of Protopy ointment has not been investigated.

ho e) Magnitude of titration steps and resulting precautions f) The change in pulmonary function and the need for pulmonary function monitoring g) Smoking in relation to induced alteration in pharmacokinetics

Patients who met each of the following criteria: • No evidence of circulating blasts or extramedullary disease • An M1 bone marrow (≤ 5 % blasts) • Recovery of peripheral counts (platelets ≥ 100 x 109/ l and ANC ≥ 1.0 x 109/ l)

since the phosphate buffer may interact with the zinc in the suspension and alter the timing of action of the insulin in an unpredictable way. lp

These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have ng neutralising antibodies to erythropoietin should not be switched to darbepoetin alfa (see section 4.8). lo Active liver disease was an exclusion criteria in all studies of Nespo, therefore no data are available from patients with impaired liver function. Since the liver is thought to be the principal route of no

Laisvė s pr.

CR+ nCR + PR CR + nCR+

Time to response CR + PR (days) a

Partial Response (PR) %

ed Excipients:

Response rate (CR, nPR, or PR)

≥ 0.5 to < 0.8 ≥ 0.8 to < 1.2

What Neupopeg contains

th 6.2 Incompatibilities

Figure 2. Observed Cha

Move horizontally to the appropriate P/PR line (P/PR = 1,6)

Partial Response Duration of Response**, CR or PR (Months)