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19:48 May 16, 2005
English to English translations [PRO] Medical - Medical: Pharmaceuticals
English term or phrase:fixed and free combination
What do free and fixed mean in this context (provided below)?
1. Does “fixed combination” mean “combination medicament (two compounds in a single dosage form)”?
2. Does “free combination” mean “combination of separate/different dosage forms”?
3. Medicament suited for the combined use according to claim 1 or 2, which comprises roflumilast and R, R-formoterol in fixed or free combination.
4. Medicament according to claim 3, which is a fixed oral combination.
5. Medicament according to claim 3, which is a fixed oral combination containing roflumilast in a daily dosage of from 100 to 500 pg and R, R-formoterol in a daily dosage of from 10 to 120 pg.
6. Medicament according to claim 3, which is a free combination comprising roflumilast in an oral formulation and R, R-formoterol in a formulation suited for administration by inhalation.
7. Medicament according to claim 3, which is a free combination comprising. roflumilast in an oral formulation in a daily dosage of from 100 to 500 ug and R, R-formoterol in a formulation suited for administration by inhalation in a daily dosage of from 10 to 50 ug.
Synergistic Combination Comprising Roflumilast and (R, R)-Formoterol
The combination therapy which is the subject matter of this invention comprises administering roflumilast with R, R-formoterol to prevent onset of a pulmonary disease event or to treat an existing condition. The two compounds may be administered together in a single dosage form. Or they may be administered in different dosage forms. They may be administered at the same time. Or they may be administered both close in time or remotely, such as where one drug is administered in the morning and the second drug is administered in the evening.
"Combined use" or "combination" within the meaning of the present invention is to be understood as meaning that the individual components can be administered simultaneously (in the form of a combination medicament), more or less simultaneously (from separate pack units) or in succession (directly in succession or else alternatively at a relatively large time interval) in a manner which is known per se and customary. As an example, one drug could be taken in the morning and one later in the day. Or in another scenario, one drug could be taken twice daily and the other once daily, either at the same time as one of the twice-a-day dosing occurred, or separately.