Abstract: The invention relates to a multiple-variable dose method for treating a disorder in which TNF? activity is detrimental, comprising administering to a subject in need thereof a first induction dose of an anti-TNF? antibody which ranges from 161 to 320 mg such that a threshold level of TNF? inhibitor is achieved within an induction phase; and subsequently administering to the subject at least one treatment dose of the TNF? inhibitor within a treatment phase, such that treatment occurs.

Abstract: The present invention relates to an assembly (101) comprising: an injection device (1) comprising a container (2) for a product, said container comprising a distal tip (3), an adaptor (5) comprising a ring (6) mounted onto said distal tip (3), characterized in that said assembly (101) further comprises a heat-shrinkable film (9) covering part (2a) of said container (2) and part (5a) of said adaptor (5), said film (9) maintaining said adaptor (5) blocked in rotation and in translation with respect to said container (2) when said film (9) is in its heat-shrunk condition. The invention further relates to a method for manufacturing such an assembly.

Abstract: A blood processing apparatus includes a measurement device having at least one chamber element extending along a longitudinal axis and including a circumferential wall extending about the longitudinal axis, a bottom wall and a top wall together defining a flow chamber. The blood processing apparatus further includes a holder for the measurement device, the holder including a base having a reception opening for receiving the measurement device and a closure element movably arranged on the base for locking the measurement device in an inserted position in the reception opening. An ultrasonic sensor of the holder is arranged on the base. The ultrasonic sensor, in the inserted position of the measurement device, faces the bottom wall of the at least one chamber element, wherein the bottom wall extends transversely with respect to the longitudinal axis.

Abstract: A method for processing an initial liquid medium including cells in an initial concentration to obtain a product liquid medium including cells in a product concentration includes supplying the initial medium to a separator via a first supply system, separating the initial medium into various constituents including the product medium, extracting the product medium from the separator via a first outlet system, measuring a physical parameter related to the concentration of the cells in the initial medium using a sensor, and controlling at least one process parameter as a function of the physical parameter. During the step of separating the initial medium, a solution is supplied to the separator at a flow rate via a second supply system. The flow rate of the solution is determined based on the at least one process parameter, and is reduced when the concentration of the cells measured in the initial medium increases.

Abstract: A tubing set for use in a blood processing apparatus comprises a measurement device (8) having at least one chamber element (80, 81) for measuring a haematocrit value of a blood fluid, wherein the at least one chamber element (80, 81) extends along a longitudinal axis (L) and comprises a circumferential wall (804, 814) extending about the longitudinal axis (L) and encompassing a flow chamber (802, 812), the at last one chamber element (80, 81) further comprising an inlet port (800, 810) for allowing a flow of a blood fluid into the flow chamber (802, 812) and an outlet port (801, 811) for allowing a flow of a blood fluid out of the flow chamber (802, 812). The tubing set furthermore comprises an inlet-side tube section (21, 31) connected to the inlet port (800, 810) and an outlet-side tube section (22, 30) connected to the outlet port (801, 811).

Abstract: The invention relates to a connection assembly for directing a medical liquid that includes a connector through which a medical liquid can be delivered, an attachment part that can be connected to connector and is attachable to a delivery device for delivery of a medical liquid through the connector, and has an opening in which the connector engages with the attachment part, and a sealing element for sealing the transition between the connector and the attachment part. The sealing element can be inserted into the opening of the attachment part in an insertion direction in such a manner that the sealing element is held between the attachment part and the connector with the attachment part attached to the connector.

Abstract: A method is described for opening a heat bonded sterile connection that includes a skin of material blocking flow between the connection site. The method includes applying external pressure to the connection site.

Abstract: A method is described for opening a heat bonded sterile connection that includes a skin of material blocking flow between the connection site. The method includes applying external pressure to the connection site.

Abstract: A method for producing a sterilized container comprises: providing a preform having a hanger arranged on a bottom of the preform, heating the preform in a heating device, feeding the heated preform into a stretching and blowing apparatus, stretching and blowing the preform in the stretching and blowing apparatus such that the container for the infusion solution is formed from the preform, cleaning the formed container in a rinsing apparatus, and drying the cleaned container in a drying device, filling the cleaned and dried container at least with an infusion solution, via a filling opening present in the container, in a filling plant, closing the container by attaching a closure cap to the filling opening of the container, sterilizing the closed container in an autoclave, wherein the hanger of the preform is oriented and folded over by a bending apparatus prior to stretching and blowing in the stretching and blowing apparatus.

Abstract: A port (1) for a catheter comprises: a housing (10) having a base plate (12); a cavity (140) arranged in the housing (10) for receiving a fluid; a membrane (13) attached to the housing (10) and arranged on an opening (102) of the housing (10) for sealing the opening (102) such that the cavity (140) is enclosed in the housing (10) in a fluid-tight manner; and a connector (15) for connecting a catheter (2) to the housing (10) to provide a fluid connection between the cavity (140) and the catheter (2). The port (1) has an outer shape defined by the housing (10) and the membrane (13) attached to the housing (10). In addition at least one adapter piece (3, 4) is provided, the at least one adapter piece (3, 4) in a preassembly state being separate from the housing (10) and being attachable to the housing (10) to alter the outer shape of the port (1), wherein the port (1) is operational with or without the at least one adapter piece (3, 4) attached to the housing (10).

Abstract: The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, an histidine buffering agent such as histidine (or histidine buffer system such as histidine/imidiazolium-histidine), and a sugar stabiliser such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

Abstract: A valve device (1) for a medical system comprises a valve housing (10), an inlet port (102) arranged on the valve housing (10), an outlet port (103) arranged on the valve housing (10), a flow duct (12) extending through the valve housing (10) connecting the inlet port (102) and the outlet port (103) to allow for a fluid flow (P) through the valve housing between the inlet port (102) and the outlet port (103), and a closure element (11) arranged on the valve housing (10) for selectively opening and closing the flow duct (12).

Abstract: An ampoule for a medical liquid comprises an ampoule body for accommodating a medical liquid and a connection part for connecting a removal device to the ampoule, which connection part extends in a longitudinal extension direction and adjoins the ampoule body. The connection part and the ampoule body are formed as one piece and the connection part has a threaded segment having at least two thread turns arranged thereon, which are axially offset from each other in the longitudinal extension direction. The ampoule enables simple attachment of a removal device, creates a tight transition between a connection part and the removal device, is simple and economical to produce, and can provide a defined attachment state for the removal device on the ampoule.

Abstract: The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, a citrate buffering agent/system such as sodium citrate/citric acid, and a sugar stabilizer such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. prefilled syringes) to reduce unnecessary waste of the drug.

Abstract: The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, an acetate buffering agent/system such as sodium acetate/acetic acid, and a sugar stabilizer such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

Abstract: A method and an installation for aseptic filling of a receptacle with an enteral nutrition solution includes making available a filling device with a first sealing device preferably in a fixed position, and in which a first aseptic zone is provided, and wherein the first sealing device is located in a position having an opening; taking hold of a receptacle; guiding the receptacle to the first sealing device in such a way that the receptacle, bears sealingly on the opening of the first sealing device, and the first aseptic zone, in which at least an attachment piece of the receptacle is arranged at least in part, is closed; delivering a sterilizing agent, into the first aseptic zone, such that the channel of the attachment piece of the receptacle is at least partially sterilized; guiding the receptacle to the filling nozzle within the first aseptic zone in such a way that the filling nozzle protrudes at least partially into the channel of the attachment piece of the receptacle; filling the receptacle with the

Abstract: A needleless injection port assembly includes first and second body parts and a resilient barrier received within the body. A cannula attached to the first body part is received within an internal cavity of the resilient barrier. The resilient barrier is moveable between a less axially compressed first position in which fluid flow through the injection port assembly is prevented and a more axially compressed second position in which fluid flow through the assembly is allowed. An interference fit is provided between the resilient barrier and the cannula to seal against fluid flow through the cannula when the resilient barrier is in the first position. The cannula has an internal fluid passageway with a non-circular cross section providing increased fluid flow.

Abstract: The present disclosure relates to emulsions for parenteral administration comprising 1000 to 5000, preferably 1500 to 3000 IU, vitamin A per ml, wherein the emulsions are free of polysorbates and polyoxyethylene/polyoxypropylene block copolymers. The present disclosure further relates to a method for manufacturing the compositions of the disclosure as well as to the use of the compositions of the disclosure.

Abstract: Described herein are pharmaceutical packaging systems which prevent oxidative degradation of oxygen-sensitive drugs, such systems including a primary packaging container with an oxygen permeable component, a secondary packaging with very low permeability to oxygen and an oxygen absorber.

Abstract: Provided herein, generally, are pharmaceutical formulations, e.g., injectable pharmaceutical formulations with improved stability, comprising morphine sulfate or a hydrate thereof, and methods of producing and using the same. Also provided herein are kits comprising the formulations, e.g., injectable morphine formulations.