Medicament bag

Abstract

The present disclosure relates to a medicament bag comprising a port having a seal configured to close an internal volume of the medicament bag, and a flap configured to cover the port. The flap comprises a port element releasably connected to the port.

Description

TECHNICAL FIELD The present disclosure relates to a medicament bag and in particular to a medicament bag comprising a flap connected to a port of the medicament bag. BACKGROUND Drug products produced and dispensed through the pharmacy require attachment of a physical label which includes both patient and medication information to prevent drug administration errors. The label and its content must be visible or accessible. Pharmacists look to place their labels on hard, flat, smooth surfaces to keep the label as flat as possible for consistency, legibility, and security of the label. Usually, a label is placed on an infusion bag directly. This label may have information regarding the specific patient, medication name and dose, expiration or administration information, etc. This label varies by pharmacy, region, type of therapy, and administration device used, and is a primary medication safety strategy. Label sizes are not standard between pharmacies and vary widely. Even within a single pharmacy location, there may be multiple label sizes in use. Variation in label size prevents the option to design devices to a single specification for label size. Designing a device accommodating a maximum label size is similarly impractical. When the shape, size, or features prevent labelling in the preferred way, pharmacists will try alternate methods including “flagging”, or wrapping a label around an object and sticking it to itself in such a way that the label protrudes from the object. The practice of flagging labels is very common, generally used when labelling small boxes, vials, inhalers, and syringes. While common, the method of flagging is not preferred as the exposed label protrudes and is susceptible to getting torn off. An example of devices with obvious limitations that prompt changes in labelling practice include elastomeric pumps. Elastomeric pumps experience drastic changes in shape that preclude pharmacists from labelling the container of the drug product directly and steer them towards flagging the tubing instead. The combination of exposure and flexure of the tubing carries risk of label damage and detachment. For IV therapy, flexible containers (such as DEHP or EVA) are commonly used. However, in some devices, the film layers of the medicament bag may be required to be more rigid in order to preserve long term drug stability, as medications may be prefilled (as opposed to being added just before administration in the IV scenario) and since pressure may be exerted on the bag itself for dispensing. Moreover, when medicament bags are filled to different volumes, the thickness of the bag and contour of the bag may change, preventing simple, repeatable label placement. Even if label placement is successful (or is possible) on the filled bag, there are potential undesired effects to system function. Pharmacy labels may interfere with medication cassette features and interfaces, potentially obstructing proper operation of the device and preventing medication administration if improperly placed. Applied labels may selectively stiffen portions of the bag, either through additional thickness or tension between portions of the bag surface, creating undesired or unpredictable changes to drug delivery or full bag emptying. Also, as labels are generally created in a pharmacy, they are not standardised with respect to size, placement, or importantly, adhesives. As current pharmacy labelling takes place shortly before dispensing to a patient, longterm stability of the drug in the bag is not required. However, for longer storage periods it may be desirable to avoid labelling the bag material directly, to avoid deleterious effect on barrier properties or additional leachables (e.g., adhesive residues or components) in the drug product as substances from the adhesive migrate through the bag material. Application of the label is compulsory, but it needs to be in a location that does not interfere with functionality of the medicament bag or the delivery device. To complicate matters, selection of labelling location is typically at the discretion of a pharmacist or pharmacy technician, who may not typically interact with products with labelling location limitations or typically deals only with products with obvious limitations. Prior art or “ordinary” IV bags feature two ports. A first port is used to fill the bag with medication, often using a needle; this port is self-sealing elastomeric material. Once filled by a pharmacist or pharmacy technician, this port is no longer needed and is not used again. The second port, which is comparatively larger and not self-sealing, is left closed during filling and is only opened during administration, when an IV spike / set is inserted. To protect against contamination or spiking the incorrect port during administration, pharmacists commonly place a port seal over the first port after filling and verification of the preparation. Port seals are generally plastic or foil materials with an adhesive backing, optionally with a tamper-evident feature to prevent removal. Many different port seal designs are available, and as they do not affect product function in the IV scenario, they are not standardised. This adds a risk to primary container as already described with the labels above. More specifically, if pharmacists “transfer” their IV mental model to the port provided on the Keystone flexible container, use of the device may be impossible, or if the port seal is removed prior to use, adhesive residues or portions of the port seal may be retained on the sealing surfaces, adversely affecting product function. Thus, improved solutions are needed to allow pharmacists to retain their mental model while protecting proper product function. Thus, improved solutions to these considerations are needed to preserve medication safety while speeding drug development and commercialisation by reducing analytic / mechanical characterisation work required. These objects are met with the features of the present disclosure. SUMMARY The invention is specified by the independent claims. Preferred embodiments are defined in the dependent claims. In the following description, although numerous features may be designated as optional, it is nevertheless acknowledged that all features comprised in the independent claims are not to be read as optional. The present disclosure relates to a medicament bag comprising a port having a seal configured to close an internal volume of the medicament bag, and a flap configured to cover the port. The flap comprises a port element releasably connected to the port. Various embodiments may preferably implement the following features. Preferably, the port element is a snap-fit member configured to engage the port to releasably connect the flap to the port. Preferably, the snap-fit member is configured to engage a lateral side of the port or to fit over an entry passage or the seal of the port. Preferably, the port element is releasably heat welded to the port. Preferably, the flap is formed in a substantial U-shape around the port. Preferably, the flap substantially covers at least a first side of the medicament bag. Preferably, the flap at least partially covers a second side of the medicament bag opposite the first side, wherein preferably, the flap is releasably connected to the second side. Preferably, the flap is integrally formed with the medicament bag. Preferably, a fixed end of the flap is attached to or integrally formed with the medicament bag at a side opposite of the port. Preferably, a loose end of the flap is provided at the port, wherein preferably, the port element is provided at or towards the loose end. Preferably, a loose end of the flap is provided at the second side of the medicament bag. Preferably, the port element comprises a stopper configured to contact the seal of the port. Preferably, the flap comprises a perforation configured to allow removal of the flap from the medicament bag. Preferably, the flap is welded to a seam of the medicament bag. Preferably, the flap is formed of a film layer of the medicament bag. Preferably, the flap is at least partially formed of an elastic material. Preferably, the port element is configured to be removed from the port by elastic deformation of the flap. Preferably, the flap comprises at least two elastic portions. Preferably, the at least partially elastic flap comprises at least one opening and / or at least two legs. Preferably, the flap is at least partially transparent. Preferably, a portion of the flap is at least partially opaque, and provided with one or more contrasting colours configured to allow inspection of a content of the internal volume of the medicament bag. Preferably, one or more of the colours are black, white, or grayscale. Preferably, the flap comprises a label and / or a sequence information. Preferably, the label and / or sequence information is placed on an inelastic portion of the flap. In the present disclosure, the terms “vertical”, “vertically”, “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and / or component (second axis, y-axis). Similarly, the terms “horizontal”, “horizontally”, “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction (first axis, x-axis). A height direction may refer to a third axis direction (z-axis) perpendicular to the x-y-plane. Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and / or component. Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis. Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to a / an / the element, apparatus, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise. BRIEF DESCRIPTION OF THE DRAWINGS Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings. In the figures, the same reference numerals denote the same or similar elements. Figures 1A and 1B show a medicament bag having a flap according to an embodiment of the present disclosure. Figures 2A and 2B show a medicament bag having a flap in an engaged state according to an embodiment of the present disclosure. Figure 2C shows a cross-sectional view of an engagement of a flap and a port according to an embodiment of the present disclosure. Figures 3A to 3C show attachment of a port element to a port of a medicament bag according to an embodiment of the present disclosure. Figures 4A and 4B show flaps according to embodiments of the present disclosure. Fig. 5 shows a medicament bag having a flap according to an embodiment of the present disclosure. DETAILED DESCRIPTION The present disclosure relates to a medicament bag 1 as shown in Figs. 1A and 1B comprising a port 2 allowing a fluid to enter and exit an internal volume of the medicament bag 1. The port 2 may comprise a seal configured to close the internal volume of the medicament bag 1. A flap 3 is provided to cover the port 2. The flap 3 comprises a port element 32 releasably connected to the port 2. Figs. 1A and 1B schematically show the medicament bag 1 and its elements wherein, for reasons of lucidity, the port element 32 and the port 2 are depicted as being separated from each other. This may be referred to as a pre-engagement position. The flap 3 and the port element 32 are not configured to close the port 2 which, as outlined above, is closed by a seal. Rather, the flap 3 and the port element 32 are provided to protect the port and indicate whether the medicament bag 1 has been used or tampered with. Moreover, the flap 3 provides an attachment surface for labelling the medicament bag 1. The flap 3 may be formed of the same material as the medicament bag 1. It may be integrally formed with the medicament bag 1 by, e.g., providing a larger lower film layer which, during the welding process, is folded over to form the flap 3. Also, the flap 3 may be attached to the medicament bag 1, e.g., glued or welded to the medicament bag 1. Particularly, the flap 3 may be attached to the medicament bag 1 at the lower end, i.e., the end distant from the port 2. The flap 3 may be formed such that a particular shape following a shape of the medicament bag 1 at the port 2 region, in particular a U-shape, may be generated over the port 2 (see Figs. 1A and 1B). In that manner, the flap 3 may hold its position over the port 2. Moreover, as shown in Fig. 1B, the flap 3 may extend further downwards and may be attached to the medicament bag 1 by a removal member 5 (see dotted lines). The removal member 5 may be attached to the medicament bag 1 via a ring 51 or via a releasable glue connection. The ring 51 may also serve as a pull ring 51, e.g., for entering with a finder and facilitating removal of the flap 3. On said removal member 5, a label or sequence information 41 may be provided. This information 41 may provide further guidance to a patient, e.g., in case of a regimen comprising a plurality of drugs that need to be delivered in a particular order. A label 4 may be attached on the flap 3 as indicated in Figs. 1A and 1B. While in Fig. 1A, the flap 3 substantially covers a first side of the medicament bag, the flap in Fig. 1B extends to at least partially also cover a second side of the medicament bag 1. A width of the flap 3 (lateral direction, x-axis) may be equal to or smaller than a width of the medicament bag 1. The flap 3 may be centrally / symmetrically arranged with respect to a middle axis of the medicament bag 1. Although in Figs. 1A and 1B, the port element 32 is depicted to be located laterally of the port, the disclosure is not limited thereto and the port element 32 may also be provided to fit over the port 2. The port element 32 may be a snap-fit member configured to engage the port 2 to releasably connect the flap 3 to the port 2. The snap-fit member may be configured to engage a lateral side of the port 2 or to fit over an entry passage or the seal of the port 2. The port element 32 may also be releasably heat welded to the port 2. The heat welding may be performed laterally or on top. For example, at least one pin, bridge, or the like may be provided to releasably heat weld the port element 32 to the port 2. As outlined above, the flap 3 may be formed in a substantial U-shape around the port. In an embodiment, the flap 3 substantially covers at least a first side of the medicament bag 1. In an embodiment, the flap 3 at least partially covers a second side of the medicament bag 1 opposite the first side. In an embodiment, the flap 3 is releasably connected to the second side, e.g., by a removal member 5. In an embodiment, the flap 3 is integrally formed with the medicament bag 1. In an embodiment, a fixed end of the flap 3 is attached to or integrally formed with the medicament bag 1 at a side opposite of the port 2. In an embodiment, a loose end of the flap 3 is provided at the port 2. The port element 32 may be provided at or towards the loose end. Also, a loose end of the flap 3 may be provided at the second side of the medicament bag 1. The loose end may comprise a removal member 5. In an embodiment, the port element 32 comprises a stopper (not shown) configured to contact the seal of the port 2. The port element 32 may not be provided to close or seal the medicament bag 1 but rather to protect the port 2 prior to use. In an embodiment, the flap 3 comprises a perforation configured to allow removal of the flap 3 from the medicament bag 1. That is, the perforation forms a breaking point and allows the flap 3 to be removed during use after verifying the content. In an embodiment, the flap 3 is welded to a seam of the medicament bag 1. The flap 3 may be formed of a film layer of the medicament bag 1. Fig. 2A shows a side view of the medicament bag 1 as described above with the port element 32 attached to or snapped over the port 2 (engaged position). Fig. 2B shows a configuration where the port element 32 is releasably connected, in particular heat welded, to the port 2. In this embodiment, two welding bridges are shown as an example but the present disclosure is not limited thereto. Fig. 2C is a cross-sectional view schematically showing a port element 32 snapped over the port 2. This view is a top view corresponding to the engaged configuration shown in Fig. 2A. The port element 32 may be flexible to an extent allowing attachment and removal of the port element 32 to the port 2. In particular, the port element 32 may be provided to allow removal of the port element 32 also for people with impaired dexterity or finger strength and without a risk of damaging the port element 32 or the port 2. In an embodiment shown in Figs. 3A to 3C, the flap 3 is formed of an elastic material. The figures show an attachment of the port element 32 to the port 2, wherein the removal process comprises equivalent steps in reverse order. In Fig. 3A, the flap 3 is loose and no protection of the port 2 is provided. As indicated by the arrow in Fig. 3B, the flap 3 can be elastically stretched in the longitudinal direction (upwards). In that manner, the port element 32 can, e.g., be put over the port 2 for protecting the latter (Fig. 3C). Due to the elastic force of the flap 3, the port element 32 is securely held on the port 2. Consequently, the port element 32 is configured to be removed from the port 2 by elastic deformation of the flap 3, i.e., in reverse order. Hence, a process may be as follows. In an initial state, the flap 3 is in a compressed / shortened condition. The lower portion of the flap is affixed to the medicament bag 1 via adhesive, thermal welding, mechanical connection or is integrally formed with the medicament bag 1 (see also above). The port element 32 may have a snap fit connection or may have an inverted shape of the port 2 sized to fit over the port 2. A user may hold the medicament bag 1 at its lower portion and pull the flap 3 upwards. The flap 3 elastically extends from a first length to a second length. After the port element 32 is placed over the port 2, the user releases the flap 3, “snapping” the port element 32 into place over the port 2 or port seal. As described above, the flap 3 may be provided with a perforated section strong enough to withstand the pulling force during elastic deformation of the flap 3 but configured to allow removal of the flap 3 if desired. This allows the flap 3 with attached labels etc. to be separated from the medicament bag 1 and to facilitate recycling of the respective elements. Figs. 4A and 4B are embodiments of an elastic flap 3. In an embodiment, in order to prevent accidental removal of the label 4 during the elastic deformation, the flap 3 may comprise at least one elastic portion 31 and at least one inelastic portion to which the label 4 is attached. In Fig. 4A, the inelastic portion is indicated by the dashed lines, wherein the flap comprises elastic portions 31 respectively provided above and below. For example, the label 4 may be attached within the inelastic portion of Fig. 4A as indicated by the dotted lines, preventing deformation or damage (e.g., tearing) during extension of the elastic flap 3. The dotted area 4 may denote the label 4 itself or the label attachment surface which might be smaller than the label 4. The flap 3 may further comprise at least one opening and / or legs to improve the elastic behaviour. In Fig. 4B, the flap 3 comprises elastic legs 31 formed by an opening and a further opening in the flap 3 to improve the elastic behaviour. Also, the complete flap 3 may be made from an elastic material, i.e., comprise a single elastic portion 31, and a label 4 is attached between the dashed lines. Due to the openings / legs, the comparatively thinner elements may deform more than the centre section such that an attached label 4 may stay in place. If the flap 3 is completely made of an elastic material, attachment of a label 4, e.g., by gluing, to the elastic flap 3, the adhesive surface may have the effect of stiffening this particular area sufficiently (though the underlying substrate is itself elastic), thus creating an inelastic portion of the flap 3. Attachment and removal of the port element 32 to and from the port 2 is performed as described above. As outlined above, the present disclosure is not limited to the shown embodiment and the flap 3 may be made to be fully elastic or to comprise one or more elastic portions 31 and one or more inelastic portions. The flap 3 may be made as a two-piece construction. As outlined above, the label 4 attachment surface may be attached to the elastic flap 3 only in the centre section, permitting extension of the comparatively thinner legs preferentially over the centre section where the label 4 is attached. Also, in such a configuration, the label attachment surface may be inelastic while the flap 3 and thus the port element 32 may retain an elastic function. As shown, elastic legs may be provided (as opposed to an entirely elastic element) to control ease and extend of the elongation relative to the bottom of the medicament bag 1 and the port 2 on top of the medicament bag 1. Alternatively, the flap 3 may be made of a single part where only a portion, e.g., the bottom portion or the top portion, is provided with an elastic element. Hence, flexible and inflexible regions are combined. This may be achieved, e.g., by two-shot moulding or over moulding with an elastic material. In an embodiment, the flap 3 is at least partially transparent allowing visual inspection of the medicament bag 1. Thus, the content of the internal volume of the medicament bag 1, e.g., a drug, may be inspected. A portion of the flap 3 may be at least partially opaque. Said portion may be provided with one or more contrasting colours configured to allow inspection of a content of the internal volume of the medicament bag (1). One or more of the colours may be black, white, or grayscale. As outlined above, the flap 3 may comprise a label 4 and / or a sequence information. Such information may also be provided on the removal member 5- Fig. 5 shows a medicament bag 1 having a flap 3 with a space for applying a label 4 as described above. The figure shows the medicament bag 1 in a filled state as delivered to a patient with the port element 32 attached to the port 2. The flap 3 is connected to the medicament bag 1 at a lower portion of the medicament bag 1. In case the medicament bag 1 is inserted into a medicament delivery device, e.g., a cassette of a medicament delivery device, the protective flap 3 conforms the label 4 to the surface of the cassette, reducing the likelihood of accidental removal from the device in the event of the label catching on something. Moreover, the flap 3 protects the port 2 from damage, fits the existing pharmacy mental model, is intentionally difficult to remove inadvertently, avoiding unintended removal while retaining the label’s 4 position through shipping and manipulation, enhancing legibility and medication safety. Moreover, as the protective flap 3 is movable, inspection of the drug product is possible, either during manufacturing or filling by a pharmacist. Alternatively, the back side (facing the bag surface) may be colored, as with a black, gray, or white surface (or combinations thereof), allowing a predictable, consistent background for detailed inspection, as for particulate matter. Such inspection is common for manual visual inspection of parenteral products manufactured in a high-volume pharmaceutical manufacturing facility. However, this is not commonly available in pharmacy environments, and but is not available as a “built in” option for empty parenteral containers, especially in pharmacy. Regardless, this surface would be visible through the opposite side of the medicament bag 1 from the protective flap 3 and would still allow external labeling of the filled bag 1 without interference with inspection. Notably, this feature can be used during dispensing and prior to administration. This feature may also be colored (e.g., with a black and white portion or other sufficiently contrasting portions), allowing for effective particulate and / or foreign matter inspection(s) according to compendial (e.g., USP <1>, EMA Annex 1, USP <790, EP 2.9.20, EP 5.17.12, or JP 6.06) or other requirements. As outlined above, the flap 3 may be extended to cover both sides of the bag 1. The first side may be provided with label space as explained previously. The other side may also comprise information such as regimen sequence or content information and / or an attachment / removal member 5. Advantageously, this allows labeling to fit pharmacy workflow, but this information may be placed “table down” in the package, exposing the top surface with the removal affordance and sequence number to a patient, improving intuitiveness and avoiding removal of the port element / port protector 32 until the proper time has arrived for administration. In contrast to labelling, marking is intended for tracking primary containers during manufacturing, assembly and inspection. It offers also valuable information if any non-conformance occurs in the field and the issued sample can be identified by the legal manufacturer. For instance, this information can include lot information, a universal device identifier (UDI), expiration information, or other indicia required to track a medicament bag 1 / device through manufacturing or during post-market surveillance activities. As described above, any treatment of the film, i.e., the medicament bag 1 in direct contact with the drug bear risks. Herein, a “flag" (flap 3) on any or both sides of the flexible medicament bag 1 is presented. By design the flexibility is given in direction of the port 2. Top and bottom side of the bag 1 are by design more rigid and consequently deform less. As the top area contains the port 2 connection to distil the drug from the primary container (medicament bag 1), the bottom part offers a preferred area for attaching the flap 3. Marking on the flap 3 could be performed by any method, such as lasering (either removal of a dark imprinted area to create “reversed” printing, or by marking dark areas on a light background), printing, embossing etc. As this area of the film is not in direct contact with the drug, barrier properties are not adversely impacted. The medicament bag described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behget’s disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer. Exemplary types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and / or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation W137 (CDW137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDW123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumorinfiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins. Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. Exemplary drugs that could be included in the delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz. Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine. Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution. Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g., an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, MiniCHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE. Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the invention which is defined by the following claims.

Claims

1. Medicament bag (1), comprising:a port (2) having a seal configured to close an internal volume of the medicament bag (1);a flap (3) configured to cover the port (2);wherein the flap (3) comprises a port element (32) releasably connected to the port (2).

2. Medicament bag (1) according to claim 1, wherein the port element (32) is a snap-fit member configured to engage the port (2) to releasably connect the flap (3) to the port (2).

3. Medicament bag (1) according to claim 2, wherein the snap-fit member is configured to engage a lateral side of the port (2) or to fit over an entry passage or the seal of the port (2).

4. Medicament bag (1) according to claim 1, wherein the port element (32) is releasably heat welded to the port (2).

5. Medicament bag (1) according to any one of claims 1 to 4, wherein the flap (3) is formed in a substantial U-shape around the port (2).

6. Medicament bag (1) according to any one of claims 1 to 5, wherein the flap (3) substantially covers at least a first side of the medicament bag (1), andwherein preferably, the flap (3) at least partially covers a second side of the medicament bag (1) opposite the first side,wherein preferably, the flap (3) is releasably connected to the second side.

7. Medicament bag (1) according to any one of claims 1 to 6, wherein the flap (3) is integrally formed with the medicament bag (1).

8. Medicament bag (1) according to any one of claims 1 to 8, wherein a fixed end of the flap (3) is attached to or integrally formed with the medicament bag (1) at a side opposite of the port (2), and / orwherein a loose end of the flap (3) is provided at the port (2), wherein preferably, the port element (32) is provided at or towards the loose end.

9. Medicament bag (1) according to any one of claims 6 to 8, wherein a loose end of the flap (3) is provided at the second side of the medicament bag (1).

10. Medicament bag (1) according to any one of claims 1 to 9, wherein the port element (32) comprises a stopper configured to contact the seal of the port (2).

11. Medicament bag (1) according to any one of claims 1 to 10, wherein the flap (3) comprises a perforation configured to allow removal of the flap (3) from the medicament bag (1), and / orwherein the flap (3) is welded to a seam of the medicament bag (1), orwherein the flap (3) is formed of a film layer of the medicament bag (1).

12. Medicament bag (1) according to any one of claims 1 to 11, wherein the flap (3) is at least partially formed of an elastic material (31),wherein preferably, the port element (32) is configured to be removed from the port (2) by elastic deformation of the flap (3).

13. Medicament bag (1) according to claim 12, wherein the flap (3) comprises at least two elastic portions (31), and / orwherein the at least partially elastic flap (3) comprises at least one opening and / or at least two legs.

14. Medicament bag (1) according to any one of claims 1 to 13, wherein the flap (3) is at least partially transparent, and / orwherein a portion of the flap (3) is at least partially opaque, and provided with one or more contrasting colours configured to allow inspection of a content of the internal volume of the medicament bag (1),wherein preferably, one or more of the colours are black, white, or5 grayscale.

15. Medicament bag (1) according to any one of claims 1 to 14, wherein the flap (3) comprises a label (4, 41) and / or a sequence information (4, 41),wherein preferably, the label (4,41) and / or sequence information (4, 41) is placed on an inelastic portion of the flap (3).

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