| Item | DT | Card | Conf | Description | Label |
|---|
hl7:manufacturedProduct
| | | | | UVMe tail |
@classCode
| cs | 1 … 1 | F | MANU |
hl7:templateId
| II | 1 … 1 | M | | UVMetail |
@root
| uid | 1 … 1 | F | 2.16.840.1.113883.10.21.4.11 |
hl7:manufacturedMaterial
| | | | | UVMetail |
@classCode
| cs | 0 … 1 | F | MMAT |
@determinerCode
| cs | 0 … 1 | F | KIND |
hl7:code
| CE | 1 … 1 | R | The code element SHALL be present and describes the code of the medication. The medication may be either - a brand/product or
- described as a generic/scientific name or
- a descriptor of a magistral preparation/compound medicine
If the medicine has no code / is uncoded (e.g., magistral preparations, compound medicine, ...) nullFlavor="NA" SHALL be used. | UVMetail |
@nullFlavor
| cs | 0 … 1 | | |
hl7:originalText
| ED | 1 … 1 | R | The originalText shall contain a reference whose URI value points to the name and strength of the medication in the corresponding section.text, or just the name alone if strength is not relevant. | UVMetail |
hl7:reference
| TEL | 1 … 1 | R | | UVMetail |
hl7:translation
| CE | 0 … * | | Product code(s) from any organizational or juristdictional system | UVMetail |
| | CONF | | shall be drawn from concept domain "Product Code" |
|
hl7:name
| EN | 0 … 1 | R | The element SHOULD contain the name of the medication (e.g., "Adol 500mg Caplet"). The medication may be either - a brand/product or
- described as a generic/scientific name or
- a descriptor of a magistral preparation/compound medicine
| UVMetail |
pharm:formCode
| CE | 0 … 1 | | This code represents the pharmaceutical dose form (e.g., tablet, capsule, liquid) and SHOULD be present, if not implied by the product. It MAY be present if implied by the product. The value of this code may affect the units used in the substance administration quantity element. | UVMetail |
hl7:lotNumberText
| ST | 0 … 1 | | The lotNumberText element MAY be present and is a string representation of a lot number of this specific instance of the product. The provided lot number SHALL refer to the primary packaged item described in the Packaging element. | UVMetail |
pharm:expirationTime
| TS | 0 … 1 | | The pharm:expirationTime element MAY be present and SHALL contain a value attribute containing the date (e.g., specific date, specific date including time) of expiration of this specific instance of the product. The value given in the pharm:expirationTime element SHALL refer to the primary packaged item described in the Medicine Packaging element. | UVMetail |
@value
| | 1 … 1 | R | |
pharm:asContent
| | 0 … * | | This structure describes the packaging of the medication and MAY be present. It represents the primary description of the packaging of the medicine (e.g., the medicine is packaged in ampoules of 50ml volume each) and may include additional packaging information of how many of the primary packaged items are within an outer package (e.g., 5 ampoules are packaged in a box).
The primary description of the package SHOULD be consistent with the given pharmaceutical dose form (pharm:formCode of the medication, see chapter “Medication Form Code”). Example: a consistent pharmaceutical dose form to the package form “Ampoules” would be e.g., “Solution for injection”.
In case the package describes a product, the pharm:code element provides the code for the product and SHOULD be present.
In case the package describes a product, and the package has a brand name, it SHOULD be described in the pharm:name element (e.g., Xylocaine 1% with Adrenaline Inj, 5 injections package).
The pharm:formCode element represents the form of the product (e.g., tablet container, bottle, ...) and SHOULD be present, if not implied by the product. It MAY be present if implied by the product. It SHALL be present if the asSuperContent element is present.
The pharm:capacityQuantity element SHALL be present and describes the capacity of the packaging.
If the capacityQuantity is given in countable units, the unit attribute SHALL NOT be present. If the capacityQuantity is given in non-countable units, the unit attribute SHALL be present and the value SHALL be out of the UCUM code system.
A pharm:asSuperContent element MAY be present to represent the quantity of the given primary packaged item (e.g., ampoule of 50ml) within an outer package (e.g., 5 ampoules in a box). It SHALL contain a pharm:containerPackagedMedicine element which SHALL contain a pharm:capacityQuantity element describing the quantity of the given primary packaged item present in the outer package. If the capacityQuantity is given in countable units, the unit attribute SHALL NOT be present. If the capacityQuantity is given in non-countable units, the unit attribute SHALL be present and the value SHALL be out of the UCUM code system. | UVMetail |
@classCode
| cs | 1 … 1 | F | CONT |
| | Example | Packaged Medicinal Product with formCode <pharm:asContent classCode="CONT">
<pharm:containerPackagedProduct classCode="CONT" determinerCode="INSTANCE">
<!-- Packaged Medicinal Product -->
<pharm:code codeSystem="1.999.999" code="PC_ID" displayName="Packaged Product Name"/> <pharm:name>100 MIRACLE PILLS(TM)</pharm:name> <pharm:formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="30009000" displayName="Box" CodeSystemName="EDQM"/> </pharm:containerPackagedProduct></pharm:asContent> |
| | Example | General example <pharm:asContent classCode="CONT">
<pharm:containerPackagedProduct classCode="CONT" determinerCode="INSTANCE">
<!-- Medicinal product code (package-level) -->
<pharm:code code=" " displayName=" " codeSystem=" " codeSystemName=" "/> <!-- Brand name (package) -->
<pharm:name> . . . </pharm:name> <pharm:formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/> <pharm:capacityQuantity value=" " unit=" "/> <pharm:asContent>
<pharm:containerPackagedProduct classCode="CONT" determinerCode="INSTANCE">
<pharm:capacityQuantity value=" " unit=" "/> </pharm:containerPackagedProduct> </pharm:asContent> </pharm:containerPackagedProduct></pharm:asContent> |
| | Example | Medicinal product with pharmaceutical dose form ”Tablets”, available as a “Tablet container” with 30 tablets <pharm:asContent classCode="CONT">
<pharm:containerPackagedProduct classCode="CONT" determinerCode="INSTANCE">
<!-- .. -->
<pharm:formCode code=" " displayName="Tablet container" codeSystem=" " codeSystemName=" "/> <!-- 30 tablets in the package -->
<pharm:capacityQuantity value="30"/> </pharm:containerPackagedProduct></pharm:asContent> |
| | Example | Medicinal product with pharmaceutical dose form 'Solution for injection', available as “Ampoules” with 50ml volume, packaged as 5 ampoules per box <pharm:asContent classCode="CONT">
<pharm:containerPackagedProduct classCode="CONT" determinerCode="INSTANCE">
<!-- .. -->
<pharm:formCode code=" " displayName="Ampoules" codeSystem=" " codeSystemName=" "/> <pharm:capacityQuantity value="50" unit="ml"/> <!-- 50ml per ampoule -->
<pharm:asContent>
<pharm:containerPackagedProduct classCode="CONT" determinerCode="INSTANCE">
<!-- 5 ampoules in a box -->
<pharm:capacityQuantity value="5"/> </pharm:containerPackagedProduct> </pharm:asContent> </pharm:containerPackagedProduct></pharm:asContent> |
| | Example | Packaged Medicinal Product with multiple layers packaging <pharm:asContent>
<pharm:containerPackagedProduct>
<!-- Inner Package -->
<pharm:code codeSystem="..." code="..." displayName="..."/> <pharm:asContent>
<pharm:containerPackagedProduct>
<!-- Intermediate Package -->
<pharm:asContent>
<pharm:containerPackagedProduct>
<!-- Outer Package / Packaged Medicinal Product -->
</pharm:containerPackagedProduct> </pharm:asContent> </pharm:containerPackagedProduct> </pharm:asContent> </pharm:containerPackagedProduct></pharm:asContent> |
pharm:quantity
| PQ | 0 … 1 | | | UVMetail |
pharm:containerPackagedProduct
| | 1 … * | R | | UVMetail |
@classCode
| cs | 1 … 1 | F | CONT |
@determinerCode
| cs | 1 … 1 | F | INSTANCE |
pharm:code
| CE | 0 … 1 | | | UVMetail |
pharm:name
| EN | 0 … * | | | UVMetail |
pharm:formCode
| CE | 0 … 1 | | | UVMetail |
pharm:capacityQuantity
| PQ | 1 … 1 | M | | UVMetail |
@value
| | 1 … 1 | R | |
@unit
| cs | 0 … 1 | | |
pharm:asContent
| | 0 … * | | In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the "2 blisters"
In the case of
\--Box
\-----5 vials
it represents the Packaged Medicinal Product. | UVMetail |
@classCode
| cs | 1 … 1 | F | CONT |
pharm:quantity
| PQ | 0 … 1 | | | UVMetail |
pharm:containerPackagedProduct
| | 1 … * | R | | UVMetail |
@classCode
| cs | 1 … 1 | F | CONT |
@determinerCode
| cs | 1 … 1 | F | INSTANCE |
pharm:code
| CD | 0 … 1 | | | UVMetail |
pharm:name
| ST | 0 … 1 | R | It represents the Name of the Package Item or of the Packaged Medicinal Product.
If this is the most inner <pharm:containerPackagedProduct> than this element can be used for the brand name. | UVMetail |
pharm:formCode
| CE | 1 … 1 | | | UVMetail |
pharm:capacityQuantity
| PQ | 1 … 1 | M | | UVMetail |
@value
| | 1 … 1 | R | |
@unit
| cs | 0 … 1 | | |
pharm:asContent
| | 0 … * | R | In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the "2 blisters"
In the case of
\--Box
\-----5 vials
it represents the Packaged Medicinal Product. | UVMetail |
@classCode
| cs | 1 … 1 | F | CONT |
pharm:quantity
| PQ | 0 … 1 | | | UVMetail |
pharm:containerPackagedProduct
| | 1 … * | R | It represents the intermediate Package Item or the Packaged Medicinal Product | UVMetail |
@classCode
| cs | 1 … 1 | F | CONT |
@determinerCode
| cs | 1 … 1 | F | INSTANCE |
pharm:code
| CD | 0 … 1 | | | UVMetail |
pharm:name
| ST | 0 … 1 | R | | UVMetail |
pharm:formCode
| CE | 1 … 1 | R | | UVMetail |
pharm:capacityQuantity
| PQ | 0 … 1 | R | | UVMetail |
@value
| | 1 … 1 | R | |
@unit
| cs | 0 … 1 | | |
pharm:asContent
| | 0 … * | R | In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the Packaged Medicinal Product.
| UVMetail |
@classCode
| cs | 1 … 1 | F | CONT |
pharm:quantity
| PQ | 0 … 1 | | | UVMetail |
pharm:containerPackagedProduct
| | 1 … * | R | When present, it represents the Packaged Medicinal Product | UVMetail |
@classCode
| cs | 1 … 1 | F | CONT |
@determinerCode
| cs | 1 … 1 | F | INSTANCE |
pharm:code
| CD | 0 … * | | | UVMetail |
pharm:name
| ST | 0 … * | R | When present, it can be used to represent the brand name. | UVMetail |
pharm:formCode
| CE | 1 … 1 | R | | UVMetail |
pharm:capacityQuantity
| PQ | 0 … 1 | | | UVMetail |
pharm:quantity
| PQ | 0 … * | | | UVMetail |
pharm:asSpecializedKind
| | 0 … * | R | | UVMetail |
@classCode
| cs | 1 … 1 | F | GRIC |
| | Example | <pharm:asSpecializedKind classCode="GRIC">
<pharm:generalizedMedicineClass classCode="MMAT">
<pharm:code code=" " displayName=" " codeSystem=" " codeSystemName=" "/> </pharm:generalizedMedicineClass></pharm:asSpecializedKind> |
pharm:generalizedMedicineClass
| | 0 … * | | | UVMetail |
@classCode
| cs | 1 … 1 | F | MMAT |
pharm:code
| | 1 … 1 | R | | UVMetail |
pharm:name
| | 0 … * | | | UVMetail |
pharm:ingredient
| | 0 … * | | | UVMetail |
@classCode
| cs | 1 … 1 | F | ACTI |
| | Example | <pharm:ingredient classCode="ACTI">
<pharm:quantity>
<cda:numerator xsi:type="PQ" value=" " unit=" "/> <cda:denominator xsi:type="PQ" value=" " unit=" "/> </pharm:quantity> <pharm:ingredient classCode="MMAT" determinerCode="KIND">
<pharm:code code=" " displayName=" " codeSystem="2.16.840.1.113883.6.73" codeSystemName="ATC WHO"/> </pharm:ingredient></pharm:ingredient> |
pharm:quantity
| | 0 … 1 | | | UVMetail |
| | Example | 10 mg of the ingredient per ml <pharm:quantity>
<cda:numerator xsi:type="PQ" value="10" unit="mg"/> <cda:denominator xsi:type="PQ" value="1" unit="ml"/></pharm:quantity> |
| | Example | 2% of the ingredient <pharm:quantity>
<cda:numerator xsi:type="PQ" value="2" unit="%"/> <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> |
| | Example | 5mg of the ingredient <pharm:quantity>
<cda:numerator xsi:type="PQ" value="5" unit="mg"/> <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> |
cda:numerator
| | 0 … 1 | | | UVMetail |
cda:denominator
| | 0 … 1 | | | UVMetail |
pharm:ingredientSubstance
| | 0 … 1 | | | UVMetail |
@classCode
| cs | 1 … 1 | F | MMAT |
@determinerCode
| cs | 1 … 1 | F | KIND |
pharm:code
| | 0 … 1 | | | UVMetail |
pharm:name
| | 1 … 1 | R | | UVMetail |
hl7:manufacturerOrganization
| | 0 … 1 | R | Contains 2.16.840.1.113883.10.12.151 CDA Organization (DYNAMIC) | UVMetail |
Under pre-publication review
CDA Organization