http://terminology.hl7.org/CodeSystem/v3-ActCode
Code | Display | Definition |
REP_HALF_LIFE | representative half-life | **Description:**This observation represents an 'average' or 'expected' half-life typical of the product. |
SPLCOATING | coating | **Definition:** A characteristic of an oral solid dosage form of a medicinal product, indicating whether it has one or more coatings such as sugar coating, film coating, or enteric coating. Only coatings to the external surface or the dosage form should be considered (for example, coatings to individual pellets or granules inside a capsule or tablet are excluded from consideration). **Constraints:** The Observation.value must be a Boolean (BL) with true for the presence or false for the absence of one or more coatings on a solid dosage form. |
SPLCOLOR | color | **Definition:** A characteristic of an oral solid dosage form of a medicinal product, specifying the color or colors that most predominantly define the appearance of the dose form. SPLCOLOR is not an FDA specification for the actual color of solid dosage forms or the names of colors that can appear in labeling. **Constraints:** The Observation.value must be a single coded value or a list of multiple coded values, specifying one or more distinct colors that approximate of the color(s) of distinct areas of the solid dosage form, such as the different sides of a tablet or one-part capsule, or the different halves of a two-part capsule. Bands on banded capsules, regardless of the color, are not considered when assigning an SPLCOLOR. Imprints on the dosage form, regardless of their color are not considered when assigning an SPLCOLOR. If more than one color exists on a particular side or half, then the most predominant color on that side or half is recorded. If the gelatin capsule shell is colorless and transparent, use the predominant color of the contents that appears through the colorless and transparent capsule shell. Colors can include: Black;Gray;White;Red;Pink;Purple;Green;Yellow;Orange;Brown;Blue;Turquoise. |
SPLIMAGE | image | **Description:** A characteristic representing a single file reference that contains two or more views of the same dosage form of the product; in most cases this should represent front and back views of the dosage form, but occasionally additional views might be needed in order to capture all of the important physical characteristics of the dosage form. Any imprint and/or symbol should be clearly identifiable, and the viewer should not normally need to rotate the image in order to read it. Images that are submitted with SPL should be included in the same directory as the SPL file. |
SPLIMPRINT | imprint | **Definition:** A characteristic of an oral solid dosage form of a medicinal product, specifying the alphanumeric text that appears on the solid dosage form, including text that is embossed, debossed, engraved or printed with ink. The presence of other non-textual distinguishing marks or symbols is recorded by SPLSYMBOL. **Examples:** Included in SPLIMPRINT are alphanumeric text that appears on the bands of banded capsules and logos and other symbols that can be interpreted as letters or numbers. **Constraints:** The Observation.value must be of type Character String (ST). Excluded from SPLIMPRINT are internal and external cut-outs in the form of alphanumeric text and the letter 'R' with a circle around it (when referring to a registered trademark) and the letters 'TM' (when referring to a 'trade mark'). To record text, begin on either side or part of the dosage form. Start at the top left and progress as one would normally read a book. Enter a semicolon to show separation between words or line divisions. |
SPLSCORING | scoring | **Definition:** A characteristic of an oral solid dosage form of a medicinal product, specifying the number of equal pieces that the solid dosage form can be divided into using score line(s). **Example:** One score line creating two equal pieces is given a value of 2, two parallel score lines creating three equal pieces is given a value of 3. **Constraints:** Whether three parallel score lines create four equal pieces or two intersecting score lines create two equal pieces using one score line and four equal pieces using both score lines, both have the scoring value of 4. Solid dosage forms that are not scored are given a value of 1. Solid dosage forms that can only be divided into unequal pieces are given a null-value with nullFlavor other (OTH). |
SPLSHAPE | shape | **Description:** A characteristic of an oral solid dosage form of a medicinal product, specifying the two dimensional representation of the solid dose form, in terms of the outside perimeter of a solid dosage form when the dosage form, resting on a flat surface, is viewed from directly above, including slight rounding of corners. SPLSHAPE does not include embossing, scoring, debossing, or internal cut-outs. SPLSHAPE is independent of the orientation of the imprint and logo. Shapes can include: Triangle (3 sided); Square; Round; Semicircle; Pentagon (5 sided); Diamond; Double circle; Bullet; Hexagon (6 sided); Rectangle; Gear; Capsule; Heptagon (7 sided); Trapezoid; Oval; Clover; Octagon (8 sided); Tear; Freeform. |
SPLSIZE | size | **Definition:** A characteristic of an oral solid dosage form of a medicinal product, specifying the longest single dimension of the solid dosage form as a physical quantity in the dimension of length (e.g., 3 mm). The length is should be specified in millimeters and should be rounded to the nearest whole millimeter. **Example:** SPLSIZE for a rectangular shaped tablet is the length and SPLSIZE for a round shaped tablet is the diameter. |
SPLSYMBOL | symbol | **Definition:** A characteristic of an oral solid dosage form of a medicinal product, to describe whether or not the medicinal product has a mark or symbol appearing on it for easy and definite recognition. Score lines, letters, numbers, and internal and external cut-outs are not considered marks or symbols. See SPLSCORING and SPLIMPRINT for these characteristics. **Constraints:** The Observation.value must be a Boolean (BL) with <u>true</u> indicating the presence and <u>false</u> for the absence of marks or symbols. **Example:** |