LABEL for Rocuronium, roll

ASTM D4267 - 07(2015): Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers.

ISO 26825:2020: Anaesthetic and respiratory equipment -- User-applied labels for syringes containing drugs used during anaesthesia -- Colours, design and performance.

• The label must be self-adhesive.
• If the labels are supplied in tape form, the place where the tape is to be cut between the labels must be perforated or clearly marked.
• If there is backing material, the label must be easily detachable from it and from adjacent labels.
• The label material should allow the user to write additional information (e.g. drug concentration) on the label with a ball-point pen, without smudging or blurring.
• Background colours and patterns should be in accordance with ISO specifications. The background colour must not be such as to impair the legibility of any additional information on the label using a black ball-point pen.
• To designate a drug of opposite action (including antagonists), use 1 mm wide diagonal stripes of the designated colour, alternating with 1 mm wide white stripes. At least the top 20 % of the label should be marked with diagonal stripes. The top of the drug name must be separated from the diagonal stripes by at least 0.5 mm.
• Each label should be between 25 mm and 40 mm in length and between 10 mm and 15 mm in width.
• The height of the letters of the drug name should be as large as possible and not less than 2.5 mm in a plain font (sans serif) with similar proportions of line and space within the letters (bold or semi-bold style):
• lower case letters with an initial upper case letter
• lower case letters with the distinctive parts of similar drug names in upper case letters (so-called 'tall-man' lettering)
• all-upper case lettering should not be used
• Except for drugs of opposite action (including antagonists), the drug name should be printed in the upper half of the label to allow space for writing the strength of the drug.
• All letters should be black except for the labels for suxamethonium and adrenaline, which should be printed on the background colour with inverted bold letters in a black bar running from one edge of the upper half of the label to the other, with the rest of the label showing the coloured background.
• The concentration unit can be pre-printed at the bottom right corner of the label​.

Note for Tall Man Lettering:

There is a lack of standardisation regarding the name pairs to be included and the letters to be in uppercase. It is recommended to follow the list provided by the FDA and IMSP (Institute for Safe Medication Practice): DOPamine, diazePAM, ePHEDrine and fentaNYL.

Others are proposed by the CCWG: KETAmine, PROPofol, THIOpental, MIDAzolam, ATRAcurium, VECUronium, SUXAmenthonium (= succinylcholine), NEOstigmine, MORPhine, NALoxone, LIDOcaine, BUPIvacaine, ONDAnsetron, DEXAmethasone, aTROPine, PHENylephrine, ADREnaline, ANTIbiotic, OXYTocin.

Presentation in rolls. The number of labels per roll varies according to the manufacturer: 400 to 1000 labels per roll.

The quantity to be ordered should be the number of rolls (not the number of labels).

Some rolls are presented in dispenser boxes, while other manufacturers offer different models of label dispensers for 6 to 24 rolls.

Dispensor for syringe labels

• Below 25°C - Protect from sunlight - Protect from humidity
• Keep the labels in their protective packaging, away from dust, until their use.