LABEL for Bupivacaine, 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 area where the tape should be cut between 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 additional information (e.g. drug concentration) to be written with a ball-point pen, without smudging or blurring.
• Background colours and patterns should adhere ISO specifications. The background colour must not impair the legibility of any additional information on the label when using a black ball-point pen.
• To designate a drug with opposite actions (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 have diagonal stripes. The top of the drug name must be separated from the diagonal stripes by at least 0.5 mm.
• Each label should measure 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, but not less than 2.5 mm. The font should be a plain sans-serif style, with similar proportions of line and space within the letters (bold or semi-bold style):
• lowercase letters with an initial uppercase letter
• lowercase letters with distinctive parts of similar drug names in uppercase (so-called 'tall-man' lettering)
• all-uppercase lettering should not be used
• Except for drugs with opposite actions (including antagonists), the drug name should be printed in the upper half of the label, leaving space to write the drug's strength.
• 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 on Tall Man Lettering:

Due to the lack of standardisation regarding the name pairs and the uppercase letters to use, 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 depending on the manufacturer: 400 to 1000 labels per roll.

The quantity to be ordered should be based on 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 that can hold 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.