Excipients for Label and Corresponding Information for the Package Leaflet*
| Name | Threshold Level | Information for the Package Leaflet |
|---|---|---|
| Arachis oil | Zero | Whenever arachis oil appears, peanut oil should appear beside it. If you are allergic to peanut or soya, do not use this medicinal product. |
| Benzoic acid and benzoates | Zero | It may increase the risk of jaundice in newborn babies. |
| Benzyl alcohol | Exposures less than 90 mg/kg/day | Must not be given to premature babies or neonates. May cause toxic reactions and allergic reactions in infants and children up to 3 years old. |
| 90 mg/kg/day | Must not be given to premature babies or neonates. Due to the risk of fatal toxic reactions arising from exposure to benzyl alcohol in excess of 90 mg/kg/day, this product should not be used in infants and children up to 3 years old. | |
| Castor oil polyoxyl and castor oil polyoxyl hydrogenated | Zero | May cause severe allergic reactions. |
| Chlorocresol | Zero | May cause allergic reactions. |
| Ethanol | Less than 100 mg per dose | This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 〈dose〉. |
| 100 mg to 3 g per dose | This medicinal product contains …vol % ethanol (alcohol), i.e., up to …mg per dose, equivalent to …mL beer, …mL wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children, and high-risk groups such as patients with liver disease or epilepsy. | |
| 3 g per dose | This medicinal product contains …vol % ethanol (alcohol), i.e., up to …mg per dose, equivalent to …mL beer, …mL wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children, and high-risk groups such as patients with liver disease or epilepsy. The amount of alcohol in this medicinal product may alter the effects of other medicines. The amount of alcohol in this medicinal product may impair your ability to drive or use machines. | |
| Fructose | Zero | If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Patients with rare hereditary problems of fructose intolerance should not take this medicine. |
| 5 g | Contains x g fructose per dose. This should be taken into account in patients with diabetes mellitus. | |
| Galactose | Zero | If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. SPC proposal: Patients with rare hereditary problems of galactose intolerance (e.g., galactosaemia) should not take this medicine. |
| 5 g | Contains x g galactose per dose. This should be taken into account in patients with diabetes mellitus. | |
| Glucose | 5 g | Contains x g glucose per dose. This should be taken into account in patients with diabetes mellitus. |
| Heparin (as an excipient) | Zero | May cause allergic reactions and reduced blood cell counts, which may affect the blood clotting system. Patients with a history of heparin-induced allergic reactions should avoid the use of heparin-containing medicines. |
| Organic mercury compounds (such as thiomersal phenylmercuric nitrate, acetate, borate) | Zero | This medicinal product contains <(e.g., thiomersal)> as a preservative and it is possible that <you/your child> may experience an allergic reaction. Tell your doctor if <you/your child> have/has any known allergies. Tell your doctor if <you/your child> have/has experienced any health problems after previous administration of a vaccine. |
| Parahydroxybenzoates and their esters | Zero | May cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm. |
| Phenylalanine | Zero | This medicine contains phenylalanine. May be harmful for people with phenylketonuria. |
| Potassium | Less than 1 mmol per 〈dose〉 | This medicine contains potassium, less than 1 mmol (39 mg) per 〈dose〉, i.e., essentially “potassium-free.” |
| 1 mmol per 〈dose〉 | This medicine contains x mmol (or y mg) potassium per 〈dose〉. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. | |
| 30 mmol/L | May cause pain at the site of injection. | |
| Propylene glycol and esters | 400 mg/kg adults 200 mg/kg children | May cause alcohol-like symptoms. |
| Sesame oil | Zero | May rarely cause severe allergic reactions. |
| Sodium | Less than 1 mmol per 〈dose〉 | This medicinal product contains less than 1 mmol sodium (23 mg) per 〈dose〉, i.e., essentially “sodium-free.” |
| 1 mmol per 〈dose〉 | This medicinal product contains x mmol (or y mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet. | |
| Sorbitol | Zero | If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. SPC proposal: Patients with rare hereditary problems of fructose intolerance should not take this medicine. |
| Soya oil (and hydrogenated soya oil) | Zero | (Medicinal product) contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product. |
↵* Information in the table is based on “Excipients in the label and package leaflet of medicinal products for human use,” Vol. 3B, Guidelines for Medicinal Products for Human Use, Safety, Environment and Information, July 2003.