Source: Health Products and Food Branch (CA) Revision Year: 2017
DIMENHYDRINATE INJECTION USP / SANDOZ DIMENHYDRINATE.
| Product | Routes of Administration | Dosage Form / Strength | Nonmedicinal Ingredients |
|---|---|---|---|
| Dimenhydrinate Injection USP | Intramuscular injection (or IV administration if diluted) | Parenteral / 50 mg/mL 1 mL ampoules | propylene glycol 50% and water for injection. |
| Dimenhydrinate Injection USP | Intramuscular injection (or IV administration if diluted) | Parenteral / 50 mg/mL 5 mL multidose vials | benzyl alcohol 5%, propylene glycol 50% and water for injection. |
| Dimenhydrinate Injection USP | Intravenous injection | Parenteral / 10 mg/mL 5 mL single use vials | ethyl alcohol 10% and water for injection |
| Sandoz Dimenhydrinate | Rectal | Suppositories / 50 mg | hard fat. |
| Suppositories / 100 mg |
NMI = Non-medicinal ingredients
Dimenhydrinate Injection USP for IM administration or IV administration if diluted Ampoules 50 mg/mL:
Active: 50 mg dimenhydrinate.
NMI: propylene glycol 50% and water for injection.
Dimenhydrinate Injection USP for IM administration or IV administration if diluted Multidose vials 50 mg/mL:
Active: 50 mg dimenhydrinate.
NMI: benzyl alcohol 5%, propylene glycol 50% and water for injection.
Dimenhydrinate Injection USP for IV administration:
Single use vials 10 mg/mL.
Active: 10 mg dimenhydrinate.
NMI: ethyl alcohol 10% and water for injection
Sandoz Dimenhydrinate Suppositories 50 mg:
Active: 50 mg dimenhydrinate.
NMI: hard fat.
Sandoz Dimenhydrinate Suppositories 100 mg:
Active: 100 mg dimenhydrinate.
NMI: hard fat.
For IM administration or IV administration if diluted. Each mL contains dimenhydrinate 50 mg, propylene glycol 50% and water for injection. (See Dosage and Administration, if used for IV administration). Available in ampoules of 1 mL, boxes of 10 ampoules.
For IM administration or IV administration if diluted. Each mL contains dimenhydrinate 50 mg, benzyl alcohol 5%, propylene glycol 50% and water for injection. (See Dosage and Administration, if used for IV administration). Available in multidose vials of 5 mL, boxes of 10.
LATEX-FREE STOPPER: Stopper contains no dry natural rubber.
For IV administration only. Each mL contains: dimenhydrinate 10 mg, ethyl alcohol 10% and water for injection. Available in single use vials of 5 mL, boxes of 10.
LATEX-FREE STOPPER: Stopper contains no dry natural rubber.
Each suppository contains 50 mg dimenhydrinate, and hard fat. Boxes of 10.
Each suppository contains 100 mg dimenhydrinate, and fat. Boxes of 10.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
Sandoz Canada Inc., Jules-Léger, Boucherville, QC, Canada, J4B 7K8 203644 |
Date of revision:
December 22, 2017 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
