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HSA Approval

VOTMINE INJECTION 10 ML VIAL (50MG/ML)

SIN11495P

VOTMINE INJECTION 10 ML VIAL (50MG/ML)

VOTMINE INJECTION 10 ML VIAL (50MG/ML)

April 25, 2001

DUOPHARMA (SINGAPORE) PTE LTD

DUOPHARMA (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantDUOPHARMA (SINGAPORE) PTE LTD
Licence HolderDUOPHARMA (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION

**RECOMMENDED DOSE:** **Injection:** **Usual Adult and Adolescent Dose:** Antiemetic; or Antivertigo agent – Intramuscular, 50 mg repeated every four hours as needed. Intravenous, 50 mg in 10 mL of 0.9% sodium chloride injection, administered slowly over a period of at least two minutes, repeated every four hours as needed. **Usual Pediatric Dose: Antiemetic; or Antivertigo agent** – Intramuscular, 1.25 mg per kg of body weight or 37.5 mg per square meter of body surface, every six hours as needed, not to exceed 300 mg per day. Intravenous, 1.25 mg per kg of body weight or 37.5 mg per square meter of body surface, in 10 ml of 0.9% sodium chloride injection, administered slowly over a period of at least two minutes, every six hours as needed, not to exceed 300 mg per day. Note: Premature and full-term neonates – Use is not recommended. **Usual Geriatric Dose:** See Usual Adult and Adolescent Dose. Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. As this preparation contains benzyl alcohol, its use should be avoided in children under two years of age. Not to be used in neonates. **ROUTE OF ADMINISTRATION:** Injection: For I.M. and I.V. injection

INTRAVENOUS, INTRAMUSCULAR

Medical Information

**INDICATIONS:** Prevention and relief of motion sickness, treatment of vertigo, nausea or vomiting associated with electroshock therapy, anaesthesia and surgery; labirinthine disturbances and radiation sickness.

**CONTRAINDICATIONS:** Dimenhydrinate is contraindicated in patients known to be allergic to this drug.

A04AD

其它镇吐药

Manufacturer Information

DUOPHARMA (SINGAPORE) PTE. LTD.

DUOPHARMA (M) SDN BHD

Active Ingredients

DIMENHYDRINATE

50 mg/ml

Dimenhydrinate

Documents

Package Inserts

Votmine Inj_PI_Proposed.pdf

Approved: January 20, 2021

Download

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