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HSA Approval

YSP HYOSCINE INJECTION 20MG/ML

SIN16636P

YSP HYOSCINE INJECTION 20MG/ML

YSP HYOSCINE INJECTION 20MG/ML

November 7, 2022

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantYUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
Licence HolderYUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

Product Classification

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

Formulation Information

INJECTION, SOLUTION

**Dosage and Administration(s):** YSP Hyoscine Injection 20mg/ml may be administered by Intramuscular or intravenous injection. Adults One ampoule (20mg) should be given Im or IV, repeated after half an hour if necessary. Intravenous injection should be performed ‘slowly’ (in rare cases a marked drop in blood pressure and even shock may be produced). When used in endoscopy this dose may need to be repeated more frequently. Maximum daily dose of 100mg. Not recommended for children under 12 years old. **Mode of Administration:** Intramuscular or intravenous

INTRAVENOUS, INTRAMUSCULAR

Medical Information

**Indication(s):** YSP Hyoscine Injection 20mg/ml is indicated in acute spasm, as in renal or biliary colic, in radiology for differential diagnosis of obstruction. It also indicated to reduce spasm and pain in pyelography, and in other diagnostic procedures where spasm may be a problem.

**Contraindications:** YSP Hyoscine Injection 20mg/ml are contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients - narrow angle glaucoma - hypertrophy of the prostate with urinary retention - mechanical stenosis in the gastrointestinal tract - paralytical or obstructive ileus - megacolon - tachycardia - myasthenia gravis YSP Hyoscine Injection 20mg/ml should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.

Manufacturer Information

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

Y.S.P. Industries (M) Sdn. Bhd.

Active Ingredients

Hyoscine N-butylbromide

20mg/ml

Scopolamine

Documents

Package Inserts

YSP HYOSCINE INJECTION PI.pdf

Approved: June 23, 2023

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