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HSA Approval

HERBESSER FOR INJECTION 10 mg/ampoule

SIN06013P

HERBESSER FOR INJECTION 10 mg/ampoule

HERBESSER FOR INJECTION 10 mg/ampoule

June 5, 1991

PHARMAFORTE SINGAPORE PTE LTD

PHARMAFORTE SINGAPORE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantPHARMAFORTE SINGAPORE PTE LTD
Licence HolderPHARMAFORTE SINGAPORE PTE LTD

Product Classification

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

Formulation Information

INJECTION, POWDER, FOR SOLUTION

**DOSAGE AND ADMINISTRATION** The drug (10 mg or 50 mg as diltiazem hydrochloride) is dissolved in at least 5 ml of physiological saline or glucose solution for injection before use and administered as follows: - Tachyarrhythmia (supraventricular) Usually for adults, 10 mg of diltiazem hydrochloride as a single dosage is intravenously injected slowly for about 3 minutes. The dosage may be adjusted depending on the patient's age and symptoms. - Emergency treatment for abnormal hypertension during operation Intravenous bolus injection: Usually for adults, 10 mg of diltiazem hydrochloride as a single dosage is intravenously injected slowly for about one minute. The dosage may be adjusted depending on the patient's age and symptoms. Intravenous drip infusion: Usually for adults, 5 to 15 mcg of diltiazem hydrochloride/kg body weight per minute is intravenously injected in drip infusion. After blood pressure is lowered to the target level, adjust the drip infusion rate while monitoring blood pressure. - Hypertensive emergency Usually for adults, 5 to 15 mcg of diltiazem hydrochloride/kg body weight per minute is intravenously injected in drip infusion. After blood pressure is lowered to the target level, adjust the drip infusion rate while monitoring blood pressure. - Unstable angina Usually for adults, 1 to 5 mcg of diltiazem hydrochloride/kg body weight per minute is intravenously injected in drip infusion. The dosage should be started with a low dose and may be adjusted depending on the patient's symptoms. The maximum dosage should be 5 mcg of diltiazem hydrochloride/kg body weight per minute.

INTRAVENOUS

Medical Information

**INDICATIONS** - Tachyarrhythmia (supraventricular) - Emergency treatment for abnormal hypertension during operation - Hypertensive emergency - Unstable angina

**CONTRAINDICATIONS (HERBESSER Injection is contraindicated in the following patients.)** 1. Patients with severe hypotension or cardiogenic shock \[The symptoms may be exacerbated.\] 2. Patients with 2nd or more degree atrioventricular block or sick sinus syndrome (continuous sinus bradycardia less than 50 beats/ minute, sinus arrest, sinoatrial block, etc.) \[Excessively inhibitory effect of the drug on cardiac stimulus-formation and conduction may occur.\] 3. Patients with severe congestive heart failure \[The symptoms of heart failure may be exacerbated.\] 4. Patients with severe cardiomyopathy \[The symptoms of heart failure may be exacerbated.\] 5. Patients with a history of hypersensitivity to any of the ingredients in the drug 6. Pregnant women or women who may possibly be pregnant \[See PRECAUTIONS -Use during Pregnancy, Delivery or Lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.\]

C08DB01

diltiazem

Manufacturer Information

PHARMAFORTE SINGAPORE PTE LTD

MITSUBISHI TANABE PHARMA CORPORATION

Active Ingredients

DILTIAZEM HCl

10 mg/ampoule

Diltiazem

Documents

Package Inserts

Herbesser Injection PI.pdf

Approved: September 3, 2010

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