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HSA Approval

NEODOL INJECTION 25 mg/ml

SIN09444P

NEODOL INJECTION 25 mg/ml

NEODOL INJECTION 25 mg/ml

July 16, 1997

NAINA MOHAMED & SONS PRIVATE LIMITED

NAINA MOHAMED & SONS PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantNAINA MOHAMED & SONS PRIVATE LIMITED
Licence HolderNAINA MOHAMED & SONS PRIVATE LIMITED

Product Classification

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

Formulation Information

INJECTION

**Dosage and Administration:** IM dose of 75mg once daily. In severe condition, 75mg twice daily. In renal colic, a dose of 75mg repeated once after 30 minutes if necessary. **Special populations** **Established cardiovascular disease or significant cardiovascular risk factors** The use of high dose diclofenac (150mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If diclofenac treatment is needed, patients with established cardiovascular disease, uncontrolled hypertension or significant cardiovascular risk factors (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated only after careful consideration and at doses ≤ 100 mg daily when initial treatment with diclofenac injection continues with diclofenac tablets or suppositories for more than 4 weeks. As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, diclofenac should always be prescribed at the lowest effective daily dose and for the shortest duration possible.

INTRAMUSCULAR

Medical Information

**Indications:** Relief of pain and inflammation in condition such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, renal colic, acute gout.

**Contraindications:** Diclofenac Sodium is contraindicated in patients with history of Hypersensitivity, active peptic ulcer or Gastrointestinal bleeding, and those who are known to develop asthma, urticaria or other allergic reactions with aspirin or other NSAID's. Acute porphyria is a contraindication for Diclofenac. The use of high dose diclofenac (150mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension.

M01AB05

diclofenac

Manufacturer Information

NAINA MOHAMED & SONS PRIVATE LIMITED

BROWN & BURK PHARMACEUTICAL LTD

Active Ingredients

DICLOFENAC SODIUM

25 mg/ml

Diclofenac

Documents

Package Inserts

Neodol Injection PI.pdf

Approved: September 29, 2022

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NEODOL INJECTION 25 mg/ml - HSA Approval | MedPath