Finished product reference
Insulin Isophane
Injection · Parenteral · 100 IU/1mL · 3 mL
- List code
- 19877
- Pharmacologic class
- Antidiabetic: intermediate-acting human insulin (NPH)
What it is and how it works
Isophane (NPH) insulin is human insulin complexed with protamine, forming a suspension that is slowly absorbed after subcutaneous injection. Onset is about 1–2 hours with a duration of up to about 24 hours; insulin lowers blood glucose by promoting peripheral glucose uptake and inhibiting hepatic glucose production.
Indications
Treatment of diabetes mellitus requiring insulin, usually as basal insulin alone or combined with short-acting insulin or oral agents.
Dosage and administration (summary)
Subcutaneous injection once or twice daily; dose individualised according to blood glucose monitoring. Resuspend by gentle rolling and inversion before use; must not be given intravenously.
Contraindications
Hypoglycaemia; hypersensitivity to human insulin, protamine or excipients.
Warnings and precautions
Hypoglycaemia, including nocturnal hypoglycaemia, is the main risk. Rotate injection sites to avoid lipodystrophy and cutaneous amyloidosis; changes in insulin type require supervision. Combination with thiazolidinediones may cause fluid retention and heart failure.
Pregnancy
Insulin is the treatment of choice in pregnancy; requirements change through pregnancy and need close monitoring.
Storage and supply
Store unopened at 2–8 °C; do not freeze. In use, keep below 25–30 °C for up to 4–6 weeks according to the product; protect from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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