Nimodipine Injection 10mg/50ml

Nimodipine Injection 10mg/50ml | Cerebral Vasospasm & Ischemia Treatment
    

  • Dosage: Nimodipine 10mg
  • Volume:  100 ml 
  • Packaging: Sterile bottle for injection, 30 bottles in carton
  • Shelf Life: 36 months 

Click to add this item to cart.

Product Description

Product NameNimodipine Injection
Specification10mg/50mL (0.2mg/mL)
Dosage FormSterile, Nonpyrogenic Solution for Intravenous Infusion
Active IngredientNimodipine
Pharmacological ClassDihydropyridine Calcium Channel Blocker / Cerebrovascular Selective Calcium Antagonist
Route of AdministrationIntravenous infusion only (via infusion pump). NOT for intramuscular, subcutaneous, or direct intravenous bolus injection. Use non-PVC administration tubing (nimodipine may leach from PVC).
Packaging50mL sterile glass ampoule or vial (with rubber stopper and aluminum seal)
StorageStore below 25°C, protected from light. Do not freeze. Keep ampoules/vials in outer carton until use.
Shelf Life36 months (unopened)

Product Overview

Nimodipine Injection 10mg/50mL is a sterile, nonpyrogenic solution of nimodipine intended for intravenous infusion. Each 50mL ampoule or vial contains 10mg of nimodipine at a concentration of 0.2mg/mL. Nimodipine is a lipophilic dihydropyridine calcium channel blocker with preferential cerebrovascular selectivity. The intravenous formulation is designed for use in patients with aneurysmal subarachnoid hemorrhage (SAH) who are unable to tolerate oral therapy or in whom oral absorption is unreliable, and for the prevention and treatment of ischemic neurological deficits due to cerebral vasospasm following SAH.

Nimodipine Injection 10mg/50ml: What the Published Guidance Says

The resuscitation, antidote and critical-care injectables that a functioning emergency department cannot run without — most of them named directly on the WHO Model List.

Nimodipine Injection 10mg/50ml is specified against its own monograph, pack size and market registration, so the guidance below is worth reading together with the Emergency & Critical Care range overview.

These points are quoted because they shape how Nimodipine Injection 10mg/50ml is specified, labelled and purchased — including strength selection, pack size and the artwork wording. Confirm each one against the approved product information in your market before finalising a purchase order.

Nimodipine Injection 10mg/50ml — Supply Parameters

Product NameNimodipine Injection
Specification10mg/50mL (0.2mg/mL)
Dosage FormSterile, Nonpyrogenic Solution for Intravenous Infusion
Active IngredientNimodipine
Pharmacological ClassDihydropyridine Calcium Channel Blocker / Cerebrovascular Selective Calcium Antagonist
Route of AdministrationIntravenous infusion only (via infusion pump). NOT for intramuscular, subcutaneous, or direct intravenous bolus injection. Use non-PVC administration tubing (nimodipine may leach from PVC).
StorageStore below 25°C, protected from light. Do not freeze. Keep ampoules/vials in outer carton until use.
Therapeutic groupEmergency & Critical Care — Emergency & Critical Care
ManufacturerSinophare Bio-technology Co., Ltd. (GMP, China)
Documentation suppliedCOA, HPLC/GC data, stability data, dossier package

The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: Heparin Sodium Injection 2mL:5000IU, Citicoline Injection 2ml:250mg Ampoule, Aceglutamide Injection 100mg/5mL, Dobutamine Injection 12.5mg/mL 2mL, Diphenhydramine Injection 50mg/mL 2mL, Dexamethasone Injection 8mg/2mL, Acetylcysteine Injection 1g/5mL, Phentolamine Injection 10mg/1mL.

Quality Control, Pharmacopoeial Standards & Documentation

Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.

Nimodipine Injection 10mg/50ml is released against the pharmacopoeial monograph named on your order (USP, EP, BP or CP). Where no monograph exists for the exact presentation, the specification is agreed with you in writing before manufacture and is attached to the certificate of analysis.

Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.

A typical release panel for this presentation covers:

  • Testing for description and identification
  • Testing for assay of the active substance
  • Testing for related substances and impurities
  • Testing for dissolution or release profile (solid oral forms)
  • Testing for uniformity of dosage units
  • Testing for water content and pH where applicable

COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.

Packaging, Labelling & Export

  • Pack size: 50mL sterile glass ampoule or vial (with rubber stopper and aluminum seal). Non-standard pack sizes can be quoted against your artwork.
  • Storage: Store below 25°C, protected from light. Do not freeze. Keep ampoules/vials in outer carton until use..
  • Shelf life: 36 months (unopened). Stability data for the marketed pack is included in the dossier.
  • Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
  • Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.

Registration, Dossier & Tender Support

Sinophare Bio-technology Co., Ltd. holds DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. That registration identifies the legal manufacturer on the certificate of analysis, the GMP certificate and the documents filed with your national medicines authority.

  • CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
  • Site Master File and GMP certificate for the manufacturing workshops.
  • Method validation, stability protocol and the shelf-life justification for the marketed pack.
  • Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
  • Tender and framework documentation, including pre-qualification questionnaires and sample logistics.

This page describes Nimodipine Injection 10mg/50ml as a product of the emergency and critical-care injectables named in the WHO Model List family. A WHO or national listing is a supply-context fact, not an approval in your market; marketing authorisation remains specific to each country.

Frequently Asked Questions

What pack size is available for Nimodipine Injection 10mg/50ml?

The reference pack is 50mL sterile glass ampoule or vial (with rubber stopper and aluminum seal). Non-standard blister, bottle and carton configurations are quoted against your artwork, matched to the stability data already held for the presentation.

What documentation comes with a shipment of Nimodipine Injection 10mg/50ml?

Each batch ships with a certificate of analysis covering description, identification, assay and related substances, plus stability data for the marketed pack and the GMP certificate of the manufacturing site. Shelf life: 36 months.

Does the batch documentation for Nimodipine Injection 10mg/50ml support a registration filing?

Each batch ships with a certificate of analysis covering description, identification, assay and related substances, plus stability data for the marketed pack and the GMP certificate of the manufacturing site. Shelf life: 36 months. The full CTD dossier and the authority assessment file are supplied as part of a registration order; routine shipments carry the COA and stability data only.

Which of these emergency medicines are on the WHO Model List?

Epinephrine (adrenaline), atropine, dexamethasone injection, calcium gluconate, acetylcysteine, furosemide and heparin appear on the Model List. Confirm current listing for every molecule against the Model List and your national essential medicines list.

Do you supply acetylcysteine as the paracetamol antidote?

Yes. Acetylcysteine injection is available for paracetamol overdose management; the Model List names acetylcysteine among specific antidotes.

Related Emergency & Critical Care Products

Browse the full Emergency & Critical Care range; all Injectables; the complete product catalogue.

Request a Quotation for Nimodipine Injection 10mg/50ml

Send the specification, pack size, quantity and destination market for Nimodipine Injection 10mg/50ml 10mg and we will confirm availability, lead time and documentation. Tender quantities and registration samples are handled on the same quotation.

Request a quotation

Sources & Regulatory Notes

Reference information only. The published guidance summarised on this page is quoted for professional and regulatory-context purposes and does not constitute medical advice, a prescribing recommendation or a promotion of any product for a particular indication. Prescribing decisions must follow the approved product information and national treatment guidelines in the market of use.

<< return to products