Hospital Injectable Products · LP-205
Vitamin K1 Injection
Generic medicine development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-205Hospital Injectable Products
- Generic identity
- Vitamin K1Injection
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Ingredient reference
Record identity and reference background.
- Portfolio reference
- LP-205
- Generic ingredient
- Vitamin K1
- Dosage form
- Injection
- Proposed strength
- 10 mg/mL
- Proposed pack
- Ampoule 1 mL; carton 10 ampoules
- Portfolio category
- Hospital Injectable Products
About Vitamin K1
Vitamin K1, also called phytonadione or phytomenadione, supports synthesis of vitamin-K-dependent clotting factors. Injectable preparations have defined roles in preventing or treating certain vitamin-K-related bleeding problems. They are not equivalent to oral supplements and are not a universal treatment for every coagulopathy. The formulation, patient age and clinical indication determine the appropriate product and route.
How to read this profile
Scientific information relates to the ingredient and dosage-form context. It is not approved Luang Pharma labelling, a clinical recommendation, or evidence of equivalence to a referenced product. Multiple strengths or presentations represent separate proposed variants and must not be treated as interchangeable.
02 · Professional background
Scientific & clinical reference
Read the clinical context, selected safety considerations and presentation-specific information below.
Clinical context and therapeutic role
Assessment considers the cause of abnormal coagulation, the severity of bleeding and exposure to medicines such as vitamin K antagonists. Newborn prophylaxis and treatment of an adult anticoagulation-related problem require separate clinical protocols and product eligibility. The catalogue lists a concentrated ampoule without establishing neonatal suitability. This page does not provide an anticoagulant-reversal or newborn-administration regimen.
Important safety considerations
Injectable vitamin K1 can cause serious or life-threatening hypersensitivity reactions, including around administration. Injection-site reactions can occur. The response to vitamin K depends on the underlying cause of the clotting problem, and correction is not instantaneous. Anticoagulated patients require professional review of the balance between bleeding and thrombosis. Product excipients and route-specific risks are particularly important for infants and vulnerable patients.
These are selected considerations, not a complete list. Use the current instructions or approved label for the exact authorised product and seek appropriate professional advice.
Presentation, handling and storage
The record lists a 10 mg/mL ampoule. Verify the exact vitamin K1 formulation, solubilizing system, preservatives and authorized routes and ages. It must not be treated as proof that the ampoule is suitable for newborn prophylaxis.
Professional preparation must follow the authorized label and local aseptic procedures. Confirm the correct container, concentration, route and expiry before use. Storage, transport, dilution compatibility and any period after opening or reconstitution require product-specific evidence; this page does not establish them.
Final composition, instructions, shelf life and storage conditions are not established by this portfolio entry. They must come from the controlled documentation for the specific product.
Points for professional review
Confirm the cause of coagulopathy, relevant laboratory results, bleeding severity, interacting therapy and product eligibility. Use the exact authorized label and appropriate monitoring.
03 · Product enquiry
Documentation & regulatory status
Evidence status
What is established — and what remains open
This record has received an editorial evidence-layer review. The review separates catalogue facts from unresolved product-specific fields and external context; it is not medical, regulatory or market-authorisation approval.
Layer 01
Controlled catalogue facts
- Generic ingredient
- Vitamin K1
- Dosage form / presentation
- Injection
- Catalogue strength
- 10 mg/mL
- Catalogue pack
- Ampoule 1 mL; carton 10 ampoules
- Portfolio category
- Hospital Injectable Products
Layer 02
Unresolved product-specific fields
- The catalogue establishes Vitamin K1 injection at 10 mg/mL in a 1 mL ampoule but does not identify phytonadione formulation type, excipients/emulsifier system, authorised route, light-protection requirements or storage.
- External phytonadione injectable-emulsion labels show that excipients, routes and light/storage controls are product-specific and therefore cannot be imported into LP-205.
- Approved indication, patient eligibility and dosing or test interpretation are not established by this portfolio record.
- Registration/authorization, manufacturing or site status, supply availability, storage conditions and shelf life remain product- and market-specific evidence items.
Layer 03
Attributed external context
- DailyMed: phytonadione injectable emulsion 10 mg/mL — external comparatorgovernment-hosted external product label
These references provide scientific or regulatory context only. They are not Luang Pharma product labelling, registration, manufacturing evidence, equivalence evidence or confirmation of supply.
Layer 04
Documents required to close the record
- Sterile product specification confirming exact active chemical/formulation identity, concentration, container/fill, authorised route(s), excipients/preservatives and preparation/compatibility controls.
- Destination-market authorisation or other lawful supply-route evidence plus the approved label/leaflet, where applicable.
- Product-specific composition/excipient, storage, shelf-life and pack-control documentation.
- Manufacturing-site and supply-status evidence before any public claim of installed capability, registration, availability or equivalence.
For LP-205, identify the destination country, intended professional use, proposed presentation and the role of your organisation. The appropriate supply route and available documentation must be confirmed for that case.
- Confirm the legal entity, manufacturing site and authorised scope for the proposed supply chain.
- Confirm product registration or another lawful route, approved labelling and the applicable destination requirements.
- Request relevant product information, specifications and supporting evidence through the company contact.
- Confirm storage, transport, traceability, complaints and safety-reporting responsibilities before any agreement.
The public catalogue extends beyond the initial planned facility modules. A listing does not mean that the dosage form is installed, qualified or licensed at Boten.
04 · External sources
Sources and further reading
External sources are provided for reference. Their authors do not endorse Luang Pharma, and another product’s authorisation does not transfer to this portfolio record. Source availability and wording can change.
Professional enquiries
Request product-specific evidence for LP-205.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.