Hospital Injectable Products · LP-198
Oxytocin Injection
Generic medicine development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-198Hospital Injectable Products
- Generic identity
- OxytocinInjection
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Ingredient reference
Record identity and reference background.
- Portfolio reference
- LP-198
- Generic ingredient
- Oxytocin
- Dosage form
- Injection
- Proposed strength
- 10 IU/mL
- Proposed pack
- Ampoule 1 mL; cold-chain carton
- Portfolio category
- Hospital Injectable Products
About Oxytocin
Oxytocin is a hormone medicine that stimulates uterine contraction. Injectable products have important uses in obstetric care, including defined labour-management and postpartum bleeding contexts. Those settings require different clinical assessments and protocols. The source entry is a professional-use ampoule candidate; it should not be presented as suitable for unsupervised administration or elective use without an appropriate obstetric indication.
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
Clinical decisions consider maternal condition, pregnancy and labour circumstances, uterine history and the available monitoring environment. Labour-related use requires appropriate assessment of fetal wellbeing and uterine activity, while postpartum bleeding needs rapid evaluation of its cause and coordinated care. A concentration and cold-chain carton description are not a treatment algorithm. No infusion method, labour-induction schedule or postpartum regimen is provided by this educational catalogue.
Important safety considerations
Excessive uterine activity can compromise the fetus or contribute to uterine injury. Fluid and electrolyte disturbances, including water intoxication, can occur with inappropriate exposure. Maternal cardiovascular effects and serious hypersensitivity are additional concerns. Previous uterine surgery and other obstetric factors require specialist assessment. Product-selection or administration errors can have severe consequences, so use requires an authorized obstetric protocol, trained staff and appropriate monitoring.
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 catalogue describes 10 IU/mL ampoules. Confirm the activity basis, excipients, authorized routes and container specification. The listed cold-chain presentation does not by itself establish validated transport limits, excursion acceptance or shelf life for the candidate.
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 obstetric indication, maternal and fetal assessment where relevant, product identity, handling requirements and monitoring. Use only within an appropriate clinical care pathway.
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
- Oxytocin
- Dosage form / presentation
- Injection
- Catalogue strength
- 10 IU/mL
- Catalogue pack
- Ampoule 1 mL; cold-chain carton
- Portfolio category
- Hospital Injectable Products
Layer 02
Unresolved product-specific fields
- The catalogue establishes oxytocin injection at 10 IU/mL in a 1 mL ampoule and describes a cold-chain carton, but it does not establish exact formulation, authorised route, validated storage range, excursion limits or shelf life.
- External 10-units/mL oxytocin presentations use product-specific containers, excipients and storage instructions; those details are not transferred to LP-198.
- 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: oxytocin injection 10 USP units/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-198, 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-198.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.