Hospital Injectable Products · LP-195
Magnesium sulfate Injection
Generic medicine development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-195Hospital Injectable Products
- Generic identity
- Magnesium sulfateInjection
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Ingredient reference
Record identity and reference background.
- Portfolio reference
- LP-195
- Generic ingredient
- Magnesium sulfate
- Dosage form
- Injection
- Proposed strength
- 500 mg/mL
- Proposed pack
- Ampoule 10 mL; carton 10 ampoules
- Portfolio category
- Hospital Injectable Products
About Magnesium sulfate
Magnesium sulfate is an electrolyte medicine with defined parenteral uses. It can be relevant to magnesium replacement and particular obstetric or cardiac protocols, depending on the diagnosis and authorized formulation. It is not a general sedative or a substitute for assessment of an electrolyte disorder. The concentrated ampoule in this catalogue requires professional handling and must be clearly distinguished from non-injectable magnesium products.
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 assessment includes the indication, kidney function, magnesium status and other electrolytes. Obstetric use for prevention or control of eclamptic seizures occurs within a comprehensive care pathway and does not replace blood-pressure management or obstetric assessment. Cardiac and replacement contexts have different requirements. The catalogue does not provide dilution instructions, administration rates or treatment protocols; these must come from current local guidance and the specific authorized label.
Important safety considerations
Excess magnesium can cause loss of reflexes, muscle weakness, hypotension, respiratory depression and cardiac complications. Kidney impairment increases the risk of accumulation. Other medicines affecting neuromuscular or cardiac function require review. Concentration and route errors can be dangerous, especially with a concentrated ampoule. Clinical observation and relevant laboratory monitoring are essential, and staff must be equipped to respond to serious toxicity. Prolonged continuous exposure in pregnancy can harm fetal bone development; obstetric use requires specialist oversight.
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 source lists 500 mg/mL ampoules. Confirm the magnesium sulfate hydration state and strength-expression basis, approved route, required preparation and excipients. Do not equate the stated mass with elemental magnesium or another magnesium salt.
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 protocol-specific indication, renal function, electrolytes, interacting medicines and monitoring. Independently verify concentrated-ampoule selection and preparation under authorized procedures.
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
- Magnesium sulfate
- Dosage form / presentation
- Injection
- Catalogue strength
- 500 mg/mL
- Catalogue pack
- Ampoule 10 mL; carton 10 ampoules
- Portfolio category
- Hospital Injectable Products
Layer 02
Unresolved product-specific fields
- The catalogue establishes magnesium sulfate injection at 500 mg/mL in 10 mL ampoules but does not state the hydration-state/strength-expression basis, authorised route, dilution requirements, excipients or administration protocol.
- An external 500 mg/mL magnesium sulfate label illustrates formulation-specific handling only; it does not establish the Luang product as the same hydrate or presentation.
- 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: magnesium sulfate injection 500 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-195, 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-195.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.