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Ringer-lactate "SAD"
Ringer-lactate "SAD" is a Small molecule drug developed by K. C. Rasmussen. It is currently FDA-approved. Also known as: Ringer-laktat "SAD", B 05 BB 01, Amgros A/S..
Ringer-lactate "SAD" is a small molecule solution used in clinical trials to treat conditions such as autoimmune hepatitis and blood loss. It is administered as part of a randomized, double-blind, placebo-controlled study to evaluate its efficacy.
At a glance
| Generic name | Ringer-lactate "SAD" |
|---|---|
| Also known as | Ringer-laktat "SAD", B 05 BB 01, Amgros A/S. |
| Sponsor | K. C. Rasmussen |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- CONTRAINDICATIONS AND WARNINGS Amnesteem must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Amnesteem in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following Amnesteem exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion and premature births have been reported. Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. If pregnancy does occur during treatment of a female patient who is taking Amnesteem, Amnesteem must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Special Prescribing Requirements Because of Amnesteem’s teratogenicity and to minimize fetal exposure, Amnesteem is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Amnesteem must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Amnesteem must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE (see PRECAUTIONS ). Do not get pregnant causes birth defects INFORMATION FOR PHARMACISTS Access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) to obtain an authorization and the “do not dispense to patient after” date. Amnesteem must only be dispensed in no more than a 30 day supply. REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM. An Amnesteem Medication Guide must be given to the patient each time Amnesteem is dispensed, as required by law. This Amnesteem Medication Guide is an important part of the risk management program for the patient.
Common side effects
Key clinical trials
- sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS (PHASE1)
- Effect of Colloid Versus Crystalloid on Coagulation (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ringer-lactate "SAD" CI brief — competitive landscape report
- Ringer-lactate "SAD" updates RSS · CI watch RSS
- K. C. Rasmussen portfolio CI
Frequently asked questions about Ringer-lactate "SAD"
What is Ringer-lactate "SAD"?
Ringer-lactate "SAD" is a Small molecule drug developed by K. C. Rasmussen.
Who makes Ringer-lactate "SAD"?
Ringer-lactate "SAD" is developed and marketed by K. C. Rasmussen (see full K. C. Rasmussen pipeline at /company/k-c-rasmussen).
Is Ringer-lactate "SAD" also known as anything else?
Ringer-lactate "SAD" is also known as Ringer-laktat "SAD", B 05 BB 01, Amgros A/S..
What development phase is Ringer-lactate "SAD" in?
Ringer-lactate "SAD" is FDA-approved (marketed).
Related
- Manufacturer: K. C. Rasmussen — full pipeline
- Also known as: Ringer-laktat "SAD", B 05 BB 01, Amgros A/S.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing