Vraylar

Hazard statements (CLP)

H361

Code

Statements

H361

Suspected of damaging fertility or the unborn child

2.1 Classification of the substance or mixture

OSHA Regulatory Status This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Reproductive toxicity Category 2

2.2 Label elements

Emergency Overview Warning

Hazard statements

H361 - Suspected of damaging fertility or the unborn child Appearance Capsule Physical state Solid Odor No information available Chemical Name Symptoms Cariprazine Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. This medication is not approved for the treatment of patients with dementia-related psychosis Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) were (6.1) Schizophrenia extrapyramidal symptoms and akathisia; Bipolar mania: extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness Chemical Name

Medical Conditions Generally Aggravated by Exposure

Cariprazine This medication is contraindicated in patients with history of a hypersensitivity reaction tocariprazine. Reactions have ranged from rash, pruritus, urticaria, and events suggestiveof angioedema (e.g., swollen tongue, lip swelling, face edema, pharyngeal edema, andswelling face).

Precautionary statements

P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P281 - Use personal protective equipment as required P308 + P313 - IF exposed or concerned: Get medical advice/attention P405 - Store locked up P501 - Dispose of contents/ container to an approved waste disposal plant P280 - Wear protective gloves/protective clothing/eye protection/face protection

Further information

Unknown Acute Toxicity 100% of the mixture consists of ingredient(s) of unknown toxicity Over the counter drugs in their solid form are considered exempt under the criteria of the Federal OSHA Hazard Communication Standard 20 CFR 1910.1200. However, in an industrial setting where a component's occupational exposure limit may be surpassed, than can be considered hazardous