Calciject, manufactured by Omega Laboratories Limited, is a calcium-based injectable medication available in Canada. Understanding its composition, usage, safety, and regulatory aspects requires a detailed examination of its product information, associated documentation, and the regulatory framework within which it operates. This article delves into various aspects of Calciject, aiming to provide a comprehensive overview for healthcare professionals and interested individuals. We will explore the product's specifications, its place within the Canadian drug regulatory landscape, and relevant safety considerations.
Product Identification and Composition:
The provided code C00P1059/V;80827 Calciject, along with the mention of "Calciject Inj 100mg/Ml," clearly identifies the product as Calciject injection containing 100mg of calcium per milliliter. The "C00P1059/V" likely represents a specific internal or regulatory identification code within the Canadian pharmaceutical system. The "80827" portion, potentially part of a Drug Identification Number (DIN) or a similar identifier, further specifies the product within the Canadian regulatory framework. The significance of the "AIG" (Active Ingredient Group) and its three-digit strength identifier, with a tolerance of -2% to +10%, highlights the regulatory control over the active ingredient concentration. This tolerance range ensures consistency in the medication's potency despite minor variations during manufacturing. Precise details on the exact chemical composition of the calcium salt used (e.g., calcium gluconate, calcium chloride) would require consulting the full product monograph or Safety Data Sheet (SDS).
Omega Laboratories Limited:
Omega Laboratories Limited is the manufacturer of Calciject. Understanding their role necessitates researching their licensing and compliance with Health Canada regulations. Reputable pharmaceutical manufacturers adhere to stringent Good Manufacturing Practices (GMP) to ensure product quality, safety, and efficacy. Information regarding Omega Laboratories’ manufacturing processes, quality control measures, and adherence to regulatory standards is crucial for assessing the reliability and trustworthiness of Calciject. This information is typically available through Health Canada's website or directly from Omega Laboratories.
Calciject Drug Information:
The product information for Calciject should include crucial details such as:
* Indications: The specific medical conditions for which Calciject is indicated. This might include hypocalcemia (low blood calcium), treatment of calcium deficiencies, or other specific clinical uses. The product monograph will clearly define the approved uses.
* Dosage and Administration: The recommended dosage, frequency of administration, and the proper method of injection (e.g., intravenous, intramuscular). This section is critical for safe and effective use and should be followed meticulously by healthcare professionals.
* Contraindications: Conditions or situations where the use of Calciject is prohibited or strongly discouraged. This might include pre-existing conditions that could be exacerbated by calcium administration.
* Warnings and Precautions: Potential adverse effects, interactions with other medications, and precautions to be taken during administration. This section emphasizes patient safety and highlights potential risks associated with Calciject.
* Adverse Reactions: A detailed list of possible side effects, ranging from mild to severe, allowing healthcare providers to monitor patients for adverse events and take appropriate action. The frequency and severity of these reactions should also be reported.
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