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Excipients with Known Action


Announcement: List of Excipients with Known effect available in the medicines authorized for use in Lebanon

Date March 5th, 2024

The Lebanese National Pharmacovigilance Program (LNPVP) at the Ministry of Public Health (MoPH) has undertaken a comprehensive review of the available medicines authorized for use in the Lebanese market, with the collaboration and support of drug distributors and Marketing Authorization Holders (MAH) who actively contributed to the project.

The Role of Excipients in Medicines

According to the European Medicines Agency (EMA), excipients, constituents in medicines excluding the active substance, play crucial roles in drug formulation. These roles range from aiding in manufacturing processes to enhancing stability, bioavailability, and patient acceptability.

Understanding Excipients with Known Effect in Drug Formulation

Excipients contribute to product identification, overall safety attributes, effectiveness, and the delivery of the drug in use. Additionally, they play a key role in maintaining the integrity of drug products during storage. Although excipients are generally considered 'inert’, it is important to note that some may have a recognized action or effect in specific circumstances. Excipients with known effects may pose challenges in sensitive patients (those with allergies or specific intolerance syndromes), necessitating particular precautions during use. Therefore, to ensure the highest level of safety, it is advisable to consider these excipients when prescribing, dispensing, or providing advice on any medication.

The objective of the project

The main objective of the project was to establish a thorough compilation of excipients with known effects present in medications authorized for use in the Lebanese market in 2024. This compilation specifically focused on drugs for which input was received from both drug distributors and Marketing Authorization Holders (MAHs). As such the list is not exhaustive, and Healthcare professionals should give special care to controlling the excipients when prescribing or dispensing any medication.The received list underwent rigorous cleaning, validation, and compilation processes to serve as a valuable reference for identifying excipients with known effects that might be subject to inquiry.

List of Excipients with Known effect available in the medicines authorized for use in Lebanon
 
Excipients with a Known Effect List to be filled by the drug distributors
 
On behalf of the Lebanese National Pharmacovigilance Program (LNPVP) at the Ministry of Public Health (MoPH), we kindly request to provide information regarding your products in the context of a project on “Excipients with a Known Effect or Action”. 

The information related to pharmaceutical excipients with known effects is important in pharmacy practice. In general, excipients are considered to be ‘inert’. Whilst it is desirable that excipients should have little or no pharmacological action of their own, some do indeed have a recognized action or effect in certain circumstances. Excipients with a known effect have the particularity of being poorly tolerated in sensitive patients (allergic or presenting a particular intolerance syndrome) and require certain precautions for use. Consequently, in order to guarantee the best level of safety, it is useful to take these excipients into account when prescribing, dispensing or even advising of any medication.

The project aims to provide a list of drugs marketed in Lebanon with their corresponding excipients that have a known action or effect in certain circumstances.
 
You are therefore kindly requested to identify, from the provided list (Excipients with a Known Effect List to be filled by the drug distributors), the excipients with a known effect that are present in your corresponding drug products.

To this end, you are kindly invited to apply the following instructions:

The below link for the excel sheet (Excipients with a Known Effect List to be filled by the drug distributors) is a list of the products marketed in Lebanon with their relevant information. It is extracted from the latest Drugs Public Price List from the MoPH’s official website. (extracted on 7th March, 2023) Excipient List to be filled by drug distributors in Lebanon
 
For each of your products:
  1. In the “Agent” column (Column C), apply the filter to choose your company name; this will display only your products in the “Brand name” column (Column D).
  2. In the “Excipients” column (Column K), choose for each of your products the identified excipients from the dropdown list provided. To access the dropdown list, select the cell (under the ‘Excipient” column) corresponding to each product; a downwards arrow will appear at the lower-right corner of the cell. Select it and choose from the provided list of excipients.
  3. If your product contains more than one excipient, include each in a separate column (Columns M and O). Add as much columns as needed. If your product doesn’t contain any of the listed excipients, select the “None” option from the excipients’ dropdown list.
  4. Fill the “Route of Administration” column (Column J) appropriately using the drop down list. (Capitalize only the first letter)
  5. Fill the “Comment” column (Column Q) with any information present on the label and /or package leaflet regarding the identified excipients. If nothing is mentioned keep the cell blank.
  6. Please refer to raw number 4 as an example.
  7. Send us the filled excel sheet at the following email addresses: excipients.moph@gmail.com or excipients@moph.gov.lb
  8. Ensure that your file is named as follow: (name of the distributor-excipientlist2023),Example: Mersaco-excipientlist2023
 
You are kindly expected to reply back within 2 months after receiving this email (by May 31st, 2023), the latest.
 
Thank you for your time and cooperation.

Reminder,

Reference to previous communication related to the submission of Excipients with a known Action list, we would like to kindly remind all drug distributers and local manufacturers to complete this list by May 31st, 2023.

As per the previously shared instruction, the list must be filled out with utmost accuracy. It is essential to carefully select the appropriate excipient(s) and indicate the salt with its corresponding dose in the excipient dose section. Additionally, it is important to include any relevant package leaflet information in the comment section. We stress the importance of adhering to these instructions to ensure the safety and efficacy of medication use.

In case there are there are no excipients with known action in your corresponding products, please verify this by an email to excipients.moph@gmail.com.

We appreciate your cooperation in this matter.

Quality Assurance of Pharmaceutical Products Department
Lebanese National Pharmacovigilance Program
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ATC Name B/G Ingredients Dosage Form Price
J01DH51 CILANEM G Imipenem anhydrous - 500mg, Cilastatin (sodium) - 500mg Injectable solution 850,652 L.L
R06AD52 CODOPALM G Promethazine HCl - 5mg/5ml, Sodium gentisate - 0.5mg/5ml Syrup 149,742 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS L G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:106.5 mmol/l, Sodium chloride - Na+:135 mmol/l Injectable solution L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 16mg, Amlodipine - 10mg Capsule, hard 1,540,044 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LM G Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 8mg, Amlodipine - 10mg Capsule, hard 1,368,032 L.L
R06AE07 CETALLERG G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, film coated 180,075 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:111.5 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
R06AE07 CETIMED G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, scored 360,918 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS2 G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.5 mmol/l, Sodium acetate - Cl-:111 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
L01EA01 CEMIVIL G Imatinib - 100mg 100mg Tablet, film coated 12,763,090 L.L
R06AE07 CETRAK G Cetirizine (dihydrochloride) - 10mg 10mg Tablet 147,823 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS3 G Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.60 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
N01BB02 CHLORHYDRATE DE LIDOCAINE RENAUDIN G Lidocaine (HCl) - 10mg/ml 1% Injectable solution 591,291 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS R G Potassium chloride - K+:1.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.40 mmol/l, Sodium acetate - Cl-:105.8 mmol/l, Sodium chloride - Na+:140.5 mmol/l Injectable solution L.L
B05ZA CONCENTRATE SOLUTIONFOR HEMODIALYSIS TYPE A G Hemodialytics, concentrates - Injectable solution L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE B+ G Hemodialytics, concentrates - Injectable solution L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE J G Hemodialytics, concentrates - Injectable solution L.L
R06AE07 CETIMED G Cetirizine (dihydrochloride) - 5mg/5ml 5mg/5ml Solution 415,951 L.L
J01BA01 CHLORAMPHENICOL PALMITATE G Chloramphenicol (palmitate) - 125mg/5ml 125mg/5ml Suspension 159,981 L.L
J01EE01 CO-TRIMOXAZOLE G Trimethoprim - 160mg, Sulfamethoxazole - 800mg Tablet 7,529,090 L.L
J01BA01 CHLORAMPHENICOL G Chloramphenicol - 250mg 250mg Capsule 166,381 L.L
J01EE01 CO-TRIMOXAZOLE G Trimethoprim - 160mg, Sulfamethoxazole - 800mg Tablet 183,019 L.L
J05AR01 CONDINE G Lamivudine - 150mg, Zidovudine - 300mg Tablet, film coated 5,818,474 L.L
R06AE09 CALIVIDA G Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 447,948 L.L
J01FA09 CLAMYCIN G Clarithromycin - 250mg 250mg Tablet, film coated 641,205 L.L
J01FA09 CLAREM 250 G Clarithromycin - 250mg 250mg Tablet, film coated 467,657 L.L
R06AE09 CALIVIDA G Levocetirizine dihydrochloride - 0.5mg/ml 0.5mg/ml Solution 1,158,264 L.L
J01FA09 CLAREM 500 G Clarithromycin - 500mg 500mg Tablet, film coated 686,704 L.L
A03FA01 CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN G Metoclopramide HCl - 10mg/2ml 10mg/2ml Injectable solution 530,818 L.L
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