Meptid 100 mg/ml Solution for Injection
- Name:
Meptid 100 mg/ml Solution for Injection
- Company:
Almirall Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/07/20
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 27/7/2020
Click on this link to Download PDF directly
Almirall Limited
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Almogran 12.5 mg Film-coated tablet | Active Ingredients Almotriptan D, L-hydrogen malate |
| Medicine Name Ilumetri 100 mg solution for injection in pre-filled syringe | Active Ingredients Tildrakizumab |
| Medicine Name Meptid 100 mg/ml Solution for Injection | Active Ingredients Meptazinol hydrochloride |
| Medicine Name Meptid 200 mg Film-Coated Tablets | Active Ingredients Meptazinol hydrochloride |
| Medicine Name Skilarence 30 mg gastro-resistant tablets | Active Ingredients Dimethyl fumarate |
| Medicine Name Skilarence 30 mg, 120 mg gastro-resisistant tablets | Active Ingredients Dimethyl fumarate |
| Medicine Name Solaraze 3% Gel | Active Ingredients Diclofenac Sodium |
| Medicine Name Vaniqa 11.5% cream | Active Ingredients Eflornithine hydrochloride monohydrate |
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 27 July 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Updated with opioid warning as per UK CHM recommendation.
Updated on 27 July 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated with opioid warning as per UK CHM recommendation.
Updated on 21 January 2020 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Date of revision: July 2019
Updated on 21 January 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Reordering of Adverse Effects as per SmPC.
Updated on 21 January 2020 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Date of revision July 2019
Updated on 21 January 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Reorder of side effects as per SmPC
Updated on 20 January 2020 PIL
Reasons for updating
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Change of Almirall Logo on printed artwork.
Updated on 22 September 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 22 September 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 31 March 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 31 March 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 Addition of QRD ADR reporting statement.
Updated on 26 March 2015 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 17 March 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- section 4.3 updated to strengthen the safety statements already under sections 4.4 and 4.5 namely contraindicating use during an asthma attacks and for patients on MAOIs and for 14 days after stopping MAOIs
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· section 2 updated in line with QRD
· section 3 for the injection updated to align with the description parameter as detailed in the finished product specification
· section 4.5 updated with minor rewording
· section 4.8 updated by ranking undesirable events under headings of frequency using the following convention: very common (≥ 1/10); common (≥1/100 to ≤1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data). This was purely a formatting request by the IMB; where within section 4.8, it was written that these were the "most commonly reported adverse reactions", these AEs were slotted under the tabular heading very common and those detailed as uncommon were slotted under the uncommon tabular heading under the relevant system organ class; "occassional reports" were re-classified as very rare reports.
· section 4.9 updated with minor rewording
section 7 updated with change of name of MAH from "Laboratorios Almirall SA" to Almirall SA
· section 3 for the injection updated to align with the description parameter as detailed in the finished product specification
- section 4.3 updated to strengthen the safety statements already under sections 4.4 and 4.5 namely contraindicating use during an asthma attacks and for patients on MAOIs and for 14 days after stopping MAOIs
· section 4.5 updated with minor rewording
· section 4.8 updated by ranking undesirable events under headings of frequency using the following convention: very common (≥ 1/10); common (≥1/100 to ≤1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data). This was purely a formatting request by the IMB; where within section 4.8, it was written that these were the "most commonly reported adverse reactions", these AEs were slotted under the tabular heading very common and those detailed as uncommon were slotted under the uncommon tabular heading under the relevant system organ class; "occassional reports" were re-classified as very rare reports.
· section 4.9 updated with minor rewording
section 7 updated with change of name of MAH from "Laboratorios Almirall SA" to Almirall SA
Updated on 11 March 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to name of manufacturer
Updated on 30 June 2009 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
None provided
Updated on 18 June 2009 PIL
Reasons for updating
- New PIL for new product