D vitamini içeren ilaçlar hk. (5 iş günü içinde)
D vitamini içeren ilaçlar hk. (5 iş günü içinde), ENG
MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY Medicines and Medical Devices Agency of Turkey NORMAL
17.09.2019
DOSSIER
Ref: Our Association announcement dated 11.10.2019, with No. E.159357
The referred announcement regarding the medicines containing vitamin D alone has been revoked and it is necessary to arrange as follows the sections on indication, posology, warnings and precautions in the Summary of Product Characteristics (SPC) and Package Leaflet (PL) of the referred products.
For parenteral products containing vitamin D: The term “oral” cannot be used in the product name and SPC-PL information.
Indications: It should be arranged as: “It is indicated only for patients with gastrointestinal malabsorption in vitamin D deficiency”.
For Orally Administered Products Containing Vitamin D: Indications: It should be arranged as “It is indicated for the treatment, maintenance and prophylaxis of vitamin D deficiency.” For Products Administered Orally (in Liquid-Solid Form) and Parenterally: Posology and mode of administration: The statement reading, “Your doctor will decide on how to use the medicine. Use as advised by your doctor.”
Age Group Recommended Prophylactic /Maintenance Dose Therapeutic Dose for Vitamin D Deficiency Highest Tolerable Dose for Maintenance Therapy and Prophylaxis of High-Risk Groups (To be specified in the warnings section) Daily treatment ** Weekly administration Newborn 400 IU/day (10 µg/day) 1000 IU/day (25 µg/day) NA 1000 IU/day (25 µg/day) No. : 62820468-000-E.210253 Subject : Medicines containing vitamin D
1 month-1 year 400 IU/day (10 µg/day) 2000-3000 IU/day (50-75 µg/day) NA 1500 IU/day (37.5 µg/day) 1-10 years 400-800* IU/day (10-20 µg/day) 3000-5000 IU/day (75-125 µg/day) NA 2000 IU/day (50 µg/day)
11-18
years
400-800* IU/day (10-20
µg/day)
3000-5000
IU/day (75-125
µg/day)
NA 4000 IU/day
(100 µg/day)
Adults
above 18
years
600-1500 IU/day
(15-37.5 µg/day)
7000-10.000
IU/day (175-
250 µg/day)
50.000 IU/week
(1250
µg/week)***
4000 IU/day
(100 µg/day)
- The dose may be increased to 1000 IU where necessary. ** It may be used for up to 6-8 weeks. *** In case it is preferred to use the weekly dose instead of the daily dose, 50,000 IU may be used once as a single weekly dose for up to 6-8 weeks. It is not advised to use of more than 50,000 IU of vitamin D at once.
Special Warnings and Precautions for Use: In case of use during pregnancy, the relevant sections of the SPCs and PL should be arranged in line with the following information: a) Although routine use of medicines containing vitamin D is not recommended during pregnancy, where necessary, they should be used under the supervision of a doctor. b) Prophylactic use of medicines containing vitamin D during pregnancy should not exceed a maximum dose of 1000 IU/day.
I hereby submit for your information and kindly request that objections to this decision, if any, are submitted to the Clinical Evaluation Unit within 5 workdays and that no SPC/PL application for vitamin D is made to the Clinical Evaluation Unit and Pharmacological Evaluation Unit during this period.
Spec. Pharm. Oğuzhan KOYUNCU
on behalf of the President of the Agency
Head of Department
Distribution: Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers Association of Turkey Turkish Pharmaceutical Industry Association Association of Innovator Pharmaceutical Companies Self-Care Products Association
RESTRICTED Revoked
MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY Medicines and Medical Devices Agency of Turkey NORMAL
11.10.2019
DOSSIER
Ref: a) Our Association announcement dated 18.03.2019, with No. E.46137 b) Our Association announcement dated 27.03.2019, with No. E.51756 The announcements indicated in (a) and (b) regarding the medicines containing vitamin D alone have been revoked and it is necessary to arrange as follows the sections on indication, posology, warnings and precautions in the Summary of Product Characteristics (SPC) and Package Leaflet (PL) of the referred products.
For parenteral products containing vitamin D: The term “oral” cannot be used in the product name and SPC-PIL information.
For Products Administered Parenterally containing more than 50,000 IU of Vitamin D: Indications: It should be arranged as: “It is indicated only for patients with gastrointestinal malabsorption in vitamin D deficiency”.
Posology: The statement reading, “Your doctor will decide on how to use the medicine. Use as advised by your doctor.” should be written before the table “Posology and mode of administration” under the title “For Orally (in Liquid-Solid Form) and Parenterally Administered Products”.
For Orally Administered Products Containing 50,000 IU of Vitamin D: Indications: It should be arranged as “It is indicated only for patients with intestinal fat malabsorption in vitamin D deficiency”.
Posology: The statement reading, “Your doctor will decide on how to use the medicine. Use as advised by your doctor.” should be written before the table “Posology and mode of administration” under the title “For Orally (in Liquid-Solid Form) and Parenterally Administered Products”.
No. : 62820468-000-E.159357 Subject : Medicines containing vitamin D
For Products Containing 50,000 IU and less of vitamin D: Indications: “It is indicated for the treatment, maintenance and prophylaxis of vitamin D deficiency.” For Products Administered Orally (in Liquid-Solid Form) and Parenterally: Posology and mode of administration:
Age Group Recommended Prophylactic / Maintenance Dose Therapeutic Dose for Vitamin D Deficiency Highest Tolerable Dose for Maintenance Therapy and Prophylaxis of High-Risk Groups (To be specified in the warnings section) Daily treatment ** Weekly administration Newborn 400 IU/day (10 µg/day) 1000 IU/day (25 µg/day) NA 1000 IU/day (25 µg/day) 1 month-1 year 400 IU/day (10 µg/day) 2000-3000 IU/day (50-75 µg/day) NA 1500 IU/day (37.5 µg/day) 1-10 years 400-800* IU/day (10-20 µg/day) 3000-5000 IU/day (75-125 µg/day) NA 2000 IU/day (50 µg/day)
11-18
years
400-800* IU/day (10-20
µg/day)
3000-5000
IU/day (75-125
µg/day)
NA 4000 IU/day
(100 µg/day)
Adults
above 18
years
600-1500 IU/day
(15-37.5 µg/day)
7000-10.000
IU/day (175-
250 µg/day)
50.000 IU/week
(1250
µg/week)***
4000 IU/day
(100 µg/day)
- The dose may be increased to 1000 IU where necessary. ** It may be used for up to 6-8 weeks. *** In case it is preferred to use the weekly dose instead of the daily dose, 50,000 IU may be used once as a single weekly dose for up to 6-8 weeks.
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Special Warnings and Precautions for Use In case of use during pregnancy, the relevant sections of the SPCs and PLs should be arranged in line with the following information: a) Although routine use of medicines containing vitamin D is not recommended during pregnancy, where necessary, they should be used under the supervision of a doctor. b) Prophylactic use of medicines containing vitamin D during pregnancy should not exceed a maximum dose of 1000 IU/day.
I hereby submit for your information and kindly request that the SPC/PL applications relating to the products in which abovementioned changes are made are sent to the Clinical Evaluation Unit within 10 workdays for review.
Spec. Pharm. Hacer COŞKUN ÇETİNTAŞ on behalf of the President of the Agency Head of Department
Distribution: Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers Association of Turkey Turkish Pharmaceutical Industry Association Association of Innovator Pharmaceutical Companies Self-Care Products Association
1 / 2
Revoked
RESTRICTED MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY Medicines and Medical Devices Agency of Turkey
NORMAL 18.03.2019
DOSSIER
The indication, posology, warnings and precautions sections in the Summary of Product Characteristics (SPC) and Package Leaflet (PL) of the medicines containing vitamin D alone should be arranged as indicated below: Indications: The indications of the preparations containing more than 50,000 IU of vitamin D, to be used parenterally, should be arranged as: “It is indicated only for patients with gastrointestinal malabsorption in vitamin D deficiency”. Posology and mode of administration:
Age Group Recommended Prophylactic / Maintenance Dose Therapeutic Dose for Vitamin D Deficiency Highest Tolerable Dose for Maintenance Therapy and Prophylaxis of High-Risk Groups (To be specified in the warnings section) Daily treatment ** Weekly administration Newborn 400 IU/day (10 µg/day) 1000 IU/day (25 µg/day) NA 1000 IU/day (25 µg/day) 1 month-1 year 400 IU/day (10 µg/day) 2000-3000 IU/day (50-75 µg/day) NA 1500 IU/day (37.5 µg/day) 1-10 years 400-800* IU/day (10-20 µg/day) 3000-5000 IU/day (75-125 µg/day) NA 2000 IU/day (50 µg/day) Number : 62820468-000-E.46137 Subject : Medicines containing vitamin D
2 | 2
11-18
years
400-800* IU/day (10-20
µg/day)
3000-5000
IU/day (75-125
µg/day)
NA 4000 IU/day
(100 µg/day)
Adults
above 18
years
600-1500 IU/day
(15-37.5 µg/day)
7000-10.000
IU/day (175-
250 µg/day)
50.000 IU/week
(1250
µg/week)***
4000 IU/day
(100 µg/day)
- The dose may be increased to 1000 IU where necessary. ** It may be used for up to 6-8 weeks. *** In case it is preferred to use the weekly dose instead of the daily dose, 50,000 IU may be used once as a single weekly dose for up to 6-8 weeks. Note: The sections related with the posology of the preparations containing more than 50,000 IU of vitamin D and to be used parenterally should be arranged as "Your doctor will decide on how you should use your medicine. Take it as advised by your doctor.”
Special Warnings and Precautions for Use (In case of use during pregnancy, the relevant sections of the SPCs and PLs should be arranged in line with the following information.): a) Although routine use of medicines containing vitamin D is not recommended during pregnancy, where necessary, they should be used under the supervision of a doctor. b) Prophylactic use of medicines containing vitamin D during pregnancy should not exceed a maximum dose of 1000 IU/day.
I hereby submit for your information and kindly request that the SPCs/PLs in which abovementioned changes are made are sent to the Pharmacological Evaluation Unit until 12.04.2019 for review.
Dr. Pharm. Harun KIZILAY
Deputy President of the Agency
Distribution:
Association of Research-Based Pharmaceutical Companies
Pharmaceutical Manufacturers Association of Turkey
Turkish Pharmaceutical Industry Association
Association of Innovator Pharmaceutical Companies
Self-Care Products Association