Calcium folinate 15mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Calcium folinate

থেকে পাওয়া:

Viatris UK Healthcare Ltd

এটিসি কোড:

V03AF03

INN (আন্তর্জাতিক নাম):

Calcium folinate

ডোজ:

15mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 08010000; GTIN: 5016695030159

তথ্য লিফলেট

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Calcium Folinate 15mg 10
Label Leaflet
1473319
900830
1473319
PL 04569/0212
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LL0424AH
150
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356541
4
United Kingdom
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5016695030159
N/A
4
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v3/July 2017
Pharma Code
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Vendor Job No.
Trackwise Proof No.
Client Market
Keyline/Drawing No.
Barcode Info
3D Render ID
06 Feb 2019
II/II
11:28
Varnish
Free
Keyline
Calcium Folinate 15mg 10
Label Leaflet
1473319
900830
1473319
PL 04569/0212
N/A
LL0424AH
150
N/A
356541
4
United Kingdom
N/A
5016695030159
N/A
4
Myriad Pro
52 x 101 mm
8pt
6pt
braille
calcium
folinate
#15 mg
tablets
calcium
folinate
#15 mg
tablets
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পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Calcium Folinate 15 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 19.07 mg of calcium folinate, which is equivalent
to
15 mg folinic acid.
Excipient with known effect:
Each tablet contains 155 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
Off white to pale yellow scored biconvex tablets marked with "CF/15"
on one side
and "G" on the other.
4.1
THERAPEUTIC INDICATIONS
Calcium Folinate is indicated in:
1.
Neutralising the immediate toxic effects of folic acid antagonists,
e.g.
Methotrexate.
2.
Calcium Folinate Rescue - a treatment technique using Calcium Folinate
in conjunction with folic acid antagonists, e.g. methotrexate, to
minimise
systemic toxicity.
3.
The
treatment
of
megaloblastic
anaemias
due
to
sprue,
nutritional
deficiency, pregnancy, infancy, liver disease and malabsoption
syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children_
_Calcium Folinate Rescue _
Depending upon the dose of methotrexate administered, dosage regimens
of
calcium folinate vary.
Up to 120 mg calcium folinate is generally given, usually in divided
doses
over 12 to 24 hours by intramuscular injection, bolus intravenous
injection or
intravenous infusion in normal saline. This is followed by 12 to 15mg
intramuscularly or 15 mg orally every 6 hours for 48 hours.
Rescue therapy is usually started 24 hours after the commencement of
methotrexate administration.
_ _
_Neutralising the immediate toxic effects of folic acid antagonists: _
If overdosage of methotrexate is suspected, the dose of Calcium
Folinate
should be equal to or greater than the dose of the methotrexate, and
should be
administered within one hour of the methotrexate administration.
_Megaloblastic anaemia (folinate deficiency) _
_Adults:_ One tablet of calcium folinate per day
_Children: _Other more suitable formulations are available_. _
Method of administration
For oral use.
4.3
CONTRAINDICATIONS