SODIOFOLIN 50 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: DISODIUM FOLINATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Sodiofolin 50 mg/ml, solution for injection or
infusion
Folinic acid (as disodium folinate)
Read all of this leaflet carefully before you start
using this medicine.
- Keep this leaflet. You may need to read it again.
-  you have any further questions, ask your doctor or
If
pharmacist.
- 
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
-  any of the side effects gets serious, or if you notice
If
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Sodiofolin 50 mg/ml is and what it is used for
2. Before you use Sodiofolin 50 mg/ml
3. How to use Sodiofolin 50 mg/ml
4. Possible side effects
5. How to store Sodiofolin 50 mg/ml
6. Further information

WHAT SODIOFOLIN 50 MG/ML IS AND WHAT IT
1. 
IS USED FOR
- 
Folinic acid, a compound derived from the vitamin
B12 group, is an antidote to the anticancer medicine
methotrexate (rescue therapy).
- 
Folinic acid increases the action of the anticancer
medicine fluorouracil; the two substances are used
together for treatment of cancer.
Sodiofolin 50 mg/ml has been prescribed by your
doctor:
- either for the prevention of possible side-effects

resulting from methotrexate therapy
- or for treatment of cancer in combination therapy

with fluorouracil
2. BEFORE YOU USE SODIOFOLIN 50 MG/ML
Do not use Sodiofolin 50 mg/ml
-  you are allergic (hypersensitive) to disodium
if
folinate or any of the other ingredients of Sodiofolin
50 mg/ml (see point 6 of this leaflet).
- in combination with fluorouracil if you:
- are pregnant or breast feeding,
-  ave severe diarrhoea (watery stools or bowel
h
movements),
-  ave symptoms of gastrointestinal toxicity such as
h
diarrhoea, feeling or being sick or mouth ulcers.
Your doctor will monitor these symptoms until they
resolve.
-  you have certain blood disorders (pernicious anaemia
if
or other anaemias due to shortage of vitamin B12).

Your doctor will check these before your treatment.
Take special care when taking Sodiofolin 50 mg/ml
-  you are of older age or debilitated, as elderly or
if
debilitated patients may be at increased risk of
severe toxicity.
-  you are suffering from convulsion (epilepsy),
if
as you are at increased risk of seizures. This will
require regular monitoring of your blood in order to
check the level of anti-epileptic medication.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
- 
Sodiofolin 50 mg/ml is used for the treatment of
cancer in combination with fluorouracil. You must be
aware that this combination of medicines might cause
side-effects (see point 4 of this leaflet). If any of the
side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
- 
The effectiveness of some medicines (phenytoin,
primidone and phenobarbital) used to treat
convulsion (epilepsy) may be reduced which may
lead to increased risk of seizures.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
You should not take Sodiofolin 50 mg/ml in combination
with fluorouracil if you are pregnant, planning to become
pregnant or while you are breast-feeding.
Driving and using machines
Your ability to drive or operate machinery is not affected

by Sodiofolin 50 mg/ml. But you should consider your
general condition before driving or operating machinery.
3. HOW TO USE SODIOFOLIN 50 MG/ML
Sodiofolin 50 mg/ml will be given to you
- by an injection into your vein (intravenous injection)
or
- by a drip given into a vein (intravenous infusion).
The dose given depends on your size. It varies with your
surface area. Technically, this is measured in square
metres (m2), but actually is worked out from your height
and weight.
Preventing possible side-effects during a therapy with
methotrexate (rescue treatment)
Your doctor uses Sodiofolin 50 mg/ml as a preventive
treatment, which follows the administration of
methotrexate. Sodiofolin 50 mg/ml is given intravenously
(into your vein). The used amount depends on the
measured methotrexate blood levels.
The infusion thearapie using Sodiofolin 50 mg/ml
starts not later than 18 to 30 hours after the start of
methotrexate infusion.
The infusion therapy using Sodiofolin 50 mg/ml ends
72 hours after the start of methotrexate infusion at the
earliest.
Treatment of carcinoma using Sodiofolin 50 mg/ml in
combination with fluorouracil
All dosage schedules have been determined by clinical
studies carried out in large numbers of patients. Your
doctor can choose from weekly, monthly or other
regimens. All schedules use a combination of the two

substances disodium folinate (Sodiofolin 50 mg/ml) and
fluorouracil.
The following schedules have been used in adults and
elderly in the treatment of advanced carcinoma of the
colon and rectum and are given as examples. There are
no data on the use of these combinations in children.
Your doctor will explain to you how this works and how
often you will receive your mediciation:
1. 
Weekly schedule of fluorouracil and Sodiofolin 50 mg/ml.
This involves either:
-  2 hour intravenous infusion (‘drip’) of Sodiofolin
A
50 mg/ml, followed by a single intravenous injection
of fluorouracil (‘Moderately high dose fluorouracil
treatment’).
or
-  1 - 2 hour intravenous infusion of Sodiofolin
a
50 mg/ml, followed by a 24 hour infusion of
fluorouracil (‘High dose fluorouracil treatment’)
given weekly in cycles of six weeks according to your
response. The six week cycle may be repeated after
an interval of 2 weeks, if necessary, and the number of
cycles will depend on the response of the tumor.
2. 
Monthly schedule of fluorouracil and Sodiofolin
50 mg/ml.
This involves single intravenous injections of Sodiofolin
50 mg/ml, followed by a single intravenous injection of
fluorouracil, given once a day together for 5 successive
days (= 1 cycle). The cycle is repeated after 4 weeks,
and then according to the response of the tumour.
This schedule may be followed at a higher dosage
(‘Moderately high dose Sodiofolin 50 mg/ml’) or
alternatively, at a lower dosage (‘Low dose Sodiofolin
50 mg/ml’).

If you receive more Sodiofolin 50 mg/ml than you
should
It is very unlikely that you will receive more Sodiofolin
50mg/ml than you should. You will be monitored by a
doctor or a nurse during the treatment with this medicine
to ensure safe and proper administration of the solution.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sodiofolin 50 mg/ml can cause side
effects, although not everybody gets them.
The following side effects have been observed when
Sodiofolin 50 mg/ml was administered:
- Isolated cases of allergic reactions such as

sensitisation (state of being sensitive) and urticaria
(hives), including mild or severe allergic reactions
(e.g. swelling of lips or tongue or face, difficulty
breathing, chest pain, collapse). If you experience
any of these allergic reactions please consult your
doctor or hospital immediately.
- Gastrointestinal (digestive) disorders after high

doses
- Occasionally fever
Sodiofolin 50 mg/ml can enhance the action and the
side-effects of the anticancer medicine fluorouracil.
The most frequently reported side-effects of this
combination therapy are:
- life-threatening diarrhoea (watery stools or bowel

movements) has been observed in patients receiving
the weekly “moderately high-dose fluorouracil”
regimen.
- dehydration
- stomatitis (oral ulceration)

- leucopenia (decrease in the number of white blood

cells)
If you experience stomatitis (mild to moderate oral
ulceration) or diarrhoea (watery stools or bowel
movements) two times per day, be sure to consult your
doctor immediately.
Less commonly:
- infections
- thrombocytopenia (decrease in the number of blood

platelets)
- nausea (sickness) with or without vomiting
- constipation
- feeling of discomfort
- alopecia (loss of hair)
- dermatitis (inflammation of the skin)
- anorexia (lack of appetite)
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE SODIOFOLIN 50 MG/ML

Keep the vial in the outer carton in order to protect from
light.
6. FURTHER INFORMATION
What Sodiofolin 50 mg/ml contains
- 
The active substance is Folinic acid (as disodium
folinate.
-  he other ingredients are sodium hydroxide,
T
hydrochloric acid and water for injection.
What Sodiofolin 50 mg/ml looks like and contents of
the pack
One 2 ml / 4ml / 6 ml / 7 ml / 8 ml / 10 ml / 18 ml vial
contains 109.3 mg / 218.6 mg / 327.9 mg / 382.55 mg
/ 437.2 mg / 546.5 mg / 983.7 mg disodium folinate
equivalent to 100 mg / 200 mg / 300 mg / 350 mg / 400 mg /
500 mg / 900 mg folinic acid.
Sodiofolin 50 mg/ml is supplied in sealed glass vials in
packs of 1 or 5. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
medac
Gesellschaft für klinische Spezialpräparate mbH
Fehlandtstr. 3
20354 Hamburg, Germany

Do not use Sodiofolin 50 mg/ml after the expiry date
which is stated on the label. The expiry date refers to
the last day of that month.

Manufacturer:
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel, Germany

Store in a refrigerator (2 °C - 8 °C).

This leaflet was last approved in 06/2008.

Keep out of the reach and sight of children.

85500-VPGB
CA

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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