SODIOFOLIN 50 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: DISODIUM FOLINATE

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Sodiofolin 50 mg/ml · 85500-VPGB · DA · 06.14 · Pharma-Code: 71
Format: 592 x 112 mm · HKS 44 · Corrective action: KV01_osc_18.06.14 / KV02_osc_19.06.14

Package leaflet: Information for the user

Sodiofolin 50 mg/ml
solution for injection/infusion
Folinic acid (as disodium folinate)
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Sodiofolin is and what it is used for
2. What you need to know before you use Sodiofolin
3. How to use Sodiofolin
4. Possible side effects
5. How to store Sodiofolin
6. Contents of the pack and other information

1. What Sodiofolin is and what it 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.

• have symptoms of gastrointestinal toxicity such
as diarrhoea, feeling or being sick or mouth ulcers.
Your doctor will monitor these symptoms until
they resolve.
• if you have certain blood disorders (pernicious
anaemia or other anaemias due to shortage of
vitamin B12).
Your doctor will check these before your treatment.

Sodiofolin 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. What you need to know before you use Sodiofolin
Do not use Sodiofolin
• if you are allergic to disodium folinate or any of the
other ingredients of this medicine (listed in section 6).
• in combination with fluorouracil if you:
• are pregnant or breast-feeding,
• have severe diarrhoea (watery stools or bowel
movements),

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Sodiofolin
• if you are elderly or very weak, as you may have
a higher risk of side effects.
• if you are suffering from epilepsy, as you have
an increased risk of fits (seizures). You will need
to have regular blood tests to check the levels of
anti-epileptic medicine in your blood.
Other medicines and Sodiofolin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
• Sodiofolin 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 section 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
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
You should not take Sodiofolin 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, but you should consider your general
condition before driving or operating machinery.

3. How to use Sodiofolin
Sodiofolin 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 as a preventive treatment,
which follows the administration of methotrexate.
Sodiofolin is given intravenously (into your vein).
The used amount depends on the measured
methotrexate blood levels.
The infusion therapy using Sodiofolin starts not later
than 18 to 30 hours after the start of methotrexate
infusion.
The infusion therapy using Sodiofolin ends 72 hours
after the start of methotrexate infusion at the earliest.

Treatment of cancer using Sodiofolin in combination
with fluorouracil
All dose 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)
and fluorouracil.
The following schedules have been used in adults and
elderly in the treatment of advanced cancer 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 medicine:
1. Weekly schedule of fluorouracil and Sodiofolin.
This involves either:
• a 2 hour intravenous infusion (‘drip’) of Sodiofolin,
followed by a single intravenous injection of
fluorouracil (‘Moderately high dose fluorouracil
treatment’).
or
• a 1 – 2 hour intravenous infusion of Sodiofolin,
followed by a 24 hour infusion of fluorouracil
(‘High dose fluorouracil treatment’) given weekly

in cycles of 6 weeks according to your response.
The 6 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 tumour.
2. Monthly schedule of fluorouracil and Sodiofolin.
This involves single intravenous injections of
Sodiofolin, 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’) or alternatively,
at a lower dosage (‘Low dose Sodiofolin’).
If you receive more Sodiofolin than you should
It is very unlikely that you will receive more Sodiofolin
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.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

Sodiofolin 50 mg/ml · 85500-VPGB · DA · 06.14 · Pharma-Code: 71
Format: 592 x 112 mm · HKS 44 · Corrective action: KV01_osc_18.06.14 / KV02_osc_19.06.14

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

• dehydration
• ulceration of the mouth (stomatitis)
• decrease in the number of white blood cells
(leucopenia)

By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Sodiofolin

The following side effects have been observed
when Sodiofolin 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 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.

If you experience stomatitis (mild to moderate
ulceration of the mouth) or diarrhoea (watery stools
or bowel movements) two times per day, be sure to
consult your doctor immediately.
Less commonly:
• infections
• decrease in the number of blood platelets
(thrombocytopenia)
• sickness (nausea) with or without vomiting
• constipation
• feeling of discomfort
• loss of hair (alopecia)
• inflammation of the skin (dermatitis)
• lack of appetite (anorexia)
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via www.mhra.gov.uk/yellowcard.

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date which is
stated on the label. The expiry date refers to the last day
of that month.

What Sodiofolin looks like and contents of the pack
One 2 ml / 4 ml / 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 is supplied in sealed glass vials in packs
of 1 or 5. Not all pack sizes may be marketed.

This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany:
Oncofolic 50 mg/ml,
Injektions- oder Infusionslösung
Italy
Sodiofolin 50 mg/ml,
soluzione iniettabile o per infusione
Spain:
Sodiofolin 50 mg/ml,
solución inyectable y para perfusión
United Kingdom: Sodiofolin 50 mg/ml,
solution for injection/infusion

Marketing Authorisation Holder and
Manufacturer
This leaflet was last revised in 06/2014.

Store in a refrigerator (2 °C – 8 °C).
Keep the vial in the outer carton in order to protect
from light.

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

6. Contents of the pack and other information
What Sodiofolin contains
• The active substance is folinic acid
(as disodium folinate).
• The other ingredients are sodium hydroxide,
hydrochloric acid and water for injection.

85500-VPGB
DA

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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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