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NAMEDICA 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Namedica 20 mg/ml concentrate for solution for infusion
Irinotecan hydrochloride trihydrate
The name of this product is Namedica 20 mg/ml concentrate for solution for infusion, which will be referred to
as ‘Namedica’ or ‘Namedica Solution’ throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or 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.
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.

In this leaflet:
1.
What Namedica is and what it is used for
2.
Before you use Namedica
3.
How to use Namedica
4.
Possible side effects
5.
How to store Namedica
6.
Further information

1. WHAT NAMEDICA IS AND WHAT IT IS USED FOR
Namedica belongs to a group of medicines called cytostatics (anti-cancer medicines).
It is used for the treatment of advanced cancer of colon and rectum in adults, either in combination with other
medicines (i.e. 5-fluorouracli/folinic acid, bevacizumab, cetuximab, capecitabine) or alone.

2. BEFORE YOU USE NAMEDICA
Do not use Namedica
- if you are allergic (hypersensitive) to irinotecan hydrochloride trihydrate or any of the other
ingredients of Namedica Solutioin;
- if you have any other bowel disease or a history of bowel obstruction;
- if you are breast-feeding (see “Pregnancy and breast-feeding”);
- if you have high levels of bilirubin (a waste blood product) in the blood (more than 3 times the upper limit
of normal);
- if you have an imbalance of your blood cells (severe bone marrow failure);
- if you are in a poor general health (evaluated by an international standard);
- if you are using the natural remedy St John´s wort (Hypericum perforatum).
If you receive Namedica in combination with cetuximab or bevacizumab or capecitabine, please make sure that
you also read the package leaflet for these medicines. The combination could lead to additional
contraindications.

Take special care with Namedica
This medicine is intended for adults only. Check with your doctor if this medicine has been prescribed for use in
a child.
Elderly patients require more intense surveillance during treatment.

As Namedica is an anti-cancer medicine it will be administered to you in a special unit and under supervision of
a doctor qualified in the use of anti-cancer medicines. The units’ personnel will explain to you what you need to
take special care of during and after the treatment. This leaflet may help you to remember that.
If you receive Namedica in combination with cetuximab or bevacizumab or capecitabine, please make sure that
you also read the package leaflet for these medicinal products.
In the first 24 hours after administration of Namedica
During administration of Namedica Solution (30 – 90 minutes) and within 24 hours after administration you may
experience some of the following symptoms:
- diarrhoea
- sweating
- abdominal pain
- watering eyes
- visual disturbance
- excessive mouth watering
The medical term for these symptoms is “acute cholinergic syndrome”. If you have any of these symptoms,
immediately tell your doctor who will give you any treatment necessary.
From the day after treatment with Namedica until next treatment
During this period you may experience various symptoms, which may be serious and require immediate
treatment and close supervision.
Diarrhoea
If your diarrhoea starts more than 24 hours after administration of Namedica (“delayed diarrhoea”) it may be
serious. It is often seen about 5 days after administration. The diarrhoea should be treated immediately and kept
under close supervision. Immediately after the first liquid stools do the following:
1. Take any antidiarrhoeal treatment that the doctor has given you, exactly as he/she has told you. The
treatment must not be changed without consulting the doctor.
2. Drink large amounts of water and rehydration fluids, immediately (i.e. water, soda water, fizzy drinks, soup
or oral rehydration therapy).
3. Immediately inform your doctor who is supervising the treatment, and tell him/her about the diarrhoea. If
you are not able to reach the doctor, contact the hospital unit supervising the Namedica treatment. It is very
important that they are aware of the diarrhoea.
You must immediately tell the doctor, or the unit supervising the treatment, if
- you have diarrhoea as well as fever (over 38 °C)
- you have severe diarrhoea (and vomiting ) with excessive loss of water requiring intravenous hydration
- you still have diarrhoea 48 hours after starting the diarrhoea treatment
Note! Do not take any treatment for diarrhoea other than that given to you by your doctor and the fluids
described above. Follow the doctor’s instructions. The antidiarrhoeal treatment should not be used preventive,
even though you have experienced delayed diarrhoea at previous cycles.
Nausea and vomiting
If you have nausea and/or vomiting contact your doctor or the hospital unit immediately.
Neutropenia
Namedica may cause a decrease in the number of some of your white blood cells, which play an important role
in fighting infections. This is called neutropenia. Neutropenia is often seen during treatment with Namedica and
is reversible. Your doctor should arrange for you to have regular blood tests to monitor these white blood cells. If
you have any fever (over 38°C) this may be an indication of infection associated with this neutropenia and
requires immediate treatment. Therefore, if you have any fever, and particularly if you also have diarrhoea,
contact your doctor or nurse immediately, that they can give you the necessary treatment.
Breathing difficulties
If you have any breathing difficulties contact your doctor immediately.
Impaired liver function
Before treatment with Namedica is started and before every following treatment cycle your doctor will monitor
your liver function (by blood tests).

Impaired kidney function
As this medicine has not been tested in patients with kidney problems, please check with your doctor if you have
any kidney problems.
Heart problems
If you are at risk of having a heart attack your doctor should monitor you very carefully while you are given
Namedica and action should be taken to minimize the risk factors (e.g. smoking, high blood pressure, high levels
of blood lipids).
Lowered resistance to Infections
Vaccination with a live or life-attenuated vaccine is not recommended in patients receiving Namedica, because
this might result in serious or fatal infections. Killed or inactivated vaccines may be administered; however, the
response to such vaccines may be diminished.
If you have one or more of the symptoms mentioned above, after you have returned home from the
hospital, you should immediately contact the doctor or the hospital unit supervising your Namedica
treatment.

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. This is also valid for herbal medicines, strong vitamins and minerals.
The following medications can alter the effects of Namedica:
- carbamazepine, phenobarbital or phenytoin (medicines for the treatment of epilepsy)
- ketoconazole (used to treat fungal infections)
- rifampicin (used for the treatment of tuberculosis)
- atazanavir sulphate (used to treat HIV infection)
- the herbal medicine St John’s Wort (Hypericum perforatum, a treatment for depression. This must not be
used during and between treatments with Namedica, as it may decrease the effect of Namedica.
- Oral anticoagulants (used to reduce blood clotting)
- Yellow fever vaccine (must not be used while you are treated with Namedica)
- Other live attenuated vaccines are also not recommended (see section “Take special care with Namedica”,
chapter “Lowered resistance to Infections”).
- Ciclosporine and Tacrolimus (both used to reduce the activity of the immune system, e.g. after organ
transplant)
If you require an operation, please tell your doctor or anaesthetist that you are using this medicine, as it may alter
the effect of some medicines used during surgery.

Pregnancy and breast-feeding
You should not be given Namedica if you are pregnant unless clearly indicated by your doctor.
Women of child-bearing age should avoid becoming pregnant.
Contraceptive measures must be taken by both male and female patients of reproductive age during and for at
least three months after cessation of therapy.
Still, if you become pregnant during this period you must immediately inform your doctor.
It is not known whether Namedica is excreted in human milk.
Consequently you must not breast-feed while you are treated with Namedica.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
During the first 24 hours after administration of Namedica you may feel dizzy or have visual disturbances. If this
happens to you do not drive or use any tools or machines.

This medicine may also cause other side effects which affect your ability to drive and use tools and machines.
Contact your doctor or pharmacist if you are unsure.

Important information about some of the ingredients of Namedica Solution
Namedica Solution contains sorbitol. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.

3. HOW TO USE NAMEDICA
Namedica will be given to you by a doctor or nurse, the solution is infused into the vein (as a drip).
Namedica is for adults only.
Dosage
The amount of infusion you are given will depend on your age, size, weight and general medical condition. It
will also depend on any other treatment you may have received for your cancer. Your doctor will calculate your
body surface area in square metres (m2).
If you have been treated before, when used alone, you receive an infusion of 350 mg/m2 over a 30 to 90
minute period every three weeks.
If you have not been treated before you receive an infusion of 180 mg/m2 over a 30 to 90 minute period once
every two weeks. Each treatment is followed by an infusion with folinic acid and 5-fluorouracil (other cancer
treatments).
If you receive Namedica in combination with cetuximab, Namedica must not be administered earlier than 1 hour
after the end of the cetuximab infusion. Please follow the advice if your doctor regarding your current treatment.
If you receive Namedica in combination with bevacizumab, please consult the bevacizumab leaflet.
If you receive Namedica in combination with capecitabine, please consult the capecitabine leaflet.
These dosages may be adjusted by your doctor depending on your condition and any side effects you may have.

The dose should be chosen carefully in elderly patients and more intense surveillance is required.
Namedica is not recommended for patients with kidney disorders.
Please tell your doctor if you have a genetic disorder with a reduced activity of the enzyme UGT1A1 (uridine
diphosphate glucuronosyltransferase 1A1).
Duration of treatment
Treatment is continued as long as possible. If the cancer gets worse or the side effects are unacceptable, the
treatment will be stopped.

If you receive more Namedica than you should
Namedica will be given to you by a doctor or nurse who is familiar with this type of treatment so the chance is
very small to be given an overdose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Namedica can cause side effects, although not everybody gets them. Your doctor will discuss
these side effects with you and explain the risks and benefits of your treatment.

Some of these side effects must be treated immediately (see also information in section “Take special care
with Namedica”).
Very common side effects (more than 1 in 10 patients)
- Blood disorders:
- Decreased number of a certain type of white blood cells (neutropenia) which increases the risk of
infections.
- Decrease number of red blood cells (anaemia) which can make the skin pale and cause weakness and
breathlessness.
- Decreased number of blood platelets (thrombocytopenia) which increases the risk of bruising and
bleeding (in combination therapy).
- Fever and infections (in monotherapy).
- Delayed severe diarrhoea.
- Severe nausea and vomiting (in monotherapy).
- Hair loss (the hair grows again after end of treatment).
- Transient and mild to moderate increase in serum levels of some liver enzymes (AST, ALT, alkaline
phosphate) or bilirubin (in combination therapy).
Common side effects (less than 1 in 10 patients but more than 1 in 100)
- Severe transient acute cholinergic syndrome: the main symptoms are defined as early diarrhoea and various
other symptoms such as abdominal pain; red, sore, itching or weeping eyes (conjunctivitis); running nose
(rhinitis); low blood pressure; widening of the blood vessels (vasodilation); sweating; chills; a feeling of
general discomfort and illness; dizziness; visual disturbances; pupil contraction; watering eyes and increased
salivation, occurring during or within the first 24 hours after the infusion of Namedica.
- Decreased number of blood platelets (thrombocytopenia) which increases the risk of bruising and bleeding
(in monotherapy).
- Fever and infections (in combination therapy).
- Infections associated with a severe decrease in the number of a certain type of white blood cells
(neutropenia) resulting in death in 3 cases.
- Fever associated with a severe decrease in the number of a certain type of white blood cells (febrile
neutropenia).
- Severe nausea and vomiting (in combination therapy).
- Loss of water (dehydration), commonly associated with diarrhoea and /or vomiting.
- Constipation.
- Severe weakness (asthenia).
- Transient and mild to moderate increase in serum levels of some liver enzymes (transaminases, alkaline
phosphatase) or bilirubin (in monotherapy).
- Transient and mild to moderate increase of creatinine in the blood.
- Transient severe (grade 3) increase in serum levels of bilirubin (in combination therapy).
Uncommon side effects (less than 1 in 100 patients but more than 1 in 1,000)
- Mild allergic reaction (skin rash including red itchy skin, urticaria, conjunctivitis, rhinitis).
- Mild skin reactions.
- Mild reactions at the infusion site.
- Lung disease presenting as shortness of breath, dry cough, and inspiratory crackles (interstitial pulmonary
disease); early effects such as breathing difficulties.
- Partial or complete blockage of the bowel (intestinal blockage, ileus).
- Stomach and intestines bleeding.
- Bowel inflammation which causes abdominal pain and/or diarrhoea (a condition known as pseudomembraneous colitis).
- Kidney problems (renal insufficiency), low blood pressure or cardio-circulatory failure have been observed
in patients who experienced episodes of dehydration associated with diarrhoea and/or vomiting or sepsis.
Rare side effects (less than 1 in 1,000 patients but more than 1 in 10,000)
- Severe allergic reactions causing swelling of the hands, feet, ankles, face, lips, mouth or throat, which may
cause difficulty in swallowing or breathing (anaphylatic/ anaphylactoid reaction).
- Muscular contraction or cramps and numbness (paraesthesia).
- Inflammation of the large bowel causing abdominal pain (colitis including typhlitis, ischemic and ulcerative
colitis).
- Intestinal perforation, loss of appetite (anorexia), abdominal pain, inflammation of the mucous membranes.
- Inflammation of the pancreas (pancreatitis) which may cause abdominal pain.
- Increased blood pressure during and following administration.

-

Decreased levels of potassium and sodium in the blood, mostly related to diarrhoea and vomiting.

Very rare effects (less than 1 in 10,000 patients)
- Bruising or bleeding easily due to your body destroying its own blood platelets (peripheral
thrombocytopenia with antiplatelet antibodies [one case]).
- Temporary speech disorders.
- Increase in levels of some digestive enzymes which break down sugars and fats.
Side effects resulting from the combination with other medicines
If you receive Namedica in combination with certain other medicines, some of the side effects you may
experience can also be related to this combination.
Namedica in combination with:
- Cetuximab: an acne-like rash.
- Capecitabine: formation/presence of blood clots, obstruction/occlusion of a blood vessel by a blood clot
(very common), severe allergic reactions, insufficient blood flow to the heart muscle often resulting in chest
pain (cardiac ischemia), heart attack and fever associated with a severe decrease in the number of a certain
type of white blood cells (febrile neutropenia) (common).
- Capecitabine and bevacizumab: decrease in the number of a certain type of white blood cells (neutropenia),
formation/presence of blood clots, obstruction/occlusion of a blood vessel by a blood clot (embolism), high
blood pressure, insufficient blood flow to the heart muscle often resulting in chest pain (cardiac ischemia)
and heart attack. These side effects are common.
Please make sure that you also read the package leaflet for these medicines.
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 NAMEDICA
Do not refrigerate or freeze.
Keep the vial in the outer carton in order to protect from light.
Keep out of the reach and sight of children.
Do not use Namedica Solution after the expiry date which is stated on the vial and on the box after “EXP”. The
expiry date refers to the last day of the month.
For single use only.
The infusion solution should be prepared immediately prior to use and infusion commenced as soon as
practicable after preparations.

6. FURTHER INFORMATION
What Namedica Solution contains
- The active substance is irinotecan hydrochloride trihydrate.
Each ml of the concentrate contains 20 mg irinotecan hydrochloride trihydrate equivalent to 17.33 mg
irinotecan.
Each vial with 2 ml of the concentrate contains 40 mg irinotecan hydrochloride trihydrate.
Each vial with 5 ml of the concentrate contains 100 mg irinotecan hydrochloride trihydrate.
- The other ingredients are sorbitol (E420), lactic acid (E270), sodium hydroxide (E524), hydrochloric acid
(E507) and water for injection.

What Namedica Solution looks like and contents of the pack
Namedica concentrate for solution for infusion is a pale yellow, clear aqueous solution.
Namedica 40 mg/2 ml and 100 mg/5 ml are available in boxes containing one single amber glass vial.
Pack sizes:
One vial of 2 ml/pack
One vial of 5 ml/pack

Marketing Authorisation Holder and Manufacturer
Regiomedica GmbH
Teichstr. 66
79539 Lörrach
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany:
Namedica 20 mg/ml
France:
NAMEDICA 20 mg/ml
Sweden:
Namedica 20 mg/ml
The Netherlands: Narimed 20 mg/ml
United Kingdom: Namedica 20 mg/ml
This leaflet was last approved in January 2012

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Namedica hydrochloride trihydrate 20 mg/ml concentrate for solution for infusion
The following information is intended for medical or healthcare professionals only:
Instruction for use – Cytotoxic
Handling of Namedica
As with all antineoplastic agents, caution should be exercised when handling Namedica. Dilution should be
carried out under aseptic conditions by trained personnel in a designated area. Precaution should be taken to
avoid contact with the skin and mucous membranes.
Protection instructions for preparation of Namedica Solution for infusion:
1. Protective chamber should be used and protective gloves as well as protective gown should be worn. If there
is a no protective chamber available mouth cover and goggles should be used.
2.

Opened containers, like injection vials and infusion bottles and used cannulae, syringe, catheters, tubes and
residuals of cytostatics should be considered as hazardous waste and undergo disposal according to the local
guidelines for the handling of HAZARDOUS WASTE.

3.

Follow the instructions below in case of spillage:
- protective clothing should be worn
- broken glass should be collected and placed in the container for HAZARDOUS WASTE.
- Contaminated surfaces should be flushed properly with copious amounts of cold water.
- the flushed surfaces should then be wiped thoroughly and the materials used for wiping should be
disposed as HAZARDOUS WASTE.

4.

In the event of Namedica contact with the skin, the areas should be rinsed with plenty of running water and
then washed with soap and water. In case of contact with mucous membranes, wash the contacted aria
thoroughly with water. If you have any discomfort, contact a doctor.

5.

In case of contact of Namedica with eyes, wash them thoroughly with plenty of water, contact an
ophthalmologist immediately.

Preparation of infusion solution
Namedica concentrate for solution for infusion is intended for intravenous infusion only after diluting prior to
administration in the recommended diluents, either 0.9 % Sodium chloride solution for infusion or 5 % glucose
solution for infusion. Aseptically withdraw the required amount of Namedica concentrate for solution from the
vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle. The infusion should be thoroughly
mixed by manual rotation.
If any precipitate is observed in the vials or after reconstitution the product should be discarded according to the
standard procedures for cytotoxic agents.
Namedica should not be delivered as an intravenous bolus or an intravenous infusion shorter than 30 minutes or
longer than 90 minutes.
Disposal
All items used for preparation, administration or otherwise coming into contact with Namedica should undergo
disposal according to local guidelines for the handling of cytotoxic compounds.

Expand Transcript

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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