metex

Hauptinformation

  • Handelsname:
  • metex PEN 20 mg Injektionslösung im Fertigpen
  • Darreichungsform:
  • Injektionslösung im Fertigpen
  • Zusammensetzung:
  • Methotrexat-Dinatrium 21.94mg
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • metex PEN 20 mg Injektionslösung im Fertigpen
    Deutschland
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
  • Zulassungsnummer:
  • 88088.00.00
  • Letzte Änderung:
  • 11-03-2018

Packungsbeilage

Package leaflet: Information for the user

Metojectpen 7.5 mg solution for injection in pre-filled pen

Metojectpen 10 mg solution for injection in pre-filled pen

Metojectpen 12.5 mg solution for injection in pre-filled pen

Metojectpen 15 mg solution for injection in pre-filled pen

Metojectpen 17.5 mg solution for injection in pre-filled pen

Metojectpen 20 mg solution for injection in pre-filled pen

Metojectpen 22.5 mg solution for injection in pre-filled pen

Metojectpen 25 mg solution for injection in pre-filled pen

Metojectpen 27.5 mg solution for injection in pre-filled pen

Metojectpen 30 mg solution for injection in pre-filled pen

methotrexate

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 or pharmacist.

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 or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Metojectpen is and what it is used for

What you need to know before you use Metojectpen

How to use Metojectpen

Possible side effects

How to store Metojectpen

Contents of the pack and other information

1.

What Metojectpen is and what it is used for

Metojectpen is indicated for the treatment of

active rheumatoid arthritis in adult patients.

polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to

nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate.

moderate to severe psoriasis in adult patients, and severe psoriatic arthritis in adults.

mild to moderate Crohn’s disease in adult patients when adequate treatment with other

medicines is not possible.

Rheumatoid arthritis

(RA)

is a chronic collagen disease, characterised by inflammation of the

synovial membranes (joint membranes). These membranes produce a fluid which acts as a lubricant

for many joints. The inflammation causes thickening of the membrane and swelling of the joint.

Juvenile arthritis

concerns children and adolescents less than 16 years. Polyarthritic forms are

indicated if 5 or more joints are affected within the first 6 months of the disease.

Psoriasis

is a common chronic skin disease, characterised by red patches covered by thick, dry,

silvery, adherent scales.

Psoriatic arthritis

is a kind of arthritis with psoriatic lesions of the skin and nails, especially at the

joints of fingers and toes.

Metojectpen modifies and slows down the progression of the disease.

Crohn’s disease is a type of inflammatory bowel disease that may affect any part of the gastrointestinal

tract causing symptoms such as abdominal pain, diarrhoea, vomiting or weight loss.

2.

What you need to know before you use Metojectpen

Do not use Metojectpen:

if you are allergic to methotrexate or any of the other ingredients of this medicine (listed in

section 6).

if you suffer from liver or severe kidney diseases or blood diseases.

if you regularly drink large amounts of alcohol.

if you suffer from a severe infection, such as tuberculosis, HIV or other immunodeficiency

syndromes.

if you suffer from mouth ulcers, stomach ulcer or intestinal ulcer.

if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”).

if you receive vaccinations with live vaccines at the same time.

Warnings and precautions

Talk to your doctor or pharmacist before taking Metojectpen if:

you are elderly or if you feel generally unwell and weak.

you have problems with the way your liver works.

you suffer from dehydration (water loss).

Special precautionary measures for treatment with Metojectpen

Methotrexate temporarily affects sperm and egg production, which is reversible in most cases.

Methotrexate can cause miscarriage and severe birth defects. You must avoid becoming pregnant

when using methotrexate and for at least six months after treatment has stopped. See also section

“Pregnancy, breast-feeding and fertility”.

Recommended follow-up examinations and safety measures

Even when Metojectpen is administered in low doses, severe side effects can occur. In order to detect

them in time, check-ups and laboratory tests have to be carried out by your doctor.

Before therapy

Before starting the treatment, blood samples will be taken in order to check that you have enough

blood cells, tests to check your liver function, serum albumin (a protein in the blood) and kidney

function. Your doctor will also check if you suffer from tuberculosis (infectious disease in

combination with little nodules in the affected tissue) and a chest X-ray will be taken.

During therapy

You will have the following tests at least once a month during the first six months and at least every

three months thereafter:

Examination of the mouth and throat for changes of the mucosa.

Blood tests.

Check of liver function.

Check of kidney function.

Check of respiratory system and if necessary lung function test.

Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported

with methotrexate. If you experience symptoms of spitting or coughing up blood you should contact

your doctor immediately.

Methotrexate may affect your immune system and vaccination results. It may also affect the result of

immunological tests. Inactive, chronic infections (such as herpes zoster [shingles], tuberculosis,

hepatitis B or C) may flare up.

During therapy with Metojectpen you must not be vaccinated with

live vaccines.

Radiation-induced dermatitis and sun-burn can reappear under methotrexate therapy (recall-reaction).

Psoriatic lesions can exacerbate during UV-irradiation and simultaneous administration of

methotrexate.

Enlarged lymph nodes (lymphoma) may occur and if this is the case, therapy must be stopped.

Diarrhoea can be a possible side effect of Metojectpen and requires an interruption of therapy. If you

suffer from diarrhoea please speak to your doctor.

Certain brain disorders (encephalopathy/leukoencephalopathy) have been reported in cancer patients

receiving methotrexate. Such side effects cannot be excluded when methotrexate is used to treat other

diseases.

Other medicines and Metojectpen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. Please note that this also applies to medicines that you will take

in the future

The effect of the treatment may be affected if Metojectpen is administered at the same time as certain

other medicines:

Antibiotics

such as: tetracyclines, chloramphenicol, non-absorbable broad-spectrum antibiotics,

penicillines, glycopeptides, sulphonamides, ciprofloxacin and cefalotin (medicines to

prevent/fight certain infections).

Non-steroidal anti-inflammatory

drugs or

salicylates

(medicines against pain and/or

inflammation such as acetylsalicylic acid, diclofenac and ibuprofen or pyrazole).

Probenecid

(medicine against gout).

Weak organic acids like loop

diuretics

(“water tablets”).

Medicines, which may have adverse effects on the

bone marrow

, such as trimethoprim-

sulphamethoxazole (an antibiotic) and pyrimethamine.

Other

medicines used to treat rheumatoid arthritis

such as leflunomide, sulphasalazine and

azathioprine.

Mercaptopurine (a

cytostatic

medicine).

Retinoids (medicine against

psoriasis

and other dermatological diseases).

Theophylline (medicine against

bronchial asthma

and other lung diseases).

Some medicines against

stomach trouble

such as omeprazole and pantoprazole.

Hypoglycaemics (medicines that are used to

lower the blood sugar

Vitamins containing

folic acid

may impair the effect of your treatment and should only be taken when

advised by your doctor.

Vaccination with live vaccine must be avoided.

Metojectpen with food, drink and alcohol

Alcohol as well as large amounts of coffee, caffeine-containing soft drinks and black tea should be

avoided during treatment with Metojectpen.

Pregnancy, breast-feeding and fertility

Pregnancy

Do not use Metojectpen during pregnancy or if you are trying to become pregnant. Methotrexate can

cause birth defects, harm the unborn child or cause miscarriage. It is associated with malformations of

the skull, face, heart and blood vessels, brain and limbs. Therefore, it is very important that

Methotrexate is not given to pregnant patients or patients planning to become pregnant.

In women of child-bearing age, any possibility of pregnancy must be excluded with appropriate

measures, e.g. pregnancy test before starting treatment. You must avoid becoming pregnant whilst

taking methotrexate and for at least 6 months after treatment is stopped by using reliable contraception

throughout this time (see also section “Warnings and precautions”).

If you do become pregnant during treatment or suspect you might be pregnant, speak to your doctor as

soon as possible. You should be offered advice regarding the risk of harmful effects on the child

through treatment.

If you wish to become pregnant you should consult your doctor, who may refer you for specialist

advice before the planned start of treatment.

Breast-feeding

Stop breast-feeding prior to and during treatment with Metojectpen.

Male fertility

The available evidence does not indicate an increased risk of malformations or miscarriage if the

father takes methotrexate less than 30 mg/week. However, a risk cannot be completely excluded.

Methotrexate may be genotoxic. This means that the medicine may cause genetic mutation.

Methotrexate can affect sperm production with the potential to cause birth defects. Therefore, you

should avoid fathering a child or to donate semen whilst taking methotrexate and for at least 6 months

after treatment is stopped.

Driving and using machines

Treatment with Metojectpen may cause adverse reactions affecting the central nervous system, such as

tiredness and dizziness. Thus the ability to drive a vehicle and/or to operate machines may, in certain

cases, be compromised. If you feel tired or drowsy do not drive or use machines.

Metojectpen contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose; i.e. essentially “sodium-free”.

3.

How to use Metojectpen

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure.

Your doctor decides on the dose, which is adjusted individually to you. Usually it takes 4 – 8 weeks

before there is any effect of the treatment.

Metojectpen is administered subcutaneously (under the skin) by or under the supervision of a

physician or healthcare staff as an injection

once a week only.

Together with your doctor you decide

on a suitable weekday each week on which you receive your injection.

Use in children and adolescents

The doctor decides on the appropriate dose in children and adolescents with polyarthritic forms of

juvenile idiopathic arthritis.

Metojectpen is not recommended in children less than 3 years of age

due to insufficient experience

in this age group.

Method and duration of administration

Metojectpen is injected

once weekly!

The duration of the treatment is determined by the treating physician. Treatment of rheumatoid

arthritis, juvenile idiopathic arthritis, psoriasis vulgaris, psoriatic arthritis and Crohn’s disease with

Metojectpen is a long-term treatment.

At the start of your therapy, Metojectpen will be injected by medical staff. However, your doctor may

decide that you are able to learn how to inject Metojectpen under the skin yourself. You will then

receive appropriate training.

Under no circumstances should you try to inject Metojectpen yourself before you have received

such training.

You can also find guidance on how to use Metojectpen in the section “Instructions for use” at the end

of this leaflet.

Please note that all of the contents have to be used.

The manner of handling and throwing away of the medicine and pre-filled pen must be in accordance

with local requirements. Pregnant healthcare personnel should not handle and/or administer

Metojectpen.

Methotrexate should not come into contact with the surface of the skin or mucosa. In the event of

contamination, the affected area must be rinsed immediately with plenty of water.

If you use more Metojectpen than you should

If you use more Metojectpen than you should, talk to your doctor immediately.

If you forget to use Metojectpen

Do not take a double dose to make up for a forgotten dose.

If you stop using Metojectpen

If you stop using Metojectpen, talk to your doctor immediately.

If you have the impression that the effect of Metojectpen is too strong or too weak, talk to your doctor

or pharmacist.

4.

Possible side effects

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

The frequency as well as the degree of severity of the side effects depends on the dosage level and the

frequency of administration. As severe side effects may occur even at low dosage, it is important that

you are monitored regularly by your doctor. Your doctor will do

tests to check for abnormalities

developing in the blood (such as low white blood cells, low platelets, lymphoma) and changes in the

kidneys and the liver.

Tell your doctor immediately

if you experience any of the following symptoms, as these may

indicate a serious, potentially life-threatening side effect, which require urgent specific treatment:

persistent dry, non-productive cough, shortness of breath and fever

; these may be signs of

an inflammation of the lungs [common]

spitting or coughing blood;

these might be signs of bleeding from the lungs [not known]

symptoms of liver damage such as yellowing of the skin and whites of the eyes

methotrexate can cause chronic liver damage (liver cirrhosis), formation of scar tissue in the

liver (liver fibrosis), fatty degeneration of the liver [all uncommon], inflammation of the liver

(acute hepatitis) [rare] and liver failure [very rare]

allergy symptoms such as skin rash including red itchy skin, swelling of the hands, feet,

ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or

breathing) and feeling you are going to faint;

these may be signs of severe allergic reactions

or an anaphylactic shock [rare]

symptoms of kidney damage such as swelling of the hands, ankles or feet or changes in

frequency of urination or decrease (oliguria) or absence of urine (anuria);

these may be

signs of kidney failure [rare]

symptoms of infections, e.g. fever, chills, achiness, sore throat;

methotrexate can make you

more susceptible to infections. Severe infections like a certain type of pneumonia

Pneumocystis carinii pneumonia

) or blood poisoning (sepsis) may occur [rare]

symptoms such as weakness of one side of the body (stroke) or pain, swelling, redness

and unusual warmth in one of your legs (deep vein thrombosis); This may happen when

a dislodged blood clot causes a blockage of a blood vessel

(thromboembolic event) [rare]

fever and serious deterioration of your general condition, or sudden fever accompanied

by a sore throat or mouth, or urinary problems

; methotrexate can cause a sharp fall in

certain white blood cells (agranulocytosis) and severe bone marrow suppression [very rare]

unexpected bleeding, e.g. bleeding gums, blood in the urine, vomiting blood or bruising,

these can be signs of a severely reduced number of blood platelets caused by severe

courses

bone marrow depression [very rare]

symptoms such as severe headache often in combination with fever, neck stiffness,

feeling sick, vomiting, disorientation and sensitivity to light

may indicate an inflammation

of the membranes of the brain (acute aseptic meningitis) [very rare]

certain brain disorders (encephalopathy/leukoencephalopathy) have been reported in cancer

patients receiving methotrexate. Such side effects cannot be excluded when methotrexate

therapy is used to treat other diseases. Signs of this kind of brain disorders may be

altered

mental state,

movement disorders (ataxia), visual disturbances or disturbances of

memory [not known]

severe skin rash or blistering of the skin (this can also affect your mouth, eyes and

genitals)

; these may be signs of conditions called Stevens Johnson syndrome or burned skin

syndrome (toxic epidermal necrolysis/Lyell’s syndrome) [very rare]

In the following, please find the other side effects that may occur:

Very common:

may affect more than 1 in 10 people

Inflammation of the mouth lining, indigestion, feeling sick, loss of appetite, abdominal pain.

Abnormal liver function test (ASAT, ALAT, bilirubin, alkaline phosphatase).

Common:

may affect up to 1 in 10 people

Mouth ulcers, diarrhoea.

Rash, reddening of the skin

itching.

Headache, tiredness, drowsiness.

Reduced blood cell formation with decrease in white and/or red blood cells and/or platelets.

Uncommon:

may affect up to 1 in 100 people

Throat inflammation.

Inflammation of the bowels, vomiting, inflammation of pancreas, black or tarry stools,

gastrointestinal ulcers and bleeding.

Increased sensitivity to light, loss of hair, increased number of rheumatic nodules, skin ulcer,

shingles, inflammation of blood vessels, herpes-like skin rash, hives.

Onset of diabetes mellitus.

Dizziness, confusion, depression.

Decrease in serum albumin.

Decrease in the number of all blood cells and platelets.

Inflammation and ulcer of the urinary bladder or vagina, reduced kidney function, disturbed

urination.

Joint pain, muscle pain, reduction of bone mass.

Rare:

may affect up to 1 in 1,000 people

Inflammation of gum tissue.

Increased skin pigmentation, acne, blue spots on the skin due to vessel bleeding (ecchymosis,

petechiae), allergic inflammation of blood vessels.

Decreased number of anti-bodies in the blood.

Infection (incl. reactivation of inactive chronic infection), red eyes (conjunctivitis).

Mood swings (mood alterations).

Visual disturbances.

Inflammation of the sac around the heart, accumulation of fluid in the sac around the heart,

obstruction of cardiac filling due to fluid in the sac around the heart.

Low blood pressure.

Formation of scar tissue in the lung (pulmonary fibrosis), shortness of breath and bronchial

asthma, accumulation of fluid in the sac around the lung.

Stress fracture.

Electrolyte disturbances.

Fever, wound-healing impairment.

Very rare:

may affect up to 1 in 10,000 people

Acute toxic dilatation of the gut (toxic megacolon).

Increased pigmentation of the nails, inflammation of the cuticles (acute paronychia), deep

infection of hair follicles (furunculosis), visible enlargement of small blood vessels.

Pain, loss of strength or sensation of numbness or tingling in arms and legs, changes in taste

(metallic taste), convulsions, paralysis, meningism.

Impaired vision, non-inflammatory eye disorder (retinopathy).

Loss of sexual drive, impotence, male breast enlargement, defective sperm formation

(oligospermia), menstrual disorder, vaginal discharge.

Enlargement of lymphatic nodes (lymphoma).

Lymphoproliferative disorders (excessive growth of white blood cells).

Not known:

frequency cannot be estimated from the available data

Increased number of certain white blood cells.

Nosebleed.

Proteins in urine.

Feeling of weakness.

Bone damage in the jaw (secondary to excessive growth of white blood cells).

Subcutaneous application of methotrexate is locally well tolerated. Only mild local skin reactions

(such as burning sensations, erythema, swelling, discolouration, severe itching, pain) were observed,

decreasing during therapy.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via (see details below). By reporting

side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5.

How to store Metojectpen

Keep this medicine out of the sight and reach of children.

Store below 25 °C.

Keep the pre-filled pens in the outer carton in order to protect from light.

Do not use this medicine after the expiry date stated on the carton and pre-filled pen after EXP. The

expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Metojectpen contains

The active substance is methotrexate.

1 pre-filled pen with 0.15 ml solution contains 7.5 mg methotrexate.

1 pre-filled pen with 0.2 ml solution contains 10 mg methotrexate.

1 pre-filled pen with 0.25 ml solution contains 12.5 mg methotrexate.

1 pre-filled pen with 0.3 ml solution contains 15 mg methotrexate.

1 pre-filled pen with 0.35 ml solution contains 17.5 mg methotrexate.

1 pre-filled pen with 0.4 ml solution contains 20 mg methotrexate.

1 pre-filled pen with 0.45 ml solution contains 22.5 mg methotrexate.

1 pre-filled pen with 0.5 ml solution contains 25 mg methotrexate.

1 pre-filled pen with 0.55 ml solution contains 27.5 mg methotrexate.

1 pre-filled pen with 0.6 ml solution contains 30 mg methotrexate.

The other ingredients are sodium chloride, sodium hydroxide and hydrochloric acid for pH

adjustment and water for injections.

What Metojectpen looks like and contents of the pack

This medicinal product is presented as a solution for injection in pre-filled pen.

The solution is clear, yellow-brown.

The following pack sizes are available:

Metojectpen is available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.

Alcohol

pads are included in the package.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

medac

Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

Tel: +49 4103 8006 0

Fax: +49 4103 8006 100

This medicinal product is authorised in the Member States of the EEA under the following

names:

Austria, Bulgaria, Czech Republic, Finland, Greece, Hungary, Netherlands, Romania, Slovak

Republic, Slovenia, Spain, United Kingdom:

Metoject PEN

Iceland, Sweden:

Metojectpen

Germany:

metex PEN

Estonia, Latvia, Lithuania, Norway:

Metex

Poland, Portugal:

Metex PEN

Denmark:

Metex Pen

Belgium:

Metoject

This leaflet was last revised in 2018-10-05

Instructions for use

Recommendations

Carefully read the instructions below before starting your injection.

Always use the injection technique advised by your doctor, pharmacist or nurse.

Additional information

The manner of handling and throwing away of the medicine and pre-filled pen must be in accordance

with local requirements. Pregnant healthcare personnel should not handle and/or administer

Metojectpen.

Methotrexate should not come into contact with the surface of the skin or mucosa. In the event of

contamination, the affected area must be rinsed immediately with plenty of water.

What you need in order to administer your injection using the Metojectpen pre-filled pen

You need:

1 Metojectpen pre-filled pen

1 alcohol pad

Metojectpen pre-filled pen components:

Injection button

Handling area

Transparent control zone

a) With cap before injection

b) After cap removal before injection

c) After injection

What you need to do before administering your injection

Wash your hands very carefully.

Remove the system from its packaging.

Check the Metojectpen pre-filled pen before using it:

If the Metojectpen pre-filled pen appears to be damaged

do

not use

it. Use another one and contact your doctor,

pharmacist or nurse.

In case a small air bubble is visible through the transparent

control zone, this will not affect your dose nor will it harm

you.

If you are not able to see or to check the system correctly

prior to injection, ask someone around you for assistance.

Set the Metojectpen pre-filled pen on a clean flat surface (such as a table).

Where you should administer the injection

The most appropriate zones for your injection are:

- upper thighs,

- abdomen except around the navel.

If someone around you administers the injection for

you, the person may also use the top of the zone at the

back of the arm, just below the shoulder.

Change the injection area with each injection. This will

minimise any reactions at the injection site.

Never inject into areas where the skin is tender, bruised,

red or hard or where you have scars or stretch marks. If

you have psoriasis, you should not try to inject directly

into any raised, thick, red or scaly skin patches or

lesions.

How to prepare the injection

Clean your skin in the chosen injection zone using the

enclosed alcohol pad.

Hold the Metojectpen pre-filled pen with one hand in

the handling area.

Do not remove the cap before you are ready to

administer the injection.

Use your other hand to pull the cap straight off. The

small needle shield comes off with the cap

automatically. If not, use another pen and contact your

doctor, pharmacist or nurse.

Do not press the button until you are ready to inject.

If you are unable to remove the cap, ask someone

around you for assistance.

Note: Once you have removed the cap, perform your injection without delay.

With your free hand, build a skin fold by gently

squeezing the area of the cleaned skin at the injection

site.

The fold must be held pinched until the Metojectpen

pre-filled pen is removed from the skin after the

injection.

Position the uncapped transparent end of Metojectpen

pre-filled pen perpendicular to the fold of skin.

Without pressing the button

, push the Metojectpen

pre-filled pen firmly onto your skin in order to unlock

the button.

If you are unable to push the Metojectpen pre-filled pen

to the stop-point, ask someone around you for

assistance.

How to administer the injection:

While holding the Metojectpen pre-filled pen firmly

against the skin,

now press

the button

with your

thumb.

You will hear a click which indicates the start of the

injection. Keep holding the pen against the raised skin

until all of the medicine is injected. This can take up

5

seconds

Note:

Do not remove the Metojectpen pre-filled pen from the skin before the end of the injection to avoid

incomplete injection.

If the injection is not triggered, release the button, make sure that the Metojectpen pre-filled pen is

pressed firmly against the skin and push hard on the button.

If you have troubles with your hearing, count 5 seconds from the moment you have pressed the button

and then lift the Metojectpen pre-filled pen from the injection site.

Remove the Metojectpen pre-filled pen from the

injection site, perpendicular to the skin (pull up).

The protective shield automatically moves into place

over the needle. The protective shield is then locked

and the needle is protected.

In case of a slight bleeding use a plaster.

Before throwing away the Metojectpen pre-filled pen,

check visually that there is no liquid left in the pen, at the

bottom of the

transparent control zone

. If there is liquid

left in the pen, not all of the medicine has been injected

correctly and you should consult your doctor.

Note

To avoid any injury,

never insert your fingers in the opening of the protective tube

covering the

needle.

Do not destroy the pen.

Whom should you contact in case of need

For any problem or question, contact your doctor, pharmacist or nurse.

If you or someone around you is injured by the needle, consult your doctor immediately and throw

away the Metojectpen pre-filled pen.

29-6-2018

Medicines Safety Update, Volume 9, Number 2, June 2018

Medicines Safety Update, Volume 9, Number 2, June 2018

Oral methotrexate dosing, medicines associated with a risk of neuropsychiatric adverse events, and clozapine and gastrointestinal effects

Therapeutic Goods Administration - Australia

20-6-2018

Methotrexat

Methotrexat

Umsetzung des Beschlusses der Europäischen Kommission zum PSUR Single Assessment betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff „Methotrexat“.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

5-3-2012

Danish Pharmacovigilance Update, 16 February 2012

Danish Pharmacovigilance Update, 16 February 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Risk of overdose with methotrexate in the treatment of rheumatoid arthritis as well as intensified monitoring of heart rate and blood pressure in connection with treatment with Gilenya.

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