Metex pen

Package leaflet: Information for the user

Metex PEN, 7.5 mg, solution for injection in a pre-filled pen
Metex PEN, 10 mg, solution for injection in a pre-filled pen
Metex PEN, 12.5 mg, solution for injection in a pre-filled pen
Metex PEN, 15 mg, solution for injection in a pre-filled pen
Metex PEN, 17.5 mg, solution for injection in a pre-filled pen
Metex PEN, 20 mg, solution for injection in a pre-filled pen
Metex PEN, 22.5 mg, solution for injection in a pre-filled pen
Metex PEN, 25 mg, solution for injection in a pre-filled pen
Metex PEN, 27.5 mg, solution for injection in a pre-filled pen
Metex PEN, 30 mg, solution for injection in a pre-filled pen
Methotrexatum
Please read this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Metex PEN is and what it is used for
2. Important information before using Metex PEN
3. How to use Metex PEN
4. Possible side effects
5. How to store Metex PEN
6. Contents of the pack and other information

1. What Metex PEN is and what it is used for

Indications for Metex PEN medicinal product

• Active rheumatoid arthritis in adult patients, and polyarticular forms of severe, active juvenile idiopathic arthritis when response to non-steroidal anti-inflammatory drugs (NSAIDs) is inadequate,
• Moderate to severe psoriasis in adult patients, and severe psoriatic arthritis in adults,
• Crohn’s disease of mild to moderate severity in adult patients when treatment with other medications is not possible.

Rheumatoid arthritis (RA) is a chronic disease classified among the collagenoses, characterized by inflammation of the synovial membranes lining the joints. These membranes produce fluid that acts as a lubricant for many joints. The inflammatory process causes thickening of the membranes and joint swelling.
Juvenile arthritis occurs in children and adolescents under the age of 16. The polyarticular form is defined by involvement of five or more joints within the first six months of the disease.
Psoriasis is a common chronic skin disease characterized by red patches covered with thick, dry, silvery, tightly adherent scales.
Psoriatic arthritis refers to joint inflammation, particularly affecting fingers and toes, associated with psoriatic skin and nail changes.
Metex PEN modifies and slows the progression of the disease.
Crohn’s disease is a type of inflammatory bowel disease that may affect any segment of the gastrointestinal tract, causing symptoms such as abdominal pain, diarrhoea, vomiting, or weight loss.

2. Information before using Metex PEN

When not to use Metex PEN

• if the patient is allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has liver disease, severe kidney disease or blood disorders;
• if the patient regularly consumes large amounts of alcohol;
• if the patient has severe infections, such as tuberculosis, HIV infection or other immunodeficiency syndromes;
• if the patient has oral mucosal ulcers, gastric or intestinal ulcers;
• if the patient is pregnant or breastfeeding (see section "Pregnancy, breastfeeding and fertility");
• if the patient is simultaneously receiving a vaccine containing live microorganisms.

Warnings and precautions
Before starting treatment with Metex PEN, discuss with your doctor or pharmacist:

• if the patient is elderly, debilitated or in poor general health;
• if the patient has liver function disorders;
• if the patient has dehydration (lack of water in the body);
• if the patient has diabetes and is using insulin.

Special precautions for the use of Metex PEN
Methotrexate temporarily impairs the production of sperm and egg cells; in most cases, this effect is reversible. Methotrexate may cause miscarriage and severe congenital malformations. Women should avoid becoming pregnant during methotrexate treatment and for at least 6 months after treatment ends. Men should avoid impregnating their partner during methotrexate treatment and for at least 3 months after treatment ends. See also section "Pregn游戏副本

3. How to use Metex PEN

Important warning regarding dosing of Metex PEN (methotrexate):
In the treatment of rheumatoid arthritis, juvenile idiopathic arthritis,
psoriasis, psoriatic arthritis, and Crohn's disease, Metex PEN must be used only once a week.
Taking more Metex PEN (methotrexate) than prescribed may result in death. Please read section 3 of this leaflet carefully. If you have any questions, consult your doctor or pharmacist before taking this medicine.
This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will decide on the dosage, which is individually adjusted to the patient.
Therapeutic effects are usually observed only after 4 to 8 weeks of treatment.
Metex PEN is administered as a subcutaneous injection by or under the supervision of a doctor or qualified healthcare professional once weekly only.
The patient should agree with the doctor on a specific day of the week for the injection.

Use in children and adolescents
The doctor will determine the appropriate dose for children and adolescents with polyarticular juvenile idiopathic arthritis.
Metex PEN is not recommended for use in children under 3 years of age due to insufficient experience in this age group.

Method and timing of administration
Metex PEN is injected once a week!
The duration of treatment is determined by the treating physician. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, and Crohn's disease with Metex PEN is long-term.
At the beginning of treatment, Metex PEN may be administered by healthcare personnel. However, the doctor may decide that the patient is capable of self-injecting Metex PEN. The patient will be properly trained accordingly. Never attempt self-injection without prior training.
Instructions on how to correctly use Metex PEN are provided in the "Instructions for Use" section at the end of this leaflet.
Remember to use the entire contents of the pre-filled syringe.
Preparation of the medicine for use and disposal of the pre-filled auto-injector must comply with local requirements.
Healthcare personnel who are pregnant should not prepare or (and) administer the medicinal product Metex PEN.
Methotrexate must not come into contact with skin or mucous membranes. In case of contact, the affected area should be immediately rinsed thoroughly with plenty of water.

If you use more Metex PEN than you should
If you have used more Metex PEN than prescribed, contact your doctor immediately.

If you forget to use Metex PEN
Do not use a double dose to make up for a missed dose.

Stopping Metex PEN
If you stop using Metex PEN, inform your doctor immediately.
If you feel that the effect of Metex PEN is too strong or too weak, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency and severity of adverse reactions depend on the dose size and frequency of
administration. Since serious adverse reactions may occur even after administration of small
doses, regular medical examinations are necessary. Therefore, the doctor should
perform examinations to rule out abnormalities in blood parameters (e.g. low
white blood cell count, platelets, lymphoma) and changes in the liver and kidneys.
You should inform the doctor immediately if any of the following symptoms
occur in the patient, as they may indicate serious, potentially life-threatening
adverse reactions requiring urgent treatment:

• persistent dry cough without sputum, shortness of breath, and fever; these may be symptoms of lung inflammation [common]
• coughing up blood; this may be a sign of bleeding from the lungs [frequency not known]
• signs of liver damage, e.g. yellowing of the skin and whites of the eyes; methotrexate may cause chronic liver damage (liver cirrhosis), scarring of liver tissue (liver fibrosis), fatty degeneration of the liver (fatty liver) [all uncommon], liver inflammation (acute hepatitis) [rare], and liver failure [very rare]
• allergic symptoms such as skin rash, including itchy redness of the skin, swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), and the patient may feel faint; these may be symptoms of severe allergic reactions or anaphylactic shock [rare]
• signs of kidney damage such as swelling of the hands, ankles, or feet or changes in frequency of urination, reduced volume (oliguria), or absence of urine (anuria); these may be symptoms of kidney failure [rare]
• signs of infection such as fever, chills, pain, sore throat; methotrexate may increase susceptibility to infections. Serious infections such as a specific type of pneumonia (pneumonia caused by Pneumocystis jirovecii) and blood poisoning (sepsis) may occur [rare]
• symptoms such as weakness on one side of the body (stroke) or pain, swelling, redness, and unusual warmth in one leg (deep vein thrombosis); this may occur when a dislodged blood clot blocks a blood vessel (thromboembolic event) [rare]
• symptoms such as fever and severe worsening of general health or sudden fever accompanied by sore throat or mouth pain or urinary disturbances; methotrexate may cause acute decrease in certain white blood cells (agranulocytosis) and severe bone marrow suppression [very rare]
• unexpected bleeding, e.g. bleeding gums, blood in urine, in vomit, or appearance of blood spots (petechiae); these may be symptoms of significant decrease in platelet count due to severe bone marrow suppression [very rare]
• symptoms such as severe headache with accompanying fever, neck stiffness, nausea, vomiting, disorientation, and sensitivity to light may indicate meningitis (acute aseptic meningitis) [very rare]
• in cancer patients receiving methotrexate treatment, certain brain function disorders (encephalopathy/leukoencephalopathy) have been reported. Occurrence of such adverse reactions cannot be ruled out when methotrexate is used in the treatment of other diseases. Symptoms of such brain function disorders include altered mental state, movement disorders (ataxia), visual and memory disturbances [frequency not known]
• severe skin rash or blisters on the skin (which may also occur in the mouth, eyes, and genital organs); these may be symptoms of Stevens-Johnson syndrome or skin burn-like syndrome (toxic epidermal necrolysis/Lyell's syndrome) [very rare]

Other adverse reactions that may occur are listed below:
Very common: may occur in more than 1 patient in 10

• inflammation of the mucous membrane of the mouth, indigestion, nausea, decreased appetite, abdominal pain,
• abnormal liver function tests (AST, ALT, bilirubin, alkaline phosphatase).

Common: may occur in 1 patient in 10

• mouth ulcers, diarrhea,
• rash, redness of the skin, itching,
• headache, fatigue, drowsiness,
• reduced blood cell production leading to decreased white and/or red blood cells and/or platelets.

Uncommon: may occur in 1 patient in 100

• sore throat,
• intestinal inflammation, vomiting, pancreatitis, black or tarry stools, bleeding and ulcers from the gastrointestinal tract,
• reactions resembling sunburn due to increased skin sensitivity to sunlight, hair loss, increased number of rheumatoid nodules, skin ulceration, shingles, vasculitis, herpes-like rash, urticaria,
• onset of diabetes,
• dizziness, confusion, depression,
• decreased albumin concentration in serum,
• decreased number of all blood cells and platelets,
• inflammation and ulceration of the bladder or vagina, impaired kidney function, urinary disturbances,
• joint pain, muscle pain, decreased bone mass.

Rare: may occur in 1 patient in 1,000

• gingivitis,
• increased skin pigmentation, acne, blue spots on the skin due to bleeding from blood vessels (bruising, petechiae), allergic vasculitis,
• decreased concentration of antibodies in blood,
• infection (including latent chronic infection), redness of the eyes (conjunctivitis),
• mood changes (mood swings),
• visual disturbances,
• inflammation of the sac surrounding the heart, fluid accumulation in the pericardium, impaired heart filling due to fluid in the pericardial sac,
• low blood pressure,
• formation of scar tissue in the lungs (pulmonary fibrosis), shortness of breath and bronchial asthma, fluid accumulation in the pleural sac around the lung,
• stress fractures,
• electrolyte disturbances,
• fever, impaired wound healing.

Very rare: may occur in 1 patient in 10,000

• acute toxic dilation of the large intestine (toxic megacolon),
• increased pigmentation of nails, inflammation of the nail cuticle (acute paronychia), deep infection of hair follicles (folliculitis), visible enlargement of small blood vessels,
• pain, loss of muscle strength, or sensation of numbness or tingling, reduced sensitivity to stimuli, taste disturbances (metallic taste), seizures, meningeal reaction,
• impaired vision, non-inflammatory eye disease (retinopathy),
• decreased libido, impotence, breast enlargement in men, disturbances in sperm production (oligospermia), menstrual disorders, vaginal discharge,
• enlarged lymph nodes (lymphoma),
• lymphoproliferative disorders (overproduction of white blood cells).

Frequency not known: frequency cannot be determined from available data

• increased number of certain white blood cells,
• nosebleeds,
• proteinuria,
• feeling of fatigue,
• jaw bone damage (due to overproduction of white blood cells),
• tissue damage at the injection site,
• redness and peeling of the skin,
• swelling.

Subcutaneously administered doses of methotrexate are locally well tolerated. Only
mild local skin reactions (such as burning sensation, erythema, swelling, discoloration, itching,
intense itching, pain) have been observed, decreasing during treatment.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, PL-02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
website: ://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Metex PEN

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Store the prefilled automatic injection devices in their outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and the auto-injector under
"Expiry date". The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Metex PEN contains

• The active substance is methotrexate. One pre-filled semi-automatic syringe with a solution volume of 0.15 ml contains 7.5 mg of methotrexate. One pre-filled semi-automatic syringe with a solution volume of 0.2 ml contains 10 mg of methotrexate. One pre-filled semi-automatic syringe with a solution volume of 0.25 ml contains 12.5 mg of methotrexate. One pre-filled semi-automatic syringe with a solution volume of 0.3 ml contains 15 mg of methotrexate. One pre-filled semi-automatic syringe with a solution volume of 0.35 ml contains 17.5 mg of methotrexate. One pre-filled semi-automatic syringe with a solution volume of 0.4 ml contains 20 mg of methotrexate. One pre-filled semi-automatic syringe with a solution volume of 0.45 ml contains 22.5 mg of methotrexate. One pre-filled semi-automatic syringe with a solution volume of 0.5 ml contains 25 mg of methotrexate.

One pre-filled semi-automatic syringe with a solution volume of 0.55 ml contains 27.5 mg
of methotrexate.
One pre-filled semi-automatic syringe with a solution volume of 0.6 ml contains 30 mg
of methotrexate.

• Other ingredients are sodium chloride, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections.

What Metex PEN looks like and contents of the pack
Metex PEN is a solution for injection in a pre-filled syringe.
The solution is clear and yellowish-brown in colour.

Metex PEN pre-filled semi-automatic syringe is a three-step automatic injector with a yellow cap and a yellow injection button.

Metex PEN pre-filled semi-automatic syringe is a two-step automatic injector with a transparent protective cap and a blue needle shield.
The following pack sizes are available:
Metex PEN is available in packs containing 1, 2, 4, 5, 6, 10, 11, 12, 14, 15 or 24 pre-filled semi-automatic syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Telephone: +49 4103 8006-0
Fax: +49 4103 8006-100

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria, Czech Republic, Finland, Greece, Spain, Netherlands, Slovakia, Slovenia, Hungary, United Kingdom (Northern Ireland):
Metoject PEN
Iceland, Sweden:
Metojectpen
Germany:
metex PEN
Estonia, Lithuania, Latvia, Norway:
Metex
Poland, Portugal:
Metex PEN
Denmark:
Metex Pen
Belgium:
Metoject

Instructions for use
Recommendations

• Before administering the medicine, carefully read the instructions below.
• Always follow the injection technique recommended by your doctor, pharmacist or nurse.

Additional information
Disposal of unused medicine and the pre-filled semi-automatic syringe must comply with local regulations. Healthcare professionals who are pregnant should not prepare or (and) administer the medicinal product Metex PEN.
Methotrexate must not come into contact with skin or mucous membranes. In case of contact, the affected area must be immediately rinsed thoroughly with plenty of water.

Components of the Metex PEN injector:

Injection button
Area for holding the injector
Transparent control zone
Cap

a) With cap before injection
b) After removing the cap before injection
c) After injection has been administered

What to do before administering the injection

1. Wash your hands thoroughly.
2. Remove the device from its packaging.
3. Inspect the Metex PEN injector before use:

If the Metex PEN injector appears damaged,

do not use it. Use another injector and contact your doctor, pharmacist or nurse.
If a small air bubble is visible in the transparent control zone, this does not affect the dose and does not pose a risk to the patient.
If the patient is unable to properly see or inspect the injector before injection, ask another person for help.

4. Place the Metex PEN injector on a clean, flat surface (e.g. a table).

Where to administer the injection
The most suitable injection sites

include:

• the upper thigh,
• the abdomen, except the area around the navel.
  • If another person administers the injection to the patient, it may also be given into the upper, back part of the upper arm, just below the shoulder.
  • Always select a different injection site each time. This will help reduce the risk of local reactions at the injection site.
  • Never inject the medicine into areas that are painful, bruised, red, hardened, scarred or have stretch marks. If the patient has psoriasis, do not inject the medicine directly into raised, thickened, red or flaking skin areas or lesions.

How to prepare for the injection

5. Select the injection site and clean

the selected injection site and the surrounding skin area.

• Do not remove the cap before preparing for injection.

6. Hold the injector in one hand at the designated holding area, with the cap pointing upwards. With the other hand, gently remove the cap with a straight motion (do not bend or twist the cap). A small needle shield inside the cap should automatically detach along with the cap. If the needle shield does not detach, use another injector and contact your doctor, pharmacist or nurse.

• If the patient has difficulty removing the cap, ask another person for help.

Warning: After removing the cap, administer the injection immediately.

7. Create a skin fold by gently pinching the cleaned skin area selected for injection.

• Hold the skin fold until the injector is withdrawn from the skin after the injection.

8. Place the exposed, transparent end

of the Metex PEN injector perpendicularly onto the skin fold.

9. Without pressing the button, firmly press the Metex PEN injector against the skin to unlock the button.

• If the patient cannot firmly and steadily press the Metex PEN injector against the skin, ask another person for help.

How to administer the injection:

10. While firmly holding the Metex PEN injector pressed against the skin, press the button with your thumb.

11. A clicking sound will be heard, indicating the start of the injection. Keep holding the injector pressed against the skin until the full dose of medicine has been injected. This may take up to 5 seconds.

Warning:
To avoid incomplete injection, do not remove the Metex PEN injector from the skin before the injection is complete.
If the injection does not start, release the button, ensure the Metex PEN injector is firmly pressed against the skin, and press the button firmly again.
If you cannot hear the click, count 5 seconds from the moment you pressed the button, then lift the injector away from the injection site.

12. Remove the Metex PEN injector from the injection site

by pulling it straight out, perpendicularly to the skin.

13. The protective shield automatically returns to cover the needle. The shield then locks into place, covering the needle.
14. If there is minor bleeding, apply an adhesive dressing.

Before disposing of the Metex PEN injector, visually check whether any liquid remains in the transparent control zone at the bottom. If liquid remains in the injector, this indicates that an incomplete dose was administered, and you should contact your doctor immediately.

Warning
To avoid needlestick injuries, never insert fingers into the opening of the protective needle shield.
Do not destroy the injector.

Who to contact if needed

• For any problems or questions, contact your doctor, pharmacist or nurse.
• In case of a needlestick injury to the patient or another person, seek immediate medical advice and dispose of the Metex PEN injector.

INSTRUCTIONS FOR USE

Before using the prefilled semi-automatic injector for subcutaneous injection,
read this entire Instructions for Use. Read this Instructions for Use
each time you receive a new prescription and keep this Instructions for Use for reference
in case you need information after use.

Important information to read before administering an injection using a prefilled semi-automatic injector with Metex PEN
The injection should be administered using a prefilled semi-automatic injector with Metex PEN once weekly, always on the same day of the week.
Pregnant women should not administer or prepare the medication.

• Keep the injector in a safe place, out of sight and out of reach of children.
• In case of contact with the medication, immediately rinse the affected area thoroughly with plenty of water.

Do NOT remove the protective cap until immediately before administering the injection.
Do NOT share your injector with anyone else.
Do NOT use the injector if:

• it has fallen on a hard surface or appears damaged;
• the clear yellow solution has changed color, is cloudy, or contains solid particles;
• it has been frozen or stored at temperatures above 25°C;
• the expiration date has passed. If in doubt, consult a healthcare professional.

How to store the prefilled semi-automatic injector with Metex PEN

• Store below 25°C.
• Transport and store the injector in its outer packaging to protect it from light.
• Keep the injector in a safe place, out of sight and out of reach of children.

Do NOT freeze.
Do NOT store above 25°C.
Metex PEN prefilled semi-automatic injector (Fig. A)
The Metex PEN prefilled semi-automatic injector is a two-step, automatic fixed-dose injector for single use. It is available in 10 different doses ranging from 7.5 mg to 30 mg.
Before use After use

Protective cap Blue needle shield
(clear) (locks in place after
injection, needle inside)
Control window

(yellow medication inside) Protective cap
(needle shield
Plunger inside)
(position depends on prescribed dose)
Blue plunger body

(indicates complete
injection)
Medication label
7.5 mg 15 mg 30 mg
(for checking dose (example doses)
and expiration date)
Color-coded area
(unique for each dose)
Fig. A
Materials needed for administering the injection (Fig. B)
On the day of your weekly injection, find a comfortable location, ensure it is well-lit, and that you have a clean, flat surface available—such as a table—on which to place the materials needed for the injection.
Required item:

• Metex PEN prefilled semi-automatic injector.

• A calendar to track the weekly injection day;
• A skin cleansing agent, e.g., alcohol swab, or if unavailable, soap and water;
• A cotton swab or gauze pad to wipe the injection site;
• A sharps container compliant with local regulations.

Metex PEN calendar Skin cleansing Cotton swab or Sharps
indicating the weekly injection device agent gauze container
injection day Ryc. B autoinjector for cleaning skin

Preparing to administer the injection

• Wash hands with soap and water.
• Carefully remove the syringe from the packaging.

Fig. C
2. Check the injector before use

(Fig. D)

• Check the expiration date on the injector label.
• Do not use the injector if the Fig. D expiration date has passed.
• Check the medicine through the viewing window by turning it upside down or gently shaking it. The medicine in the injector should be clear and yellow.
  • Do not inject if the solution is cloudy, has changed color, or contains solid particles.
  • It is normal to see one or more small air bubbles. Do not attempt to remove them.
  • A scale may be visible in the viewing window; this does not require attention.
• Check that the injector is not damaged and that the cap is properly attached. Do not use the injector if it appears damaged or if the cap has been removed or is not securely attached.

If the expiration date of the injector has passed,
if it appears damaged or does not look as expected,
do not use it and contact a healthcare professional.
Before proceeding with further steps,
carefully place the injector on a clean,
flat surface, such as a table.
3. Choose the injection site (Fig. E)

• The patient may self-inject in:
  • the upper thigh,
  • the lower abdomen, except for the area within 5 cm of the navel.
• If the injection is administered by a caregiver, the back of the upper arm may also be used.
• Use a different site than the one used for the last injection.

When choosing the injection site:
do not inject into other parts of the body;
do not inject into bruised, tender, peeling, red, or hardened skin;
do not inject into moles, scars, or stretch marks;
do not inject through clothing.

Site
Site
for
for
caregiver
caregiver
only
only
Fig. E
4. Clean the injection site (Fig. F)

• Clean the injection site with an alcohol-based disinfectant; if unavailable, use water and soap.
• Wait until the skin is dry. Do not fan or do not blow on the cleaned area. Do not touch the injection site again until the injection is completed. Fig. F

Administering the dose
5. Remove the cap (Fig. G)

The protective cap should only be removed when
the patient is ready to administer the
injection.
Do not attempt to reattach the cap to the
injector after removal.

• Hold the injector with the cap pointing upward and firmly remove the cap in one motion. Fig. G Do not bend or do not twist the cap while removing it.
• Immediately discard the cap.
• Small droplets of medicine may appear. This is normal.
• Administer the injection immediately after removing the cap.

Do not touch the blue needle shield with fingers.
Touching the blue needle shield may
accidentally activate the injection
and cause injury.

6. Position the injector (Fig. H)

• Place the open blue needle shield perpendicularly (at a 90-degree angle) against the skin, with the viewing window facing toward you so it remains visible.
• It may be more comfortable to pinch a skin fold by gently squeezing the area around the injection site between the thumb and other fingers before injecting, but this is not necessary with this injector. Fig. H

7. Start the injection (Fig. I)

• To start the injection, press the injector firmly and completely against the skin. This will retract the blue needle shield into the injector and automatically start the injection.
• The first audible click indicates the start of the injection. The blue plunger rod will move downward.
• Continue holding the injector firmly pressed against the skin until the entire Fig. I dose is injected. Once the injection has started, do not change the position of the injector.

8. Hold the injector in place to complete
the injection (Fig. J)

• Continue holding the injector firmly pressed against the skin for 5 seconds.
• The injection is complete when:
  • a second click is heard shortly after the first;
  • or: the blue plunger rod has stopped moving and completely fills the viewing window;
  • or: 5 seconds have passed. Fig. J

9. Completing the injection (Fig. K)

• Remove the injector straight upwards from the injection site.
• The blue needle shield automatically returns into place around the needle and locks.
• Check the control window to ensure no yellow medicine residue remains visible. If yellow medicine is still visible in the window, the full dose may not have been delivered. In this case, or if there are any other Fig. K doubts, contact a healthcare professional.

Do not touch the blue needle shield after
administration of the injection, as this may
cause injury.
After the injection

10. Care for the injection site (Fig. L)

• A small drop of blood may appear at the injection site. This is normal. If needed, press gently with a swab or gauze.
• If necessary, cover the injection site with a small dressing.

Do not rub the injection site.
Fig. L

11. Disposing of the injector (Fig. M)
Each injector is for single use only. Do not
re-cap the injector.
The used injector and protective cap must
be stored out of sight and out of reach of
children.
Fig. M

• The cap and injector must be disposed of immediately after use. The method of disposal of the medicine and the prefilled semi-automatic injector must
  comply with local regulations.

• Discard used materials into a household waste container. The cardboard box can be disposed of in paper recycling.

Prefilled semi-automatic injectors of
Metex PEN that have expired, are no longer
needed, or are unfit for use must be
disposed of safely.