Enbrel PFS_Patient

Patient package insert in accordance with the pharmacists’ regulations (preparations) - 1986
The dispensing of this medicine requires a physician’s prescription.
Read this package insert carefully in its entirety before using this medicine.
±π∏∂ ≠ © «dCײ® WœUOB« WLE½√ Vłu0 pKN²LK …dA½
uÐ ÂeK ¡«Ëb« «c¼
∫¡«Ëb« ‰ULF²Ý« q³ UNKUJÐ …dAM« wzØ√d≈
Pre-filled syringe containing solution for subcutaneous injection
Enbrel 25 mg- each pre-filled syringe contains active ingredient:
Enbrel 50 mg- each pre-filled syringe contains active ingredient:
Etanercept 25 mg
Etanercept 50 mg
Each pre-filled syringe also contains:
Sucrose, Sodium chloride, L-Arginine hydrochloride, Sodium phosphate monobasic dihydrate, Sodium
phosphate dibasic dihydrate, Water for injections.
Therapeutic group: Immunosystem suppressive.
Therapeutic Action: Enbrel is a biotechnological preparation, anti tumour necrosis factor (TNF)
that is indicated for the treatment of rheumatoid arthritis in adults and children above 4 years of age,
psoriatic arthritis in adults, ankylosing spondylitis in adults and moderate to severe plaque psoriasis
in adults.
When should this medicine not be used?
If you are pregnant or breastfeeding. You should not breastfeed during treatment with Enbrel.
It is not known whether the active ingredient of this medicine is excreted in human milk.
If there is a known sensitivity (allergy) to the active ingredient or to any of the other ingredients
of the preparation.
In case of severe infection in the blood (sepsis- infection which is life threatening or requiring
hospitalization or intravenous antibiotics) or risk of sepsis.
Do not initiate treatment with Enbrel if you have an active chronic or topical infection.
Do not use certain vaccines (such as orally administered Polio) in combination with Enbrel.
Do not use this medicine without consulting a physician before starting treatment:
If you or your child suffer from infection, including topical infection that lasts for a long time (such
as foot ulcer), from problems in the heart function (congestive heart failure), from impairment of the
nervous system, blood dyscrasias, history of recurring infections, diabetes or other conditions that
may increase the risk for infection, hepatitis C, multiple sclerosis, inflammation of the eye nerve.
If you or your child suffer or suffered in the past from tuberculosis or if you were in contact with a
person suffering from tuberculosis.
If you or your child are going to get a vaccine.
Your physician may perform a test for the presence of hepatitis B before starting treatment with Enbrel.
Your physician may wish to follow up the treatment with Enbrel in the following cases: worsening
of hepatitis C infection, if you or your child develop a new infection or are going to undergo a surgery.
Inform your physician immediately if signs suggestive of tuberculosis (e.g., persistent cough, weight
loss, lack of energy, low-grade fever) or other infection appear during or after treatment with Enbrel.
Inform your physician if you or your child were exposed to varicella during the treatment with Enbrel.
It is possible that your physician will decide to further continue your or your child’s follow up after
completion of the treatment with Enbrel.
The needle cover contains a material called latex (dry natural rubber). Contact your physician in
case of a known latex hypersensitivity to you or to the person who assists in injecting the medicine
to you before using Enbrel.
If you are sensitive to any food or drug, you should inform the physician before taking the medicine.
Drug interactions:
If you are taking another medicine concomitantly or if you have just finished treatment with another
medicine, inform the attending physician in order to prevent side effects or lack of efficacy arising
due to drug interactions.
In clinical trials, no interactions have been observed when Enbrel was administered with
glucocorticoids, salicylates (except for sulfasalazin), nonsteroidal anti-inflammatory drugs, analgesics
or methotrexate.
Do not use preparations containing the active ingredients anakinra or abatacept during the treatment
with Enbrel.
Side effects:
In addition to the desired effect of the medicine, adverse reactions may occur during the course of
using this medicine.
Common side effects are: injection site reactions (including bruising, bleeding, redness, pain, itching,
Side effects requiring special attention:
Infections (including common cold, sinusitis, bronchitis, urinary system infections, skin infections):
refer to the physician immediately.
Severe infections (including pneumonia, skin infections, joint infections, sepsis and broad spread
of infections), local swelling of the skin, low count of platelets, low count of white and red blood cells,
tuberculosis, convulsions, abnormal liver function tests (rare): refer to the physician immediately.
Allergic reaction such as difficulties in breathing or swallowing, pressure in the chest, snorting while
breathing, dizziness, swelling of the face, neck, arms and legs, mood changes (e.g., nervousness,
anxiety, fast heartbeats, skin redness, feeling of warmth, severe rash, itching: discontinue treatment
and seek immediate medical aid.
Signs of infection, such as high fever that may be accompanied with cough, shortness of breath,
chill, weakness or warm, red, sensitive, painful skin or joint areas: refer to your physician immediately.
Signs of blood abnormalities, e.g. persistent fever, sore throat, bleeding, bruising, paleness (rare):
refer to your physician immediately.
Signs of neural abnormalities, e.g. numbness, itching, changes in vision, eye pains, developing arm
or leg weakness (rare): refer to your physician immediately.
Signs of worsening of heart failure such as: fatigue, shortness of breathing during exercise, swelling
in the ankles, sense of fullness in the stomach, shortness of breathing or cough at night, bluish
fingernails or lips (rare): refer to your physician immediately.
In the event that you experience side effects not mentioned in this leaflet, or if there is a change in
your general health, consult your physician immediately.
Laboratory evaluations:
Based on the results of clinical studies, normally no special laboratory evaluations are necessary,
in addition to routine careful medical management.
Dosage is according to physician’s instructions only.
Do not exceed the recommended dose.
This medicine is to be taken at specific time intervals as determined by the attending physician. If
you forgot to take your Enbrel dose at the specified time, take the dose as soon as you remember
(you should skip the missed dose if the next dose should be taken on the day after), but never take
a double dose to compensate for a missed one!
Directions for use:
See next page - Instructions for preparing and giving an injection.
How can you contribute to the success of the treatment?
Complete the full course of treatment as instructed by the physician.
Even if there is an improvement in your health, do not discontinue use of this medicine without
consulting your physician.
Avoid poisoning!
This medicine, and all other medicines, must be stored in a safe place out of the reach of children
and/or infants, to avoid poisoning.
If you have taken an overdose, or if a child accidentally swallowed the medicine, proceed immediately
to a hospital emergency room and bring the package of the medicine with you.
Do not induce vomiting unless explicitly instructed to do so by a physician!
This medicine has been prescribed for the treatment of your ailment; therefore it may cause harm
to other people who have not been prescribed this medicine by their physician. Do not give this
medicine to your relatives, neighbors or acquaintances.
Do not take medicines in the dark! Check the label and the dose each time you take your medicine.
Wear glasses if you need them.
Store in the original pack in the refrigerator between 2-8°C. Do not freeze!
Even if kept in their original container and stored as recommended, medicines may be kept for a
limited period only. Please note the expiry date of the medicine! In case of doubt, consult the
pharmacist who dispensed the medicine to you. Do not store different medications in the same
License number:
Enbrel 25 mg: 142-52-31949-00
Enbrel 50 mg: 142-53-31950-00
Manufacturer: Wyeth Medica Ireland, Ireland.
Registration Holder: Neopharm Ltd.,
P.O.Box 7063, Petach Tiqva 49170, Tel: 03-9373737.
The format of this leaflet has been defined by the Ministry of Health; its content has been checked
and approved – June 2010.
bK'« X% sI×K ÎôuK× Íu% WMI×
Etanercept 25 mg
Etanercept 50 mg
Etanercept 25 mg:‫כלמזרקמכילחומרפעיל‬-‫מ"ג‬25‫אנברל‬
Etanercept 50 mg:‫כלמזרקמכילחומרפעיל‬-‫מ"ג‬50‫אנברל‬
∫WUFH« …œU*« vKŽ WMI× q Íu²% ≠ rGK ≤µ ‰d³½≈
∫WUFH« …œU*« vKŽ WMI× q Íu²% ≠ rGK µ∞ ‰d³½≈
Sucrose, Sodium chloride, L-Arginine hydrochloride, Sodium phosphate monobasic
dihydrate, Sodium phosphate dibasic dihydrate, Water for injections.
∫vKŽ Íu²% pcË
Sucrose, Sodium chloride, L-Arginine hydrochloride, Sodium phosphate monobasic
dihydrate, Sodium phosphate dibasic dihydrate, Water for injections.
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»UN²« ÃöF hÒB ¨(Tumor Necrosis Factor) TNF œUC ÍuOŠ włuuMJð dCײ u¼ ‰d³½≈
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‫המיועד‬,(Tumor Necrosis Factor)TNF‫אנברלהינותכשירביוטכנולוגינוגד‬:‫פעילות
להקפיא‬.2-8°C ‫במקררבטמפרטורהשל‬,‫לשמורבאריזההמקורית‬:‫אחסנה‬
∫¡«Ëb« qO−ð r—
Æ«bMd¹√ ¨«bMd¹√ UJ¹b X¹«Ë ∫Z²M*«
∞≥π≥∑≥∑≥∑ ∫nðU¼ ¨¥π±∑∞ UçJð `²OÄ ¨∑∞∂≥ ƻƒ ƨ÷Æ —Uu¾O½ ∫qO−²« VŠU
Æ≤∞±∞ Ê«d¹eŠ ≠ UNK³ s ÒdÔ√Ë UN½uLC h×ÔË W×B« …—«“Ë q³ s …dAM« Ác¼ WGO
2010‫יוני‬- ‫פורמטעלוןזהנקבעע"ימשרדהבריאותותוכנונבדקואושרעלידו‬
SH Z571005609999B/PFP JUN10
sI×K e¼Uł ‰uK× ‰d³½ù sI(«Ë dOCײ« ULOKFð
sI(« u×½ dOCײ« ∫vË_« WKŠd*«
sI×K hÒB<« ÊUJ*« —UO²š« ∫WO½U¦« WKŠd*«
sI×K e¼U'« ‰uK;« ≠ ‰d³½≈ ‰uK× sIŠ ∫W¦U¦« WKŠd*«
sI(« «Ëœ√ s hÒK²« ∫WFЫd« WKŠd*«
Step 1: Setting up for an injection
Step 2: Choosing an injection site
Step 3: Injecting the Enbrel solution
Step 4: Disposing of supplies
ÆsI×K e¼U'« ‰d³½≈ ‰uK; sI(«Ë dOCײ« WOHO WOU²« ULOKF²« ÕdAð
Æ„bu sI(« Ë√ wð«c« sI(« WI¹dDÐ W{dL*« Ë√ p³O³Þ „býd¹ ·uÝ
ÆWŽd−K sI(«Ë dOCײ« WOHO rN s bÒQ²« q³ ¡«Ëb« sIŠ Í؉ËU% ô
The following instructions explain how to prepare and inject Enbrel. Please read the
instructions carefully and follow them step by step. You will be instructed by your doctor
or his/her assistant on the techniques of self-injection or on giving an injection to a child.
Do not attempt to administer an injection until you are sure that you understand how to
prepare and give the injection.
This injection should not be mixed with any other medicine.
Step 1: Setting up for an injection
Select a clean, well-lit, flat working surface.
Take the Enbrel carton containing the pre-filled syringes out of the refrigerator and
place it on the flat work surface. Remove one pre-filled syringe and one alcohol
swab and place them on the work surface. Do not shake the pre-filled syringe of
Enbrel. Place the carton containing any remaining pre-filled syringes back into the
refrigerator. Please see “Storage“ section for instructions on how to store Enbrel.
If you have any questions about storage, contact your doctor, nurse, or pharmacist
for further instructions.
You should allow 15 to 30 minutes for the Enbrel solution in the syringe to
reach room temperature. DO NOT remove the needle cover while allowing it to
reach room temperature. Do not warm Enbrel in any other way (for example, do not
warm it in a microwave or in hot water).
Assemble the additional supplies you will need for your injection. These include an
alcohol swab and a cotton ball or gauze.
Wash your hands with soap and warm water.
Make sure the solution in the pre-filled syringe is clear, colourless or pale yellow,
and practically free from visible particles. Otherwise, do not inject the solution. Use
a different Enbrel pre-filled syringe, then contact your pharmacist for assistance.
sI×K e¼U'« ‰uK;« ≠ ‰d³½≈ ‰uK× sIŠ ∫W¦U¦« WKŠd*«
Pick up the pre-filled syringe from the flat work surface. Remove the needle cover
by firmly pulling it straight off the syringe (see Diagram 2). Be careful not to bend
or twist the cover during removal to avoid damage to the needle.
When you remove the needle cover, there may be a drop of liquid at the end of the
needle; this is normal. Do not touch the needle or allow it to touch any surface. Do
not touch or bump the plunger. Doing so could cause the liquid to leak out.
Wipe the site where Enbrel is to be injected with an alcohol swab, using a circular
motion. DO NOT touch this area again before giving the injection.
When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
With the other hand, hold the syringe like a pencil.
With a quick, short motion, push the needle all the way into the skin at an angle
between 45° and 90° (see Diagram 3). With experience, you will find the angle that
is most comfortable for you or the child. Be careful not to push the needle into the
skin too slowly, or with great force.
When the needle is completely inserted into the skin, release the skin that you are
holding. With your free hand, hold the syringe near its base to stabilise it. Then push
the plunger to inject all of the solution at a slow, steady rate (see Diagram 4).
When the syringe is empty, pull the needle out of the skin, being careful to keep it
at the same angle as inserted. There may be a little bleeding at the injection site.
You can press a cotton ball or gauze over the injection site for 10 seconds. Do not
rub the injection site. If needed, you may cover the injection site with a bandage.
ÆrOI²*« qLF« `D s WMI;« ÍØcš Ʊ
Æ©≤ rÝ—® …dÐù« s rOI² qJAÐË …uIÐ t³×Ý WDÝ«uÐ …dÐù« ¡UDž ÍØŸe½≈
Æ…dÐù« WÐU≈ lM* ¨t²«“≈ ‰öš ¡UDG« ÍØÃÒuFð ö¾ ÍØ—cŠ≈
ÍØ`Lð ôË …dÐù« ”U9 ŸuM2 ÆWOFO³Þ WUŠ Ác¼ Æ…dÐù« ·dÞ w qzUÝ …dD ÊuJð b ¨…dÐù« ¡UDž W«“≈ bFÐ
Æ×U)« v« qzU« »Òdð p– VÒ³¹ b ÆWMI×LK WC*« f³J ÍØfLKð ô ÆÊU `D Í√ fLKð Ê√ …dÐû
ÆsI(« q³Ë rOIF²« bFÐ WIDM*« Ác¼ ÍØfLKð ô ÆW¹dz«œ Wd×Ð ‰u× ‘Uý WDÝ«uÐ sI(« WIDM ÍØ`≈
ÆrKI« s¹Øp9 ULK¦ W‡O½U¦« „bOÐ WMI;« ÍØp≈ Æ…bŠ«Ë bOÐ sI(« WIDM ÍØp≈ ¨sI(« WIDM nH& bFÐ
Æ©≥ rÝ—® Wł—œ π∞≠¥µ 5Ð U W‡¹Ë«eÐ bK'« qš«œ v« …dÐù« ÍØlœ« …dOBË WF¹dÝ Wd×Ð
ÆpKHD Ë√ pHM sI×K d¦√ W×¹d*« W¹Ë«e« s¹Øb& ·uÝ Xu« —Ëd l
Æ…bz«“ …u ‰ULF²ÝUÐ Ë√ “ö« s d¦√ W¾ODÐ …—uBÐ bK−K …dÐù« ÍØlbð ö¾ ÍØ—cŠ≈
¨UNðbŽU s Uγ¹d WMI;« ÍØp√ …Òd(« „bOÐ Æ„bOÐ bK'« „U≈ ÍØ—ÒdŠ ¨UNKUJÐ bK'« qš«œ …dÐù« ÊuJð UbMŽ
Æ©¥ rÝ—® U³¦ÐË ¡j³Ð tKUJÐ ‰uK;« sI( fÐUJ« ÍØlœ« Êü« ÆUNðU³Ł≈ qł√ s
ÆbK'« v« UNUšœ≈ W¹Ë«“ fHMÐ bK'« s WMI;« ÍØÃdš√ ¨Wž—U WMI;« ÊuJð UbMŽ
ÆÌÊ«uŁ ±∞ …b* sI(« ÊUJ v« ÍÒeG« ‘Uý Ë√ sD WFD ‚UB≈†p½UJSÐ ÆsI(« WIDM w nOHš Âœ n¹e½ dNE¹ b
Æp– v« WłU(« XŽœ «–≈ WIBK« ‰ULF²Ý« p½UJSÐ ÆsI(« ÊUJ ÍØpÒbð ô
ÆjI …bŠ«Ë …d ‰ULF²Ýô WBB WMI;«
Æ…dÐù«Ë WMI;« ‰ULF²Ý« ÍØbOFÔð ô
ÆsI(« bFÐ …dÐù« ¡UDž ŸuM2
ÆwbOB« Ë√ W{dL*« ¨VO³D« ULOKF² UÎIË WMI;«Ë …dÐù« s ÍØhÒKð
The pre-filled syringe is for single-use administration only. The syringe and needle should
NEVER be re-used. NEVER re-cap a needle. Dispose of the needle and syringe as
instructed by your doctor, nurse or pharmacist.
If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar
with Enbrel.
sI(« «Ëœ√ s hÒK²« ∫WFЫd« WKŠd*«
Step 4: Disposing of supplies
«bŽ U ¨sD³«©»® ¨„—uK wU_« rI« jÝË ©√® ∫w¼ sI×K e¼U'« ‰d³½≈ ‰uK× sI( UNÐ v
u*« oÞUM*« ÀöŁ Ʊ
Æ©1 rÝ—® 5Ž«—c« s ÍuKF« ¡e−K WOł—U)« WIDM*« ©Ã® ¨…ÒdB« ‰uŠ «d²LO²MÝ µ WIDM
ÊUJL 5Ž«—cK ÍuKF« ¡e−K WOł—U)« WIDM*« ÍØ—U²ð ö ¨pHM sI×K e¼U'« ‰uK;« s¹ØsI% XM «–≈
ÆoÐU« ÊUJ*« sŽ q_« vKŽ «d²LO²MÝ ≥ bFÔÐ vKŽ sI(« s ÍØbÒQð ÆÈdš√ WIDM w …b¹bł WŽdł q sIŠ V−¹ Æ≤
UNO błuð sU√ w WŽd'« sIŠ sŽ ÍØlM²≈ ÆUγK
Ë√ dLŠ√ ¨UÎÐUB ¨UÎÝUŠ tO bK'« ÊuJ¹ ÊUJ w ÍØsI% ô
Æ©WIÐU« sI(« sU√ UNO s¹ØqÒ−ð WLzUIÐ ÍØsF²Ý«® Òbý UöŽ Ë√ WÐb½
¨“—UÐ bKł ∫q¦ ¨WÐUB WIDM w dýU³*« sI(« Í؉ËU% ö ¨·«bB« s ¨pKHÞ Ë√ X½« ¨ÍØw½UFð XM «–≈ Æ≥
Æ©·«bB« sŽ Z²Mð bK'« w UÐU
≈® ‚uIA Ë√ dLŠ√ ¨pOLÝ
Step 3: Injecting the Enbrel solution
sI(« u×½ dOCײ« ∫vË_« WKŠd*«
sI×K hÒB<« ÊUJ*« —UO²š≈ ∫WO½U¦« WKŠd*«
The three recommended injection sites for Enbrel using a pre-filled syringe include:
(1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right
around the navel; and (3) the outer area of the upper arms (see Diagram 1). If you
are self injecting, you should not use the outer area of the upper arms.
A different site should be used for each new injection. Each new injection should
be given at least 3 cm from an old site. Do not inject into areas where the skin is
tender, bruised, red, or hard. Avoid areas with scars or stretch marks (It may be
helpful to keep notes on the location of the previous injections).
If you or the child have psoriasis, you should try not to inject directly into any raised,
thick, red, or scaly skin patches (“psoriasis skin lesions”).
‫ הכנהלקראתהזרקה‬:‫שלבראשון‬
ÆÈdš√ W¹Ëœ√ l WMI;« Ác¼ Èu²× jKš ŸuM2
Æ«ÎbOł ¡UCË nOE½ ¨rOI² qLŽ `D ÍØd²š≈
ÆrOI² qLŽ `D vKŽ ÍØl{Ë Włö¦« s sU;« vKŽ W¹u²;« W“d« ÍØÃdš√
ÆqLF« `D vKŽ ÍØl{Ë ‰u× ‘UýË sU;« ÈbŠ≈ ÍØÃdš√
Æ©¢WMI;«¢ wK¹ ULO® ‰uK;« vKŽ W¹u²;« WMI;« ÍØÒið ô
ÆsU;« wUÐ UNOË W“d« Włö¦« w ÍØl{
ÆsI×K e¼U'« ‰d³½≈ ‰uK× s¹e² W³MUÐ ¢s¹e²«¢ bMÐ v« ÍØt³²½≈
ÆWOU{≈ «œUý—≈ wIK² ¨wbOB« Ë√ W{dL*« ¨VO³D« ÍØlł«d ¨¡«Ëb« s¹eð Òh¹ ULO WK¾Ý√ p¹b X½U «–≈
ÆWdG« …—«dŠ Wł—œ v« qÒu²« s WMI;« w ‰uK;« sJL²O WIOœ ≥∞≠Ë ±µ 5Ð U ÍØdE²½≈
Æ—UE²½ô« «c¼ ¡UMŁ√ WMI; ¡UDž ÍØŸeMð ô
Æ©sšU« ¡U*« X% Ë√ í¹ËËdJO*« ∫q¦® Èdš√ WI¹dÞ ÍQÐ sI×K e¼U'« ‰d³½≈ ‰uK× ÍØsÒð ô
ÆsI(« WOKLF WÐuKD*« WOU{ù« «Ëœ_« ÍØlLł≈
ÆÍÒeG« ‘Uý Ë√ sD ¨‰u× ‘Uý ∫w¼ WOU{ù« «Ëœ_«
ÆÊuÐUB«Ë sšU« ¡U*UÐ p¹b¹ ÍØqž≈
ÆWOzd U¾¹eł ÊËbÐË dH
_« v« qO1 ÊuKÐ Ë√ ÊuK« .bŽ ¨UÎIz«— WMI;« w ‰uK;« Êu s ÍØbÒQð
ƉuK;« sIŠ ŸuMLL ¨◊ËdA« Ác¼ dÒuð ÂbŽ ‰UŠ w
Æ…bŽU*« wIK² wbOB« WFł«dË Èdš√ WMI× ‰ULF²Ý« pOKŽ WU(« Ác¼ w
Step 2: Choosing an injection site
.‫יאתהמזרקממשטחהעבודההשטוח‬/‫ הרם‬.1
‫יבאזורזהלאחרהחיטוי‬/‫אלתיגע‬.‫יאתאזורההזרקהעםפדאלכוהולתוךתנועהמעגלית‬/‫ נגב‬.2
‫י‬/‫בידהשנייההחזק‬.‫צבוטוהחזקאתאזורההזרקהבידאחת‬,‫ לאחרשאזורההזרקההתייבש‬.3
‫מעלות‬90-‫מעלותל‬45‫יאתהמחטלתוךהעורבזוויתשבין‬/‫דחוף‬,‫ בתנועהמהירהוקצרה‬.4
‫תוךהקפדהעלשמירתהזוויתבההכנסתאת‬,‫יאתהמחטמהעור‬/‫הוצא‬,‫ כשהמזרקריק‬.6
‫ השמדתהציוד‬:‫שלברביעי‬
e¼U'« ‰d³½≈ ‰uK× ÊudF¹ s¹c« ¨wbOB« Ë√ W{dL*« ¨VO³D« WFł«d ¡UłdU Èdš√ WK¾Ý√ p¹b X½U «–≈
Æ«ÎbOł sI×K
Diagram 1
Diagram 2
Diagram 3
Diagram 4