Instructions for Use INTRON A (In-tron-aye) (Interferon alfa-2b, recombinant) Powder for Solution

Transcription

1 Instructins fr Use INTRON A (In-trn-aye) (Interfern alfa-2b, recmbinant) Pwder fr Slutin Be sure that yu read, understand, and fllw these instructins befre injecting INTRON A. Yur healthcare prvider shuld shw yu hw t prepare, measure, and inject INTRON A prperly befre yu use it fr the first time. Ask yur healthcare prvider if yu have any questins. Befre starting, cllect all f the supplies that yu will need t use fr preparing and injecting INTRON A. Fr each injectin yu will need the fllwing supplies: 1 vial f INTRON A pwder fr slutin 1 vial f sterile water fr injectin (diluent) 1 single-use dispsable syringe and needle 1 cttn ball r gauze 2 alchl swabs Yu will als need a puncture-prf dispsable cntainer t thrw away used syringes, needles and vials. Imprtant: Never re-use dispsable syringes and needles. The vial f mixed INTRON A shuld be used right away. D nt mix mre than 1 vial f INTRON A at a time. If yu d nt use the vial f prepared slutin right away, stre it in a refrigeratr and use within 24 hurs. See the end f these Instructins fr Use fr infrmatin abut Hw shuld I stre INTRON A? After mixing, thrw away (discard) the vial f INTRON A after yu withdraw ne dse f medicine. Make sure yu have the right syringe and needle t use with INTRON A. Yur healthcare prvider shuld tell yu what syringes and needles t use t inject INTRON A. Hw shuld I prepare a dse f INTRON A? Befre yu inject INTRON A, the pwder must be mixed with 1 ml (cc) f the sterile water fr injectin (diluent) frm the INTRON A vial package. 1. Find a clean, well-lit, flat wrk surface. 2. Get ne f yur INTRON A vial packages. Check the date printed n the cartn. Make sure that the expiratin date has nt passed. 3. Wash yur hands well with sap and water. Keep yur wrk area, yur hands, and injectin site clean t decrease the risk f infectin (See Figure 1).

2 Figure 1 4. Gently warm the vial f diluent by slwly rlling the vial in the palms f yur hands fr ne minute (See Figure 2). Figure 2 5. Remve the prtective plastic cap frm the tps f bth vials (INTRON A pwder and the diluent). Clean the rubber stpper n the tp f bth vials with an alchl swab (See Figure 3). Figure 3 6. Open the package fr the syringe (See Figure 4) yu are using and if it des nt have a needle attached, then attach a new needle t the syringe. Figure 4

3 7. Remve the needle cver frm the syringe. Fill the syringe with air by pulling the plunger back t 1 ml (See Figure 5). Figure 5 8. Hld the diluent vial n yur flat wrk surface. D nt tuch the cleaned rubber stpper (See Figure 6). Figure 6 9. Push the needle straight dwn thrugh the middle f the rubber stpper f the diluent vial and slwly inject all the air frm the syringe int the air space abve the diluent (See Figure 7). Figure Keep the needle in the vial. Turn the vial upside dwn and make sure the tip f the needle is in the diluent. Slwly pull the plunger back t fill the syringe with diluent t the 1 ml mark n the side f the syringe (See Figure 8).

4 Figure With the needle still inserted in the vial, check the syringe fr air bubbles (See Figure 9). If there are any air bubbles, gently tap the syringe with yur finger until the air bubbles rise t the tp f the syringe. Slwly push the plunger up t remve the air bubbles. If yu push diluent back int the vial, slwly pull back n the plunger t again draw 1 ml f diluent back int the syringe. Figure Remve the needle frm the vial. D nt let the syringe tuch anything. 13. Insert the needle thrugh the center f the rubber stpper f the INTRON A pwder vial. D nt tuch the cleaned rubber stpper. Place the needle tip, at an angle, against the side f the INTRON A pwder vial (See Figure 10).

5 Figure 10 Slwly push the plunger dwn t inject the diluent int the vial. The stream f liquid shuld run dwn the sides f the glass vial. T prevent bubbles frm frming, d nt aim the stream f diluent directly n the medicine in the bttm f the vial. D nt remve the needle frm the vial. 14. Gently swirl the INTRON A vial in a circular mtin until the pwder is cmpletely disslved (See Figure 11). Figure 11 D nt shake the vial. If any pwder remains undisslved in the vial, gently turn the vial upside dwn until all f the pwder is disslved. The slutin may lk cludy r bubbly fr a few minutes. If air bubbles d frm, wait until the slutin settles and all bubbles rise t the tp. Then withdraw yur dse frm the vial. 15. After the INTRON A cmpletely disslves, the slutin shuld be clear and clrless t light yellw, withut particles. D nt use the mixed slutin if yu see particles in it, r it is nt clear and clrless t light yellw. 16. With the needle in the vial, turn the vial upside dwn (See Figure 12).

6 Figure 12 Hld the vial with ne hand. Be sure the tip f the needle is in the INTRON A slutin. Slwly pull the plunger back t fill the syringe with the exact amunt f INTRON A int the syringe that yur healthcare prvider tld yu t use. 17. With the needle still inserted in the vial, check the syringe fr air bubbles. If yu see any air bubbles, gently tap the syringe with yur finger until the air bubbles rise t the tp f the syringe (See Figure 13). Figure Slwly push the plunger up t remve the air bubbles. If yu push slutin back int the vial, slwly pull back n the plunger again t draw the crrect amunt f INTRON A slutin back int the syringe. 19. D nt remve the needle frm the vial. Lay the vial and syringe n its side n yur flat wrk surface until yu are ready t inject the INTRON A slutin. Hw shuld I chse a site fr injectin? Based n yur treatment, yur healthcare prvider will tell yu if yu shuld inject a dse f INTRON A under the skin (subcutaneus injectin) r int the muscle (intramuscular injectin). If it is t difficult fr yu t inject, ask smene wh has been trained t give injectins t help yu. FOR SUBCUTANEOUS INJECTION

7 The best sites fr injectin are areas n yur bdy with a layer f fat between skin and muscle, such as (See Figure 14): the frnt f yur middle thighs the uter area f yur upper arms the abdmen, except arund the navel FOR INTRAMUSCULAR INJECTION Figure 14 The best sites fr injectin int yur muscle are (See Figure 15): the frnt f the middle thighs the upper arms the upper uter areas f the buttcks Figure 15 Yu shuld use a different site each time yu inject INTRON A t avid sreness at any ne site. D nt inject INTRON A int an area where the skin is irritated, red, bruised, infected r has scars, stretch marks, r lumps.

8 Hw shuld I inject a dse f INTRON A? 20. Clean the injectin site with a new alchl swab. Wait fr the skin t dry. 21. Pick up the vial and syringe frm yur flat wrk surface. Remve the syringe and needle frm the vial. Hld the syringe in the hand that yu will use t inject INTRON A. D nt tuch the needle r allw it t tuch the wrk surface. 22. With ne hand, pinch a fld f the skin at the cleaned injectin site. 23. Fr subcutaneus injectin (under the skin): With the ther hand, hld the syringe (like a pencil) at a 45-degree angle t the skin. With a quick "dart-like" mtin, push the needle int the skin (See Figure 16). Figure Fr intramuscular injectin (int the muscle): Hld the syringe (like a pencil) at a 90-degree angle t the skin. With a quick "dart-like" mtin, push the needle int the muscle (See Figure 17). Figure After the needle is inserted, remve the hand used t pinch the skin and use it t hld the syringe barrel. Pull the plunger back slightly. If n bld is present in the syringe, inject the medicine by gently pushing the plunger all the way dwn the syringe barrel, until the syringe is empty.

9 If bld cmes int the syringe, the needle has entered a bld vessel. D nt inject INTRON A. Withdraw the needle and thrw away the syringe and needle in the puncture-prf cntainer. See Hw shuld I dispse f used syringes, needles and vials?. Then, repeat steps 1 thrugh 25 with a new dse f INTRON A and inject the medicine at a new injectin site. 26. When the syringe is empty, pull the needle ut f the skin. Place a cttn ball r gauze ver the injectin site and press fr several secnds. D nt massage the injectin site. If there is bleeding, cver the injectin site with a bandage. 27. Thrw away the used syringe, needle, and vial. See "Hw shuld I dispse f used syringes, needles and vials?". Hw shuld I dispse f used syringes, needles, and vials? Thrw away used syringes, needles, and vials in a puncture-prf cntainer, such as sharps cntainer, r a hard cntainer like a metal can with a lid. Always place needles facing dwn. D nt use glass r clear plastic cntainers fr dispsal f needles and syringes. Always keep the puncture-prf cntainer ut f the reach f children. D nt thrw away used needles, syringes, r the puncture-prf cntainer in husehld trash and d nt recycle them. Check with yur healthcare prvider fr instructins abut the right way t thrw away used needles and syringes. There may be special state and lcal laws fr dispsal f used needles and syringes. Always fllw the instructins f yur healthcare prvider. Hw shuld I stre INTRON A? INTRON A Pwder fr Injectin: Befre mixing, stre in the refrigeratr between 36 F t 46 F (2 C t 8 C). After mixing the INTRON A Pwder fr Injectin, use the slutin right away r stre the slutin in the refrigeratr fr up t 24 hurs between 36 F t 46 F (2 C t 8 C). Allw the slutin t cme t rm temperature befre using. D nt freeze Intrn A. Keep away frm heat. Thrw away any medicine left in the vial after yu withdraw 1 dse. Keep INTRON A and all medicines ut f the reach f children.

10 Manufactured by: Merck Sharp & Dhme Crp., a subsidiary f Merck & C., Inc., Whitehuse Statin, NJ 08889, USA U.S. License Number 0002 Cpyright 1996, 2011 Merck Sharp & Dhme Crp., a subsidiary f Merck & C., Inc. All rights reserved. U.S. Patent Ns. 5,935,566 and 6,610,830 Revised: 02/2016 usifu-mk2958-pwi-1ml-1602r003