United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - interferon beta-1b (unii: ttd90r31wz) (interferon beta-1b - unii:ttd90r31wz) - interferon beta-1b 0.25 mg in 1.0 ml - extavia is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. extavia is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any other component of the formulation. risk summary although there have been no well-controlled studies in pregnant women, available data, which include prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. administration of interferon beta-1b to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose (see animal data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data human data the majority of the observational studies reporting on pregnancies exposed to interferon beta-1b did not identify an association between the use of interferon beta-1b during pregnancy and an increased risk of major birth defects. animal data when interferon beta-1b (doses ranging from 0.028 to 0.42 mg/kg/day) was administered to pregnant rhesus monkeys throughout the period of organogenesis (gestation days 20 to 70), a dose-related increase in the incidence of abortion was observed. the low-effect dose is approximately 3 times the recommended human dose of 0.25 mg on a body surface area (mg/m2 ) basis. a no-effect dose for embryo-fetal developmental toxicity in rhesus monkeys was not established. risk summary there are no data on the presence of interferon beta-1b in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for extavia and any potential adverse effects on the breastfed child from extavia or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of interferon beta-1b did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. extavia (interferon beta-1b) patient instructions for use if your doctor decides that you or a caregiver may be able to give your injections of extavia at home, your doctor or nurse should instruct you on the right way to prepare and inject extavia. to lower your risk of infection, it is important that you follow the technique that your doctor or nurse discussed with you to prepare and inject extavia.  do not try to inject extavia yourself until you have been shown by your doctor or nurse the right way to prepare and give the injections. it is important for you to read, understand, and follow these instructions. call your doctor if you or your caregiver has any questions about the right way to prepare or inject extavia. important safety information - the rubber cap on the diluent pre-filled syringe is made of natural rubber latex. tell your doctor if you are allergic to rubber or latex. - do not leave the blister pack containing extavia where others might tamper with it. - keep the blister pack containing extavia out of the reach of children. - do not open the blister pack or take out any of the items until right before you are ready to use them. - do not use extavia if the seal on the vial is broken. if the seal is broken, the product may not be safe for you to use. - do not use extavia after the expiration date shown on the blister pack label or box (figure 1). if it has expired, return the entire pack to the pharmacy. figure 1 - do not use any of the items in the blister pack more than one time. see the section at the end of this leaflet, “dispose of used syringes, needles, and vials.” throw away any open and unused medicine. gather your supplies. you will need the following supplies to get ready to give your injection of extavia: - a blister pack containing the following items (figure 2) a vial of extavia a pre-filled syringe of diluent (0.54% sodium chloride solution) a vial adapter with a 27-gauge needle attached (in its own container) two (2) alcohol wipes - a vial of extavia - a pre-filled syringe of diluent (0.54% sodium chloride solution) - a vial adapter with a 27-gauge needle attached (in its own container) - two (2) alcohol wipes figure 2 - a dry cotton ball and gauze - a sharps disposal container (figure 3). see the section “dispose of used syringes, needles, and vials.” figure 3 prepare for self-injection - wash your hands well with soap and water. - open the blister pack by peeling off the label and take out all the items. make sure the blister pack containing the vial adapter is sealed. check to make sure the rubber cap on the diluent syringe is firmly attached. - turn the blister pack over, and place the vial in the well (vial holder) and place the pre-filled syringe in the u-shaped trough (figure 4). figure 4 mix extavia 4.       remove the extavia vial from the well and take the cap off the vial (figure 5). figure 5 5.       place the vial back in the vial holder. 6.       use an alcohol wipe to clean the top of the vial (figure 6). wipe in one direction only. figure 6 7.       leave the alcohol wipe on top of the vial until step 9 below. 8.       peel the label off the container with the vial adapter in it, but do not remove the vial adapter. the vial adapter is sterile, so do not touch it. 9.       remove the alcohol wipe from the top of the vial. pick up the container that holds the vial adapter. turn over the container keeping the vial adaptor inside. put the adapter on top of the vial. push down on the adapter until it pierces the rubber top of the vial and snaps in place (figure 7). lift the container off the vial adapter. figure 7 10.       remove the rubber cap from the pre-filled syringe using a twist and pull motion (figure 8). throw away the rubber cap. figure 8 11.       remove the vial from the vial holder by grasping the vial. do not touch any part of the vial adapter. be careful not to pull the vial adapter off the top of the vial. 12.       connect the pre-filled syringe of diluent to the vial adapter by turning clockwise and tighten carefully (figure 9). figure 9 13.       slowly push the plunger of the pre-filled syringe all the way in. this will push all of the liquid from the syringe into the vial (figure 10). continue to hold the plunger while you mix extavia with the liquid from the syringe. if you do not hold the plunger in, it may return to its original position after you let go. figure 10 14.       gently swirl the vial to completely dissolve the white powder (extavia). do not shake. shaking and even gentle mixing can cause foaming of the medicine. if there is foam, let the vial sit until the foam settles. 15.       after the powder dissolves, look closely at the solution in the vial. do not use the solution if it is not clear or colorless, or if it contains particles. the injection should be given right away after you mix extavia and let any foam in the solution settle. if you must wait for any reason before giving yourself the injection, you may refrigerate the medicine after you mix it. but you should use it within three hours. 16.       with your thumb still pushing the plunger, turn the syringe and vial, so that the vial is on top (figure 11). 17.       slowly pull the plunger back to withdraw the entire contents of the vial into the syringe. figure 11 18.       turn the syringe so that the needle end is pointing up. remove any air bubbles by tapping the outside of the syringe with your fingers (figure 12). slowly push the plunger to the 1 ml mark on the syringe or to the mark that matches the amount of extavia prescribed by your doctor. if too much solution is pushed back into the vial, return to step 16. figure 12 19.       remove the vial adapter and the vial from the syringe by twisting the vial adapter (figure 13). figure 13 choose an injection site - extavia is injected under the skin and into the fat layer between the skin and the muscles (subcutaneous tissue). the best areas for injection are where the skin is loose and soft and away from the joints, nerves, and bones. do not use the area near your navel (belly button) or waistline. if you are very thin, use only the thigh or outer surface of the arm for injection. - choose a different site each time you give yourself an injection. figure 14 shows different areas for giving injections. do not inject in the same area for two injections in a row. keep a record of your injections to help make sure you change (rotate) your injection sites. if there are any sites that are difficult for you to reach, you can ask someone who has been trained to give the injection to you. figure 14 - do not inject extavia in a site where the skin is red, bruised, infected, or scabbed, has broken open, or has lumps, bumps, or pain. tell your doctor if you find skin conditions like the ones mentioned here or any other unusual looking areas where you have been given injections. injecting extavia 20.       using a circular motion, clean the injection site with an alcohol wipe, starting at the injection site and moving outward (figure 15). let the skin area air dry. figure 15 21.       remove the cap from the needle (figure 16). figure 16 22.       gently pinch the skin around the site with your thumb and forefinger of the other hand (figure 17). insert the needle straight up and down into your skin at a 90˚ angle with a quick, dart-like motion. figure 17 23.       once the needle is in your skin, slowly pull back on the plunger. if blood appears in the syringe, it means that you have entered a blood vessel. do not inject extavia. withdraw the needle. throw away the syringe and needle in your puncture-proof container. do not use the same syringe or any of the other supplies that you used for this injection. repeat the above steps to prepare your dose using a new blister pack. choose and clean a new injection site. 24.       if no blood appears in the syringe, slowly push the plunger all the way in until the syringe is empty (figure 18). remove the needle from the skin; then place a dry cotton ball or gauze pad over the injection site. gently massage the injection site for a few minutes with the dry cotton ball or gauze pad. throw away the syringe in your puncture-proof disposal container. figure 18 dispose of used syringes, needles, and vials   - to prevent needle-stick injury and spread of infection, do not try to re-cap the needle. - place used needles, syringes, and vials in a closeable, puncture-resistant container. you may use a sharps container (such as a red biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). do not use glass or clear plastic containers. ask your doctor for instructions on the right way to throw away (dispose of) the container. there may be state and local laws about how you should throw away used needles and syringes. - do not throw used needles, syringes, or vials in your household trash or recycle. - throw away any unused medicine. do not save any unused extavia for a future dose. - keep the disposal container, needles, syringes, and vials of extavia out of the reach of children. manufactured by: novartis pharmaceuticals corporation east hanover, nj 07936 u.s. license no. 1244 this instructions for use has been approved by the u.s. food and drug administration.           revised: november 2021 © novartis t2021-147

Israel - English - Ministry of Health

medison pharma ltd - peginterferon beta 1a - solution for injection - peginterferon beta 1a 125 mcg / 0.5 ml - peginterferon beta-1a - plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis

Israel - English - Ministry of Health

medison pharma ltd - peginterferon beta 1a - solution for injection - peginterferon beta 1a 63 mcg / 0.5 ml - peginterferon beta-1a - plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis

Israel - English - Ministry of Health

medison pharma ltd - peginterferon beta 1a - solution for injection - peginterferon beta 1a 94 mcg / 0.5 ml - peginterferon beta-1a - plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis

Canada - English - Health Canada

biogen canada inc - peginterferon beta-1a; peginterferon beta-1a - kit - 63mcg; 94mcg - peginterferon beta-1a 63mcg; peginterferon beta-1a 94mcg - interferons

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - interferon beta-1b, quantity: 0.25 mg/ml - injection, powder for - excipient ingredients: albumin; mannitol - betaferon is indicated for the treatment of: - ambulatory patients with relapsing-remitting multiple sclerosis (ms) characterised by at least two attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery. - betaferon is also indicated for the reduction of frequency and severity of clinical relapses, and for the slowing of progression of disease in patients with secondary progressive multiple sclerosis. - the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - interferon beta-1b 0.25mg (20% excess in quantity filled) - injection with diluent - 8 miu - active: interferon beta-1b 0.25mg (20% excess in quantity filled) excipient: albumin hydrochloric acid mannitol sodium hydroxide hydrochloric acid sodium chloride water for injection - betaferon is indicated for: · the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded, · the treatment of ambulatory patients, with relapsing-remitting multiple sclerosis characterised by at least two attacks of neurological dysfunction over a two year period followed by complete or incomplete recovery. · the reduction of frequency and severity of clinical relapses and for slowing the progression of disease in patients with secondary progressive multiple sclerosis

European Union - English - EMA (European Medicines Agency)

bayer ag  - interferon beta-1b - multiple sclerosis - immunostimulants, - betaferon is indicated for the treatment ofpatients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

New Zealand - English - Medsafe (Medicines Safety Authority)

biogen nz biopharma ltd - interferon beta-1a 30ug;   - injection with diluent - 30 mcg - active: interferon beta-1a 30ug   excipient: albumin dibasic sodium phosphate monobasic sodium phosphate sodium chloride water for injection - indicated for the treatment of relapsing forms of multiple sclerosis (ms).

New Zealand - English - Medsafe (Medicines Safety Authority)

biogen nz biopharma ltd - interferon beta-1a 60 µg/ml - solution for injection - 30 mcg/0.5ml - active: interferon beta-1a 60 µg/ml excipient: arginine hydrochloride glacial acetic acid polysorbate 20 sodium acetate trihydrate water for injection - indicated for the treatment of relapsing forms of multiple sclerosis (ms).