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

viatris pty ltd - amoxicillin sodium, quantity: 1060 mg (equivalent: amoxicillin, qty 1000 mg) - injection, powder for - excipient ingredients: - fisamox is indicated in the treatment of infections due to susceptible strains of the organisms listed below. fisamox powder for injection is intended for use where the patients condition precludes the administration of the oral form. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however in emergency cases where the causative organism has not yet been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. septicaemia (bacterial) h. influenzae, e. coli (see microbiology), p. mirabilis, streptococci, s. pneumoniae, s. faecalis and salmonella typhi. skin and skin structure streptococci, non-beta-lactamase-producing staphylococci, e. coli (see microbiology). respiratory, acute and chronic h. influenzae, streptococci, s. pneumoniae, non-beta-lactamase-producing staphylococci, e. coli (see microbiology). genito-urinary tract (complicated and uncomplicated), acute and chronic e. coli (see microbiology), p. mirabilis and s. faecalis. gonorrhoea n. gonorrhoeae (non-beta-lactamase-producing) prophylaxis of endocarditis fisamox may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with prosthetic heart valves or those who have previously had endocarditis.

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

emd serono, inc. - tesamorelin acetate (unii: lgw5h38ve3) (tesamorelin - unii:mqg94m5eeo) - tesamorelin 2 mg in 2 ml

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

theratechnologies inc. - tesamorelin acetate (unii: lgw5h38ve3) (tesamorelin - unii:mqg94m5eeo) - tesamorelin 1 mg in 1 ml - egrifta is indicated for the reduction of excess abdominal fat in hiv-infected adult patients with lipodystrophy. limitations of use: - long-term cardiovascular safety of egrifta has not been established. consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. - egrifta is not indicated for weight loss management as it has a weight neutral effect. - there are no data to support improved compliance with anti-retroviral therapies in hiv-positive patients taking egrifta. egrifta is contraindicated in patients with: - disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. - active malignancy. any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy [see warnings and precautions (5.1)] . - known hypersensitivity to tesamorelin or the excipients in egrifta [see warnings and precautions (5.5)]. - pregnant women because mo

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

theratechnologies inc. - tesamorelin acetate (unii: lgw5h38ve3) (tesamorelin - unii:mqg94m5eeo) - egrifta sv is indicated for the reduction of excess abdominal fat in hiv-infected adult patients with lipodystrophy. limitations of use: - long-term cardiovascular safety of egrifta sv has not been established. consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. - egrifta sv is not indicated for weight loss management as it has a weight neutral effect. - there are no data to support improved compliance with anti-retroviral therapies in hiv-positive patients taking egrifta sv. egrifta sv is contraindicated in: - patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. - patients with active malignancy. any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy [see warnings and precautions (5.1)] . - patients with known hypersensitivity to tesamorelin or the excipients in egrifta sv [see warnings and precautions (5.5)]. - pregnant women because modifying visceral adipose tissue offers no benefit in a pregnant woman and could result in fetal harm [see use in specific populations (8.1)]. risk summary egrifta sv is contraindicated in pregnant women because modifying visceral adipose tissue offers no benefit in pregnant women and could result in fetal harm [see clinical considerations and contraindications (4)] . administration of tesamorelin acetate to rats during organogenesis resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, based on measured drug exposure (auc). if egrifta sv is used during pregnancy, or if the patient becomes pregnant while taking it, discontinue egrifta sv.  the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk during pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes. modifying pregnancy-associated physiologic changes in visceral adipose tissue with egrifta sv offers no known benefit and could result in fetal harm. data animal data tesamorelin acetate administration to rats during organogenesis and lactation resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, respectively, based on measured drug exposure (auc). actual animal dose was 1.2 mg/kg. during organogenesis, lower doses approximately 0.1 to 1-times the clinical dose caused delayed skull ossification in rats. actual animal doses were 0.1 to 0.6 mg/kg. no adverse developmental effects occurred in rabbits using doses up to approximately 500 times the clinical dose. risk summary the centers for disease control and prevention recommend that hiv-infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. there are no data on the presence of tesamorelin in human milk, the effects on the breastfed child, or the effects on milk production. because of both the potential for (1) hiv-1 infection transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive patients), and (3) any possible adverse effects of tesamorelin, mothers should not breastfeed if they receive egrifta sv. the safety and effectiveness of egrifta sv in pediatric patients have not been established. in pediatric patients with open epiphyses, treatment with egrifta sv may result in linear growth acceleration and excessive growth. egrifta sv is not indicated for use in pediatric patients with open or closed epiphyses. there is no information on the use of egrifta sv in patients greater than 65 years of age. instructions for use egrifta sv® (eh-grif-tuh ess-vee) (tesamorelin) for injection for subcutaneous use this instructions for use contains step-by-step information on how to use the 2 mg vial of egrifta sv. each 2 mg vial of egrifta sv must be mixed with 0.5 ml of the sterile water for injection provided in the injection box given to you by the pharmacy. use only one egrifta sv 2 mg vial from the medication box to prepare your dose. the recommended dose of egrifta sv is 1.4 mg (0.35 ml). be sure that you read, understand, and follow this instructions for use before using egrifta sv. your healthcare provider should show you how to mix and inject egrifta sv before you inject it for the first time. ask your healthcare provider if you have any questions. keep this instructions for use in case you need to look at it again later. important information for use of egrifta sv - do not use a syringe or needle more than 1 time. - do not share your syringe or needles with other people, even if the needle has been changed. you may give other people a serious infection, or get a serious infection from them.  - if you are missing any supplies from the boxes given to you by the pharmacy or if any of the supplies look damaged, call your pharmacist or contact  toll-free at 1-833-23thera (1-833-238-4372) right away. if you are missing any supplies from the boxes given to you by the pharmacy or if any of the supplies look damaged, call your pharmacist or contact  toll-free at 1-833-23thera (1-833-238-4372) right away. preparing for your egrifta sv injection step 1: find a well-lit, clean, and flat surface, such as a table. step 2: gather your supplies: - medication box that contains 30 egrifta sv 2 mg single-dose vials - injection box that contains the following: 30 single-dose 10 ml bottles of sterile water for injection, used for mixing 60 sterile 1 ml syringes 60 sterile 1" 20-gauge needles, used for mixing 30 sterile ½” 30-gauge needles, used for injection - 30 single-dose 10 ml bottles of sterile water for injection, used for mixing - 60 sterile 1 ml syringes - 60 sterile 1" 20-gauge needles, used for mixing - 30 sterile ½” 30-gauge needles, used for injection - other supplies needed two alcohol pads one sterile gauze one adhesive bandage sharps disposal container or a puncture resistant container for throwing away used needles and syringes after you are done with them. (see “how should i dispose of the used syringes, needles, bottles and vials?” ) - two alcohol pads - one sterile gauze - one adhesive bandage - sharps disposal container or a puncture resistant container for throwing away used needles and syringes after you are done with them. (see “how should i dispose of the used syringes, needles, bottles and vials?” ) for each injection using egrifta sv 2 mg vial you will need: (see figure a) figure a step 3: take out the following from the injection box: - one sterile water for injection bottle - two 1 ml syringes - two 1" 20-gauge needles used for mixing - one ½" 30-gauge needle used for injection step 4: take 1 vial of egrifta sv 2 mg from the medication box. step 5: prepare to use your supplies: - wash your hands with soap and water. dry your hands with a clean towel. - take off the plastic caps from the egrifta sv 2 mg vial and the sterile water for injection bottle. - clean the rubber stoppers on the top of the egrifta sv 2 mg vial and sterile water for injection bottle with an alcohol pad. how to mix egrifta sv 2 mg vial step 1: place a 1" 20-gauge needle used for mixing, with its protective needle cap in place, onto a 1 ml syringe. hold the syringe firmly and twist the needle cap clockwise (to the right) until it closes securely. (see figure b) figure b step 2: carefully remove the protective needle cap by pulling it straight off. do not twist the needle cap. insert the needle through the rubber stopper of the sterile water for injection bottle. (see figure c) figure c step 3:  with the needle still in the sterile water for injection bottle, turn the bottle and syringe upside down. pull back the plunger until the sterile water reaches the 0.5 ml mark on the syringe. (see figure d) figure d step 4: remove the syringe with needle attached from the sterile water bottle.throw away the bottle containing the unused sterile water for injection. (see “how should i dispose of the used syringes, needles, bottles and vials? ”) insert the needle into the rubber stopper of the egrifta sv 2 mg vial. with the needle at a slight angle, slowly push the plunger of the syringe all the way down so that the sterile water goes down the inside wall of the egrifta sv 2 mg vial instead of directly onto the powder to avoid foaming. (see figure e) figure e step 5: remove the needle from the egrifta sv 2 mg vial (see figure f) and throw away the syringe and needle. (see “how should i dispose of the used syringes, needles, bottles and vials?” ) figure f step 6: roll the egrifta sv 2 mg vial gently in your hands for 30 seconds, until the sterile water and egrifta sv powder are mixed well. do not shake the vial. (see figure g) figure g note: - after mixing, the solution should look clear and colorless, with no particles in it. - do not use egrifta sv if it looks cloudy, discolored, or if you see particles in it. - call your healthcare provider, pharmacist, or contact  toll-free at 1-833-23thera (1-833-238-4372) right away if the solution is cloudy, discolored, or contains particles. step 7: place a new unused 1" 20-gauge needle used for mixing, with its protective needle cap in place, onto a new unused 1 ml syringe. hold the syringe firmly and twist the needle cap clockwise (to the right) until it closes securely. (see figure h) figure h step 8: carefully remove the protective needle cap by pulling it straight off. do not twist the needle cap. do not throw away the needle cap. insert the needle through the rubber stopper of the egrifta sv 2 mg vial. (see figure i) figure i step 9: with the needle still in the egrifta sv 2 mg vial, turn the vial and syringe upside down. pull the syringe back until you see just the tip of the needle going through the rubber stopper. pull back on the plunger of the syringe until all of the liquid inside the vial is in the syringe. the medicine should be at around the 0.4 ml mark on the syringe. (see figure j) figure j step 10:  remove the needle from the vial. (see figure k) figure k step 11:  place the protective needle cap on its side on a clean flat surface. without touching the needle, hold the syringe and slide the needle carefully into the needle cap. (see figure l). figure l step 12:  push the protective needle cap all the way in or until it snaps shut (see figure m). do not touch the needle cap until it covers the needle completely. figure m step 13:  with the protective needle cap securely on the needle, remove the needle by holding the syringe firmly and twisting the needle cap counterclockwise (to the left). (see figure n)  throw away the needle. (see “how should i dispose of the used syringes, needles, bottles and vials?” ) figure n step 14: place a ½" 30-gauge needle to be used for your injection, with its protective needle cap and pink needle shield in place, onto the syringe. hold the syringe firmly and twist the needle cap and pink needle shield clockwise (to the right) until it closes securely. (see figure o) figure o where do i inject egrifta sv 2 mg vial? inject egrifta sv into the stomach-area (abdomen). (see figure p) - choose an injection site that is at least 2 inches (5 cm) away from your belly button. (see the shaded area in figure p) - do not inject into areas with scar tissue or bruises. - do not inject into your belly button. - avoid areas with any hard bumps from previous injections. - rotate the site for each injection. this may help prevent bruising or irritation. you may want to write down the date and location of each daily injection to help you remember. figure p how to inject your 1.4 mg dose of egrifta sv do not remove the needle cap until you are ready to inject. step 1:  hold the syringe with the needle facing up. pull the pink needle shield down away from the white protective needle cap. carefully remove the needle cap by pulling it straight off the needle. do not twist the needle cap. (see figure q) do not touch the needle. figure q step 2:  tap the syringe gently with your finger to force any air bubbles to rise to the top. slowly push up on the plunger to remove any air and bubbles and until the medicine in the syringe is at the 0.35 ml mark of the syringe. (see figure r) figure r step 3:  clean the injection site you have selected with an alcohol pad and let it dry. hold the syringe in one hand. with your other hand, gently pinch a fold of skin at your cleaned injection site. hold the skin between your thumb and fingers. (see figure s) figure s step 4:  hold the syringe at a 90 degree angle to the skin. with a quick, dart-like motion, insert the needle straight into the skin. most of the needle should go beneath the skin. (see figure t) figure t step 5:  remove your hand from the pinched area of skin after the needle is inserted. be careful not to remove the needle from the skin. step 6: slowly push the plunger of the syringe all the way down until all of the medicine in the syringe has been injected. (see figure u) figure u pull the needle out of your skin. be careful to pull the needle out at the same angle as it was inserted. step 7: while holding the syringe in one hand, gently press the pink needle shield against a hard, flat surface until you hear a “click” and the injection needle is covered by the pink needle shield. (see figure v) figure v - apply pressure to the injection site with gauze for 30 seconds. if there is bleeding, apply an adhesive bandage to the site. - throw away the syringe. (see “how should i dispose of the used syringes, needles, bottles and vials?” ) how should i dispose of the used syringes, needles, bottles and vials? - do not recap the needle or remove the needle from the syringe after you inject egrifta sv. - put your used egrifta sv needles and syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal . - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - if another person receives a needle stick with a used needle, that person should be told to contact a healthcare provider right away. - keep the sharps container away from children and pets. if you have any questions, call your healthcare provider. you can call  toll-free at 1-833-23thera (1-833-238-4372) or visit the egrifta sv website at: www.egriftasv.com for more information. how should i store egrifta sv 2 mg vials, sterile water for injection, syringes and needles? - you will be given 2 boxes from the pharmacy when you get your prescription of egrifta sv: store the 2 mg egrifta sv vials in the medication box they come in, at room temperature between 68°f to 77°f (20°c to 25°c). store the sterile water for injection, syringes and needles that come in the injection box at room temperature between 68°f to 77°f (20°c to 25°c). - store the 2 mg egrifta sv vials in the medication box they come in, at room temperature between 68°f to 77°f (20°c to 25°c). - store the sterile water for injection, syringes and needles that come in the injection box at room temperature between 68°f to 77°f (20°c to 25°c). - keep egrifta sv vials out of the light. - after mixing, use egrifta sv right away . throw away any unused egrifta sv after mixing. - do not store, freeze or refrigerate egrifta sv after it has been mixed with the sterile water. - throw away any sterile water for injection left in the bottle after use. - do not use egrifta sv after the expiration date (exp) printed on the carton and vial labels. keep egrifta sv and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. egrifta sv® is a registered trademark of theratechnologies inc. manufactured by: theratechnologies inc., 2015 peel street, suite 1100, montréal, québec, canada h3a 1t8 us licence no. 2091 for theratechnologies inc. revised: 03/2024

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

viatris pty ltd - amoxicillin sodium -

Canada - English - Health Canada

theratechnologies inc - tesamorelin (tesamorelin acetate) - kit - 2mg - tesamorelin (tesamorelin acetate) 2mg - somatotropin agonists*

Canada - English - Health Canada

theratechnologies inc - tesamorelin (tesamorelin acetate) - kit - 1mg - tesamorelin (tesamorelin acetate) 1mg - somatotropin agonists*

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

theratechnologies inc. - tesamorelin acetate (unii: lgw5h38ve3) (tesamorelin - unii:mqg94m5eeo) - egrifta is indicated for the reduction of excess abdominal fat in hiv-infected adult patients with lipodystrophy. limitations of use: - long-term cardiovascular safety of egrifta has not been established. consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. - egrifta is not indicated for weight loss management as it has a weight neutral effect. - there are no data to support improved compliance with anti-retroviral therapies in hiv-positive patients taking egrifta egrifta is contraindicated in patients with: - disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. - active malignancy. any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy [see warnings and precautions (5.1)] . - known hypersensitivity to tesamorelin or the excipients in egrifta [see warnings and precautions (5.5)]. - pregnant women because mod

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - amoxicillin sodium 1063 g equivalent to 1000 mg amoxicillin;   - powder for injection - 1 g/10ml - active: amoxicillin sodium 1063 g equivalent to 1000 mg amoxicillin   - fisamox is indicated in the treatment of infections due to susceptible strains of the organisms listed below. gram-negative organisms: haemophilus influenzae escherichia coli proteus mirabilis neisseria gonorrhoea gram-positive organisms: streptococcus species streptococcus penumoniae non-penicillinase-producing staphylococci fisamox powder for injection is intended for use where the patient's condition precludes the administration of the oral form. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however in emergency cases where the causative organism has not yet been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. prophylaxis of endocarditis: fisamox may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with prosthetic heart valves or those who have previously had endocarditis.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - amoxicillin sodium 531.6mg equivalent to 500 mg amoxicillin;   - powder for injection - 500 mg/10ml - active: amoxicillin sodium 531.6mg equivalent to 500 mg amoxicillin   - fisamox is indicated in the treatment of infections due to susceptible strains of the organisms listed below. gram-negative organisms: haemophilus influenzae escherichia coli proteus mirabilis neisseria gonorrhoea gram-positive organisms: streptococcus species streptococcus penumoniae non-penicillinase-producing staphylococci fisamox powder for injection is intended for use where the patient's condition precludes the administration of the oral form. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however in emergency cases where the causative organism has not yet been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. prophylaxis of endocarditis: fisamox may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with prosthetic heart valves or those who have previously had endocarditis.