তাঞ্জানিয়া - ইংরেজি - Tanzania Medicinces & Medical Devices Authority

macleods pharmaceuticals limited, india - dolutegravir sodium - film coated tablet - 10

আয়ার্লণ্ড - ইংরেজি - HPRA (Health Products Regulatory Authority)

noridem enterprises limited - colistimethate sodium - powder for solution for injection/infusion - colistin

আয়ার্লণ্ড - ইংরেজি - HPRA (Health Products Regulatory Authority)

noridem enterprises limited - colistimethate sodium - powder for solution for injection/infusion - colistin

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

encube ethicals private limited - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as haemophilus vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterium vaginitis, or anaerobic vaginosis).    note for purposes of this indication, a clinical diagnosis of bacterial vaginosis is  usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% koh solution, and (c) contains clue cells on microscopic examination. gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent lactobacillus morphology, (b) predominance of gardnerella morphotype, and (c) absent or few white blood cells. other pathogens commonly associated with vulvovaginitis, e.g., trichomonas vaginalis , chlamydia trachomatis , n. gonorrhoeae , candida albicans , and herpes simplex virus should be ruled out. metronidazole vaginal gel is contraindicated in pa

তাঞ্জানিয়া - ইংরেজি - Tanzania Medicinces & Medical Devices Authority

neomedic limited, united kingdom - amoxicillin , clavulanic acid - oral tablet - 625

মাল্টা - ইংরেজি - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - powder for oral suspension - clavulanic acid 125 mg amoxicillin 875 mg - antibacterials for systemic use

মাল্টা - ইংরেজি - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - powder for oral suspension - clavulanic acid 125 mg amoxicillin 1000 mg - antibacterials for systemic use

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

cordavis limited - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - hyrimoz is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. hyrimoz can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). hyrimoz is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. hyrimoz can be used alone or in combination with methotrexate. hyrimoz is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. hyrimoz can be used alone or in combination with non-biologic dmards. hyrimoz is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. hyrimoz is indicated for the treatment of moderately to severely active crohn’s disease in adults and pediatric patients 6 years of age and older. hyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use: the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf-blockers [see clinical studies (14.7)] . hyrimoz is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. hyrimoz should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions (5)] . hyrimoz is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients . hyrimoz is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients . none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn’s disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data ). adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see clinical considerations ). in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data ). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester (see data ). risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16 to 19.7 mcg/ml in cord blood, 4.28 to 17.7 mcg/ml in infant serum, and 0 to 16.1 mcg/ml in maternal serum. in all but 1 case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for hyrimoz and any potential adverse effects on the breastfed child from hyrimoz or from the underlying maternal condition. the safety and effectiveness of hyrimoz have been established for: pediatric assessments for hyrimoz demonstrate that hyrimoz is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, hyrimoz is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero-exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)]. adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of hyrimoz have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn’s disease the safety and effectiveness of hyrimoz for the treatment of moderately to severely active crohn’s disease have been established in pediatric patients 6 years of age and older. use of hyrimoz for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1 ), clinical pharmacology (12.2, 12.3), clinical studies (14.6) ]. the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of hyrimoz have not been established in pediatric patients with crohn’s disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of hyrimoz in patients 65 years of age and older. in patients treated with hyrimoz, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)]. hyrimoz® (hye-ri-moze) (adalimumab-adaz) 40 mg/0.8 ml 20 mg/0.4 ml single-dose prefilled syringe with bd ultrasafe passive™ needle guard and finger flange injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe with bd ultrasafe passive™ needle guard and finger flange it is important that you: how should you store hyrimoz single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your prefilled syringe carton are: not included in your hyrimoz prefilled syringe carton are: figure b : items not included in the carton before your injection figure c : needle guard is not activated – the single-dose prefilled syringe is ready for use figure d : needle guard is activated – do not use preparing the prefilled syringe contact your pharmacist if: figure e : choose your injection site figure f : clean your injection site figure g : pull the needle cap off figure h : insert the needle figure i : hold the syringe figure j : lift the needle straight out figure k : slowly release the plunger figure l: dispose of your used prefilled syringe manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 80 mg/0.8 ml, 40 mg/0.4 ml single-dose prefilled syringe with bd ultrasafe passive™ needle guard and finger flange injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe with bd ultrasafe passive™ needle guard and finger flange it is important that you: how should you store hyrimoz single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your prefilled syringe carton are: not included in your hyrimoz prefilled syringe carton are: figure b : items not included in the carton before your injection figure c : needle guard is not activated – the single-dose prefilled syringe is ready for use figure d : needle guard is activated – do not use preparing the prefilled syringe contact your pharmacist if: figure e : choose your injection site figure f : clean your injection site figure g : pull the needle cap off figure h : insert the needle figure i : hold the syringe figure j : lift the needle straight out figure k : slowly release the plunger figure l: dispose of your used prefilled syringe manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 40 mg/0.8 ml single-dose prefilled sensoready® pen injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled sensoready pen before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz sensoready pen parts in figure a, the sensoready pen is shown with the cap removed. do not remove the cap until you are ready to inject. it is important that you: note: hyrimoz prefilled syringe and injection device are not made with natural rubber latex. how should you store your sensoready pen? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your sensoready pen carton are: not included in your sensoready pen carton are: figure b : items not included in the carton before your injection preparing the sensoready pen figure c : safety checks before injection contact your pharmacist if: figure d : choose your injection site figure e : clean your injection site figure f : remove the cap figure g : hold your pen your injection you must keep holding your sensoready pen firmly against your skin until you see a green indicator fill the window and stop moving. figure h : start your injection figure i : complete your injection after your injection figure j : check the green indicator figure k : dispose of your used pen manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 80 mg/0.8 ml, 40 mg/0.4 ml single-dose prefilled sensoready® pen injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled sensoready pen before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz sensoready pen parts in figure a, the sensoready pen is shown with the cap removed. do not remove the cap until you are ready to inject. it is important that you: note: hyrimoz prefilled syringe and injection device are not made with natural rubber latex. how should you store your sensoready pen? keep hyrimoz and all medicines out of the reach of children. what do you need for your injection? included in your sensoready pen carton are: not included in your sensoready pen carton are: figure b : items not included in the carton before your injection preparing the sensoready pen figure c : safety checks before injection contact your pharmacist if: figure d : choose your injection site figure e : clean your injection site figure f : remove the cap figure g : hold your pen your injection figure h : start your injection figure i : complete your injection after your injection figure j : check the green indicator figure k : dispose of your used pen manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. this instructions for use has been approved by the u.s. food and drug administration revised: 11/2023 instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 10 mg/0.2 ml single-dose prefilled syringe injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe. it is important that you:    note: hyrimoz prefilled syringe is not made with natural rubber latex.   how should you store hyrimoz  single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children.   what do you need for your injection?    included in your prefilled syringe carton is: not included in your hyrimoz prefilled syringe carton are (see figure b ): figure b : items not included in the carton preparing the prefilled syringe    contact your pharmacist if:    figure c : choose your injection site.      figure d : choose your injection site.      figure e : pull the needle cap off.         figure f : pinch the skin and insert the needle.     figure g : press down the plunger.        figure h : dispose of the used prefilled syringe. manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners. instructions for use hyrimoz® (hye-ri-moze) (adalimumab-adaz) 10 mg/0.1 ml, 20 mg/0.2 ml single-dose prefilled syringe injection, for subcutaneous use to help avoid possible infections and to ensure that you use hyrimoz correctly, it is important that you follow these instructions. be sure that you read, understand, and follow this instructions for use before injecting hyrimoz. your doctor should show you how to prepare and inject hyrimoz properly using the hyrimoz single-dose prefilled syringe before you use it for the first time. talk to your doctor if you have any questions. figure a : hyrimoz prefilled syringe. it is important that you:    note: hyrimoz prefilled syringe is not made with natural rubber latex.   how should you store hyrimoz  single-dose prefilled syringe? keep hyrimoz and all medicines out of the reach of children.   what do you need for your injection?    included in your prefilled syringe carton are: not included in your hyrimoz prefilled syringe carton are (see figure b ): figure b : items not included in the carton preparing the prefilled syringe    contact your pharmacist if:    figure c : choose your injection site.      figure d : clean your injection site.        figure e : pull the needle cap off.         figure f : pinch the skin and insert the needle.     figure g : press down the plunger.        figure h : dispose of the used prefilled syringe. manufactured for: cordavis limited, dublin, ireland manufactured by: sandoz inc., princeton, nj 08540 us license no. 2003 all third party trademarks are the property of their respective owners.

আয়ার্লণ্ড - ইংরেজি - HPRA (Health Products Regulatory Authority)

athlone pharmaceuticals limited - phenoxymethylpenicillin potassium - tablet - beta-lactamase sensitive penicillins; phenoxymethylpenicillin

আয়ার্লণ্ড - ইংরেজি - HPRA (Health Products Regulatory Authority)

athlone pharmaceuticals limited - phenoxymethylpenicillin potassium - powder for oral solution - beta-lactamase sensitive penicillins; phenoxymethylpenicillin