PULMOZYME Ressources

Application Information

This drug has been submitted to the FDA under the reference 103532/001.

Names and composition

"PULMOZYME" is the commercial name of a drug composed of DORNASE ALFA.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
103532/001 PULMOZYME DORNASE ALFA /VIAL 1MG per ML

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
103532/001 PULMOZYME DORNASE ALFA /VIAL 1MG per ML

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Answered questions

Do you have idea about Dornase alfa, Pulmozyme Inhalation Solution?
hello, if you have any idea about how the drug is isolated, purified, solubilization and stabilization of Pulmozyme Inhalation Solution. thank you Asked by Nicholas Notti 1 month ago.

Pulmozyme came out in about 1994 and was the first new therapeutic drug for the management of cystic fibrosis in over 30 years. It is an enzyme and works by decreasing the thickness and stickiness of mucus secretions in the airways of cystic fibrosis patients. Common side effects are: Alterations in voice; fever; indigestion; itching; mild sore throat; redness around the eyes; sinus inflammation; temporary loss of voice or hoarseness; throat inflammation. One really nice thing about Pulmozyme is that it can be effectively and safely used in conjunction with standard cystic fibrosis therapies including oral, inhaled and/or parenteral antibiotics, bronchodilators, enzyme supplements, vitamins, oral or inhaled corticosteroids, and analgesics. Highly technical stuff: It is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. The protein is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing DNA encoding for the native human protein, deoxyribonuclease I (DNase). Fermentation is carried out in a nutrient medium containing the antibiotic gentamicin, 100-200 mg/L. However, the presence of the antibiotic is not detectable in the final product. The product is purified by tangential flow filtration and column chromatography. The purified glycoprotein contains 260 amino acids with an approximate molecular weight of 37,000 daltons. The primary amino acid sequence is identical to that of the native human enzyme. Answered by Clifford Granizo 1 month ago.


D o you have idea about Dornase alfa, Pulmozyme Inhalation Solution?
hello, if you have any idea about how the drug is isolated, purified, solubilization and stabilization of Pulmozyme Inhalation Solution. thank you Asked by Hwa Ornelos 1 month ago.

Some nebulizer equipment is administered at the doctors. This is done with a machine that can be trained to the use by patient. The treatment is for cycstic fibrosis, some throat problems, some breathing problems, with an inhaler. The general treatment is when due growth of the lung is not remission accurate, meaning there is a lung block or problem that doctors cannot remove perhaps congestion, or infection. Any lung inflamation must be treated with constant update. The types of drug solutions are tested for diameter capillatia to be sure there is no swelling, or poison protective coating from nearby organs, or fresh tissue. Generally the treatment is for short periods to keep constant updates in the event of unremovable problems that need be dissolved or dislodged. The success ratio of recent solutions is 20% higher than in the 1960 decade now more typical of 85-95%. Answered by Sadye Tsui 1 month ago.


How is genetic engineering used to make medicines?
How is genetic engineering involved in manufacturing process for pharmaceutical enzymes (such as pulmozyme)? What are the steps taken in order to create the medicines? Asked by Margherita Sande 1 month ago.

The steps you are asking may be "trade secrets" for the medicine companies concerned. Or that pulmozyme may be naturally occurring in nature, or its components are, before being mixed to get the substance. As to genetic engineering, it would mean developing a strain or Hybrid of individuals who are resistant to Cystic Fibriosis for which pulmozyme is used against. This would involve altering the DNA structure, as what Genetic Engineering is about. And perhaps, serum from this individuals are taken and the key element isolated and developed. Answered by Shaun Shevenell 1 month ago.

Genetic engineering techniques have been applied in numerous fields including research, biotechnology, and medicine. Medicines such as insulin and human growth hormone are now produced in bacteria, experimental mice such as the oncomouse and the knockout mouse are being used for research purposes and insect resistant and/or herbicide tolerant crops have been commercialized. Answered by Kellie Ditta 1 month ago.


21w/ Cystic Fibrosis, questioning doctors choice?
Hey, I do remember! :)But yeah, I do 1 amp of pulmozyme 2x a day, and then I switch every other month between Tobi & Coly, which I seem to do better on Tobi months, but it's affecting my ears so much that I need to stop being so resistent to Coly ha ha. But I agree, it's rough. I have been SO tired, sleeping for... Asked by Keiko Kara 1 month ago.

Okay, I was at the doctors a week ago. At the time I was feeling pretty well, did a PFT with 63% FEV1, so all was good. I did note to them that a couple of weeks before I had increased cough, but during the current week, it was pretty normal. The day after, I woke up feeling considerably worse than I had felt the day before. I have been coughing really bad ever since. It's not constant, but it is a very deep cough, with lots of mucus. I gave it another few days before calling my doctor to see if it would get better. It hasn't. I called my doctor on Tuesday on my way home from school (I'm in college). He prescribed a Z-pack for me. Which, yeah great...but I already take azithromycin 500mg every other day, so taking 250mg every day doesn't seem to make any sense to me. Should I call them again? I have been taking it, but obviously I don't see any difference, plus I have been doing my nebulizers more as well as my vest more. My mucus is very sticky, and it's hard to cough it up. The only thing that sucks is that I can't really do anything again till monday unless I call the doctor who is on call. What should I do? Answered by Sharika Mccollister 1 month ago.

Hey, I do remember! :) But yeah, I do 1 amp of pulmozyme 2x a day, and then I switch every other month between Tobi & Coly, which I seem to do better on Tobi months, but it's affecting my ears so much that I need to stop being so resistent to Coly ha ha. But I agree, it's rough. I have been SO tired, sleeping for like 12 hours a day. But, yeah I had to take tylenol today because I didn't have ibuprofin in the house, but I'm going to go get some. So, I wasn't sure about taking the z-pack in conjunction with my normal azirthromyacin, but I will now. I do have xopenex which has been helping for short periods of time. I will have to try Mucinex! Because I have never used it before, but it probably wouldn't be a bad idea! I have been coughing up more.....chunkier stuff today, it hasn't been pretty but the last few hours have been better. I'm waiting for my mouthpieces to dry so I can use my nebs again! But yeah I totally understand what you mean. We NEVER feel the same every day. We c Answered by Marcela Yaccarino 1 month ago.

Hey girl, I have CF too, u prob already knew that or remembered it:) Well first off, what aerosols are you doing everyday? I'm asking b/c I figure your probably already doing 1 ampul of Pulmozyme....I'll just tell u what I do personally. I know & get the type of coughing your talking about quite quite often. (Though my FEV1 #'s have been in the 30-37 range for 2 years steady) ..'You can go from feeling great 1 day & then the very next coughing up a lung (no pun intended LOL)...ok back to being serious...Well anyways when I start feeling worse 'pretty quick' like how u seem, I do 2 ampuls of Pulmo 2gether at once, 2 ampuls of Albuteral aerosol, & Tobi (1 at morning & night). All the aerosols SUCK, but it usually seems to help liquify the junk. (Oh & sometimes also take Musinex......could also maybe try Xopenex aerosol if you don't have some of the others.) For me, doing all this def gets the mucus out easier or atleast gets it moving in your system to where is will come out. Now, like I said...this is just what works for me...I haven't been seeing a "CF Adult Clinic Specialist" since I was 18 (until just recently last month) so since I've only had 1 visit w/ them I'm not totally up to date on what "proper treatment regime" is..so I don't want some1 to read my reply & start freaking out at me if in case its not what other CF adults do. But, w/e...its not like I'm a Dr., I'm just sharing b/c I understand. Same here-in college, social life, busy, & having come from being in your shoes (like being sick & not having the right "CF" Dr to really properly advise you, w/ REAL help....I can TOTALLY sympathize). As for the pain from coughing, probably a lil pleurisy or just the straining in your chest from coughing so hard. Try the usual stuff like IBprophen & I'm kinda hooked on using bengay or a heating pad to help. Sorry this has been long & for all the shorthand typing, but I do hope you feel better :) & fyi: I've had to take 750mg azithromycin at times in the hospital, so you might just want to take the Zpack w/ your usually does just the same. & also, downside to mucinex=it works but sometimes have gotten thrush a bit. If that happens ever for you--gargle alot of tres tres salty Hot water & eat yogurt. Ah ok lol I have to go now, but if u do have anymore ?'s just ask. Later girl Answered by Livia Eriksen 1 month ago.


Anyone with cystic fibrosis?
Just wondering :) lolAnd if you do know someone with cystic fibrosis, what is their lung function and what are their treatments? i'm sorry, you don't have to say i'm just really curious...i've never met anyone else with it so i don't really know what's "normal" and i guess... Asked by Albert Quail 1 month ago.

Just wondering :) lol And if you do know someone with cystic fibrosis, what is their lung function and what are their treatments? i'm sorry, you don't have to say i'm just really curious...i've never met anyone else with it so i don't really know what's "normal" and i guess that's what i'm asking. my lung function (fev1) is around 60%. I do vest 30 mins 3 times a day pulmozyme, hypertonic saline, tobi, zithromax, vitaman d and e, multivitams, enzymes, and right now cipro and bactrim and prednisone. Answered by Gene Cicio 1 month ago.

My daughter has CF. She is 2. She is too young to have her lung function tested yet. Her treatments include atrovent (BID unless sick then QID); Advair (BID); (pulmozyme daily unless sick then BID); vest BID for 30 min each unless sick then QID; enzymes, zithromax (3x week); source CF vitamins daily; prevacid BID; singulair daily. She has been on inhaled tobi twice. 1st time she had pseudomonas aeruginosa infection, but she cleared it! 2nd time~ bad sinus infection. About not knowing anybody with cf, I got on myspace and "talk" to a lot of people with cf and mom's of cfers. It has helped me a lot...maybe you could try it. I know its not the same, but you wouldn't want to risk getting an infection from actually "knowing" a cfer. Answered by Jonelle Wrightsman 1 month ago.

One of the toughest things about CF, I think, is that you all can't meet others with it because of possible contamination of bacteria. I work in a CF clinic. You don't say how old you are, but I'm guessing teenage. Your lung function is about average, and you take about the same amount of meds as most of the teens and 20 somethings in my clinic (leaving out the cipro and bactrim, sounds like you're having an exacerbation). Most of my patients do the vest twice and day and bump it up to three or four times when they're sick. I'm sure there are support groups on line, hope you meet up with someone that way. Answered by Reynalda Hannifan 1 month ago.

Yeah Im 16 and have CF. My Fev1 is 107% currently and FVC is 115%. I have no idea what "vest" is I just go on runs and spit out whatever comes up every week. Currently 6 ft 1 and my pancreas is still active so I don't need to take enzymes yet but I am on 500mg of flucloxacillin taken 3 times daily which rarely changes however when it does it is usually to co-amoxiclav for 2 weeks. Answered by Victorina Deperte 1 month ago.


Do you have Cystic Fibrosis and what do you use to expel mucus from lungs?
Do you have Cystic Fibrosis and what do you use to expel mucus from lungs?I have nephew 2 years old nephew just recently diagnosed with CF. doctor will not prescribe Pulmozyme saying that he is too young. What other choices we have besides chest therapies. We are using the VEST but the mucus is not being expelled. Asked by Domingo Toppa 1 month ago.

Do you have Cystic Fibrosis and what do you use to expel mucus from lungs? I have nephew 2 years old nephew just recently diagnosed with CF. doctor will not prescribe Pulmozyme saying that he is too young. What other choices we have besides chest therapies. We are using the VEST but the mucus is not being expelled. Answered by Rosalie Groeneweg 1 month ago.

That vest is garbage in my opinion. Perform CPT (chest physiotherapy) on your own. Do a web search for chest physiotherapy and start to practice. Ask his doc to order CPT and have it taught to the family. Basically, you cup your hands, position him in various drainage postitions, and pat above the area that has secretions. Positioning for drainage is key. The machines sure save time, but real CPT done with the human hand can not be beat. If the doc won't order CPT call the local hospital and ask if someone from the Respiratory department can assist you in learning CPT. He probably is too young for Pulmozyme, but not bronchodilators and steroids. I hope he is taking some of those just to make thing easier for him. CF is tough, but every year they seem to live just a bit longer. Aggressively stay with the CPT as it really does help. CPT is huge for CF patients when clearing secretions from the lungs. You could ask about mucomyst, but he is probably too little for that as well. Expectorants (cough syrups) can assist with his cough and other devices, such as Ultrasonic Nebulizers, can deliver a hypotonic aerosol to his airways that can break up dried secretions and make them easier to expel from the body. CPT + meds + aeorsol therapy (ultrasonic nebulizer is best in my opinion) + dedication will really help out at his age. Good luck. Answered by Sherice Daguerre 1 month ago.

my ex-husband used mucomist since he was a baby, and the manual chest therapy with the cupping of the hands and such, it also helps that when you do this therapy they are leaning forward, he usually leaned over the arm of the couch. this sometimes made him retch but that was also full of mucus. we did the manual therapy about once a week since it was pretty hard on him but it is of course suggested that you do it daily, but that is entirely unrealistic since it buised is ribcage quite often so badly that he couldn't handly doing it daily. Answered by Robbie Siedlik 1 month ago.

It is better to go on Medline plus and find the answer there, you will get real authentic answers there. Answered by Dallas Holeman 1 month ago.


Why would dnase 1 and alginate lyase be useful for treating cystic fibrosis?
Asked by Meryl Pomerance 1 month ago.

DNase (such as Pulmozyme) is used to thin mucus in the lungs. The opportunistic pathogen Pseudomonas aeruginosa secretes a capsule-like polysaccharide called alginate that is important for evasion of host defenses, especially during chronic pulmonary disease of patients with cystic fibrosis (CF). Most proteins for alginate biosynthesis are encoded by the 12-gene algD operon. Interestingly, this operon also encodes AlgL, a lyase that degrades alginate. Mutants lacking AlgG, AlgK, or AlgX, also encoded by the operon, synthesize alginate polymers that are digested by the coregulated protein AlgL. Answered by Marianela Dudas 1 month ago.


Cystic Fibrosis question: in 1950s (and before) life expentcancy was only about 1 year,?
whereas today it is currently 38.4, and rapidly extending. So life expectency is 38 times more in about 50 years.In which years was the biggest jump in life expentancy and what medical development was primarly the cause of this jump?What i mean is, was there some treatment that was invented that all of... Asked by Dominick Kelker 1 month ago.

whereas today it is currently 38.4, and rapidly extending. So life expectency is 38 times more in about 50 years. In which years was the biggest jump in life expentancy and what medical development was primarly the cause of this jump? What i mean is, was there some treatment that was invented that all of sudden made L.E. for CF 10 times what it was, and when did this happen? Answered by Margareta Kutt 1 month ago.


Can anybody name one treatment for cystic fibrosis?
I need this for my research for school. Asked by Rosemary Tuczynski 1 month ago.

Pulmozyme TOBI (nebulized antibiotic) The Vest airway clearance system (mucus clearance) The Acapella Device (mucus clearance) enzymes (body can't properly digest fats without these) Any other questions feel free to contact me. Answered by Michale Klebe 1 month ago.

For a baby, a nebulizer using Pulmacort and Albuterol two times a day. Answered by Gennie Ernesto 1 month ago.

bronchial inhalers daily respiratory therapy- thumpings enzymes Answered by Ricarda Burmside 1 month ago.


Aerosol Treatment for Cystic Fibrosis?
i meant perform Asked by Romeo Zipf 1 month ago.

Cystic Fibrosis patients receive a number of aerosol treatments, but it differs from patient to patient. Common nebulizer/aerosol treatments include: Albuterol Sulfate (bronchodilator) Atrovent (maintenance drug) Pulmozyme (enzyme) Colistimethate (antibiotic) Tobramycin (antibiotic) The medications are put into a nubulizer, a different nebulizer used for each medication. (ex: Tobramycin is put into a nebulizer with a filter so as to not expose the clinician to the antibiotic & Pulmozyme is put into a BAN nebulizer, which is a breath actuated nebulizer which only nebulizes upon inspiration so the patient does not waste the medication.) The nebulizer is then connected to a flow source of air or oxygen. In the hospital setting, it is connected to a 'flow meter' that is built into the wall in the patient's room. At home, an Oxygen cylinder is used as the gas source. Albuterol is usually given 4 times a day (in the hospital), Pulmozyme and Tobramycin usually once or twice a day. Possibly the most important treatment a Cystic Fibrosis patient receives is CPT, chest physiotherapy, via a Vest. The vest is placed on the patient and is connected to a machine that makes the vest vibrate at different speeds, titrated to the patient's needs. The vibrations loosen the secretions found in the lungs. Since CF patient's lungs produce an abnormal amount of mucus, the patient needs the vest to clear these secretions from the lungs. The vest is vital to maintaining a CF patient's lungs. The vest is also performed usually 4 times a day in the hospital. When a CF patient is admitted to the hospital, their treatments are sometimes performed more often than at home. Some patients receive treatments BID, or twice a day, at home. In the hospital setting, treatments are performed more often to maintain optimal lung health. Answered by Roxie Brungard 1 month ago.

Usually a nebulizer and frequent trips to the hospital. Physical therapy. Getting a back pound every night to clear out the mucus. Also when they go for their clean out you get an IV treatment in you're arm, you can leave the hospital you just have to put the meds in every hour. Also every time you eat you need enzymes. I don't no about the aerosol treatment but I am 95% sure that it is the nebulizer. I hope I helped and that you get a good grade on the project. Answered by Bebe Guttenberg 1 month ago.


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