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» LymeNet Flash » Questions and Discussion » Medical Questions » 'Gemez' (generic 'Factive'/Gemifloxacin): is it safe?

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Author Topic: 'Gemez' (generic 'Factive'/Gemifloxacin): is it safe?
Guido
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Hello there,

I am living in Germany and I am 35 years old. Yes, Germany! And I made it in here anyway! :-) No, it's not nice to exclude anyone with a *.de-domain in the e-mail address who tries to register or mail, Jenifer! We are desperate, too, sometimes, you know .... ;-)

Now, seriously: I have chronic Lyme since 1994 and was diagnosed in March 2007.

I had a massive improvement in May/June this year while taking 8 weeks of "Factive" (Gemifloxacin, 320 mg/per day). My doctor now told me to order generic Gemifloxacin (called "Gemez") from a Canadian online pharmacy:
http://www.onlinecanadarx.com/ns/customer/master_product.php?masterid=4339&xid=l29mlurv5rvuuhhej0e171i092

What my doctor and I did not know: "Gemez" is manufactured in India. I received the package today, but now, I am a little insecure ....

Is "Gemez" really clean and safe enough? The outward appearance does not inspire much confidence: they can't seem to make a reasonable paper nor cardboard down there in India ;-) , and on the blister (or even on the tablets themselves?) are black marks that might be machine oil. Sorry, but I just can't imagine that they have really the same quality standards in India as we have here in Europe or the US. And they have so much chemicals going around the food chain which are prohibited in Europe and the US ....

Now, is anybody here who actually swallowed "Gemez" and survived it? ;-) Where can I find further information about "Glendale" (the manufacturer) and "Gemez" on the internet? There doesn't seem to be much ....

Or maybe, you all just don't know, because "Gemez" is not allowed at all for sale in the US? Well, it is allowed for sale in Canada, obviously. Anyway, I seem to be the first person here in Europe to take it, and that's a pretty stupid feeling .... ;-)

I would be glad to here about any experiences.


Thanks in advance,
Guido (Germany)

Posts: 99 | From Koblenz, Germany | Registered: Oct 2009  |  IP: Logged | Report this post to a Moderator
Lymetoo
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Hey there!!! Welcome to Lymenet!!! [hi]

I wish I could help you, but I know nothing about this drug...not even the Factive. I've heard of it discussed here. That's all.

Bringing this to the top for others to help.

( I am of German descent... so a special welcome from me!! )

--------------------
--Lymetutu--
Opinions, not medical advice!

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sammy
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If you question the quality of the medication it would best not to take any chances by ingesting it.

I'm sorry, I know that this is not what you want to hear. But it is better to be safe than sorry.

You should try to contact the pharmacy for a refund. Describe the condition of the packaging. It sounds like even the blister packs were damaged somehow.

If they cannot safely store and ship the medication, how can the ensure the safety of customers? Temperature and humidity are also important factors when storing medication properly.

If the product got wet or sat in the heat for too long it may be ineffective or even dangerous. With the box and blister packaging being so messed up, i would worry about the safety and efficacy of the medication.

And if the tablets appear dirty with black oil marks as you described, send it back or throw them away, whatever you do don't take it! Scary.

Hopefully the pharmacy will work with you to properly resolve this problem. If not, try another pharmacy. You need to trust your pharmacy whether it be online or local.

You could also ask your doctor to prescribe a different medicine (such as Avelox or Levaquin) from the same class as Factive. These may be cheaper and more readily available at your local pharmacy.

Take care Guido.

Posts: 5237 | From here | Registered: Nov 2007  |  IP: Logged | Report this post to a Moderator
daniel
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Moin Guido,

so sieht man sich wieder [Wink]

Mir hat Berghoff auch das Gemez empfohlen, allerdings bekomm ich es niergendswo, auch nicht �ber Internationale Apotheken. W�rd mich mal interessieren wie du es bekommen hast?! Mir wird �berall gesagt das nur das orginale Factive verf�gbar ist, da die ein Patent auf dem Medikament haben.

mfg

Posts: 371 | From velocity of light | Registered: Sep 2009  |  IP: Logged | Report this post to a Moderator
Guido
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quote:
Originally posted by daniel:
....
W�rd mich mal interessieren wie du es bekommen hast?!
....

Klickst Du oben, Holzauge! ;-) Kommt sogar zollfrei, so clever sind sie immerhin!

But hey, I don' want to offend people with private conversations in German .... ;-)


Guido

Posts: 99 | From Koblenz, Germany | Registered: Oct 2009  |  IP: Logged | Report this post to a Moderator
Guido
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quote:
Originally posted by sammy:
....
I'm sorry, I know that this is not what you want to hear. But it is better to be safe than sorry.
....

First of all: thanks for the warm welcome!! You're really kind. :-)

"better safe than sorry": This is what I keep telling myself all the time. But I don't want to believe myself .... ;-)

The original Factive I took just was soooo good. (I have severe head symptoms, and Factive reaches the cerebrospinal fluid.)

But hey: that's a good idea. I am going to tell the online pharmacy how it looks like and that I had no idea that it comes from India, and that I want my original Factive instead. :-)


Best regards,
Guido

Posts: 99 | From Koblenz, Germany | Registered: Oct 2009  |  IP: Logged | Report this post to a Moderator
Guido
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But hey: isn't here anybody from Canada? Or is it true that it is just too cold for ticks in most of Canada? :-)

The first question would be if "Gemez" from India is really legal for sale in Canada. If so, it should have been tested by something like the Canadian Food & Drug Administration.

So, anybody here from Canada who could help me with these questions?


Guido

Posts: 99 | From Koblenz, Germany | Registered: Oct 2009  |  IP: Logged | Report this post to a Moderator
Guido
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Well, here it is:
http://www.hc-sc.gc.ca/contact/dhp-mps/hecs-dgsesc/ocs-bsc-eng.php

Health Canada should know about that stuff.

-> As I keep saying in the German forum: talking to myself is still the most effective kind of conversation. [Wink]


Guido

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sammy
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I'm still listening Guido [Smile]

You are right, if Canada is willing to sell generic Factive to their residents then they must have some sort of testing procedure to make sure that the product is safe and effective.

The batch you received just doesn't sound right. Maybe order from a different pharmacy?

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Guido
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Ooops, Methadone, Hemp .... ? I might be wrong there, or maybe just exactly right .... ? Sometimes it's hard to tell the difference in English between a drug and a medicament. [Wink]

I'll try one of these:
http://www.hc-sc.gc.ca/contact/dhp-mps/index-eng.php

Wow, that website is just *slightly* confusing. Boy, and I always thought that bureaucracy was a German disease! [Wink]


Guido

Posts: 99 | From Koblenz, Germany | Registered: Oct 2009  |  IP: Logged | Report this post to a Moderator
Guido
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quote:
Originally posted by sammy:
I'm still listening Guido [Smile]

You are right, if Canada is willing to sell generic Factive to their residents then they must have some sort of testing procedure to make sure that the product is safe and effective.

The batch you received just doesn't sound right. Maybe order from a different pharmacy?

Thanks for listening. [Smile]

Yes, what was interesting about that Pharmacy is that they did send the package without any despatcher address. (?)

I'm afraid the stuff I received just looks normal for a medicament produced in India ....

I have now asked the Pharmacy for a refund and Health Canada what they know about "Gemez". So we will see ....


Best regards,
Guido

Posts: 99 | From Koblenz, Germany | Registered: Oct 2009  |  IP: Logged | Report this post to a Moderator
lou
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You might also want to ask this question on the Canadian lyme website.

http://www.canlyme.com/

I personally am nervous about drugs manufactured in countries that do not have the same standards, and whose factories are not inspected very often. But quite a lot of generics are now being made in India, etc.

And website only "pharmacies" probably come in a variety of flavors, from really doubtful to probably OK.

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n.northernlights
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I use to get LDN that way, and the LDN people say it is of very good quality despite of coming from India.
They can tell if a source of naltrexone is not good enough.

Just ask on the LDN forums.
Should be fine.

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Guido
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quote:
Originally posted by lou:
You might also want to ask this question on the Canadian lyme website.

http://www.canlyme.com/

Okay, thanks a lot! I wouldn't have found this by myself! [Wink] They should know ....

Yes, it might be true that medicaments are produced all over the world (like anything else). But it still is a difference if something is produced in India by, let's say, a US pharmaceutical firm and is controlled by US standrads or if it is just a plain Indian product produced only for the Indian market. And for what I have got her, the latter applies.


Best regards,
Guido

Posts: 99 | From Koblenz, Germany | Registered: Oct 2009  |  IP: Logged | Report this post to a Moderator
Guido
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quote:
Originally posted by n.northernlights:
....
They can tell if a source of naltrexone is not good enough.

Just ask on the LDN forums.
Should be fine.

Err, sorry, we *are* on the "LDN" forum. (?!) [Wink]

And what is naltrexone? I'm talking about Gemifloxacin/"Factive" here. (?)


Best regards,
Guido

Posts: 99 | From Koblenz, Germany | Registered: Oct 2009  |  IP: Logged | Report this post to a Moderator
Guido
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Okay, it seems hard to get into that Canadian forum ( http://www.canlyme.com/ ), even harder for a German than here. [Wink] Members are "hand selected", and 24 hours after registration, I am not yet approved .... [bonk]

But I found out what the Canadian equivalent to the FDA is: it's the "Therapeutic Products Directorate Canada". ( http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/tpd-dpt/index-eng.php )

Eyery drug that is allowed for sale in Canada has been tested and approved by them. So that is here the question: TPD approved or not TPD approved.

I have already sent a few e-mails to "Health Canada" already, but haven't got any answers yet.


Thanks for "listening" [Smile] ,
Guido

Posts: 99 | From Koblenz, Germany | Registered: Oct 2009  |  IP: Logged | Report this post to a Moderator
Guido
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Mmmmh .... after 3 days, there is no reply from Health Canada and I'm still not accepted on the www.canlyme.com forum.

Is there maybe another Canadian forum?

Is really no one here from Canada who could help me answering my questions .... ??


Thanks,
Guido

Posts: 99 | From Koblenz, Germany | Registered: Oct 2009  |  IP: Logged | Report this post to a Moderator
   

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