Sunday, 4 March 2012

Sulmet





Dosage Form: FOR ANIMAL USE ONLY
Sulmet®

(sulfamethazine sodium)

Drinking Water Solution, 12.5%

NADA 006-084, Approved by FDA


Antibacterial


For Animal Use Only


Convenient once-a-day dosage in drinking water


Prepare fresh solutions daily


For Oral Use in Domestic Animals and Poultry. Not Sterilized.



Indications


For control and treatment of the following diseases when caused by one or more of the following pathogenic organisms susceptible to sulfamethazine.


For the treatment of:


Cattle: Bacterial Pneumonia and Bovine Respiratory Disease Complex (Shipping Fever Complex) (Pasteurella spp.)


Colibacillosis (Bacterial Scours) (Escherichia coli)


Necrotic Pododermatitis (Foot Rot) (Fusobacterium necrophorum)


Calf Diphtheria (Fusobacterium necrophorum)


Acute Metritis (Streptococcus spp.)


Beef Cattle: Acute Mastitis (Streptococcus spp.)


Swine: Porcine Colibacillosis (Bacterial Scours) (Escherichia coli)


Bacterial Pneumonia (Pasteurella spp.)


For the control of:


Chickens: Infectious Coryza (Avibacterium paragallinarum)


Coccidiosis (Eimeria tenella, Eimeria necatrix)


Acute Fowl Cholera (Pasteurella multocida)


Pullorum Disease (Salmonella Pullorum)


Turkeys: Coccidiosis (Eimeria meleagrimitis, Eimeria adenoeides)



Dosage and Administration


Dosage: Cattle, Calves and Swine:


1st day: 6 tablespoons (3 fl oz) for each 100 lb body weight providing approximately 112.5 mg/lb (247.5 mg/kg) body weight.


2nd, 3rd and 4th days: 3 tablespoons (11/2 fl oz) for each 100 lb body weight, providing approximately 56.25 mg/lb (123.75 mg/kg) body weight.


Dosage: Poultry: Add 2 tablespoons (1 fl oz) to each gallon of drinking water, or the contents of 1 gal (3.7 L) container to 128 gallons, or contents of 16 fl oz (473 mL) container to 16 gallons. Following administration directions below, this will provide a recommended dose of approximately 61 to 89 mg/lb/day (134 to 196 mg/kg/day) body weight in chickens and 53 to 130 mg/lb/day (117 to 286 mg/kg/day) body weight in turkeys, depending upon the dosage, age and class of chickens or turkeys, ambient temperature, and other factors.


Administration: Cattle, Calves and Swine: Add the required dose given above to that amount of water that will be consumed in 1 day; consumption should be carefully checked. Factors such as temperature, humidity and disease will cause variable fluid intake. As a generalization, the above animals will consume approximately 1 gallon per 100 lb body weight per day.


Administration: Chickens and Turkeys: Add the required dose given above to that amount of water that will be consumed in 1 day. Water consumption should be carefully checked to insure adequate drug intake. As a generalization, 100 turkeys will drink 1 gallon of water per day for each week of age; chickens will consume one-half this amount.


Infectious Coryza (in chickens): Medicate for 2 consecutive days.


Acute Fowl Cholera and Pullorum Disease (in chickens): Medicate for 6 consecutive days.


Coccidiosis (in chickens and turkeys): Medicate as above for 2 days, then reduce amount of Sulmet Drinking Water Solution to one-half above for 4 additional days.



Residue Warnings


Do not medicate chickens or turkeys producing eggs for human consumption. To avoid drug residues in edible flesh, withdraw medication from chickens and turkeys ten (10) days prior to slaughter for food.


Treated cattle must not be slaughtered for at least ten (10) days after the last dose. Exceeding five (5) consecutive days of treatment may cause violative tissue residue to remain beyond the withdrawal time. Do not use in calves under one (1) month of age or calves being fed an all-milk diet. Use in these classes of calves may cause violative residues to remain beyond the withdrawal time. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues.


Withdraw medication from swine fifteen (15) days prior to slaughter for food.



Precautions


For best advice in control and treatment of animal disease, consult a veterinarian. Have only medicated water available during treatment, and check carefully to insure adequate Sulmet dosage and water intake. Cattle and calves not drinking or eating must be dosed by drench or with Sulmet Oblets. For best results, treat sick animals individually.


In poultry, consult a veterinarian or poultry pathologist for diagnosis. For control of outbreaks of disease, medication should be initiated as soon as the diagnosis is determined.


Medicated cattle, swine, chickens and turkeys must actually consume enough medicated water which provides the recommended dosages.


Sulmet works fast. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Excessive dosage may cause toxic reactions. Follow above dosage and administration instructions carefully. Hatchability of eggs laid during medication with sulfas and for short periods thereafter, may be adversely affected.


Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days in cattle or swine.



Store at or below 25°C (77°F). Protect from freezing.



Not for Human Use


Restricted Drug (California) - Use Only as Directed


Manufactured for

Boehringer Ingelheim Vetmedica, Inc.

St, Joseph, MO 64506 U.S.A.



fl oz (473 mL) Label - Main Panel




fl oz (473 mL) Label - Side Panel










Sulmet 
sulfamethazine  solution










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)0010-4708
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFAMETHAZINE SODIUM (SULFAMETHAZINE)SULFAMETHAZINE SODIUM59 mL  in 473 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10010-4708-01473 mL In 1 BOTTLE, PLASTICNone
20010-4708-023700 mL In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA00608408/23/2010


Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)
Revised: 11/2010Boehringer Ingelheim Vetmedica, Inc.



Friday, 2 March 2012

Ala-Hist AC


Generic Name: codeine and phenylephrine (KOE deen and FEN il EFF rin)

Brand Names: Ala-Hist AC, Notuss-PE


What is Ala-Hist AC (codeine and phenylephrine)?

Codeine is a narcotic cough suppressant.


Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of codeine and phenylephrine is used to treat cough and nasal congestion caused by the common cold.


Codeine will not treat a cough that is caused by smoking, asthma, or emphysema.


Codeine and phenylephrine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Ala-Hist AC (codeine and phenylephrine)?


Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough and cold medicine before the MAO inhibitor has cleared from your body.

You should not use codeine and phenylephrine if you are allergic to it, or if you have severe or uncontrolled high blood pressure, severe coronary artery disease, ischemic heart disease (reduced circulation of blood to the heart), or if you are breast-feeding a baby.


Before taking this medication, tell your doctor if you have heart disease or high blood pressure, asthma or other breathing disorder, diabetes, a thyroid disorder, an enlarged prostate, or problems with urination.


Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Codeine and phenylephrine should not be given to a child younger than 6 years old.

What should I discuss with my healthcare provider before taking Ala-Hist AC (codeine and phenylephrine)?


Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough and cold medicine before the MAO inhibitor has cleared from your body. You should not use codeine and phenylephrine if you have ever had an allergic reaction to it, or if you have:

  • severe or uncontrolled high blood pressure;




  • severe coronary artery disease;




  • ischemic heart disease (reduced circulation of blood to the heart); or




  • if you are breast-feeding a baby.



If you have any of these other conditions, you may need a dose adjustment or special tests to safely take codeine and phenylephrine:



  • heart disease or high blood pressure;




  • asthma, COPD, emphysema, or other breathing disorder;




  • diabetes;




  • a thyroid disorder; or




  • enlarged prostate, urination problems.




FDA pregnancy category C. This medication may be harmful to an unborn baby. Codeine can cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while you are taking this medication. This medication can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

How should I take Ala-Hist AC (codeine and phenylephrine)?


Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.


Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Codeine and phenylephrine should not be given to a child younger than 6 years old.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash. Store codeine and phenylephrine at room temperature away from moisture and heat.

Keep track of how much of this medicine has been used from the bottle. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.


What happens if I miss a dose?


Since cough and cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, dizziness, fast or uneven heart rate, fainting, or seizure (convulsions).


What should I avoid while taking Ala-Hist AC (codeine and phenylephrine)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while you are taking this medication. Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Phenylephrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of this drug. Read the label of any other medicine you are using to see if it contains phenylephrine.

Ala-Hist AC (codeine and phenylephrine) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeat;




  • feeling like you might pass out;




  • chest tightness or congestion;




  • easy bruising or bleeding, unusual weakness;




  • severe dizziness, anxiety, restless feeling, or nervousness;




  • seizure (convulsions); or




  • painful or difficult urination.



Less serious side effects may include:



  • dizziness, drowsiness, headache;




  • dry mouth, nose, or throat;




  • nausea, vomiting, diarrhea, constipation;




  • increased sweating or urination;




  • feeling excited or restless;




  • sleep problems (insomnia);




  • blurred vision, dry eyes;




  • ringing in your ears; or




  • mild skin rash or itching.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Ala-Hist AC (codeine and phenylephrine)?


Tell your doctor if you regularly use other medicines that make you sleepy (such as pain medication, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by codeine and phenylephrine.


Tell your doctor about all other medicines you use, especially:



  • medicines to treat high blood pressure;




  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or




  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.



This list is not complete and there may be other drugs that can interact with codeine and phenylephrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Ala-Hist AC resources


  • Ala-Hist AC Side Effects (in more detail)
  • Ala-Hist AC Use in Pregnancy & Breastfeeding
  • Ala-Hist AC Drug Interactions
  • Ala-Hist AC Support Group
  • 0 Reviews for Ala-Hist AC - Add your own review/rating


  • Notuss-PE Liquid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Ala-Hist AC with other medications


  • Cold Symptoms
  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about codeine and phenylephrine.

See also: Ala-Hist AC side effects (in more detail)


Thursday, 1 March 2012

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Friday, 23 December 2011

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Thursday, 22 December 2011

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Triamcinolone is reported as an ingredient of Triamcinolona in the following countries:


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Tuesday, 13 December 2011

Nilefrin




Nilefrin may be available in the countries listed below.


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Phenylephrine is reported as an ingredient of Nilefrin in the following countries:


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