Hex-Tra

Generic Name: chlorhexidine gluconate liquid

Dosage Form: FOR ANIMAL USE ONLY
Hex-Tra

USE DIRECTIONS:

Use at full strength, do not dilute.

POST-MILKING:


Dip entire teat in Hex-Tra.  Allow to air dry.

If solution in cup becomes visibly dirty.  Then

replenish with Hex-Tra at full strength.  Do

not return unused product to original container.



PROTECT FROM FREEZING

IF FROZEN: SHAKE VIGOROUSLY

AFTER THAWING

WARNING:  CONTAINS CHLORHEXIDINE

GLUCONATE.

Not for human use.

Avoid contamination of food.  Avoid contact

with eyes.  Not for internal use.

OBSERVE LABEL DIRECTIONS

KEEP OUT OF REACH OF CHILDREN!

FIRST AID:

INTERNAL:  If swallowed, do not induce vomiting.

Drink large quantities of water.  See physician immediately.

EYES:  Flush eyes with clear water for 15 minutes.If irritated, obtain medical guidance.



GET MEDICAL ATTENTION IMMEDIATELY.

Hex-Tra

SANITIZING CHLORHEXIDINE TEAT DIP

FORMULATED WITH EMOLLIENTS AND

DERMAL CONDITIONERS

This product, when properly used, is effective as an aid

in reducing the spread of organisms which may cause

mastitis.


Active Ingredient..........0.50% Chlorhexidine Gluconate


Contains an Emollient System


Lot#:______________________

Exp. Date:___________________

Next Content:________________

Manufactured For:

Tetradyne LLC

PO Box 17003

Reno, NV 89511

Hex-Tra  teat dip  liquid

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 66399-083 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 0.50 L  in 100 L

Inactive Ingredients Ingredient Name Strength GLYCERIN 5.0 L  in 100 L

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66399-083-01 3.78 L In 1 JUG None 2 66399-083-02 18.9 L In 1 PAIL None 3 66399-083-03 56.7 L In 1 DRUM None 4 66399-083-04 113.4 L In 1 DRUM None 5 66399-083-05 207.9 L In 1 DRUM None 6 66399-083-06 945 L In 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK None 7 66399-083-07 1039.5 L In 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/10/2001

Labeler - Tetradyne LLC (130969293)

Revised: 11/2010Tetradyne LLC

TriAdvance

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are TriAdvance (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. 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. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More TriAdvance resources

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

• TriAdvance Prescribing Information (FDA)


• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare TriAdvance with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

See also: TriAdvance side effects (in more detail)

Formaldehyde Solution

Pronunciation: for-MAL-de-hyde
Generic Name: Formaldehyde
Brand Name: Examples include Formadon and Lazerformalyde

Formaldehyde Solution is used for:

Drying skin before or after surgical removal of warts or where dryness is required. It may also be used for treating excessive foot moisture or for other conditions as determined by your doctor.

Formaldehyde Solution is a drying agent. It works by drying excessive moisture.

Do NOT use Formaldehyde Solution if:

• you are allergic to any ingredient in Formaldehyde Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Formaldehyde Solution:

Some medical conditions may interact with Formaldehyde Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Formaldehyde Solution. However, no specific interactions with Formaldehyde Solution are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Formaldehyde Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Formaldehyde Solution:

Use Formaldehyde Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply with roll-on applicator to affected areas.


• Do not shake bottle with the cap removed.


• Do not bandage or wrap the affected area unless directed otherwise by your doctor.


• Wash your hands immediately after using Formaldehyde Solution, unless your hands are part of the treated area.


• If you miss a dose of Formaldehyde Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Formaldehyde Solution.

Important safety information:

• Skin should be checked for sensitivity to formaldehyde prior to application because it may be irritating and sensitizing to the skin of some patients.


• Avoid getting Formaldehyde Solution in your eyes, nose, or mouth, or on your face.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Formaldehyde Solution, discuss with your doctor the benefits and risks of using Formaldehyde Solution during pregnancy. It is unknown if Formaldehyde Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Formaldehyde Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Formaldehyde Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Skin redness or irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); persisting irritation or redness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Formaldehyde side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Formaldehyde Solution:

Store Formaldehyde Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Keep Formaldehyde Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Formaldehyde Solution, please talk with your doctor, pharmacist, or other health care provider.


• Formaldehyde Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Formaldehyde Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Formaldehyde resources

• Formaldehyde Side Effects (in more detail)
• Formaldehyde Use in Pregnancy & Breastfeeding
• Formaldehyde Support Group
• 0 Reviews · Be the first to review/rate this drug

Boots Paracetamol 500mg Capsules (GSL)

1. Name Of The Medicinal Product

PARACETAMOL 500mg CAPSULES

Boots Paracetamol 500mg Capsules

2. Qualitative And Quantitative Composition

PARACETAMOL 500mg

For excipients see 6.1.

3. Pharmaceutical Form

HARD GELATIN CAPSULES

Red cap, white body, hard gelatin capsule, containing a white free flowing powder.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of mild to moderate pain including headaches, migraine, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, muscular and back pain, neuralgia, toothache, sore throat and period pain and to relieve the symptoms of feverishness and colds and flu.

4.2 Posology And Method Of Administration

For oral administration.

Unless otherwise directed by the doctor:

Adults, the elderly and children over 12

One or two capsules to be taken 3 or 4 times a day. The doses should not be repeated more frequently than every four hours and not more more than eight capsules should be taken in 24 hours.

Children under 12

Not recommended.

4.3 Contraindications

Hypersensitivity to paracetamol or to any of the other ingredients.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or sever hepatic impairment. The hazards of overdose is greater in those with non-cirrhotic alcoholic liver disease.

The label will state:

Contains Paracetamol

Do not take with any other paracetamol-containing products.

Do not exceed the stated dose.

Immediate medical advice should be sought in the event of an overdose even if you feel well.

If symptoms persist for more than 3 days or get worse consult your doctor.

Keep out of the reach and sight of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Cholestyramine:

The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required.

Metoclopramide and Domperidone:

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. However, concurrent use need not be avoided.

Warfarin:

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Chloramphenicol:

Increased plasma concentration of chloramphenicol.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

No or negligible influence.

4.8 Undesirable Effects

Adverse effects are rare but hypersensitivity including skin rash may occur.

There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4.9 Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b, Regularly consumes ethanol in excess of recommended amounts.

Or

c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).

Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time.

If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is a peripherally acting analgesic with antipyretic activity.

ATC code: N02B E01

Mechanism of Action/ Effect

Analgesic – the mechanism of analgesic action has been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain- impulse generation.

The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Antipyretic- paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat – regulation centre to produce peripheral vasodilation resulting in increased blood flow thorough the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

5.2 Pharmacokinetic Properties

Absorption and Fate

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. The elimination half-life varies from about 1-4 hours. Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol.

A minor hydroxylated metabolite which is usually produced in very small amounts by mixed function oxidases in the liver and kidney which is usually detoxified by conjugation with glutathione, may accumulate following paracetamol overdosage and cause tissue damage.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pregelatinised maize starch

Magnesium stearate

Sodium laurilsulfate

Capsule shell:

Titanium dioxide E171

Erythrosine E127

Quinoline yellow E104

Patent Blue V E131

Gelatin

Methyl parahydroxybenzoate E218

Propyl parahydroxybenzoate E216

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Child resistant blister packs comprised of 20µm hard aluminium foil laminated to 15µm rigid PVC, and 250µm PVC. Pack sizes of 6, 8, 10, 12, 16 capsules.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Administrative Data

7. Marketing Authorisation Holder

Bristol Laboratories Ltd,

Unit 3, Canalside,

Northbridge Road,

Berkhamsted

Hertfordshire

HP4 1EG

8. Marketing Authorisation Number(S)

PL 17907/0048

9. Date Of First Authorisation/Renewal Of The Authorisation

16/02/2006

10. Date Of Revision Of The Text

July 2009

Microsporidiosis Medications

Definition of Microsporidiosis: An intestinal infection that causes diarrhoea and wasting in people with HIV. It results from two different species of microsporidia, a protozoal parasite.

Drugs associated with Microsporidiosis

The following drugs and medications are in some way related to, or used in the treatment of Microsporidiosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Albenza

Milkhouse Iodine Teat Dip

Generic Name: iodine liquid

Dosage Form: FOR ANIMAL USE ONLY
Controlled Iodine Teat Dip

TEAT DIPPING is an important part of a MASTITIS CONTROL PLAN:


1. Dip teats immediately after milking.

2. Use good milking and environmental

    management procedures.

3. Use properly functioning milking equipment.

4. Treat every quarter of every cow at dry off.

5. Identify and treat or manage clinical cases

    promptly.

6. Cull chronically infected cows.


GREAT FOR FOAMING

TEAT DIPPING IN COLD WEATHER:

When the temperature falls below 10 degrees F, or when wind chill is significant,

special precautions should be taken to avoid chapped and frozen teats.


1. Teats should be dry before turning cows out into cold weather.

2. When teats are dipped after milking, allow 30 seconds contact, and blot

    off any excess teat dip with a single service towel.

3. Warm the teat dip to reduce drying time.

4. Provide windbreaks in outside areas for cows.

5. Monitor fresh cows with swollen udders and teats since they are more

    susceptible to chapped and frozen teats.

DIRECTIONS FOR USE:


- DO NOT DILUTE.

- Dip teats immediately after milking as a routine part of milking

procedures.

- Dip to THOROUGHLY COVER at least the lower one-third of the teat

(preferably to the base of the udder), IMMEDIATELY after every milking.


TAKE TIME


OBSERVE

LABEL DIRECTIONS


- Empty and clean dip cups after each milking, or during milking, if they

become contaminated.

- Do not pour used dip back into original container.

- KEEP FROM FREEZING

- Keep container closed to prevent contamination.

- Store container in an upright position.


FIRST-AID

EYES: If contact with eyes occurs, flush with plenty of cool water for 15

minutes. Consult a physician.

INTERNAL: May be harmful if swallowed. If ingested, drink large amounts of

water or milk. DO NOT induce vomiting. Get medical attention immediately.


FOR ASSISTANCE WITH MEDICAL

EMERGENCY CONTACT:

CHEM-TEL, 1-800-255-3924


MILKHOUSE BRAND

Controlled

Iodine Teat Dip

A SANITIZING TEAT DIP

An Aid in Reducing the Spread of

Organisms Which May Cause Mastitis

ACTIVE INGREDIENTS:

Concentrated Iodophor, containing Nonylphenol, ethoxylated iodine complex.

(provides 1/2% titratable iodine, equivalent to 5,000 ppm titratable iodine)

Emollient system contains 4.50% glycerine and 0.06% lanolin.

KEEP OUT OF THE REACH OF CHILDREN

CAUTION:

HARMFUL IF SWALLOWED / EYE IRRITANT

NET CONTENTS:  1 U.S. FL. GALLON (3.78 LITERS)

STEARNS PACKAGING CORPORATION

4200 Sycamore Avenue - Madison, Wisconsin  53714

MILKHOUSE BRAND IODINE TEAT DIP  CONTROLLED iodine  liquid

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 60282-1200 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 0.5 L  in 100 L

Inactive Ingredients Ingredient Name Strength GLYCERIN 4.5 L  in 100 L LANOLIN 0.06 L  in 100 L

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 60282-1200-1 3.78 L In 1 BOTTLE, PLASTIC None 2 60282-1200-2 18.93 L In 1 PAIL None 3 60282-1200-3 56.78 L In 1 DRUM None 4 60282-1200-4 208.2 L In 1 DRUM None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/02/1982

Labeler - Stearns Packaging Corporation (006069256)

Registrant - Stearns Packaging Corporation (006069256)

Establishment
Name	Address	ID/FEI	Operations
Stearns Packaging Corporation		006069256	manufacture

Revised: 09/2010Stearns Packaging Corporation

Seromycin

Generic Name: cycloserine (Oral route)

sye-kloe-SER-een

Commonly used brand name(s)

In the U.S.

• Seromycin

Available Dosage Forms:

• Capsule

Therapeutic Class: Antitubercular

Uses For Seromycin

Cycloserine belongs to the family of medicines called antibiotics. It is used to treat tuberculosis (TB). When cycloserine is used for TB, it is given with other medicines for TB. Cycloserine may also be used for other conditions as determined by your doctor.

To help clear up your tuberculosis (TB) completely, you must keep taking this medicine for the full time of treatment, even if you begin to feel better. This is very important. It is also important that you do not miss any doses.

Cycloserine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, cycloserine is used in certain patients with the following medical condition:

• Atypical mycobacterial infections, such as Mycobacterium avium complex (MAC)

Before Using Seromycin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of cycloserine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of cycloserine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or


• Convulsive disorders such as seizures or epilepsy—Cycloserine may increase the risk of seizures in patients who drink alcohol or have a history of seizures

• Kidney disease—Cycloserine is removed from the body through the kidneys, and patients with kidney disease may need an adjustment in dose or the medicine may need to be discontinued

• Mental disorders such as mental depression, psychosis, or severe anxiety—Cycloserine may cause anxiety, mental depression, or psychosis

Proper Use of Seromycin

Cycloserine may be taken after meals if it upsets your stomach.

To help clear up your infection completely, it is very important that you keep taking this medicine for the full time of treatment , even if you begin to feel better after a few weeks. If you are taking this medicine for TB, you may have to take it every day for as long as 1 to 2 years or more. If you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 2 doses a day, the doses should be spaced about 12 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the oral dosage form (capsules):
  
  • For treatment of tuberculosis:
    
    • Adults and teenagers—250 milligrams (mg) two times a day to start. Your doctor may slowly increase your dose up to 250 mg three or four times a day. This medicine must be taken along with other medicines to treat tuberculosis.
    
    
    • Children—Use and dose must be determined by your doctor. Doses of 10 to 20 mg per kilogram (4.5 to 9.1 mg per pound) of body weight per day have been used. This medicine must be taken along with other medicines to treat tuberculosis.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Seromycin

It is very important that your doctor check your progress at regular visits.

If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.

If cycloserine causes you to feel very depressed or to have thoughts of suicide, check with your doctor immediately. Your doctor will probably want to change your medicine.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Some of cycloserine's side effects (for example, convulsions [seizures]) may be more likely to occur if you drink alcoholic beverages regularly while you are taking this medicine. Therefore, you should not drink alcoholic beverages while you are taking this medicine.

Seromycin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety


• confusion


• dizziness


• drowsiness


• increased irritability


• increased restlessness


• mental depression


• muscle twitching or trembling


• nervousness


• nightmares


• other mood or mental changes


• speech problems


• thoughts of suicide

Less common

• Convulsions (seizures)


• numbness, tingling, burning pain, or weakness in the hands or feet


• skin rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Seromycin side effects (in more detail)

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More Seromycin resources

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

• Seromycin Prescribing Information (FDA)


• Seromycin Concise Consumer Information (Cerner Multum)


• Seromycin Monograph (AHFS DI)


• Seromycin MedFacts Consumer Leaflet (Wolters Kluwer)


• Cycloserine


• Cycloserine Professional Patient Advice (Wolters Kluwer)

Compare Seromycin with other medications

• Tuberculosis, Active
• Tuberculosis, Extrapulmonary