Efam may be available in the countries listed below.
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Efam in the following countries:
International Drug Name Search
Natelle® Complete capsules for oral administration are supplied as oblong pink soft gelatin capsules, imprinted with "nComplete" in white ink.
Each capsule contains:
Docosahexaenoic Acid (DHA) from Algal Oil.........................................................250 mg
Eicosapentaenoic Acid (EPA) ....................................................... Not more than 0.625 mg
Calcium (Tricalcium Phosphate).................................................................................100 mg
Iron (Ferrous Fumarate) .................................................................................................30 mg
Vitamin C (Ascorbic Acid) ............................................................................................30 mg
Vitamin B-6 (Pyridoxine HCl) .........................................................................................25 mg
Vitamin E (D-Alpha Tocopherol)...................................................................................... 30 IU
Folic Acid ...........................................................................................................................1 mg
Vitamin D (Cholecalciferol) ........................................................................................... 400 IU
DHA is an omega-3 fatty acid. The DHA in Natelle® Complete is derived from Algal Oil (C. cohnii).
Inactive Ingredients: Gelatin (Bovine), Beeswax, Glycerine, Soybean Oil, Lecithin, Titanium Dioxide, Ethyl Vanillin, D&C Red #33, FD&C Red#40.
Natelle® Complete is indicated to provide vitamin/mineral and DHA omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal period for both lactating and non–lactating mothers, and throughout the childbearing years. Natelle® Complete may be beneficial in improving the nutritional status of women prior to conception.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.
Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Other sources of folic acid are leafy vegetables, fortified cereals and bread. Causes of neural tube defect are multifactorial and folic acid supplements alone may not prevent these birth defects.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
One capsule daily, or as directed by a physician.
Supplied in child resistant bottles of 30 capsules (NDC 18860-652-01).
Store at controlled room temperature 15°-30°C (59°-86°F).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Distributed by: AZUR PHARMA, INC. •1818 Market Street, Suite 2350 • Philadelphia, PA 19103 • www.azurpharma.com
To report a serious adverse event or obtain product information, contact (800) 890 3098.
life’sDHA™ is a trademark of Martek Biosciences Corporation.
Natelle® is a registered trademark of Pharmelle.
Rx Only
NTCMw-10-01
Physician Starter Kit Front Carton Label
natelle® COMPLETE
All-in-one Rx prenatal vitamin with
plant-based DHA
A complete formulation for you and your baby.
Distributed by: AZUR PHARMA, INC.
1818 Market Street, Suite 2350 ∙ Philadelphia, PA 19103
www.azurpharma.com
Manufactured by: Accucaps Industries Ltd.
Windsor, Ontario, Canada
Natelle® is a registered trademark of Pharmelle.
life'sDHA™ is a trademark of Martek Biosciences Corporation.
Physician Starter Kit Left-Side Carton Label
natelle® COMPLETE
All-in-one Rx prenatal vitamin with
plant-based DHA
NDA 18860-652-00
ONE PHYSICIAN SAMPLING KIT
Contains 10 Patient Starter Kits,
each containing 3 capsules
NOT FOR SALE
RX ONLY
Bottle Label
30 CAPSULES
18860-652-01
Rx Only
natelle®
COMPLETE
All-in-one Rx prenatal vitamin with
plant-based DHA
Dist by: AZUR PHARMA, INC.
1818 Market Street, Suite 2350
Philadelphia, PA 19103
www.azurpharma.com
Mfg by: Accucaps Industries, Ltd.
Windsor, Ontario, Canada
To report a serious adverse event or obtain
product information, contact (800) 890 3098.
Natelle® is a registered trademark of Pharmelle.
life'sDHA™ is a trademark of Martek Biosciences Corporation.
| Natelle Complete docosahexaenoic acid, eicosapentaenoic acid, calcium, iron, vitamin c, vitamin b-6, vitamin e, folic acid and vitamin d capsule, gelatin coated | |||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 06/24/2011 | ||
| Labeler - Azur Pharma, Inc. (805611071) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Accucaps Industries Limited | 248441727 | MANUFACTURE | |
Glimepiride Teva may be available in the countries listed below.
Glimepiride is reported as an ingredient of Glimepiride Teva in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Omeprazole is reported as an ingredient of Gastrogard in the following countries:
International Drug Name Search
Isosorbidedinitraat PCH may be available in the countries listed below.
Isosorbide Dinitrate is reported as an ingredient of Isosorbidedinitraat PCH in the following countries:
International Drug Name Search
Generic Name: hydroxyurea (hye DROX ee yoo REE a)
Brand names: Droxia, Hydrea, Mylocel
Hydroxyurea affects certain cells in the body, such as cancer cells or sickled red blood cells.
Hydroxyurea is used to treat chronic myelocytic leukemia, ovarian cancer, and certain types of skin cancer (melanoma and primary squamous cell cancer of the head and neck).
Hydroxyurea is also used to reduce pain episodes and the need for blood transfusions in people with sickle cell anemia. Hydroxyurea will not cure sickle cell anemia.
Hydroxyurea may also be used for purposes not listed in this medication guide.
Before using hydroxyurea, tell your doctor if you have bone marrow suppression, HIV or AIDS, liver or kidney disease, or if you are receiving chemotherapy or radiation.
If any powder from an open capsule is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.
Hydroxyurea can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.
severe bone marrow suppression;
severe anemia; or
low levels of platelets in your blood.
To make sure you can safely take hydroxyurea, tell your doctor if you have any of these other conditions:
bone marrow suppression;
HIV or AIDS;
if you are receiving chemotherapy or radiation.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
Hydroxyurea is either taken once per day or once every third day, depending on the condition being treated. On each of your dosing days, take the medicine at the same time of day. Your doctor may also want you to take a folic acid supplement. Follow your doctor's instructions very carefully.
If any powder from an open capsule is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.
Hydroxyurea can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.
To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.
Use hydroxyurea regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
See also: Hydroxyurea dosage (in more detail)
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.
Overdose symptoms may include drowsiness, mouth sores, and swelling with pain and purple discoloration in your hands and feet.
Do not handle hydroxyurea pills or the medicine bottle without skin protection (disposable gloves).
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
skin redness, skin ulcers, or open sores;
painful or difficult urination;
confusion, hallucinations, seizure; or
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).
Less serious side effects may include:
hair loss;
skin peeling or discoloration, mild rash;
upset stomach, constipation, diarrhea;
headache, dizziness; or
weight gain.
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.
Usual Adult Dose for Solid Tumors:
Solid Tumors:
Intermittent Therapy: 80 mg/kg administered orally as a single dose every third day.
Continuous Therapy: 20 to 30 mg/kg administered orally as a single dose daily.
Concomitant Therapy with Irradiation: Carcinoma of the head and neck: 80 mg/kg administered orally as a single dose every third day.
Administration of hydroxyurea should be begun at least seven days before initiation of irradiation and continued during radiotherapy as well as indefinitely afterwards provided that the patient may be kept under adequate observation and there is no evidence of unusual or severe reactions.
Pain or discomfort from inflammation of the mucous membranes at the irradiated site (mucositis) is usually controlled by measures such as topical anesthetics and orally administered analgesics. If the reaction is severe, hydroxyurea therapy may be temporarily interrupted; if it is extremely severe, irradiation dosage may, in addition, be temporarily postponed. However, it has rarely been necessary to terminate these therapies.
Severe gastric distress, such as nausea, vomiting, and anorexia, resulting from combined therapy may usually be controlled by temporary interruption of hydroxyurea administration.
Usual Adult Dose for Sickle Cell Anemia:
Initial Dose: 15 mg/kg (10-20 mg/kg) once a day. The dose may be increased in 5 mg/kg/day increments every 12 weeks to a maximum dose of 35 mg/kg/day.
Usual Adult Dose for Chronic Myelogenous Leukemia:
Resistant Chronic Myelocytic Leukemia: Until the intermittent therapy regimen has been evaluated, continuous therapy at 20 to 30 mg/kg administered orally as a single dose daily is recommended.
An adequate trial period for determining the antineoplastic effectiveness of hydroxyurea is six weeks of therapy. When there is regression in tumor size or arrest in tumor growth, therapy should be continued indefinitely.
Therapy should be interrupted if the white blood cell count drops below 2500/mm3, or the platelet count below 100,000/mm3. In these cases, the counts should be rechecked after three days, and therapy resumed when the counts rise significantly toward normal values. Since the hematopoietic rebound is prompt, it is usually necessary to omit only a few doses. If prompt rebound has not occurred during combined hydroxyurea tablets and irradiation therapy, irradiation may also be interrupted. However, the need for postponement of irradiation has been rare. Radiotherapy has usually been continued using the recommended dosage and technique. If severe anemia occurs, it should be corrected without interrupting hydroxyurea therapy. Because hematopoiesis may be compromised by extensive irradiation or by other antineoplastic agents, it is recommended that hydroxyurea be administered cautiously to patients who have recently received extensive radiation therapy or chemotherapy with other cytotoxic drugs.
Pain or discomfort from inflammation of the mucous membranes at the irradiated site (mucositis) is usually controlled by measures such as topical anesthetics and orally administered analgesics. If the reaction is severe, hydroxyurea therapy may be temporarily interrupted; if it is extremely severe, irradiation dosage may, in addition, be temporarily postponed. However, it has rarely been necessary to terminate these therapies.
Severe gastric distress, such as nausea, vomiting, and anorexia, resulting from combined therapy may usually be controlled by temporary interruption of hydroxyurea administration.
Some medicines can increase your risk of certain side effects while taking hydroxyurea. Tell your doctor if you are also using:
didanosine (Videx);
stavudine (Zerit); or
an interferon such as Actimmune, Alferon, Avonex, Betaseron, Extavia, Infergen, Intron, Rebetron, Rebif, or Roferon.
This list is not complete and other drugs may interact with hydroxyurea. 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.
See also: hydroxyurea side effects (in more detail)
Gastro may be available in the countries listed below.
Famotidine is reported as an ingredient of Gastro in the following countries:
International Drug Name Search
