What Invanz is used for and how to use it
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Invanz - Consumer Medicine Information

Manufacture: Merck and Co., Inc.
Country: Canada
Condition: Infection Prophylaxis, Intraabdominal Infection, Kidney Infections (Pyelonephritis), Pelvic Infections, Pneumonia, Skin or Soft Tissue Infection, Urinary Tract Infection
Class: Antibiotics/antineoplastics, Carbapenems
Form: Liquid solution, Intramuscular (IM), Intravenous (IV)
Ingredients: ertapenem sodium, sodium bicarbonate, sodium hydroxide

ertapenem for injection,

1 g /vial (as ertapenem sodium)

About this Medication

What the Medication is Used For

Your physician has prescribed INVANZ to treat one of the following infections:

  • Intra-abdominal infection
  • Skin infection, including diabetic foot infections in adults
  • Community acquired pneumonia
  • Urinary tract infection, including kidney infection
  • Acute pelvic infection
  • Prevention of surgical site infections following surgery of the colon or rectum in adults

What it Does

INVANZ is an antibiotic that has the ability to kill a wide range of bacteria that cause infections.

When it should not be Used

You or your child should not receive INVANZ intravenously if you:

  • are allergic to any of its ingredients (see What theimportant nonmedicinal ingredients are)
  • are allergic to beta-lactams, such as penicillins or cephalosporins

You or your child should not receive INVANZ intramuscularly if you:

  • are allergic to any of its ingredients (see What theimportant nonmedicinal ingredients are)
  • are allergic to beta-lactams, such as penicillins or cephalosporins
  • are allergic to local anesthetics of the amide type, particularly lidocaine hydrochloride, which is used during intramuscular administration of INVANZ

What the Medicinal Ingredient Is

Ertapenem sodium is the active ingredient.

What the Important Nonmedicinal Ingredients Are

INVANZ contains the following inactive ingredients: sodium bicarbonate and sodium hydroxide.

What Dosage Forms it Comes In

INVANZ is supplied as a sterile lyophilized powder in single dose glass vials containing 1 g of ertapenem (as ertapenem sodium) for intravenous infusion or intramuscular injection.

Warnings and Precautions

Serious Warnings and Precautions

Serious and occasionally fatal allergic reactions (anaphylaxis) have been reported in patients taking other beta-lactam antibiotics such as penicillins and cephalosporins and could occur for INVANZ.

Seizures and other central nervous system adverse effects have been reported during treatment with INVANZ and occurred most frequently in patients with central nervous system disorders (brain lesions, history of seizures) and/or kidney disorders.

BEFORE you or your child use INVANZ talk to your physician or pharmacist about any medical condition you or your child has now or has had including:

  • kidney disease in order that your physician prescribes the correct dose of INVANZ
  • allergies to any drugs, including antibiotics
  • colitis or any other gastrointestinal disease
  • are pregnant as INVANZ has not been studied in pregnant women. INVANZ should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • are breast-feeding or planning ot breastfeed as INVANZ is excreted in human milk.
    As the breast-fed baby may be affected, women who are receiving INVANZ should not breast-feed. If you intend to breast-feed, talk to you physician.
  • history of seizures or other brain disorders

Tell your physician or pharmacist if you or your child is taking valproic acid (divalproex sodium or sodium valproate), a drug used to treat seizures.

Children

INVANZ can be given to children 3 months of age and older. However, it is not approved for prevention of surgical site infections following surgery of the colon or rectum in children.

INVANZ is not recommended in children under 3 months of age as no data are available.

Interactions with this Medication

In general, INVANZ can be used with other drugs. No specific clinical interaction studies have been conducted with INVANZ, other than probenecid. You should tell your physician about all drugs that you or your child is taking or plans to take, including those obtained without a prescription, as some drugs may affect each other’s action.

Probenecid may interact with the actions of ertapenem and should not be taken with INVANZ.

Ertapenem (INVANZ) interacts with valproic acid (divalproex sodium, or sodium valproate). Your doctor will decide whether you should use INVANZ.

Proper Use of this Medication

Usual Dose

INVANZ may be infused into a vein (intravenous infusion) or injected into a muscle (intramuscular injection). When administered intravenously, INVANZ should be infused over a period of 30 minutes.

How much INVANZ should I receive

INVANZ  will be given to you or your child by a physician or another healthcare professional who will determine the most appropriate method and dose.

How long do I need to receive INVANZ

It is very important that you or your child continues to receive INVANZ for as long as your physician prescribes it.

Your physician will let you know when you or your child may stop receiving INVANZ.

Overdose

The injection schedule will be set by your physician, who will monitor your response and condition to determine what treatment is needed.

If an overdose is suspected immediately contact your doctor or another healthcare professional even if there are no symptoms. If INVANZ was not administered to you in a hospital environment you can also contact your hospital emergency department or regional poison centre.

Missed Dose

The injection schedule will be set by your physician, who will monitor your response and condition to determine what treatment is needed. However, if you are concerned that you or your child may have missed a dose, contact your physician or another healthcare professional immediately.

Side Effects and what to Do about Them

Any medicine may have unintended or undesirable effects, so-called side effects. The most common side effects in adults are diarrhea, inflammation of the vein, nausea, and headache.

Other side effects in adults include: irritation of the vein at the infusion site, vomiting, rash, vaginitis, dizziness, sleepiness, sleeplessness, seizure, swelling at injection site, low blood pressure, slow heart rate, shortness of breath, oral thrush, constipation, acid regurgitation, dry mouth, teeth staining, indigestion, loss of appetite, skin redness, itching, abdominal pain, fungal infections, abnormal taste, fatigue, swelling of the lower limbs, feeling unwell, fever, pain, chest pain, vaginal itching, and alterations in some laboratory blood tests.

Side effects in children are generally similar to those in adults. The most common side effects in children are diarrhea, pain and redness at the infusion site.

If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have colitis (inflammation of the colon caused by a bacteria, Clostridium). If this occurs, stop taking INVANZ and contact your healthcare professional immediately.

Other side effects in children include: inflammation of the vein at the infusion site, vomiting, rash, swelling, formation of a lump, itching and warmth at the infusion site, inflammation of the vein and alterations in some laboratory blood tests.

Other side effects reported with INVANZ in general use in adults or children include: severe allergic reactions (anaphylaxis), hives, abnormal movements, tremor, altered mental status (for example, aggression, agitation, confusion, delirium, decreased consciousness, disorientation, mental status changes), hallucinations, muscle weakness, unsteady walking, and serious hypersensitivity reactions combining high fever, feeling unwell and skin rash.

Serious Side Effects, how often they Happen and what to Do about Them

Symptom / effectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
Children
Commondiarrhea
Adults
Uncommonseizures
slow heart rate
Clostridium colitis (inflammation of the colon caused by a bacteria, Clostridium)
Adults or children
UncommonSerious hypersensitivity and allergic reactions, occasionally fatal, with symptoms such as severe rash with or without high fever, with itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathin
UnknownDecreased consciousness (e.g. symptoms such as persistent drowsiness, reduced response or awareness, slow to respond, shallow or irregular breathing, or stupor)

Some people may have other immediate or delayed reactions.

If you notice any unusual effect, check with your physician or pharmacist.

How to Store It

Store the dry powder at room temperature below 25 °C.

Please consult the Product Monograph for information on storage periods for reconstituted solutions.

Keep INVANZ and all medicines safely out of reach and sight of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect

or at Merck Canada Inc. by one of the following 2 ways:

  • Call toll-free at 1-800-567-2594
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-800-369-3090, or
    • Mail to: Merck Canada Inc.
      Pharmacovigilance
      16750 route Transcanadienne
      Kirkland, QC H9H 4M7

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program or Merck do not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found at:

www.merck.ca or by contacting the sponsor, Merck Canada Inc., at: 1-800-567-2594.