ALENDRONATE

Main information

  • Trade name:
  • ALENDRONATE PLUS D3 SANDOZ 70 mg/70 microgram alendronate (as sodium) and colecalciferol 70 mg/70 microgram (2800 IU) tablet bli
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALENDRONATE PLUS D3 SANDOZ 70 mg/70 microgram alendronate (as sodium) and colecalciferol 70 mg/70 microgram (2800 IU) tablet bli
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 206929
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

206929

ALENDRONATE PLUS D3 SANDOZ 70 mg/70 microgram alendronate (as sodium) and colecalciferol 70

mg/70 microgram (2800 IU) tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

16/12/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ALENDRONATE PLUS D3 SANDOZ 70 mg/70 microgram alendronate (as sodium) and colecalciferol 70

mg/70 microgram (2800 IU) tablet blister pack

Product Type

Single Medicine Product

Effective date

24/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

TRADENAMES are indicated for the treatment of:

?Osteoporosis* in select patients where vitamin D supplementation is recommended,* Prior to treatment, osteoporosis must be confirmed by:

-the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by

-the presence of osteoporotic fracture

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

4 Tablets

(S4) Prescription Only Medicine

1 Tablet

(S4) Prescription Only Medicine

Components

1. ALENDRONATE PLUS D3 SANDOZ 70 mg/70 microgram alendronate (as sodium) and colecalciferol 70 mg/70 microgram (2800 IU) tablet

blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to off-white, modified capsule-shaped uncoated tablet, debossed with

ADC on one side and 28 on the other side.

Active Ingredients

alendronate sodium

91.37 mg

colecalciferol

.07 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 01:01:53 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

ALENDRONATE PLUS D3 SANDOZ

ALENDRONATE PLUS

D3 SANDOZ

Contains the active ingredient alendronate sodium and colecalciferol

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some of the

common questions about

Alendronate Plus D3 Sandoz. It is

particularly important that you read

the sections “When to take it” and

“How to take it” before you take this

medicine.

It does not contain all the

information that is known about

alendronate and colecalciferol.

It does not take the place of talking to

your doctor and pharmacist.

All medicines have risks and

benefits. Your doctor will have

weighed the risks of you taking this

medicine against the benefits they

expect it will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What this medicine is

used for

The name of your medicine is

Alendronate Plus D3 Sandoz. It

contains the active ingredients

alendronate sodium and

colecalciferol.

It is used to treat osteoporosis and to

provide additional vitamin D.

Osteoporosis is caused by changes in

the way bone is normally maintained.

Vitamin D (colecalciferol) is an

essential nutrient required for

calcium absorption and healthy

bones.

Understanding bone

Bone is living, growing tissue.

Throughout life, our bodies are

breaking down old bone and

rebuilding new bone in a continuous

cycle. Until our late 20s, while bones

are still developing, we gain bone by

building more than we lose. From

then until about age 35 the process is

usually in balance, so that the amount

of bone lost is about equal to the

amount that is replaced. After about

age 35 this balance is disturbed, with

bone loss occurring at a slightly

faster rate than it can be replaced. In

women, after menopause, hormonal

changes cause bone loss at an even

faster rate. When bone loss is

excessive, bones can become thinner

and weaker, and therefore are more

likely to break.

Osteoporosis

“Osteo” means bone, and “porosis”

means something that has holes in it,

like a sponge. Therefore,

osteoporosis is a disease which

causes bones to become more porous,

gradually making them weaker, more

brittle and likely to break.

Osteoporosis is common in

postmenopausal women. The

menopause occurs when the ovaries

virtually stop producing the female

hormone, oestrogen, or are removed

(which may occur, for example, at

the time of a hysterectomy). At this

time, bone is removed faster than it is

formed, so bone loss occurs and

bones become weaker. The earlier a

woman reaches the menopause, the

greater the risk of osteoporosis.

Osteoporosis also occurs in men but

is less common than in women.

Early on, osteoporosis usually has no

symptoms. However, if left untreated

it can result in broken bones, also

called fractures. Although fractures

usually cause pain, fractures of the

bones of the spine may go unnoticed

until they cause height loss. Fractures

may occur during normal, everyday

activity, such as lifting, or from

minor injury that would not

ordinarily fracture normal bone.

Fractures usually occur at the hip,

spine, or wrist and can lead not only

to pain, but also to considerable

deformity and disability, such as

stooped posture from curvature of the

spine, and loss of mobility.

What should I know about

vitamin D?

Vitamin D is an essential nutrient,

required for calcium absorption and

healthy bones. The main source is

through exposure to summer

sunlight, which makes vitamin D in

our skin. Clothing or sun block can

prevent enough sunlight from getting

through. In addition, as people age,

their skin becomes less able to make

vitamin D. Very few foods are

natural sources of vitamin D.

Too little vitamin D leads to

inadequate calcium absorption and

low phosphate-minerals that make

bones strong. Even if you are eating a

diet rich in calcium or taking a

calcium supplement, your body

cannot absorb calcium properly

unless you have enough vitamin D.

Too little vitamin D may lead to bone

loss and osteoporosis. Severe vitamin

D deficiency may cause muscle

weakness which can lead to falls and

a higher risk of fracture.

How it works

Alendronate works by slowing down

the process of old bone being

removed, which allows the bone-

forming cells time to rebuild normal

bone. Alendronate not only helps

prevent the loss of bone but actually

helps to rebuild bone and make bone

less likely to fracture.

Thus, alendronate reverses the

progression of osteoporosis.

Alendronate starts working on the

bone cells immediately, but

measurable effects on bone mass

may not be seen for several months

or more.

ALENDRONATE PLUS D3 SANDOZ

Alendronate belongs to a group of

non-hormonal medicines called

bisphosphonates.

In addition to alendronate, your

medicine also contains vitamin D, an

essential nutrient required for

calcium absorption and healthy

bones.

Your doctor will have explained why

you are being treated with this

medicine.

Follow all directions given to you

by your doctor carefully.

They may differ from the

information contained in this leaflet.

Your doctor may prescribe this

medicine for another use. Ask your

doctor if you want more information.

Alendronate Plus D3 Sandoz is not

addictive.

Use in children

Do not give Alendronate Plus D3

Sandoz to a child as its effects in

children have not been established.

Before you take this

medicine

You should know that in some

people, Alendronate Plus D3 Sandoz

can irritate or burn the food pipe

(also called oesophagus).

The chances of this happening should

be reduced when you follow the

instructions for ‘How to take this

medicine’ in this leaflet.

When you must not take it

Do not take this medicine if:

you have an allergy to

alendronate, colecalciferol or

any of the ingredients listed at

the end of this leaflet

you have certain disorders of

the food pipe (oesophagus)

including those that cause

difficulty in swallowing

you are unable to stand or sit

upright for at least 30 minutes

your doctor has told you that

you currently have low blood

calcium

your dentist advises you to

consult your doctor first

Do not take this medicine if you

are pregnant or breast-feeding.

Alendronate Plus D3 Sandoz has not

been studied in pregnant or breast-

feeding women.

Do not use after the use by (expiry)

date printed on the pack.

It may have no effect at all, or worse,

an entirely unexpected effect if you

take it after the expiry date.

Do not use this medicine if the

packaging is torn or shows signs of

tampering.

Do not use it to treat any other

complaints unless your doctor tells

you to.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Do not give this medicine to anyone

else.

Before you start to take it

Tell your doctor if:

1.

You plan to become pregnant

or breast-feed

2.

You have any medical

conditions, especially the

following:

kidney disease

swallowing or digestive

problems, such as ulcers

3. You have any allergies to any

other medicines or any other

substances, such as foods,

preservatives or dyes

4. You have dental or jaw-bone

problems or are planning to have

a course of dental surgery.

5. You currently smoke or have

been a smoker in the past.

If you have not told your doctor

about any of the above, tell them

before you take this medicine.

Taking other medicines

Tell your doctor if you are taking

any other medicines including

medicines that you buy at the

chemist, supermarket or health

food shop, including herbal

medicines.

Some medicines may affect the way

other medicines work.

Some medicines are likely to

interfere with the absorption of

Alendronate Plus D3 Sandoz if

taken at the same time. These

include:

antacids, medicines used to treat

indigestion e.g. Gaviscon,

Mylanta

calcium supplements

vitamins

Therefore, take this medicine at

least 30 minutes before taking any

of these or other medicines to make

sure there is no problem with

absorption. Check with your

doctor or pharmacist if you are not

sure whether you are taking any of

these medicines.

You can take aspirin while you are

being treated with this medicine.

However, both aspirin and

Alendronate Plus D3 Sandoz may

increase the chance of stomach

upsets.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

Alendronate Plus D3 Sandoz.

How to take this

medicine

Follow carefully all directions given

to you by your doctor or pharmacist.

Their instructions may be different to

the information in this leaflet.

How much to take

Take this medicine only when

prescribed by your doctor.

The usual dose is one tablet once a

week.

Choose the day of the week that

best fits your schedule. Every

week, take one tablet on your

chosen day.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

Do not increase or adjust your dose

yourself.

When and how to take it

Take Alendronate Plus D3 Sandoz

after getting up for the day. Do not

take it at bedtime.

Swallow one tablet whole with a full

glass of plain water.

ALENDRONATE PLUS D3 SANDOZ

Do not take any food, medicines or

drinks other than plain tap water

with your tablet.

It is important to take this medicine

with plain water only, not mineral

water. Food, other drugs and mineral

water and other drinks, including

fruit juices, coffee and tea, will

reduce the effect of this medicine by

interfering with the absorption into

the body.

Stay upright for at least 30 minutes

after swallowing the tablet and do

not take any food, medicines or

drinks other than plain tap water

during this time.

Do not lie down immediately after

swallowing it.

It is important to stay upright (sitting,

standing or walking around) for at

least 30 minutes after swallowing

your tablet.

It is also very important to stay

upright until after you have eaten

your first food of the day.

These actions will help make sure

your tablet reaches your stomach

quickly and help reduce the potential

for irritation to your food pipe

(oesophagus).

Alendronate Plus D3 Sandoz is

effective only if taken when your

stomach is empty.

Food, drinks other than plain

water, and other medicines will

lessen the effect of this medicine by

interfering with its absorption into

the body.

Do not chew or suck on the tablet.

Mouth ulcers may occur if the tablet

is chewed or dissolved in the mouth.

How long to take it for

Continue taking your medicine for

as long as your doctor tells you.

Alendronate Plus D3 Sandoz can

only treat your osteoporosis, by

helping prevent further loss of bone

and continuing to rebuild bone, if

you take it every week.

Do not stop taking it unless your

doctor tells you to - even if you feel

better.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If you miss a tablet, take one tablet

on the morning after you

remember.

Do not take two tablets on the

same day. Return to taking one

tablet once a week, as originally

scheduled on your chosen day.

If you are not sure about what to

do, talk to your doctor or

pharmacist.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you take too many tablets at one

time, drink a full glass of milk. Do

not induce vomiting. Do not lie

down.

While you are taking

this medicine

Things you must do

If you develop difficulty or pain

upon swallowing, chest pain, or

new or worsening heartburn, stop

taking this medicine and call your

doctor.

If you become pregnant while

taking this medicine, stop taking

the tablets and tell your doctor.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

If you develop a toothache or

require a dental procedure, tell

your dentist that you are taking

this medicine.

If you develop new or unusual pain

in your leg, tell your doctor.

Rarely, patients have experienced

fracture in a specific part of the thigh

bone.

Make sure you have an adequate

intake of calcium in your diet.

Your doctor, dietician or pharmacist

can tell you what foods you should

eat.

Things you must not do

Do not:

Stop taking your medicine, or

change the dosage, without first

discussing it with your doctor.

Give this medicine to anyone

else, even if their symptoms seem

similar to yours

Take your medicine to treat any

other condition unless your

doctor or pharmacist tells you to

Things to be careful of

There have been side effects

reported with Alendronate Plus D3

Sandoz that may affect your ability

to drive or operate machinery.

Individual responses to this

medicine may vary (see Side

Effects).

Things that would be helpful

for your osteoporosis

Some self help measures suggested

below may help your osteoporosis.

Talk to your doctor or pharmacist

about these measures and for more

information.

Exercise -

can be helpful in

building and maintaining strong

bones. Regular exercise such as a

brisk walk is a good idea. Talk to

your doctor before you begin any

exercise program.

Diet -

eat a balanced diet. You

may need to increase the amount

of calcium in your diet by eating

calcium-rich foods or taking a

calcium supplement. Your doctor

will advise you.

Smoking -

appears to increase the

rate at which you lose bone and,

therefore, may increase your risk

of fracture. Your doctor may ask

you to stop smoking or at least

cut down.

Alcohol -

your doctor may advise

you to cut down the amount of

alcohol you drink. If you drink

ALENDRONATE PLUS D3 SANDOZ

excessively on a regular basis,

you may increase your risk of

developing osteoporosis.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking this

medicine or if you have any

questions or concerns.

Alendronate Plus D3 Sandoz helps

most people with osteoporosis, but it

may have unwanted side effects in a

few people. All medicines can have

side effects. Sometimes they are

serious, most of the time they are not.

You may need medical treatment if

you get some of the side effects

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following:

stomach pain, gas in the stomach

or bowel, wind

an uncomfortable feeling in the

stomach or belching after eating,

also called dyspepsia, or

heartburn

feeling sick (nausea), vomiting

constipation, diarrhoea

headache

aching muscles, joints and/or

bones, which rarely can be

severe.

flu-like symptoms typically at the

start of treatment, such as aching

muscles, generally feeling unwell

and rarely fever.

swelling of joints

dizziness or spinning sensation

unusual tiredness or weakness

swelling of hands, ankles or feet

hair loss

changed sense of taste

Most of these are the more common

side effects. For the most part, these

have been mild.

Tell your doctor immediately if

you notice any of the following:

skin rash or redness of the skin,

sometimes made worse by

sunlight, itchiness

mouth ulcers

blurred vision, pain or redness in

the eye

symptoms of low blood calcium

levels including muscle cramps or

spasms or tingling sensation in

the fingers or around the mouth

new or unusual pain in your hip

or thigh

These side effects are rare, and very

rarely, may be serious.

Tell your dentist and doctor

immediately if you notice any of

the following

Jaw-bone or dental problems

(including toothache). Jaw-bone

problems may include infection,

and delayed healing after a tooth

extraction or other work that

involves drilling into the jaw-

bone.

These side effects are rare and may

be serious.

If any of the following happen, stop

taking this medicine and tell your

doctor immediately:

difficulty or pain upon

swallowing

chest pain

new or worsening heartburn

These side effects may be due to

irritation or ulceration of the food

pipe. They may worsen if you

continue taking the tablets. Rarely,

these side effects may be serious.

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

swelling of the face, lips, mouth,

throat or tongue which may cause

difficulty in breathing or

swallowing

pinkish, itchy swellings on the

skin, also called hives or

nettlerash

severe skin reactions

black tar-like and/or bloody

stools These are all serious side

effects. You may need urgent

medical attention

These may be serious side effects.

You may need urgent medical

attention. These side effects are rare.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed above

may occur in some patients.

Do not be alarmed by this list of

side effects.

If you have the swelling described

above, you may be having a serious

allergic reaction to Alendronate Plus

D3 Sandoz.

Rarely, stomach or duodenal ulcers

(some severe) have occurred, but it is

not known whether these were

caused by this medicine.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice any

other effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Allergic reactions

If you think you are having an

allergic reaction to Alendronate

Plus D3 Sandoz, do not take any

more of this medicine and tell your

doctor immediately or go to the

Accident and Emergency

department at your nearest

hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing.

swelling of the face, lips, tongue,

or other parts of the body

rash, itching or hives on the skin

fainting

hayfever-like symptoms

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will

stay below 25°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

ALENDRONATE PLUS D3 SANDOZ

Heat and dampness can destroy some

medicines.

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor or pharmacist tells you

to stop taking this medicine or they

have passed their expiry date, your

pharmacist can dispose of the

remaining medicine safely.

Product description

What Alendronate Plus D3

Sandoz looks like

Alendronate Plus D3 Sandoz 70

mg/70 mcg are white to off- white,

modified capsule shaped uncoated

tablet, debossed with ‘ADC’ on one

side and ‘28’ on the other side.

Alendronate Plus D3 Sandoz 70

mg/140 mcg are white to off- white,

modified capsule shaped uncoated

tablet, debossed with ‘ADC’ on one

side and ‘56’ on the other side.

Alendronate Plus D3 Sandoz are

available in blister packs of 1 and 4

tablets.

Not all strengths and pack types may

be available.

Ingredients

Each Alendronate Plus D3 Sandoz

tablet contains 70 mg, of alendronate

sodium and 70 mcg or 140 mcg of

colecalciferol as the active

ingredients.

It also contains the following inactive

ingredients:

microcrystalline cellulose

medium chain triglycerides

gelatin

croscarmellose sodium

sucrose

silica-colloidal anhydrous

magnesium stearate

butylated hydroxytoluene

povidone

This medicine is gluten-free,

tartrazine-free and free of other azo

dyes.

Australian Registration

Numbers

Alendronate Plus D3 Sandoz 70

mg/70 mcg tablets: AUST R 206929

Alendronate Plus D3 Sandoz 70

mg/140 mcg tablets: AUST R

206935

Distributed by

Sandoz Pty Ltd

54 Waterloo Road,

Macquarie Park, NSW 2113

Australia

This leaflet was prepared in February

2015.

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FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

25-5-2018

Orphan designation:  Treprostinil sodium,  for the: Treatment of chronic thromboembolic pulmonary hypertension

Orphan designation: Treprostinil sodium, for the: Treatment of chronic thromboembolic pulmonary hypertension

On 8 February 2013, orphan designation (EU/3/13/1103) was granted by the European Commission to SciPharm S.a.r.L, Luxembourg, for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension.

Europe - EMA - European Medicines Agency

22-2-2012

Decision on general conditional reimbursement for alendronate-containing medicines

Decision on general conditional reimbursement for alendronate-containing medicines

In cooperation with the Reimbursement Committee, we have decided to grant alendronate-containing medicines general conditional reimbursement from 5 March 2012. Reimbursement is conditional as it is reserved for patients with low-energy hip fractures. For any other patients who are treated with alendronate, the doctor must apply for single reimbursement, and the guiding criteria for single reimbursement remain unchanged for these patients. Alendronate is used for the treatment of osteoporosis (brittle bon...

Danish Medicines Agency

22-2-2012

Changed criteria for single reimbursement for osteoporosis medicines other than alendronate

Changed criteria for single reimbursement for osteoporosis medicines other than alendronate

As of 5 March 2012, it will only be possible to obtain a single reimbursement grant for the other medicines used in osteoporosis treatment for patients that cannot use alendronate. The criteria for single reimbursement are changed because of the large price gaps between the different medicines, where the reimbursement price of alendronate is by far the lowest.

Danish Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety